Ovarian Cancer Clinical Trial
Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002)
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 (Î”ctDNA) is larger in participants receiving MK-4830 + pembrolizumab in combination with standard of care (SOC) therapy than in those receiving pembrolizumab + SOC therapy.
The main inclusion and exclusion criteria include but are not limited to the following:
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.
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.
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There are 45 Locations for this study
Aurora Colorado, 80045, United States
Jacksonville Florida, 32224, United States
Miami Florida, 33176, United States
Chicago Illinois, 60611, United States
Saint Louis Missouri, 63110, United States
New Brunswick New Jersey, 08901, United States
Buffalo New York, 14263, United States
Mineola New York, 11501, United States
New York New York, 10016, United States
New York New York, 10065, United States
Sioux Falls South Dakota, 57104, United States
Seattle Washington, 98109, United States
Edegem Antwerpen, 2650, Belgium
Gent Oost-Vlaanderen, 9000, Belgium
Leuven Vlaams-Brabant, 3000, Belgium
Montréal Quebec, H2X 3, Canada
Montréal Quebec, H4A 3, Canada
Temuco Araucania, 48008, Chile
Santiago Region M. De Santiago, 75009, Chile
Santiago Region M. De Santiago, 83300, Chile
Viña del Mar Valparaiso, 25205, Chile
Haifa , 31096, Israel
Jerusalem , 91031, Israel
Ramat Gan , 52656, Israel
Napoli Campania, 80131, Italy
Roma Lazio, oo168, Italy
Milan Lombardia, 20133, Italy
Milano , 20141, Italy
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Siedlce Mazowieckie, 08-11, Poland
Warszawa Mazowieckie, 02-78, Poland
Gdańsk Pomorskie, 80-21, Poland
Kielce Swietokrzyskie, 25-73, Poland
Poznan Wielkopolskie, 61-84, Poland
Singapore Central Singapore, 16858, Singapore
Singapore South West, 11907, Singapore
Hospitalet Barcelona, 08907, Spain
Madrid Madrid, Comunidad De, 28041, Spain
Barcelona , 08035, Spain
Changhua County Changhua, 50006, Taiwan
Taichung , 407, Taiwan
Tainan , 704, Taiwan
Taipei , 10002, Taiwan
Taipei , 10449, Taiwan
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