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Oncology: Clinical Studies Open For Enrollment

 

 

 

Lymphoma

 

 

Immunochemotherapy with Obinutuzumab, Ifosfamide, Carboplatin and Etoposide (O-ICE) in CAYA with recurrent refractory CD20+ Mature B-NHL

Eligibility

  • Subject is between three years and 31 years of age
  • In first or second relapse or primary induction failure CD20 positive B-cell leukemia/lymphoma 

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT02393157

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

Pilot Study Using Induction Chemo-immunotherapy followed by Consolidation with Reduced Toxicity Conditioning and Allogenic Stem Cell Transplant in Advanced Stage Mature Non-anaplastic T-Cell or NK Lymphoma/Leukemia in Children, Adolescents and Young Adults; A NK/T-Cell Lymphoma/Leukemia Consortium Study

Eligibility

  • Subject is between one year and 31 years of age
  • Patients must weigh at least 10 kilograms at the time of the study enrollment 
  • Newly diagnosed patients with histologically proven mature T- and NK- cell neoplasms

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03719105

Principal Investigator

Aliza Gardenswartz, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AALL1731, A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic

Eligibility

  • Subject is between one year and 30 years of age
  • Disease: B-ALL

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03914625

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

CIRB AALL1732 A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

Eligibility

  • Subject is between one year and 31 years of age
  • B-cell Lymphoblastic Leukemia
  • B-cell Lymphoblastic Lymphoma

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03914625

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

Safety and tolerability of myeloablative conditioning and autologous stem cell transplantation followed by Polatuzumab Vedotin (PV) immunoconjugate therapy in patients with B-cell non-Hodgkin and Hodgkin lymphoma

Enrollment Status: Enrolling

Principal Investigator

Aliza Gardenswartz, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Patients with Solid Tumors or Lymphomas and Treated with Myelosuppressive Chemotherapy

Eligibility

  • Subject is between one month and 17 years of age
  • Newly diagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrow involvement
  • Receiving myelosuppressive chemotherapy, with a febrile neutropenia rate of at least 20% as outlined in the National Comprehensive Cancer Network (NCCN) guidelines

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04570423

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

Reducing the Burden of Oncologic Chemoradiotherapy And Radiation Exposure from Diagnostic Imaging by Utilizing Targeted Immunotherapy in Children, Adolescents and Young Adults with Lymphoma (RADICAL)

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05253495

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Phase 2 Open-label Clinical Study to Evaluate the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (003)

Eligibility

  • Subject is at least 18 years of age
  • Relapsed or refractory DLBCL and is ineligible for or have failed autologous stem-cell transplant (ASCT) and have failed at least one line of prior therapy
  • Has relapsed or refractory DLBCL and is ineligible for or have failed ASCT and have failed at least two lines of prior therapy

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05139017

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Phase 2/3 Multicenter, Open-label, Randomized, Active-Control Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma. (004)

Eligibility

  • Subject is at least 18 years of age
  • Has relapsed or refractory (rr) DLBCL
  • Has progressed after at least two lines of prior therapy, and
  • Has progressed after auto-stem cell transplant (SCT) or are auto-SCT ineligible
  • Must have received prior multiagent regimen that includes an alkylating agent, anthracycline, and anti-CD20 (cluster of differentiation 20) monoclonal antibody

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05144841

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ANHL1931, A Randomized Phase 3 trial of Nivolumab (NSC# 748726 IND# 125462) in Combination with Chemo-immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-cell Lymphoma

Eligibility

  • Subject is at least two years of age
  • Primary mediastinal B-cell lymphoma (PMBCL)

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04759586

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Phase 3 Open Label, Randomized Study of Pirtobrutinib (LOXO-305) versus Ibrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314)

Eligibility

  • Male or female age 18 years or older per local regulations at time of enrollment
  • Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • For matched healthy controls, Adequate organ function - Platelets greater than or equal to (≥)50 x 10⁹/liter (L) or ≥30 x 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis, Hemoglobin ≥8 grams/deciliter (g/dL) or ≥6 g/dL in participants with documented bone marrow involvement considered to impair hematopoiesis, Absolute neutrophil count ≥0.75 x 10⁹/L or ≥0.50 × 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis and Kidney function: Estimated creatinine clearance ≥30 milliliters per minute (mL/min)
  • Exclusions:
    • Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollment
    • Known or suspected central nervous system (CNS) involvement
    • A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disease
    • Hepatitis B or hepatitis C testing indicating active/ongoing infection, based on Screening laboratory tests
    • Active uncontrolled systemic bacterial, viral, or fungal infection
    • Active cytomegalovirus (CMV) infection
    • Participants with known hypersensitivity, including anaphylaxis, to any component or excipient of Pirtobrutinib or ibrutinib

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05254743

Principal Investigator

Delong Liu, MD

Contact for Study Screening

Allyson.Pulsoni@wmchealth.org

 

ACCL1931: A Randomized Trial of Levocarnitine Prophylaxis to Prevent Asparaginase-Associated Hepatotoxicity in Adolescents and Young Adults Receiving Acute Lymphoblastic Leukemia Therapy

Eligibility

  • Male or female at least 15 years of age
  • Newly Diagnosed B-ALL, T-ALL, Lymphoblastic Lymphoma (LLy), or Mixed-Phenotype Acute Leukemia/Lymphoma (MPAL)

Enrollment Status: Enrolling

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

lauren_harrison@nymc.edu

 

A Phase I Clinical Trial to Study the Safety, Pharmacokinetics, and Efficacy of BP1002 (L-Bcl-2) Antisense Oligonucleotide in Patients with Advanced Lymphoid Malignancies

Eligibility

  • Male or female at least 18 years of age
  • Patient has a life expectancy ≥ 3 month
  • Patient has relapsed or refractory disease
  • ECOG Performance score of 0, 1, or 2
  • Adequate hepatic and renal functions
  • Recovered from the effects of any prior surgery, radiotherapy, or antineoplastic treatment (with the exception of alopecia), based on Investigator assessment.
  • Exclusion Criteria: for matched healthy controls; Active non-hematologic malignancy other than hematologic malignancies treated with immuno- or chemotherapy within the previous 12 months except active non-melanoma, non-invasive skin cancer will be allowed and Patient eligible for high dose chemotherapy and autologous stem cell transplant.

