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Monoclonal Antibodies

Nivolumab + Metformin for Colorectal Cancer

Phase 2
Waitlist Available
Led By Mehmet Akce, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR creatinine clearance ≥ 60 mL/min/1.73 m² for patients with creatinine levels > 1.5 x ULN. Creatinine clearance should be calculated per institutional standard
Prior treatment with 5 Fluorouracil (or capecitabine), oxaliplatin and irinotecan containing chemotherapy (needs to be treated with anti-epidermal growth factor receptor (EGFR) agent if extended RAS wild type)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year after study start
Awards & highlights

Study Summary

This trial is testing nivolumab and metformin as a combination therapy to see if it is more effective than nivolumab alone in treating patients who have microsatellite stable stage IV colorectal cancer that has not responded to previous treatment.

Who is the study for?
This trial is for adults with stage IV colorectal cancer that hasn't improved after standard treatments. They should be relatively active (able to care for themselves), have a life expectancy over 3 months, and their blood counts and organ functions need to meet specific levels. The cancer must be measurable by scans or physical exams.Check my eligibility
What is being tested?
The study is testing the combination of Nivolumab, an immune system-boosting drug, with Metformin, commonly used for diabetes but thought to possibly lower colorectal cancer risk. It's aimed at patients whose tumors are stable (MSS) and haven't responded to other therapies.See study design
What are the potential side effects?
Nivolumab can cause immune-related side effects like inflammation in various organs, skin rash, or hormonal gland problems. Metformin may lead to digestive issues such as stomach pain or diarrhea and could affect blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function, measured by creatinine levels, is within the normal range.
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I've been treated with specific chemotherapy drugs and, if applicable, an anti-EGFR agent.
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I am fully active or have some restrictions but can still take care of myself.
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I have a tumor that can be measured with imaging tests.
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I have stage IV colorectal cancer that can be measured.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year after study start
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year after study start for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
Biological response: carcinoembryonic antigen (CEA)
Overall survival (OS)
Progression free survival (PFS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (nivolumab, metformin)Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Metformin
2006
Completed Phase 4
~2430

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,490 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,129 Total Patients Enrolled
Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,549 Total Patients Enrolled

Media Library

Nivolumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03800602 — Phase 2
Colorectal Cancer Research Study Groups: Treatment (nivolumab, metformin)
Colorectal Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03800602 — Phase 2
Nivolumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03800602 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts still ongoing for this clinical trial?

"Unfortunately, the clinical trial hosted on clinicialtrials.gov is not currently searching for patients; it was initially posted in January 15th 2019 and last modified May 6th 2022. However, there are over 4000 other medical studies which are actively seeking to enrol participants right now."

Answered by AI

Has Metformin been legitimized by the FDA?

"Thanks to its Phase 2 classification, metformin's safety was assessed as a two on our rating scale. While there is existing data that suggests the drug can be used without excessive risk, no evidence exists yet to suggest it will effectively treat illnesses."

Answered by AI

What is the participant quota for this clinical trial?

"This research initiative is no longer recruiting participants. It was first posted on January 15th 2019 and the last update occured on May 6th 2022. For those looking for alternative studies, there are currently 3258 clinical trials actively enrolling patients who have metastatic colorectal cancer (crc) and 886 trials admitting people with Metformin treatment needs."

Answered by AI

What ailments can Metformin be employed to address?

"Metformin is the preeminent medication for treating metastatic ureter urothelial carcinoma and can additionally be administered to patients with a variety of other ailments such as malignant melanoma of skin, diet and exercise not sufficient for diabetes control, or metastatic hepatocellular carcinoma."

Answered by AI

Who else is applying?

What site did they apply to?
Emory University Hospital Midtown
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Nivolumab and Metformin in Patients With Treatment Refractory MSS Colorectal Cancer
Olumide Gbolahan 2019. "Nivolumab and Metformin in Patients With Treatment Refractory MSS Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03800602.
All > Lynch Syndrome > Colorectal Cancer
~4 spots leftby Apr 2025
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