59 Participants Needed

Nivolumab + Relatlimab for Colorectal Cancer

Recruiting at 1 trial location
JS
TB
CA
Overseen ByColleen Apostal, RN
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing two drugs, nivolumab and relatlimab, in patients with advanced colorectal cancer that is hard to treat. The drugs work by helping the immune system better recognize and attack cancer cells. The goal is to see if this combination is safe and effective for these patients.

Who Is on the Research Team?

Dr. Dung Le, MD - Baltimore, MD ...

Dung Le, MD

Principal Investigator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Are You a Good Fit for This Trial?

This trial is for adults (18+) with advanced colorectal cancer that's microsatellite stable. They must have had at least one chemo treatment, a measurable lesion, and be in good physical condition (ECOG 0 or 1). Pregnant women, those with brain metastases or severe illnesses like heart disease are excluded.

Inclusion Criteria

I am fully active or can carry out light work.
I had surgery to remove my primary tumor.
I have undergone at least one chemotherapy treatment.
See 11 more

Exclusion Criteria

I currently have an infection.
I cannot have blood drawn for medical reasons.
Hypersensitivity reaction to any monoclonal antibody
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Nivolumab and Relatlimab based on their CPM score

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Nivolumab
  • Relatlimab
Trial Overview The study tests the safety and effectiveness of combining two drugs, Nivolumab and Relatlimab, on patients with MSS advanced colorectal cancer. It includes people who've tried chemotherapy before but need new options.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Cohort C: Colorectal cancer with no biomarker evaluation requiredExperimental Treatment2 Interventions
Group II: Cohort B: Composite PD-L1/Mucin (CPM) negative colorectal cancerExperimental Treatment2 Interventions
Group III: Cohort A: Composite PD-L1/Mucin (CPM) positive colorectal cancerExperimental Treatment2 Interventions

Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:

πŸ‡ΊπŸ‡Έ
Approved in United States as Opdivo for:
πŸ‡ͺπŸ‡Ί
Approved in European Union as Opdivo for:
πŸ‡¨πŸ‡¦
Approved in Canada as Opdivo for:
πŸ‡¨πŸ‡­
Approved in Switzerland as Opdivo for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials
578
Recruited
33,600+

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceΒ·Privacy PolicyΒ·CookiesΒ·Security