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04072458

Principal Investigator

Karen Seiter, MD

Contact for Study Screening

Allyson.Pulsoni@wmchealth.org

 

 

Leukemia

 

Pilot Study Using Induction Chemo-immunotherapy followed by Consolidation with Reduced Toxicity Conditioning and Allogenic Stem Cell Transplant in Advanced Stage Mature Non-anaplastic T-Cell or NK Lymphoma/Leukemia in Children, Adolescents and Young Adults; A NK/T-Cell Lymphoma/Leukemia Consortium Study

Eligibility

  • Subject is between one year and 31 years of age
  • Patients must weigh at least 10 kilograms at the time of the study enrollment 
  • Newly diagnosed patients with histologically proven mature T- and NK- cell neoplasms

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03719105

Principal Investigator

Aliza Gardenswartz, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AALL1731, A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic

Eligibility

  • Subject is between one year and 30 years of age
  • Disease: B-ALL

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03914625

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ADVL1822: A PHASE 1/2, MULTI-CENTER, DOSE-ESCALATING STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF QUIZARTINIB ADMINISTERED IN COMBINATION WITH RE-INDUCTION CHEMOTHERAPY, AND AS A SINGLE-AGENT CONTINUATION THERAPY, IN PEDIATRIC RELAPSED/REFRACTORY AML SUBJECTS AGED 1 MONTH TO < 18 YEARS (AND YOUNG ADULTS AGED UP TO 21 YEARS) WITH FLT3-ITD MUTATIONS

Eligibility

  • Subject is between one year and 21 years of age
  • AML with at least 5% blasts in bone marrow, with or without extramedullary disease
  • First relapse or refractory to first-line high-dose chemotherapy with no more than one attempt (one to two cycles of induction chemotherapy) at remission induction - prior HSCT is permitted

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03793478

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

CIRB AALL1732 A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

Eligibility

  • Subject is between one year and 31 years of age
  • B-cell Lymphoblastic Leukemia
  • B-cell Lymphoblastic Lymphoma

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03914625

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AAML1831 CIRB, A Phase 3 Randomized Trial for Patients with de novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 with GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients with FLT3 Mutations

Eligibility

  • Subject is no older than 22 years of age
  • Newly diagnosed with de novo AML with or without extramedullary disease
  • Patient must have one of the following:
    • At least 20% bone marrow blasts (obtained within 14 days prior to enrollment)
    • Less than 20% bone marrow blasts with one or more of the genetic abnormalities associated with childhood/young adult AML as provided in the protocol (sample obtained within 14 days prior to enrollment)
    • A complete blood count (CBC) documenting the presence of at least 1,000/uL

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04293562

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AALL1631, International Phase 3 trial in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) testing imatinib in combination with two different cytotoxic chemotherapy backbones

Eligibility

  • Subject is between two and 21 years of age
  • Newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed phenotypic acute leukemia with definitive evidence of BCR-ABL1 fusion by karyotype, fluorescence in situ hybridization (FISH) and/or reverse transcriptase (RT)-PCR

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03007147

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AAML18P1, Stopping Tyrosine Kinase Inhibitors (TKI) to Assess Treatment-Free Remission (TFR) in Pediatric Chronic Myeloid Leukemia - Chronic Phase (CML-CP)

Eligibility

  • Subject is no older than 25 years of age
  • CML-CP at original diagnosis
  • Molecular remission (MR) with a BCR-ABL1 level of no more than 0.01% BCR-ABL1

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03817398

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adult Participants With Recurrent or Refractory Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma

Eligibility

  • Subject is 30 years of age or younger
  • Recurrent or refractory Hodgkin or non-Hodgkin Lymphoma and have failed at least one line or prior therapy

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05255601

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ASCT2031, A Multi-Center, Phase 3, Randomized Trial of Matched Unrelated Donor (MUD) versus HLAHaploidentical Related (Haplo) Myeloablative Hematopoietic Cell Transplantation for Children, Adolescents, and Young Adults (AYA) with Acute Leukemia or Myelodysplastic Syndrome (MDS)

Eligibility

  • Subject is 6 months to 21 years of age
  • Diagnosed with ALL, AML or MDS and no sibling donor  
  • Has not received a prior allogeneic hematopoietic stem cell transplant

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05457556

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

 

Solid Tumors


A Phase 1 Study of Vorinostat in Combination with Vincristine, Irinotecan and Temozolomide in Children, Adolescents and Young Adults with Relapsed or Refractory Solid Tumors and CNS Malignancies

Eligibility

  • Subject is between 1 year and 30 years of age
  • Patients must have a confirmed histologic diagnosis of a relapsed or refractory solid tumor or CNS malignancy

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04308330

Principal Investigator

Jeremy Rosenblum, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AGCT1531: A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors

Eligibility

  • There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT)
  • Standard risk 1: Patient must be less than 11 years of age at enrollment
  • Standard risk 2: Patients must be at least 11 and less than 25 years of age at enrollment
  • Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with metastatic germ cell tumor (stage II or higher)
  • Low risk stage I immature teratoma (IT); site: ovarian; stage: Children's Oncology Group (COG) stage I; grade: 2 or 3; histology: pure immature teratoma, mixed immature and mature teratoma; tumor markers: alpha-FP less than or equal to 1,000 ng/mL, beta-HCG institutional normal; all ages
  • Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages
  • Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; histology: must contain at least one of the following: may contain immature/mature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages
  • Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age less than 11 years
  • Standard risk 2 (SR2)
    • Site: ovarian; stage: COG stage II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age at least 11 and less than 25 years
    • Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; tumor markers: must be IGCCC good risk; post op: alpha-FP less than 1,000 ng/mL, beta-HCG less than 5,000 IU/mL and lactate dehydrogenase (LDH) less than 3.0 x normal; age at least 11 and less than 25 years
    • Site: extragonadal; stage: COG stage II; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age at least 11 and less than 25 years

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03067181

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ANBL1531 (CIRB): A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or Crizotinib Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL) (IND# 134379)

Eligibility

  • Subject is between 1 year and 30 years of age
  • Diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites
  • The following disease groups are eligible:
  • Patients with International Neuroblastoma Risk Group (INRG) stage M disease are eligible if found to have either of the following features:
    • MYCN amplification (greater than four-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features; or
    • Age greater than 547 days regardless of biologic features
  • Patients with INRG stage MS disease with MYCN amplification
  • Patients with INRG stage L2 disease with MYCN amplification
  • Patients greater than 547 days of age initially diagnosed with INRG stage L1, L2 or MS disease who progressed to stage M without prior chemotherapy may enroll within four weeks of progression to stage M
  • Patients at least 365 days of age initially diagnosed with MYCN amplified INRG stage L1 disease who progress to stage M without systemic therapy may enroll within four weeks of progression to stage M

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03126916

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

CIRB AGCT1532 A Randomized Phase 3 Trial of Accelerated versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-risk Metastatic Germ Cell Tumors

Eligibility

  • Subject is between 11 - 45 years of age
  • Histologically or cytologically confirmed germ cell tumor (non-seminoma or seminoma), or
  • Exceptionally raised tumor markers (AFP at least 1000ng/mL and/or HCG at least 5000 IU/L) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with GCT, high tumor burden, and a need to start therapy urgently
  • Primary arising in testis, ovary, retro-peritoneum, or mediastinum
  • Metastatic disease or non-testicular primary
  • Intermediate or poor prognosis

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT02582697

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Patients with Solid Tumors or Lymphomas and Treated with Myelosuppressive Chemotherapy

Eligibility

  • Subject is between 1 month and 17 years of age
  • Newly diagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrow involvement
  • Receiving myelosuppressive chemotherapy, with a febrile neutropenia rate of at least 20% as outlined in the National Comprehensive Cancer Network (NCCN) guidelines

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04570423

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

CIRB AREN1921, Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

Eligibility

  • Subject is no older than 30 years of age
  • Newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor 

