CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
Metformin +1 moredrug
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/NCT03800602
NCT03800602Phase 2Completed

Phase II Trial of Nivolumab and Metformin in Patients With Treatment Refractory MSS Metastatic Colorectal Cancer

Emory University·interventional·Posted Jan 11, 2019·Updated Sep 5, 2024

In Brief

A Phase 2 clinical trial evaluating Metformin and Nivolumab for Colorectal Adenocarcinoma and 7 related conditions. Completed, enrolled 29 participants across 3 sites.

Detailed Summary

This phase II trial studies how well nivolumab and metformin work in treating patients with microsatellite stable (MSS) stage IV colorectal cancer that has not responded to previous treatment. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Metformin is an antidiabetic drug that and may reduce the risk of colorectal cancer development in patients. Giving nivolumab and metformin may work better in treating patients with refractory microsatellite metastatic colorectal cancer.

Study Details

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJan 11, 2019
Enrollment StartJan 15, 2019
Primary CompletionSep 4, 2020
Study CompletionSep 4, 2021
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.5 years ago

Interventions

Metformindrug

Given PO

Nivolumabbiological

Given IV