pembrolizumab with chemotherapy and mk-4830 for treating participants with ovarian cancer (mk-4830-002)

Conditions: High-grade Serous Ovarian Carcinoma; Ovarian Carcinoma

Summary: the primary objective is to evaluate in participants with high-grade serous ovarian cancer (hgsoc), whether the reduction from baseline in circulating tumor dna (ctdna) at cycle 3 (δctdna) is larger in participants receiving mk-4830 + pembrolizumab in combination with standard of care (soc) therapy than in those receiving pembrolizumab + soc therapy.


Eligibility criteria:
the main inclusion and exclusion criteria include but are not limited to the following: 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 a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * 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. * 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 1 of 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 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.