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04322318

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AHEP1531 Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

Eligibility

  • Subject is no older than 30 years of age
  • Newly diagnosed with histologically-proven primary pediatric hepatic malignancies including hepatoblastoma or hepatocellular carcinoma

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03533582

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A PHASE 2 STUDY OF DS-8201A (NSC# 807708, IND# 153036) IN ADOLESCENTS, OR YOUNG ADULTS WITH RECURRENT HER2+ OSTEOSARCOMA PEPN1924 

Eligibility

  • Subject is between 12 - 39 years of age
  • Osteosarcom having received at least standard initial therapy

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04616560

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

CIRB,AOST2031, A Phase 3 Randomized Controlled Trial Comparing Open vs Thuoracoscopic Management of Pulmonary Metastases in Patients with Osteosarcoma 

Eligibility

  • Subject is no older than 50 years of age
  • Osteosarcoma
  • Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of first recurrence following completion of therapy for initially localized disease
  • Patients with newly diagnosed disease must have completed successful gross tumor resection for their primary tumor or surgical local control of primary tumor must be planned to be performed simultaneously with thoracic surgery

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05235165

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ACNS2031:A Phase 3 Study of Sodium Thiosulfate for Reduction of Cisplatin-Induced Ototoxicity in Children with Average-Risk Medulloblastoma and Reduced Therapy in Children with Medulloblastoma with Low-Risk Features

Eligibility

  • Subject is between 3 years and 22 years of age
  • Must be newly diagnosed medulloblastoma

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05382338

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

PEPN2121: A Phase 1/2 Study of Tiragolumab (NSC# 827799, IND# 161266) and Atezolizumab (NSC# 783608, IND# 161266) in Patients with Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors

Eligibility

  • Patients must have SMARCB1 (INI1) or SMARCA4 deficient tumors 
    • Renal medullary carcinoma
    • Malignant rhabdoid tumor (extra-CNS)
    • Atypical teratoid rhabdoid tumor (CNS)
    • Poorly differentiated chordoma
    • Epithelioid sarcoma
    • Other SMARCB1 or SMARCA4 deficient tumors
  • Subject must be at least 12 months of age 
  • Part A, patients must be less than 18 years old
  • Part B, patients must be 18 years or older

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05286801

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AOST2032: A Feasibility and Randomized Phase 2/3 Study of the VEFGR2/MET Inhibitor Cabozantinib in Combination with Cytotoxic Chemotherapy for Newly Diagnosed Osteosarcoma

Eligibility

  • Patients must be less than 40 years of age at time of enrollment.
  • Patients must have a body surface area of greater than or equal to 0.8m2 at the time of enrollment.
  • Patients must have a histologic diagnosis (by institutional pathologist) of newly diagnosed high grade osteosarcoma. Primary tumors of all extremity and axial sites are eligible as long as diagnosis of high-grade osteosarcoma is established. Osteosarcoma as a second malignancy is eligible if no prior exposure to systemic chemotherapies.

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05691478

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

 

Brain Tumors

 

A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Patients with Solid Tumors or Lymphomas and Treated with Myelosuppressive Chemotherapy

Eligibility

  • 1 month - 17 years of age at time of study entry
  • Has a pathologic/histologic confirmed newly diagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrow involvement 
  • Is a candidate to receive myelosuppressive chemotherapy

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT04570423

Principal Investigator

Mitchell S. Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Phase 1 Study of Vorinostat in Combination with Vincristine, Irinotecan and Temozolomide in Children, Adolescents and Young Adults with Relapsed or Refractory Solid Tumors and CNS Malignancies

Eligibility

  • Subject is between 1 year and 30 years of age
  • Patients must have a confirmed histologic diagnosis of a relapsed or refractory solid tumor or CNS malignancy

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04308330

Principal Investigator

Jeremy Rosenblum, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ACNS1422 (CIRB) A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients

Eligibility

  • Subject is between 3 years and 21 years of age
  • Classical histologic type (non LC/A) WNT medulloblastoma that is Positive nuclear beta-catenin by immunohistochemistry (IHC), Positive for CTNNB1 mutation and Negative for MYC and MYCN by fluorescence in situ hybridization (FISH); negative CNS on lumbar puncture

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT02724579

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

HEAD START 4 PROTOCOL:  Newly Diagnosed Children (Less than 10 Years Old) With Medulloblastoma and Other Central Nervous System Embryonal Tumors. Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation with Randomization to either Single-Cycle or to Three Sequential Cycles of Marrow-Ablative Chemotherapy with Autologous Hematopoietic Progenitor Cell Rescue

Eligibility

  • Subject is no more than 10 years of age
  • Diagnosis of medulloblastoma or CNS embryonal tumors of the brain or spinal cord

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT02875314

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ACNS1831, CIRB A Phase 3 Randomized Study of Selumetinib (IND # 77782) versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG)

Eligibility

  • Subject is between 2 and 21 years of age
  • Neurofibromatosis type 1 (NF1)
  • Newly diagnosed or have previously diagnosed NF-1 associated LGG that has not been treated with any modality other than surgery
  • Optic pathway gliomas

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03871257

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ACNS1833: A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine versus Selumetinib (NSC# 748727, IND# 77782) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) not associated with BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)

Eligibility

  • Subject is between 2 and 21 years of age
  • Non-neurofibromatosis type 1 (non-NF1) low-grade glioma (LGG) without a BRAFV600E mutation
  • All tumors considered low-grade glioma or low-grade astrocytoma

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04166409

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ACNS1931, A Phase 3 Study of Selumetinib (NSC# 748727, IND# 77782) or Selumetinib in Combination with Vinblastine for non-NF1, non-TSC Patients with Recurrent or Progressive Low-Grade Gliomas

Eligibility

  • Subject is between 2 and 25 years of age
  • Non-neurofibromatosis type 1 (non-NF1), non-tuberous sclerosis complex (non-TSC) low-grade glioma (LGG) without a BRAFV600E or IDH1 mutation
  • Progressive or recurrent LGG
  • Metastatic disease or multiple independent primary LGGsl
  • All tumors considered low-grade glioma or low-grade astrocytoma

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04576117

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ACNS2021, A Phase 2 Trial of Chemotherapy followed by Response-Based Whole Ventricular & Spinal Canal Irradiation (WVSCI) for Patients with Localized Non-Germinomatous Central Nervous System Germ Cell Tumor

Eligibility

  • Subject is between 3 and 30 years of age
  • Newly diagnosed with localized primary CNS NGGCT of the suprasellar and/or pineal region by pathology and/or serum or cerebrospinal fluid (CSF) elevation of AFP above institutional normal or greater than 10 ng/mL or human chorionic gonadotropin (hCG) beta greater than 100 mIU/mL
  • Suprasellar, pineal and bifocal tumors are included
  • Patients with any of the following pathological elements are eligible: endodermal sinus (yolk sac), embryonal carcinoma, choriocarcinoma, malignant/immature teratoma and mixed germ cell tumor (GCT) (i.e., may include some pure germinoma) if malignant elements listed above are present

