← Back to Search

PD-1 Inhibitor

Regorafenib + Pembrolizumab for Colorectal Cancer

Phase 2
Recruiting
Led By Ibrahim H Sahin, MD
Research Sponsored by Ibrahim Halil Sahin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a combo of drugs for people with a type of colorectal cancer. It looks at safety & effectiveness.

Who is the study for?
This trial is for adults over 18 with MSI-H colorectal cancer who can take pills and have decent organ function. They should have had limited chemotherapy, be able to use birth control, and not have other active cancers or serious health issues like uncontrolled HIV or bleeding disorders.
What is being tested?
The study tests Regorafenib combined with Pembrolizumab against Pembrolizumab alone in treating MSI-H colorectal cancer. It starts with a lead-in phase to check safety and early results, then moves into a randomized phase for more detailed efficacy data.
What are the potential side effects?
Possible side effects include fatigue, high blood pressure, liver problems, bleeding risks, immune system reactions that might cause inflammation in various organs of the body, skin reactions, and increased risk of infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate (ORR), Lead-in Phase
Progression-free Survival (PFS), Randomize Phase
Secondary study objectives
Adverse Events and Serious Adverse Events Related to Treatment
Objective Response Rate (ORR), Randomized Phase
Overall Survival (OS)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab + RegorafenibExperimental Treatment2 Interventions
Pembrolizumab: 200mg, Q3 weeks Regorafenib: 60mg Cycle 1 Day 1 90 mg Cycle 2 Day 1
Group II: PembrolizumabActive Control1 Intervention
Pembrolizumab: 200mg, Q3 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2810
Regorafenib
2014
Completed Phase 2
~1630

Find a Location

Who is running the clinical trial?

Ibrahim Halil SahinLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
BayerIndustry Sponsor
2,274 Previous Clinical Trials
25,532,497 Total Patients Enrolled
Ibrahim H Sahin, MDPrincipal InvestigatorUPMC Hillman Cancer Center
1 Previous Clinical Trials
20 Total Patients Enrolled
~103 spots leftby Jun 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top