NCT05446870

Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002)

A Randomized, Phase 2 Study of Pembrolizumab And Chemotherapy With or Without MK-4830 as Neoadjuvant Treatment for High-Grade Serous Ovarian Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2022-07-25
• Primary completion: 2023-12-20
• Completion: 2024-10-16
• First posted: 2022-07-07
• Last updated: 2025-10-01
• Results posted: 2024-12-17

Locations

45 sites across 11 countries: United States, Belgium, Canada, Chile, Israel, Italy, Poland, Singapore, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study