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04684368

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms

Eligibility

  • Patients who undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles
  • Willing and able to provide informed consent and to participate in all evaluations

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04427384

Principal Investigator

Simon Hanft, MD

Contact for Study Screening

Cristina.Falo@wmchealth.org

 

 

 

Urology

 

Prospective, multi-center single arm study of vanquish water vapor ablation for prostate cancer

Eligibility

  • Male at least 50 years of age
  • 20-80 cc prostate size determined by MRI Central Imaging
  • ≤15 ng/ml PSA
  • Cancer stage less than or equal to T2c
  • Within 12 months prior to signing consent have had a multiparametric MRI. Within 6 months prior to signing consent, have undergone a multiparametric MRI software guided fusion biopsy of the prostate (transrectal or transperineal). This must include a standard sector biopsy obtaining 10-16 cores.
  • ≤15mm diameter of qualifying lesion as measure by greatest diameter
  • Subject is willing and able to adhere to specific protocol visits and required testing throughout study
  • A single MRI region of suspicion (PI-RADS assessment of 3 or 4) with a minimum of 2 targeted cores obtained and at least one confirming GGG2 disease on biopsy (lesion may cross the mid-line). 
  • <34% of the systemic biopsy cores are positive for GGG1 and GGG2, non-systemic (mpMRI targeted) biopsy cores are excluded from this calculation. 
  • Documentation containing the tracking of all systematic and targeted cores using the targeted biopsy system’s 3D registration software. All cores must be submitted and processed to allow correlation of core location to the system’s 3D registration software.
  • Exclusion: All MRI Central Imaging confirmed by PI-RADS 4 lesions negative on biopsy, Any prior surgery, intervention, or minimally invasive therapy, (MIST) for the prostate cancer or bladder neck, Previous treatment for genital cancer, Active urinary tract infection, Active or clinically chronic prostatitis or granulomatous prostatitis, Any rectal pathology, anomaly or previous treatment that could change properties of rectal wall or insertion and use of TRUS, Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study Investigator regarding the study or affects the ability to complete the study quality of life questionnaires, No positive >GG2 cores known to be outside of the targeted treatment area (lesion plus 1 cm margin). GGG1 acceptable, Evidence of extracapsular extension of cancer (MRI read as “definite”, “frank” or “gross” ECE) as determined by MRI central Imaging, Contraindications to MRI and Subjects with an installed pacemaker or other potentially electrically conductive implants (e.g. ICD, drug infusion pump, neurostimulator and bladder stimulators) implanted within 200mm (8 inches) of the Vanquish procedure Field Generator. Implants that are within 200 mm (8 inches) and can be turned off for the duration of the study procedure are acceptable.

Enrollment Status: Enrolling

Principal Investigator

Mitchell C. Fraiman, MD

Contact for Study Screening

Danielle.Hansen@wmchealth.org

 

 

Radiation Medicine


Testing the addition of radiation therapy to the usual immune therapy treatment (atezolizumab) for patients with extensive stage small cell lung cancer (NRG-LU007: Randomized Phase II/III Trial Of Consolidation Radiation + Immunotherapy for ES-SCLC: RAPTOR trial)

Eligibility

  • Subject is at least 18 years of age
  • Diagnosis of extensive stage small cell lung cancer
  • Partial response or stable response after 4-6 cycles of etoposide/platinum (E/P) doublet plus atezolizumab  
  • Must have measurable disease and 3 or fewer observable liver metastases and no evidence of progressive disease (per RECIST)

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04402788

Principal Investigator

Aviva Berkowitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

Testing the addition of high dose, targeted radiation to the usual treatment for locally advanced inoperable non-small cell lung cancer (NRG-LU008, Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for Locally Advanced Non-Small Cell Lung Cancer)

Eligibility

  • Subject is at least 18 years of age
  • Diagnosis of stage II or III non-small cell lung cancer (NSCLC) with known PD-L1 status 
  • Must have an identified primary tumor and at least one nodal metastasis 
  • Up to 4 cycles of systemic therapy received prior to registration is allowable; any prior chemotherapy for a different cancer is also permissible
  • No evidence of distance metastases based on FDG PET/CT scan

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05624996

Principal Investigator

Aviva Berkowitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

Two Studies for Patients With High-Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial  (NRG-GU-009: Parallel Phase III Randomized Trials for High-Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk with Radiation)

Eligibility

  • Subject is at least 18 years of age 
  • Diagnosis of High-risk adenocarcinoma of prostate cancer (PSA>20ng/mL or cT3a-T4 or Gleason Score 8-10 or Node positive)
  • Is not metastatic disease outside of the pelvic nodes (M1a, M1b, or M1c) on imaging
  • No Prior systemic chemotherapy within 3 years and No prior radiotherapy to the region of the study cancer

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04513717

Principal Investigator

Mark Hurwitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score (NRG-GU010: Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification And Intensification Clinical Trial Evaluation (GUIDANCE)

Eligibility

  • Subject is at least 18 years of age 
  • Diagnosis of intermediate-risk adenocarcinoma of prostate cancer (PSA 10-20 ng/mL or stage T2b-c or Gleason Score 7) 
  • No previous radical surgery (prostatectomy) or any form of curative-intent ablation for prostatic cancer 
  • No prior hormonal therapy and No prior radiotherapy to the prostate/pelvis region

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05050084

Principal Investigator

Mark Hurwitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

Comparing Observation Versus Radiation for Newly Diagnosed Grade II Meningiomas That Have Been Completely Removed Through Surgery (NRG-BN003. Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma)

Eligibility

  • Subject is at least 18 years of age 
  • Diagnosis of unifocal intracranial meningioma, gross totally resected, and histologically confirmed as WHO grade II 
  • Is not optic nerve sheath meningioma, spinal or other extracranial meningioma, multiple meningiomas, hemangiopericytoma, or metastatic meningioma 
  • No prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of three years

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT03180268

Principal Investigator

Keith Meritz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

The Phase III 'High Five Trial' Five Fraction Radiation for High-risk Prostate Cancer

Eligibility

  • Male at least 18 years of age
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the primary outcome are eligible for this trial
  • Men who are sexually active should be willing and able to use medically acceptable forms of contraception during treatment and for 90 days after end of Radiation Therapy
  • Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer
  • No prior radical prostatectomy

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT05946213

Principal Investigator

Mark Hurwitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

A Pragmatic Randomized Phase III Trial Evaluating Total Ablative Therapy For Patients With Limited Metastatic Colorectal Cancer: Evaluating Radiation, Ablation, and Surgery [ERASur]

Eligibility

  • Male or female ≥ 18 years
  • Histologically-confirmed metastatic colorectal adenocarcinoma
  • No known microsatellite instable (MSI) tumor
  • No known BRAF V600E mutation
  • Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. No known peritoneal and/or omental metastases. If radiologic studies suggest the presence of peritoneal disease, a diagnostic laparoscopy is recommended to verify the absence of peritoneal implants
  • Primary tumor is already resected OR primary tumor is surgically amenable to resection, as determined by consultation and documentation with surgeon or documentation of discussion in the institutional multi-disciplinary tumor board where a surgeon confirms resectability. Patients with unresectable primary tumors are not eligible
  • Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
  • Patients must have no overt evidence of disease progression during systemic therapy prior to registration
  • Patients must be receiving (or have received) first-line systemic therapy for metastatic disease for a minimum of 16 weeks and a maximum of 26weeks
  • For women of childbearing potential only, a negative pregnancy test done ≤ 14 days prior to registration is required

