Nivolumab and Metformin in Patients With Treatment Refractory MSS Colorectal Cancer

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT03800602
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Metformin — DRUG
    Given PO
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Jan 15, 2019
Status verified
Sep 2024
Primary completion
Sep 4, 2020
Completion
Sep 4, 2021

Study Design

Enrollment
29 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (nivolumab, metformin)
    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.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to 1 year after study start ]

Locations (3)

FacilityCityStateZIPSite coordinators
Emory Saint Joseph's HospitalAtlantaGeorgia30342-
Emory University Hospital MidtownAtlantaGeorgia30308-
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-

Find similar trials in Atlanta, GA

By research site
Emory Saint Joseph's Hospital· Atlanta, GAEmory University Hospital Midtown· Atlanta, GAEmory University Hospital/Winship Cancer Institute· Atlanta, GA

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