NCT03832569

Study of Pembrolizumab Following Surgery in Patients With Microsatellite Instability High (MSI-H) Solid Tumors

A Single-Arm Pilot Study of Adjuvant Pembrolizumab in Patients With MSI-H Tumors With Persistent Circulating Tumor DNA Following Surgery

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the safety of the study drug, pembrolizumab, and to find out how well it works to prevent cancer from coming back in people who have had a solid tumor surgically removed, but still have tumor cells in their blood. During the study, the participant will receive either the study drug or a placebo for as long as 12 months, or until the cancer comes back, or the side effects of the treatment become too severe.

Conditions

• Solid Tumors
• Identified by NGS, PCR or IHC

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab 200 mg IV every 3 weeks over 30 minutes.

Timeline

• Start date: 2019-02-20
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2019-02-06
• Last updated: 2026-03-05

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study