NCT03657641

Regorafenib and Pembrolizumab in Treating Participants With Advanced or Metastatic Colorectal Cancer

Active, enrolled Phase 1, PHASE2 Last updated 4 July 2025

What this trial tests

Phase 1, PHASE2 trial testing Pembrolizumab in Colorectal Cancer in 75 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

21 June 2019

Primary endpoint
27 February 2023

21 June 2026

Quick facts

Lead sponsor	University of Southern California
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	75
Start date	21 June 2019
Primary completion	27 February 2023
Estimated completion	21 June 2026
Sites	3 locations across United States

Drugs / interventions tested

• Pembrolizumab (pembrolizumab) — full drug profile →
• Regorafenib — full drug profile →

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →
• Colorectal Cancer Metastatic — all drugs for Colorectal Cancer Metastatic →

Sponsor

University of Southern California

Who can join

18 and older, any sex, with Colorectal Cancer or Colorectal Cancer Metastatic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Exploring immunotherapy in colorectal cancer.
   Weng J, Li S, Zhu Z, Liu Q, et al · · 2022 · cited 250× · PMID 35842707 · DOI 10.1186/s13045-022-01294-4
2. Immunotherapy efficacy on mismatch repair-deficient colorectal cancer: From bench to bedside.
   Lizardo DY, Kuang C, Hao S, Yu J, et al · · 2020 · cited 160× · PMID 33035640 · DOI 10.1016/j.bbcan.2020.188447
3. Molecular insight of regorafenib treatment for colorectal cancer.
   Arai H, Battaglin F, Wang J, Lo JH, et al · · 2019 · cited 133× · PMID 31715423 · DOI 10.1016/j.ctrv.2019.101912
4. Molecular mechanisms targeting drug-resistance and metastasis in colorectal cancer: Updates and beyond.
   Al Bitar S, El-Sabban M, Doughan S, Abou-Kheir W. · · 2023 · cited 53× · PMID 36998426 · DOI 10.3748/wjg.v29.i9.1395
5. Adverse Events of Concurrent Immune Checkpoint Inhibitors and Antiangiogenic Agents: A Systematic Review.
   Gao L, Yang X, Yi C, Zhu H. · · 2019 · cited 42× · PMID 31680957 · DOI 10.3389/fphar.2019.01173
6. The Interplay of Autophagy and Tumor Microenvironment in Colorectal Cancer-Ways of Enhancing Immunotherapy Action.
   Koustas E, Sarantis P, Kyriakopoulou G, Papavassiliou AG, et al · · 2019 · cited 41× · PMID 31013961 · DOI 10.3390/cancers11040533
7. The Resistance Mechanisms of Checkpoint Inhibitors in Solid Tumors.
   Koustas E, Sarantis P, Papavassiliou AG, Karamouzis MV. · · 2020 · cited 40× · PMID 32344837 · DOI 10.3390/biom10050666
8. Relationship between microsatellite status and immune microenvironment of colorectal cancer and its application to diagnosis and treatment.
   Bai J, Chen H, Bai X. · · 2021 · cited 39× · PMID 33938589 · DOI 10.1002/jcla.23810