NCT04123366

Study of Olaparib (MK-7339) in Combination With Pembrolizumab (MK-3475) in the Treatment of Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer (MK-7339-007/KEYLYNK-007)

A Phase 2 Study of Olaparib in Combination With Pembrolizumab in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of treatment with olaparib (MK-7339) in combination with pembrolizumab (MK-3475) in adults with previously treated, advanced (metastatic and/or unresectable) Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-positive solid tumors.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	Olaparib	Oral tablet
BIOLOGICAL	Pembrolizumab	Intravenous infusion

Timeline

• Start date: 2019-11-18
• Primary completion: 2026-07-23
• Completion: 2026-07-23
• First posted: 2019-10-10
• Last updated: 2025-03-17

Locations

135 sites across 23 countries: United States, Argentina, Australia, Canada, Colombia, France, Germany, Guatemala, Israel, Italy, Japan, Latvia, Mexico, Peru, Poland, Puerto Rico, Romania, South Africa, South Korea, Spain, Sweden, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study