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT05946213

Principal Investigator

Mark Hurwitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

A Phase 3, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Chemoradiotherapy (CRT) versus CRT Alone in Participants with Muscle-invasive Bladder Cancer (MIBC) (KEYNOTE-992)

Eligibility

  • Male or female ≥18 years of age
  • Has a histologically confirmed initial diagnosis of muscle-invasive bladder cancer (MIBC) with predominant urothelial histology
  • Has clinically nonmetastatic bladder cancer (N0M0) determined by imaging (CT of the chest and CTU/MRU of abdomen and pelvis), assessed by the site and verified by BICR
  • Has provided tumor specimen to the central vendor to determine PD-L1 status before randomization
  • Has planned and is eligible to receive CRT and one of the protocol-specified radiosensitizing chemotherapy regimens
  • Has an ECOG performance status of 0, 1, or 2 assessed within 14 days before randomization
  • Exclusion Criteria:
    • MI secondary to ischemia due to either increased oxygen demand or decreased supply (Type 2 MI) or periprocedural MI as the index ACS event
    • Has the presence of diffuse CIS (multiple foci [4 or greater] of CIS) throughout the bladder
    • Has the presence of UC at any site outside of the urinary bladder in the previous 2 years except for Ta/T1/CIS of the upper tract if the patient has undergone a complete nephroureterectomy
    • Has the presence of any small cell or neuroendocrine component in the tumor tissue sample
    • Has a known additional malignancy that is progressing or has required active therapy within the past 3 years
    • Has the presence of bilateral hydronephrosis during the Screening period
    • Has limited bladder function with frequency of small amounts of urine (<30 mL), urinary incontinence, or requires self-catheterization or a permanent indwelling catheter

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT04241185

Principal Investigator

Mark Hurwitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

A Phase III Clinical Trial Evaluating DE-escalation of Breast RAdiation (DEBRA) for Conservative Treatment of Stage I, Hormone Sensitive, HER2-Negative, Oncotype Recurrence Score ≤ 18 Breast Cancer

Eligibility

  • Male or female ≥ 50 years and < 70 years of age
  • The patient must have an ECOG performance status of 0 or 1
  • The patient must have undergone a lumpectomy and the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS with no ink on tumor as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins
    (Patients with margins positive for LCIS are eligible without additional resection.)
  • The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination
  • Patient must have undergone axillary staging (sentinel node biopsy and/or axillary node dissection)
  • The following staging criteria must be met postoperatively according to AJCC 8th edition criteria:
    • By pathologic evaluation, primary tumor must be pT1 (≤ 2 cm)
    • By pathologic evaluation, ipsilateral nodes must be pN0. (Patients with pathologic staging of pN0(i+) or pN0(mol+) are NOT eligible.)
  • The tumor must have been determined to be ER and/or PgR positive assessed by current ASCO/CAP Guideline Recommendations for hormone receptor testing. Patients with  1% ER or PgR staining by IHC are considered positive
  • Exclusion Criteria:
    • Definitive clinical or radiologic evidence of metastatic disease
    • pT1mi and pT2–pT4 tumors including inflammatory breast cancer
    • Pathologic staging of pN0(i+) or pN0(mol+), pN1, pN2, or pN3 disease
    • Patient had a mastectomy
    • Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor
    • Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign
    • Non-epithelial breast malignancies such as sarcoma or lymphoma
    • Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters. (Patients with multifocal carcinoma are eligible.)
    • Paget’s disease of the nipple

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT04852887

Principal Investigator

Aviva Berkowitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

A Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer (HERO)

Eligibility

  • Male or female ≥ 40 years of age
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the U.S., authorization permitting release of personal health information
  • Female and Male patients who have undergone breast conserving surgery and completed a minimum of 4 cycles (12 weeks) of neoadjuvant or adjuvant chemotherapy in combination with HER2-targeted therapy
  • ECOG performance status of 0 ,1, or 2/Karnofsky performance status above 60
  • Histologically or cytologically confirmed invasive breast carcinoma
  • Tumor must have been determined to be HER2-positive by current ASCO/CAP guidelines based on local testing results
  • Patient must have undergone axillary staging, either sentinel node biopsy (SNB) or axillary lymph nodal dissection (ALND). In neoadjuvant patients, SNB following neoadjuvant therapy is strongly recommended. SNB prior to neoadjuvant therapy is discouraged, but patients are permitted if node negative (pN0)
  • Exclusion Criteria:
    • Definitive clinical or radiologic evidence of metastatic disease
    • On the Adjuvant cohort, patients with a primary tumor >2 cm on pathologic examination of the surgical specimen. On the Neoadjuvant cohort, patients with a primary tumor > 3 cm or with abnormal or suspicious ipsilateral axillary nodes by pretreatment imaging, unless demonstrated to be negative by cytologic or histologic examination
    • Pathologically positive axillary nodes at any time including of pN0(i+) or pN0(mol+) ypN0(i+) or ypN0(mol+) disease
    • Patient planning for or status-post mastectomy
    • Radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary lymph nodes, unless there is histological confirmation that these nodes are negative for metastatic disease
    • Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast), or mass or non-mass enhancement on MRI (if performed) aside from the known cancer, unless biopsied and found to be benign
    • Non-epithelial breast malignancies such as sarcoma or lymphoma
    • Paget's disease of the nipple
    • Treatment plan that includes regional nodal irradiation

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT05705401

Principal Investigator

Aviva Berkowitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org


A Phase II Double-Blinded, Placebo-Controlled Trial of Prostate Oligometastatic Radiotherapy with or without Androgen Deprivation Therapy in Oligometastatic Prostate Cancer (NRG PROMETHEAN)

