A Study Comparing Niraparib Versus Platinum-Taxane Doublet Chemotherapy as Neoadjuvant Treatment in Participants With Homologous Recombination-Deficient Stage III/IV Ovarian Cancer (COHORT-C)

NCT06964165 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 213357-COHORT-C2023-505097-16
• Study Type: interventional
• Target: 36
• Locations: 3 countries
• Sites: 21

Brief Summary

The goal of the study is to learn whether Niraparib or Platinum-Taxane Doublet chemotherapy is better in treating participants with Homologous Recombination Deficient (HRd) Stage III/IV Ovarian Cancer (OC). This study is a sub-study of the Master protocol -OPAL (NCT03574779)

Conditions

Ovarian Neoplasms

Keywords

Ovarian Cancer; Homologous Recombination Deficiency (HRD); Interval debulking surgery (IDS); Niraparib; Paclitaxel; Carboplatin

Outcome Measures

Primary Outcomes (1)

• Pre-Interval Debulking Surgery (IDS) Unconfirmed Overall Response Rate (ORR)

  Pre-IDS unconfirmed ORR is defined as the percentage of participants with unconfirmed complete or partial response on study treatment pre-IDS as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by the Investigator. Complete Response (CR) is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters

  Up to approximately 102 weeks

Secondary Outcomes (10)

• Number of Participants With Cancer Antigen (CA)-125 Progression by Gynecological Cancer InterGroup (GCIG) CA-125 Response Criteria

  At week 24

• Progression Free Survival (PFS)

  Up to approximately 154 weeks

• Overall Survival (OS)

  Up to approximately 154 weeks

• Time to First Subsequent Treatment (TFST)

  Up to approximately 154 weeks

• Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Baseline (Predose), Day 8 and 15 of Cycle 1; Day 1, 8 and 15 of Cycle 2 and Cycle 3; Pre-IDS Evaluation, and End of Treatment (Up to approximately 154 weeks).

Study Arms (2)

Cohort C (Niraparib)

EXPERIMENTAL

Drug: Niraparib

Cohort C (Carboplatin + Paclitaxel)

EXPERIMENTAL

Drug: Carboplatin; Drug: Paclitaxel

Interventions

Niraparib DRUG

Niraparib will be administered

Cohort C (Niraparib)

Carboplatin DRUG

Carboplatin will be administered

Cohort C (Carboplatin + Paclitaxel)

Paclitaxel DRUG

Paclitaxel will be administered

Cohort C (Carboplatin + Paclitaxel)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has newly diagnosed Stage III or IV ovarian, fallopian tube, or primary peritoneal cancer according to the International Federation of Gynecology and Obstetrics staging criteria.
• Participants must provide sufficient tumor tissue at Prescreening and agree to undergo a central HRD tumor testing using a fully validated assay. The participants must be HRd as per central HRD tumor testing result for eligibility.
• All participants must agree to provide tumor tissue collected from IDS.
• Participant must provide 2 formalin-fixed paraffin-embedded tissue blocks (or slides if blocks are not available) with sufficient tumor content (as confirmed by the Sponsor's designated central and/or testing laboratory) for central HRD testing at Prescreening and for exploratory biomarker testing at Prescreening or Screening. If sufficient tumor tissue is provided at Prescreening, participants do not need to provide additional tissue at Screening.
• Participant must have completed 1 run-in cycle of carboplatin-paclitaxel and not experienced disease progression after this treatment. Completion is defined as receiving ≥50% of the prescribed dose of therapy within 5 weeks.
• Participant must not have known contraindication or uncontrolled hypersensitivity to carboplatin and paclitaxel and their excipients and no known pre-existing conditions that would preclude treatment with these agents.
• Participant must not have known contraindication or uncontrolled hypersensitivity to niraparib and its excipients.
• Participant must not have symptomatic ascites or pleural effusions as defined by the following criterion: presence of fluid in the abdominal or pleural cavities requiring removal within 1 week prior to signing the informed consent.
• Participant must agree to complete Patient-reported outcome (PRO) and work productivity questionnaires throughout the study.

You may not qualify if:

• Participant has low-grade or Grade 1 epithelial Ovarian Cancer (OC) or mucinous, germ cell, transitional cell, carcinosarcoma, or undifferentiated tumor.
• Participant has contraindications to surgery.
• Participant has a bowel obstruction by clinical symptoms or Computed tomography (CT) scan, subocclusive mesenteric disease, abdominal or gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess.
• Participant has any known history or current diagnosis of Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML).
• Participant is at increased bleeding risk due to concurrent conditions (e.g., major injuries or major surgery within the past 28 days prior to the start of study treatment and/or history of hemorrhagic stroke, transient ischemic attack, subarachnoid hemorrhage, or clinically significant hemorrhage within the past 3 months).
• Participant is immunocompromised. Participants with splenectomy are allowed. Participants with known Human immunodeficiency virus (HIV) are allowed if they meet all of the following criteria:
• Cluster of differentiation 4-positive T cell count ≥350/μL and viral load \<400 copies/mL
• No history of Acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 months prior to enrollment
• No history of HIV-associated malignancy for the past 5 years
• Concurrent antiretroviral therapy as per the most current National Institutes of Health Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV started \>4 weeks prior to study enrollment
• Participant received prior treatment for high-grade non-mucinous epithelial ovarian, fallopian tube, or peritoneal cancer (e.g., prior surgery, immunotherapy, anticancer therapy \[with the exception of 1 run-in cycle of carboplatin-paclitaxel\], or radiation therapy).
• Participant has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic therapy (e.g., thyroid hormone or insulin).
• Participant is unable to swallow orally administered medication or has a gastrointestinal disorder likely to interfere with absorption of the study medication.
• Participant received whole blood transfusions in the 2 weeks prior to entry to the study (packed red blood cells and platelet transfusions are acceptable outside of 2 weeks prior to treatment).

Sponsors & Collaborators

• Tesaro, Inc.: lead

Study Sites (21)

GSK Investigational Site

San Francisco, California, 94115, United States

Location

GSK Investigational Site

Miami, Florida, 33136, United States

Location

GSK Investigational Site

Tampa, Florida, 33606, United States

Location

GSK Investigational Site

Scarborough, Maine, 04074, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02114, United States

Location

GSK Investigational Site

St Louis, Missouri, 63141, United States

Location

GSK Investigational Site

New York, New York, 10029, United States

Location

GSK Investigational Site

New York, New York, 77030, United States

Location

GSK Investigational Site

Rochester, New York, 14642, United States

Location

GSK Investigational Site

Sioux Falls, South Dakota, 57105, United States

Location

GSK Investigational Site

Seattle, Washington, 98104, United States

Location

GSK Investigational Site

Ottawa, Ontario, K1H 8L6, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2X 0A9, Canada

Location

GSK Investigational Site

Montreal, Quebec, H4A 3J1, Canada

Location

GSK Investigational Site

A Coruña, ES, 15006, Spain

Location

GSK Investigational Site

Madrid, ES, 28027, Spain

Location

GSK Investigational Site

Madrid, ES, 28033, Spain

Location

GSK Investigational Site

Madrid, ES, 28050, Spain

Location

GSK Investigational Site

Madrid, ES, 28223, Spain

Location

GSK Investigational Site

Málaga, ES, 29001, Spain

Location

GSK Investigational Site

Pamplona, ES, 31008, Spain

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

niraparib; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 9, 2025
• Study Start: April 14, 2022
• Primary Completion: June 28, 2024
• Study Completion: March 31, 2025
• Last Updated: November 26, 2025
• Results First Posted: July 15, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Locations

US (11); CA (3); ES (7)