NCT05131919

Pembrolizumab for Locally Advanced, Irresectable, Non-metastatic dMMR Colorectal Cancers

Pembrolizumab for Locally Advanced, Irresectable, Non-metastatic dMMR Colorectal Cancers. The PUMA Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, the efficacy of pembrolizumab in patients with locally advanced, irresectable dMMR colorectal cancer will be assessed.

Detailed description

In this single-center, single arm, open-label, phase II study assessing the efficacy of pembrolizumab in patients with locally advanced, irresectable dMMR colorectal cancer, 25 patients will be enrolled. All patients will be treated with pembrolizumab 200 mg intravenously on day 1 of each 3-week cycle.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Treatment with pembrolizumab 200 mg intravenously on day 1 of each 3-week cycle. Treatment will be continued for a maximum duration of 2 years, or until the tumor becomes resectable.

Timeline

• Start date: 2022-12-22
• Primary completion: 2030-07-01
• Completion: 2031-07-01
• First posted: 2021-11-23
• Last updated: 2025-12-09

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study