Eligibility

  • Male ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2 within 120 days prior to registration
  • Prior curative-intent treatment to the prostate, by either:
    • External beam and/or brachytherapy to: Prostate alone, prostate and seminal vesicles,
      prostate and pelvic nodes, or radiation to all three sites
    • Radical prostatectomy alone, radical prostatectomy plus postoperative radiotherapy to
      the prostate bed, or radical prostatectomy plus postoperative radiotherapy to the
      pelvic nodes
  • Must meet study entry criteria based on the following diagnostic workup within 180 days
    prior to registration:
    • History and physical examination;
    • Fluciclovine or PSMA PET scan (Must be positive with exception of local disease);
      PET must be combined with either CT or MRI, but a diagnostic CT or MRI
      reading/interpretation is not required
  • 1 - 5 oligometastatic lesions in bone and/or nodal/soft tissue sites on fluciclovine or
    PSMA PET within 180 days prior to registration and includes at least ONE of the
    following:
    • Bone – each metastasis is counted (for example, 2 distinct lesions in the right ilium
      count as 2 oligometastatic lesions),
    • Extrapelvic Nodal/ soft tissue – requires at least one extrapelvic inguinal or a
      nodal/soft tissue lesion superior to the iliac bifurcation (that is, AJCC M1a version 8).
  • Must have > 3 PSA values within the last two years since end of primary treatment or within the last 2 years prior to registration, whichever is less
  • Serum total testosterone >100 ng/dL within 180 days prior to registration
  • Exclusion Criteria:
    • Clinical, biopsy-proven, or radiologic (conventional or PET imaging) evidence of local tumor recurrence in the prostate and/or periprostatic/seminal vesicle region after radiotherapy, or in the prostate bed after prostatectomy
    • Currently on androgen deprivation or anti-androgen therapy
    • Definitive radiologic evidence of metastatic disease on conventional imaging, defined by one of the following:
      • Osseous metastasis on 99mTc radionuclide bone scan, or
      • Extra pelvic nodal/soft tissue disease (> 1.5 cm in short axis) on CT or MRI pelvis +/- abdomen
    • Spinal cord compression, or spinal intramedullary, brain, and/or visceral (for example liver, lung, etc.) metastasis
    • Biopsy-proven prostatic carcinoma with signet-ring, sarcomatoid, or neuroendocrine features (for example, small cell)

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT05053152

Principal Investigator

Mark Hurwitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients with Post-ProstaTEctomy Biochemical Recurrence (INDICATE)

Eligibility

  • Male ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2 within 120 days prior to registration
  • Prior curative-intent treatment to the prostate, by either:
    • External beam and/or brachytherapy to: Prostate alone, prostate and seminal vesicles,
      prostate and pelvic nodes, or radiation to all three sites
    • Radical prostatectomy alone, radical prostatectomy plus postoperative radiotherapy to
      the prostate bed, or radical prostatectomy plus postoperative radiotherapy to the
      pelvic nodes
  • Must meet study entry criteria based on the following diagnostic workup within 180 days
    prior to registration:
    • History and physical examination;
    • Fluciclovine or PSMA PET scan (Must be positive with exception of local disease);
      PET must be combined with either CT or MRI, but a diagnostic CT or MRI
      reading/interpretation is not required
  • 1 - 5 oligometastatic lesions in bone and/or nodal/soft tissue sites on fluciclovine or
    PSMA PET within 180 days prior to registration and includes at least ONE of the
    following:
    • Bone – each metastasis is counted (for example, 2 distinct lesions in the right ilium
      count as 2 oligometastatic lesions),
    • Extrapelvic Nodal/ soft tissue – requires at least one extrapelvic inguinal or a
      nodal/soft tissue lesion superior to the iliac bifurcation (that is, AJCC M1a version 8).
  • Must have > 3 PSA values within the last two years since end of primary treatment or within the last 2 years prior to registration, whichever is less
  • Serum total testosterone >100 ng/dL within 180 days prior to registration
  • Exclusion Criteria:
    • Clinical, biopsy-proven, or radiologic (conventional or PET imaging) evidence of local tumor recurrence in the prostate and/or periprostatic/seminal vesicle region after radiotherapy, or in the prostate bed after prostatectomy
    • Currently on androgen deprivation or anti-androgen therapy
    • Definitive radiologic evidence of metastatic disease on conventional imaging, defined by one of the following:
      • Osseous metastasis on 99mTc radionuclide bone scan, or
    • Extra pelvic nodal/soft tissue disease (> 1.5 cm in short axis) on CT or MRI pelvis +/- abdomen
    • Spinal cord compression, or spinal intramedullary, brain, and/or visceral (for example liver, lung, etc.) metastasis
    • Biopsy-proven prostatic carcinoma with signet-ring, sarcomatoid, or neuroendocrine features (for example, small cell)

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT05053152

Principal Investigator

Mark Hurwitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

 

Transplants

 

A Phase II Intrapatient Open-Label Dose Escalation Trial of Defibrotide in Hematopoietic Cell Transplantation (HCT) Recipients with Sinusoidal Obstructive Syndrome (SOS) Post-HCT Associated with either Renal and/or Pulmonary Dysfunction with Either Refractory or Progressive Disease Following Defibrotide Therapy

Eligibility

  • Male or female, Age 1 month - 75 years
  • HCT recipients (Auto or Allograft)
  • SOS/VOD as defined by Cairo/Cooke Diagnostic criteria (1) (Table 3) with either renal and/or pulmonary dysfunction as defined by Cairo/Cooke Grading criteria (1) (Appendix I)
  • Unresponsive to standard defibrotide therapy as defined by at least one of the following:
    • Patients with SOS/VOD failing to obtain a complete response (CR) defined by Grade I or less by Cairo/Cooke Grading criteria (1) (Appendix I). This would therefore include patients with stable disease after at least 14 days of defibrotide or partial response after at least 21 days of defibrotide (25mg/kg/day).
    • Progressive disease defined by progression of at least one grade or more from diagnostic grade as defined by Cairo/Cooke Grading criteria (1) (Appendix I) following at least 7 days of defibrotide (25mg/kg/day).
  • Exclusion Criteria
    • Patients who did not receive HCT
    • Concomitant systemic anticoagulation (excluding central venous line management, fibrinolytic instillation for central venous line occlusion, management of intermittent dialysis or ultrafiltration of CVVH)
    • Active bleeding and/or hemorrhage of at least grade 2 and above
    • History of development of Grade III/IV anaphylaxis probably or directly secondary to defibrotide
    • Female patients who are pregnant or breast feeding

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT05987124

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

 

Pediatrics

 

A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma

Eligibility

  • Male or female ≤ 30 years at the time of initial diagnosis with high-risk disease
  • Patients must be enrolled on APEC14B1 and have consented to testing through the Molecular Characterization Initiative (MCI), prior to enrollment on ANBL2131
  • Must have a diagnosis of neuroblastoma (NBL) or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamines
  • Newly diagnosed, high risk neuroblastoma (HRNBL) defined as one of the following:
    • Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M and MYCN amplification
    • Age ≥ 547 days and INRG stage M regardless of biologic features (clinical MYCN testing not required prior to enrollment)
    • Any age initially diagnosed with INRG Stage L1 MYCN amplified NBL who have progressed to stage M without systemic chemotherapy
    • Age ≥ 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to stage M without systemic chemotherapy (clinical MYCN testing not required prior to enrollment)
  • Exclusion Criteria
    • Patients who are 365-546 days of age with INRG Stage M and MYCN non-amplified NBL, irrespective of additional biologic features
    • Patients ≥ 547 days of age with INRG Stage L2, MYCN non-amplified NBL, regardless of additional biologic features
    • Patients with known bone marrow failure syndromes
    • Patients on chronic immunosuppressive medications (eg, tacrolimus, cyclosporine, corticosteroids) for reasons other than prevention/treatment of allergic reactions and adrenal replacement therapy are not eligible. Topical and inhaled corticosteroids are acceptable
    • Patients with a primary immunodeficiency syndrome who require ongoing immune globulin replacement therapy
    • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required prior to enrollment for female patients of childbearing potential
    • Lactating females who plan to breastfeed their infants
    • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
    • All institutional, food and drug administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT06172296

