NCT03800602

Nivolumab and Metformin in Patients With Treatment Refractory MSS Colorectal Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the effect of nivolumab and metformin combination on the overall response rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. SECONDARY OBJECTIVES: I. To determine the effect of nivolumab and metformin combination on clinical outcomes, progression free survival and overall survival, and biochemical response (CEA). II. To compare the effect of nivolumab and metformin combination on immune and metabolic biomarkers in the tumor microenvironment and systemic circulation (pre and post treatment paired biopsies required). OUTLINE: Patients receive metformin PO BID starting on day 1. After 14 days of metformin only period patients also receive nivolumab IV every 4 weeks starting on day 15. Courses repeat every 28 days for up to 2 years in the absence of disease progression, unacceptable toxicity or consent withdrawal After completion of study treatment, patients are followed up at day 30 and then periodically thereafter.

Conditions

• Colorectal Adenocarcinoma
• Metastatic Microsatellite Stable Colorectal Carcinoma
• Refractory Colorectal Carcinoma
• Stage IV Colorectal Cancer
• Stage IVA Colorectal Cancer
• Stage IVB Colorectal Cancer
• Stage IVC Colorectal Cancer
• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Metformin	Given PO
BIOLOGICAL	Nivolumab	Given IV

Timeline

• Start date: 2019-01-15
• Primary completion: 2020-09-04
• Completion: 2021-09-04
• First posted: 2019-01-11
• Last updated: 2024-09-05
• Results posted: 2024-09-05

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study