Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002)
- Conditions
- High-grade Serous Ovarian CarcinomaOvarian Carcinoma
- Registration Number
- NCT05446870
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Female
- Target Recruitment
- Not specified
The main inclusion and exclusion criteria include but are not limited to the following:<br><br>Inclusion Criteria:<br><br> - Has histologically-confirmed International Federation of Gynecology and Obstetrics<br> (FIGO) Stage III or Stage IV HGSOC, primary peritoneal cancer, or fallopian tube<br> cancer.<br><br> - Is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in<br> the neoadjuvant and adjuvant setting.<br><br> - Is a candidate for interval debulking surgery.<br><br> - Is able to provide archival tissue or newly obtained core, incisional, or excisional<br> biopsy of a tumor lesion.<br><br> - Has adequate organ functions.<br><br>Exclusion Criteria:<br><br> - Has a non-HGSOC histology.<br><br> - Has a history of (noninfectious) pneumonitis/interstitial lung disease that required<br> steroids or has current pneumonitis/interstitial lung disease.<br><br> - Has a known additional malignancy that is progressing or has required active<br> treatment within the past 3 years.<br><br> - Has received prior treatment for any stage of OC, including radiation or systemic<br> anticancer therapy.<br><br> - Planned or has been administered intraperitoneal chemotherapy as first-line therapy.<br><br> - Has received prior therapy with an anti-programmed cell death 1 protein (PD-1),<br> anti-programmed cell death 1 ligand 1 (PD-L1), anti-programmed cell death 1 ligand 2<br> (PD-L2), anti-immunoglobulin-like transcript 4 (ILT4), or anti-human leukocyte<br> antigen (HLA)-G agent or with an agent directed to another stimulatory or<br> coinhibitory T-cell receptor.<br><br> - Has received a live or live-attenuated vaccine within 30 days before the first dose<br> of study intervention.<br><br> - Is currently participating in or has participated in a study of an investigational<br> agent or has used an investigational device within 4 weeks before the first dose of<br> study intervention.<br><br> - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy<br> (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of<br> immunosuppressive therapy within 7 days prior the first dose of study medication.<br><br> - Has known active Central Nervous System (CNS) metastases and/or carcinomatous<br> meningitis.<br><br> - Has severe hypersensitivity to pembrolizumab, carboplatin, paclitaxel (or docetaxel,<br> if applicable), Avastin or biosimilar (if using) and/or any of their excipients.<br><br> - Has an active autoimmune disease that has required systemic treatment in past 2<br> years.<br><br> - Has an active infection requiring systemic therapy.<br><br> - Has a known history of human immunodeficiency virus (HIV) infection.<br><br> - Has a known history of hepatitis B or known active hepatitis C virus infection.<br><br> - Has received colony-stimulating factors within 4 weeks prior to receiving study<br> intervention on Day 1 of Cycle 1.<br><br> - Has had surgery <6 months prior to Screening to treat borderline ovarian tumors,<br> early-stage OC, or early-stage fallopian tube cancer.<br><br> - Has a known psychiatric or substance abuse disorder that would interfere with the<br> participant's ability to cooperate with the requirements of the study.<br><br> - Has current, clinically relevant bowel obstruction.<br><br> - Has a history of hemorrhage, hemoptysis, or active gastrointestinal (GI) bleeding<br> within 6 months prior to randomization.<br><br> - Has uncontrolled hypertension.<br><br> - Has had an allogenic tissue/solid organ transplant.<br><br> - .Has either had major surgery within 3 weeks of randomization or has not recovered<br> from any effects of any major surgery.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from Baseline in Circulating Tumor Deoxyribonucleic Acid (ctDNA)
- Secondary Outcome Measures
Name Time Method Change from Baseline in Neoadjuvant ctDNA;Pathological Complete Response (pCR) Rate;Chemotherapy Response Score (CRS);Number of Participants Who Experienced an Adverse Event (AE);Number of Participants Who Discontinued Study Treatment Due to an AE