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Phase 2, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander Participants with Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy

Eligibility

  • Male and female participants at least 12 years of age who have had allogeneic HCT.
  • Participant is Black or African American, or American Indian or Alaska Native, or Native Hawaiian or Other Pacific Islander by self-identification.
  • Previously received at least 2 and not more than 5 lines of systemic therapy for cGVHD.
  • Receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to screening.
  • Have persistent cGVHD manifestations and systemic therapy is indicated.
  • Karnofsky (if aged ≥16 years) / Lansky (if aged <16 years) Performance Score of ≥60.
  • At least 12 years of age; weight ≥ 40 kilograms (kg).
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN).
  • Total bilirubin ≤ 1.5 x ULN.
  • Exclusion Criteria
    • Participant has not been on a stable dose/regimen of systemic cGVHD treatment(s) for at least 2 weeks prior to screening. (Note: Concomitant corticosteroids, calcineurin inhibitors, sirolimus, MMF, methotrexate, rituximab, and ECP are acceptable. Systemic investigational GVHD treatments are not permitted).
    • Histological relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
    • Current treatment with ibrutinib or ruxolitinib. Prior treatment with ibrutinib or ruxolitinib is allowed with a washout of at least 28 days prior to enrollment.
    • History or other evidence of severe illness or any other conditions that would make the participant, in the opinion of the Investigator, unsuitable for the study (such as malabsorption syndromes, poorly controlled psychiatric disease, or coronary artery disease).
    • Corrected QT interval using Fridericia's formula (QTc[F]) > 480 ms.
    • Forced expiratory volume (in the first second; FEV1) ≤ 39% The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT05567406

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Phase 3, Multicenter, Randomized, Open-Label Study of Epcoritamab plus Lenalidomide compared to Rituximab plus Gemcitabine and Oxaliplatin in Participants with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Eligibility

  • Male and female, Subjects must be at least 18 years old
  • Subject is willing and able to comply with procedures required in this protocol
  • Subject must have acceptable organ (renal, liver, and hematologic) function within the screening period prior to the first dose of study drug
  • Subjects must not be incarcerated and must be freely willing and able to provide informed consent (e.g., adults under legal protection measure [e.g., under guardianship/curatorship] or unable to express their consent and select adults under psychiatric care). Investigator's discretion should be applied
  • Subject must have available adequate fresh or paraffin-embedded tissue at Screening
  • Subject must have histologically confirmed CD20+ DLBCL and documented in the most recent representative pathology report, inclusive of the following according to the 5th edition of the WHO (2022) Classification of Haematolymphoid Tumours: Lymphoid Neoplasms
  • Subject must have R/R disease and have been previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since DLBCL diagnosis
  • Subject must have an ECOG performance status score of 0 to 2
  • Life expectancy > 3 months on SOC treatment at the time of enrolling in the study
  • Exclusion Criteria
    • Prior treatment with a bispecific antibody targeting CD3 and CD20 or prior treatment with R-GemOx or GemOx
    • Lenalidomide exposure within 12 months prior to screening or history of documented refractoriness to lenalidomide with refractoriness
    • Best response to prior CAR-T therapy of SD or PD. Subject should not have received any treatment with CAR-T therapy within 90 days prior to randomization; any CAR-T related toxicity should have been resolved for at least 30 days
    • Current evidence of primary CNS lymphoma or known CNS involvement by lymphoma including leptomeningeal disease, at screening
    • Current autoimmune disease requiring immunosuppressive therapy except for up to 20 mg daily prednisone or equivalent
    • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.

Enrollment Status: Actively enrolling

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01)

Eligibility

  • Male or female < 18 years of age
  • For hematological malignancies: Confirmed diagnosis of B-precursor B-ALL or DLBCL/Burkitt lymphoma according to World Health Organization (WHO) classification of neoplasms of the lymphoid tissues
  • For solid tumor malignancies: Histologically confirmed diagnosis of neuroblastoma or Ewing sarcoma
  • Exclusion Criteria
    • History of solid organ transplant
    • Clinically significant (ie, active) cardiovascular disease
    • Known history of liver cirrhosis
    • Ongoing Grade >1 peripheral neuropathy
    • Demyelinating form of Charcot-Marie-Tooth disease
    • Diagnosed with Down syndrome
    • Ongoing graft-versus-host disease (GVHD) of any grade or receiving systemic GVHD treatment or prophylaxis
    • History of human immunodeficiency virus (HIV) infection
    • Contraindication or hypersensitivity to any of the study intervention components
    • Received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities
    • Ongoing, chronic corticosteroid therapy (exceeding 10 mg daily of prednisone equivalent). Prednisone equivalent dosing must have been stable for at least 4 weeks before Cycle 1 Day 1 (C1D1)
    • Received a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 7 days or a strong CYP3A4 inducer within 14 days before the start of study intervention or expected requirement for chronic use of a strong CYP3A4 inhibitor or inducer during the study intervention period and for 30 days after the last dose of study intervention

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT06395103

Principal Investigator

Andrew Bellantoni, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01B/LIGHTBEAM-U01)

Eligibility

  • Male or female < 18 years of age
  • Must have 1 of the following histologically or cytologically confirmed diagnosis of Relapsed or refractory classical Hodgkin lymphoma (cHL), advanced melanoma, solid tumors that are microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR), or solid tumors that are tumor mutational burden-high (TMB-H)
  • Must have recovered from all AEs from previous anticancer therapies
  • Human immunodeficiency virus (HIV)-infected participants have well controlled HIV on antiretroviral therapy (ART)
  • Exclusion Criteria
    • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
    • Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
    • Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
    • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
    • Received prior anticancer therapy with an anti-PD-1, anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) in combination with either an Anti- lymphocyte-activation gene 3 (LAG-3) agent or an Anti- T-cell immunoreceptor with immunoglobulin (Ig) and ITIM domains (TIGIT) agent
    • Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
    • Known additional malignancy that is progressing or has required active treatment within the past 1 year
    • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
    • Active autoimmune disease that has required systemic treatment in the past 2 years
    • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT06395090

Principal Investigator

Andrew Bellantoni, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

An Open-Label, Single-Arm Study of Autologous Anti-HER2 Chimeric Antigen Receptor Monocytes (CT-0525), in Participants With HER2 Over Expressing Solid Tumors

