CI

At a glance

ClinicalIndex Comparison Record
Phase 1Active· 73 enrolled / 73 target
Drug / intervention
Pembrolizumab +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03657641
NCT03657641Phase 1ActiveUpdate Overdue (0.9/mo)Completion was 40mo ago

A Phase I/II Study of Regorafenib and Pembrolizumab in Metastatic Colorectal Cancer Patients in 3rd and 4th Line Setting

University of Southern California·interventional·Posted Sep 5, 2018·Updated Jun 16, 2026

In Brief

A Phase 1 clinical trial evaluating Pembrolizumab and Regorafenib for Colorectal Cancer and Colorectal Cancer Metastatic. Active but no longer recruiting, targeting 73 participants across 3 sites.

Signals

Enrollment appears stalled

Detailed Summary

This phase I/II studies the side effects and best dose of regorafenib when given together with pembrolizumab in treating participants with colorectal cancer that has spread to other places in the body. Drugs used in chemotherapy, such as regorafenib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving regorafenib and pembrolizumab may work better at treating colorectal cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1Active
2019202020212022202320242025202620272028
First PostedSep 5, 2018
Enrollment StartJun 21, 2019
Primary CompletionFeb 27, 2023
Study CompletionDec 31, 2027
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 7.8 years ago

Arms & Interventions

Treatment (pembrolizumab, regorafenib)experimental

Participants receive pembrolizumab IV over 30 minutes on day 1 and regorafenib PO QD on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Biological: PembrolizumabDrug: Regorafenib

Interventions

Pembrolizumabbiological

Given IV

Regorafenibdrug

Given PO