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

Study results available
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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

Pembrolizumab

200 mg by IV infusion on Day 1 of each 21-day cycle

DRUG

Paclitaxel

175 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle

DRUG

Carboplatin

AUC 5 to 6 by IV infusion on Day 1 of each 21-day cycle

BIOLOGICAL

Avastin

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

Docetaxel

75 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle

Sponsors & Collaborators

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05446870 on ClinicalTrials.gov