Eligibility

  • Participant must be ≥ 18 years of age
  • Tumor tissue that is HER2-positive, following most recent therapy, by IHC using standard local assay resulting in 3+, or 2+ with confirmation by ISH testing. IHC and ISH assays and interpretation must follow the most recent ASCO/CAP guidelines and be performed in an accredited laboratory. Other tumor types (non-breast, non-gastroesophageal) will be tested according to the breast cancer ASCO/CAP guidelines
  • Histologically confirmed recurrent or metastatic solid HER2-positive tumor for which there are no available curative treatment options, AND after failure of the following systemic therapies used for the treatment of recurrent (unresectable) and/or metastatic disease:
    • Any participant with HER2-positive breast or gastroesophageal cancers who has previously been treated with at least 2 lines of FDA approved anti-HER2 therapies in the advanced/metastatic setting;
    • Other HER2-positive tumor types must have progressed following treatment with at least 2 prior standard of care lines of therapy;
    • Subjects eligible for checkpoint inhibitor therapies (e.g., PD-1/L1 inhibitors) and/or with tumors that have known actionable molecular alterations (e.g., EGFR, ALK, ROS-1, BRAF, RET, MET, KRAS); must have progressed on, or have been determined to be ineligible to receive, these therapies
  • Participant must be willing and able to undergo on-study tumor tissue biopsy procedures to provide samples for biomarker analysis pre- and post-CT-0525 infusion:
    • A participant whose tumor is not amenable to perform a safe post-baseline biopsy for the post-baseline translational studies may be allowed on the trial by mutual agreement of the Principal Investigator and Sponsor;
    • Archived tumor tissue biopsy taken after progression on the most recent therapy is acceptable to be used in lieu of a pre-treatment biopsy for translational studies
  • At least one measurable lesion (that will not be biopsied for eligibility and/or translational protocol requirements) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the Investigator/site
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0-1 at screening
  • Exclusion Criteria
    • Medical Conditions:
      • Pregnant or nursing women. The safety of this therapy on unborn children is not known. Female study subjects of reproductive potential must have a negative urine pregnancy test at enrollment. The urine pregnancy test will need to be repeated prior to treatment if greater than 4 weeks has lapsed between the enrollment pregnancy test and treatment
      • Known and previously documented human immunodeficiency virus (HIV) infection. Screening HIV test is not required in the absence of history or clinical suspicion
      • Active hepatitis B or hepatitis C infection
      • Diagnosis of immunodeficiency or exposure to systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
        • Nasal, topical or oral inhaled steroids are permissible
        • Physiologic replacement doses of steroids (mineralocorticoid or less than or equal to a prednisone 10 mg daily dose) are permissible
      • Any uncontrolled active medical disorder that would preclude participation as outlined
      • Untreated or symptomatic central nervous system (CNS) metastases or cytology proven carcinomatous meningitis
    • Prior/Concomitant Therapy: 
      • Known history of allergy or hypersensitivity to human granulocyte colony-stimulating factors such as filgrastim or pegfilgrastim, or study product excipients including human serum albumin, Cryostor (DMSO or Dextran 40), or Plasma-Lyte
      • Concurrent receipt of another anti-cancer therapy, except hormonal therapy. 
        Note: To be considered for inclusion in this study the following washout periods prior to apheresis must be completed as follows:
        • Cytotoxic chemotherapy – 2 weeks;
        • Tyrosine kinase/small molecule inhibitor – 2 weeks;
        • Biologic therapy/monoclonal antibody – 4 weeks;
        • Radiation therapy – 2 weeks;
        • Prior investigational agent(s) – at least 5 half-lives of the agent in question, or 28 days, whichever is shorter prior to enrollment into the trial;
      • With the exception of alopecia and the above Inclusion Criteria, participants must have recovered from prior treatment related toxicities.

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT06254807

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

 

Myeloma

 

A Phase 3, Open-Label Study of Elranatamab Monotherapy Versus Elotuzumab, Pomalidomide, Dexamethasone (EPd) or Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilizomib, Dexamethasone (Kd) in Participants with Relapsed/Refractory Multiple Myeloma Who Received Prior Anti-CD38 Directed Therapy

Eligibility

  • Male or female, 18 years or older
  • Prior diagnosis of multiple myeloma as defined by International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide
  • Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria
  • Measurable disease defined as at least 1 of the following: (a) Serum M-protein ≥0.5 g/dL; (b) Urinary M-protein excretion ≥200 mg/24 hours; (c) Serum involved immunoglobulin FLC ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65)
  • Have clinical laboratory values within the specified range
  • ECOG (Eastern Cooperative Oncology Group) performance status ≤2
  • Not pregnant or breastfeeding and willing to use contraception
  • Exclusion Criteria
    • Smoldering multiple myeloma
    • Plasma cell leukemia
    • Amyloidosis
    • Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin abnormalities (POEMS) syndrome
    • Known central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement
    • Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease
    • Any active, uncontrolled bacterial, fungal, or viral infection
    • Any other active malignancy within 3 years prior to enrolment (exceptions include, adequately treated basal cell or squamous cell skin cancer, carcinoma in situ)
    • Previous treatment with a B cell maturation antigen (BCMA)-directed therapy or CD3-redirecting therapy
    • Unable to receive investigator's choice therapy
    • Live attenuated vaccine within 4 weeks of the first dose of study intervention
    • Administration with an investigational product (e.g. drug or vaccine) within 30 days preceding the first dose of study intervention used in this study

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT06152575

Principal Investigator

Amir Steinberg, MD

Contact for Study Screening

Allyson.Pulsoni@wmchealth.org

 

A Randomized, 2-Arm, Phase 3 Study of Elranatamab (PF-06863135) Versus Lenalidomide in Patients with Newly Diagnosed Multiple Myeloma After Undergoing Autologous Stem-Cell Transplantation

Eligibility

  • Male or female, 18 years or older
  • Diagnosis of MM as defined according to IMWG criteria1 with measurable disease at diagnosis as defined by serum M-protein ≥0.5 g/dL (5 g/L), by urine M-protein ≥200 mg/24 hours, or by serum free light chain (FLC) assay with involved FLC level ≥10 mg/dL, provided serum FLC ratio is abnormal
  • History of 3 to 8 cycles of induction therapy for NDMM, followed by high dose therapy and ASCT. Randomization must occur within 120 days from the stem cell transplant. For participants who receive consolidation therapy after ASCT, randomization must occur within 60 days of consolidation and within 7 months from ASCT. Screening tests should be performed after the last dose of consolidation
  • PR or better according to IMWG criteria at the time of randomization
  • Identification of the dominant malignant (index) clone as assessed by central laboratory NGS test (Adaptive Biotechnologies clonoSEQ assay
  • A bone marrow aspirate sample collected at screening is required to determine MRD status
  • ECOG performance status ≤1
  • Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1
  • Not pregnant and willing to use contraception
  • Exclusion Criteria
    • Plasma cell leukemia defined as more than 20% circulating plasma cells and an absolute count >2 × 10 ⁹ /L plasma cells in peripheral blood) ².
    • Amyloidosis, Waldenström’s macroglobulinemia, or Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes (POEMS) syndrome
    • Known active central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement
    • Ongoing Grade ≥3 peripheral sensory or motor neuropathy
    • History of Guillain-Barré syndrome (GBS) or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy
    • Live attenuated vaccine within 4 weeks of the first dose
    • Known or suspected hypersensitivity to the study interventions or any of its excipients
    • Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ, or Stage 0/1 with minimal risk of recurrence per the investigator
    • Previous MM maintenance treatment
    • Prior treatment with B-cell maturation antigen (BCMA) targeted therapy

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT05317416

Principal Investigator

Amir Steinberg, MD

Contact for Study Screening

Allyson.Pulsoni@wmchealth.org