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Regorafenib in Combination With Pembrolizumab or Pembrolizumab for MSI-H Colorectal Cancer

NCT06006923 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2026-01-20

No results posted yet for this study

Summary

This is a trial of Regorafenib in combination with pembrolizumab for patients with MSI-H colorectal cancer consisting of lead-in phase examining preliminary efficacy and safety, followed by a randomized phase to further examine efficacy.

Conditions

  • MSI-H Colorectal Cancer

Interventions

DRUG

Regorafenib

A multi-kinase inhibitor that targets several receptor tyrosine kinases including vascular endothelial growth factor receptor (VEGFR), which may also have immunomodulatory affect in the tumor microenvironment.

DRUG

Pembrolizumab

An anti-PD1 blockade / immune checkpoint inhibitor treatment approved for patients with high microsatellite instability (MSI-H) colorectal cancer (CRC) as first line therapy.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Anwaar Saeed

    lead OTHER

Principal Investigators

  • Anwaar H Saeed, MD · UPMC Hillman Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-26
Primary Completion
2025-07-11
Completion
2025-11-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT06006923 on ClinicalTrials.gov