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Gynecology: Clinical Research Program

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Gynecology: Clinical Studies Open For Enrollment


 

A Two-Stage, Randomized, Controlled Trial Comparing the Safety and Efficacy of Iltamiocel with Placebo in the Treatment of Female Participants with Chronic Fecal Incontinence and a History of Obstetric Anal Sphincter Injury (DigniFI)

Eligibility

  • Adult female at least18 years of age who has primary symptoms of FI for at least 12 months as confirmed by medical history and presents with ≥4 uncontrolled passages of solid or liquid stool as recorded in a 14-Day Diary at Screening.
  • Has a history of obstetric anal sphincter injury (e.g., episiotomy, perineal tear) as confirmed by participant’s medical records and/or endoanal ultrasound.
  • Failed conservative treatment (e.g., dietary modification, antidiarrheal medications, pelvic floor muscle training, biofeedback) for at least 6 months prior to enrollment.
  • Has a Cleveland Clinic Florida Incontinence Score (CCFIS) ≥9 at Baseline.
  • For the duration of study participation, must be willing and able to comply with the study procedures, be mentally competent and able to understand all study requirements, and must agree to read and sign the informed consent form prior to any study-related procedures.
  • Exclusion Criteria:
    • Simultaneously participating in another investigational drug or device study or has completed the follow-up phase for the primary endpoint of any previous study less than 30 days prior to the first evaluation in this study.
    • Is pregnant or planning to become pregnant within the next 2 years.
    • Has an implanted stimulation neuromodulation system (sacral or tibial) and symptoms are unstable as determined by the physician.
    • Has received injection of a bulking agent within 1-year prior to the first evaluation in the study.
    • Has known rectal sensory dysfunction (e.g., hypersensitivity or hyposensitivity).
    • Any cancer that has undergone treatment within the past 12 months.

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05776277

Principal Investigator

Patrick Popiel, MD

Contact for Study Screening

Nooshin.Tavoosi@wmchealth.org

 

A Phase 2 Open-Label, Multicenter Study to Evaluate Efficacy and Safety of ZN-c3 in Adult Women with Recurrent or Persistent Uterine Serous Carcinoma Protocol GOG 3065/ZN-c3-004

Eligibility

  • Females at least 18 years of age at the time of informed consent
  • Recurrent or persistent Uterine Serous Carcinoma
  • Measurable disease
  • Treatment with at least one prior platinum-based chemotherapy regimen for management of advanced or metastatic USC

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05683691

EudraCT 2020-005172-35

Principal Investigator

Tana Pradhan, MD

Contact for Study Screening

Danielle.Hansen@wmchealth.org

 

A Phase 3, Multicenter, Open-Label, Randomized Study of Nemvaleukin Alfa in Combination with Pembrolizumab Versus Investigator’s Choice Chemotherapy in Patients with Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARTISTRY-7)

Eligibility

  • Confirmed ovarian cancer (high-grade serous, endometrioid, clear cell, fallopian tube cancer or primary peritoneal cancer
  • At least 18 years of age
  • Patient must have received at least one prior line of systemic anticancer therapy
  • Patient must have received bevacizumab
  • Patient must have had PARP inhibitor therapy if BRCA mutation exists
  • Disease progression
  • Patient NO requires or has NOT taken systemic corticosteroids

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05092360

Principal Investigator

Tana Pradhan, MD

Contact for Study Screening

Allyson.Pulsoni@wmchealth.org

 

NRG GY-019- A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum

Eligibility

  • At least 18 years of age
  • Patients must have newly diagnosed, Stage II-IV low-grade serous ovarian cancer
  • Patients must be able to take oral medications
  • Patients may not have received previous hormonal therapy for the treatment of this disease
  • Patients with NO central nervous system metastases

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04095364

Principal Investigator

Tana Pradhan, MD

Contact for Study Screening

Allyson.Pulsoni@wmchealth.org

 

NRG-GY018- A Phase 3 Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475) in addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer

Eligibility

  • At least 18 years of age
  • Diagnosis of endometrial cancer
  • Measurable stage III, measurable stage IVA, stage IVB, or recurrent endometrial cancer
  • Must have a measurable lesion on CT or MRI scan

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03914612

Principal Investigator

Tana Pradhan, MD

Contact for Study Screening

Allyson.Pulsoni@wmchealth.org

 

A Phase 2 Open-label, Multicenter Study to Evaluate Efficacy and Safety of ZN-c3 in Subjects with Malignant Tumors Harboring DNA Repair and Cell Cycle Gene Alterations

Eligibility

  • At least 18 years of age
  • Locally advanced or metastatic malignancy
  • Solid tumor with one or more relevant genetic alterations in DDR-related genes. These are defined as pathogenic (deleterious) mutations in the MRN complex genes (MRE11, RAD50, or NBN) or CCNE1 amplifications
  • Must have received prior standard therapy appropriate for their tumor type and stage of disease
  • Must have at least one measurable lesion
  • No major surgery within 28 days (any surgical incision should be fully healed prior to study drug administration)

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04158336

Principal Investigator

Tana Pradhan, MD

Contact for Study Screening

Allyson.Pulsoni@wmchealth.org