Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002)
NCT05446870 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2025-10-01
Summary
The primary objective is to evaluate in participants with high-grade serous ovarian cancer (HGSOC), whether the reduction from baseline in circulating tumor deoxyribonucleic acid (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.
Conditions
- High-grade Serous Ovarian Carcinoma
- Ovarian Carcinoma
Interventions
- BIOLOGICAL
-
200 mg by IV infusion on Day 1 of each 21-day cycle
- DRUG
-
175 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle
- DRUG
-
AUC 5 to 6 by IV infusion on Day 1 of each 21-day cycle
- BIOLOGICAL
-
According to local practice and at the choice of the investigator.
- BIOLOGICAL
-
MK-4830
800 mg by IV infusion on Day 1 of each 21-day cycle
- DRUG
-
75 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director · Merck Sharp & Dohme LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-25
- Primary Completion
- 2023-12-20
- Completion
- 2024-10-16
- FDA Drug
- Yes
Countries
- United States
- Belgium
- Canada
- Chile
- Israel
- Italy
- Poland
- Singapore
- South Korea
- Spain
- Taiwan
Study Locations
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