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Regorafenib and Nivolumab in Mismatch Repair (MMR) Refractory Colorectal Cancer

NCT03712943 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-02-09

No results posted yet for this study

Summary

The main purpose of this study is to test the safety, tolerable side effects, and determine the highest tolerable dose of the combination of Regorafenib and Nivolumab. Researchers want to find out if this combination of Regorafenib and Nivolumab can help people with metastatic colorectal cancer with mismatch repair (MMR) proficiency.

Conditions

Interventions

DRUG

Regorafenib

Regorafenib orally 80 mg daily for 21 days (3 weeks on, 1 week off).

DRUG

Nivolumab

Nivolumab 240 mg administered intravenously every 2 weeks.

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Dae W Kim, MD · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-23
Primary Completion
2021-09-01
Completion
2024-01-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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 NCT03712943 on ClinicalTrials.gov