A Randomized, Phase 2 Study of Pembrolizumab And Chemotherapy With or Without MK-4830 as Neoadjuvant Treatment for High-Grade Serous Ovarian Cancer

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 98

Inclusion Criteria

Has histologically-confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV HGSOC, primary peritoneal cancer, or fallopian tube cancer., Is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the neoadjuvant and adjuvant setting., Is a candidate for interval debulking surgery., Is able to provide archival tissue or newly obtained core, incisional, or excisional biopsy of a tumor lesion., Has adequate organ functions.

Exclusion Criteria

Has a non-HGSOC histology., Has known active Central Nervous System (CNS) metastases and/or carcinomatous meningitis., Has severe hypersensitivity to pembrolizumab, carboplatin, paclitaxel (or docetaxel, if applicable),Avastin or biosimilar (if using) and/or any of their excipients., Has an active autoimmune disease that has required systemic treatment in past 2 years., Has an active infection requiring systemic therapy., Has a known history of human immunodeficiency virus (HIV) infection., Has a known history of hepatitis B or known active hepatitis C virus infection., Has received colony-stimulating factors within 4 weeks prior to receiving study intervention on Day 1of Cycle 1., Has had surgery <6 months prior to Screening to treat borderline ovarian tumors, early-stage OC, or early-stage fallopian tube cancer., Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study., Has current, clinically relevant bowel obstruction., Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease., Has a history of hemorrhage, hemoptysis, or active gastrointestinal (GI) bleeding within 6 months prior to randomization., Has uncontrolled hypertension., Has had an allogenic tissue/solid organ transplant., Has either had major surgery within 3 weeks of randomization or has not recovered from any effects of any major surgery., Has a known additional malignancy that is progressing or has required active treatment within the past 3 years., Has received prior treatment for any stage of OC, including radiation or systemic anticancer therapy., Planned or has been administered intraperitoneal chemotherapy as first-line therapy., Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death 1 ligand 1 (PD-L1), anti-programmed cell death 1 ligand 2 (PD-L2), anti-immunoglobulin-like transcript 4 (ILT4), or anti-human leukocyte antigen (HLA)-G agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor., Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention., Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention., Has a 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 the first dose of study medication.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Among patients with detectable ctDNA at baseline, to evaluate whether the reduction from baseline in circulating tumor DNA at Cycle 3 (?ctDNA) is larger in participants receiving MK-4830 + pembrolizumab in combination with standard of care (SOC) therapy than in those receiving pembrolizumab + SOC therapy.;Secondary Objective: Among patients with detectable ctDNA at baseline, to evaluate the association between neoadjuvant ?ctDNA at Cycle 3 from baseline and surgical outcomes., To estimate the difference in pCR and CRS following neoadjuvant treatment between arms., To evaluate the safety and tolerability of the study intervention administered.;Primary end point(s): Change from Baseline in Circulating Tumor Deoxyribonucleic Acid (ctDNA)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Change from Baseline in Neoadjuvant ctDNA;Secondary end point(s):Pathological Complete Response (pCR) Rate;Secondary end point(s):Chemotherapy Response Score (CRS);Secondary end point(s):Number of Participants Who Experienced an Adverse Event (AE);Secondary end point(s):Number of Participants Who Discontinued Study Treatment Due to an AE

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