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PD-1 Inhibitor

Regorafenib + Pembrolizumab for Colorectal Cancer

Phase 2

Waitlist Available

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR), Lead-in Phase

Progression-free Survival (PFS), Randomize Phase

Secondary outcome measures

Adverse Events and Serious Adverse Events Related to Treatment

Objective Response Rate (ORR), Randomized Phase

Overall Survival (OS)

+1 more

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

Regorafenib

2014

Completed Phase 2

~1580

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Ibrahim Halil SahinLead Sponsor

1 Previous Clinical Trials

20 Total Patients Enrolled

BayerIndustry Sponsor

2,237 Previous Clinical Trials

25,326,824 Total Patients Enrolled

Ibrahim H Sahin, MDPrincipal InvestigatorUPMC Hillman Cancer Center

1 Previous Clinical Trials

20 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the combination of Pembrolizumab and Regorafenib been granted clearance by the FDA?

"The safety of the Pembrolizumab + Regorafenib combination has been rated a 2 on our scale since this is only a Phase 2 trial, indicating that there is some evidence for its security yet no proof of efficacy."

Answered by AI

Is recruitment still available for this experiment?

"This clinical trial, which originated on August 1st 2023, is not actively seeking patients at the present moment. However, 940 other medical trials are open to new participants."

Answered by AI

What objectives does this research endeavor seek to fulfill?

"This clinical trial's primary outcome, measured over a 12-month period is Progression-Free Survival (PFS) in the Randomized Phase. Secondary outcomes include Progression-Free Survival (PFS) in the Lead-In phase, Overall Survival (OS), and Objective Response Rate (ORR). These are determined by assessing criteria such as Complete Response (CR): Disappearance of all target lesions; Partial response: ≥30% decrease in sum of diameters of target lesions; or Progressive Disease:≥20% increase in sum of diameters with absolute increase ≥5mm."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Ibrahim Halil Sahin 2023. "Regorafenib in Combination With Pembrolizumab or Pembrolizumab for MSI-H Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06006923.