Nivolumab and Metformin in Patients With Treatment Refractory MSS Colorectal Cancer

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.

Timeline

Start

2019-01-15

Primary completion

2020-09-04

Completion

2021-09-04

Outcome

Missed primary endpoint

paper Two patients had stable disease, but no patients had objective response, hence the study was stopped for futility. PMID 37852737 ↗

Publications

• Akce M, Farran B, Switchenko JM, Rupji M, Kang S, Khalil L, Ruggieri-Joyce A, Olson B, Shaib WL, Wu C, Alese OB, Diab M, Lesinski GB, El-Rayes BF. Phase II trial of nivolumab and metformin in patients with treatment-refractory microsatellite stable metastatic colorectal cancer. J Immunother Cancer. 2023 Oct;11(10):e007235. doi: 10.1136/jitc-2023-007235.

Drugs

Indications