Nivolumab + Relatlimab for Colorectal Cancer

Recruiting at 1 trial location

Overseen By Colleen Apostal, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Must not be taking: Antineoplastics, Steroids, Cytotoxics, others

Disqualifiers: Brain metastases, Autoimmune disease, Immunodeficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

59 Participants Needed

Trial Summary

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.

Research Team

Dung Le, MD

Principal Investigator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria

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.

Exclusion Criteria

I currently have an infection.

I cannot have blood drawn for medical reasons.

Hypersensitivity reaction to any monoclonal antibody

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Cohort C: Colorectal cancer with no biomarker evaluation required Experimental Treatment 2 Interventions

Participants were not pre-screened for composite PD-L1/mucin (CPM) score. Participants received 480mg Nivolumab and 960mg Relatlimab (dose reduced to 480mg or 160mg).

Group II: Cohort B: Composite PD-L1/Mucin (CPM) negative colorectal cancer Experimental Treatment 2 Interventions

Participants were pre-screened for CPM score. The CPM score integrates the percent of PD-L1 expression at the tumor interface and the percent of acellular mucin in the tumor area (\[%PD-L1 + % acellular mucin\]/2) using each participant's primary tumor tissue. A CPM score cutoff of less than 15% was used to determine CPM negativity. Participants received 480mg Nivolumab and 160mg Relatlimab.

Group III: Cohort A: Composite PD-L1/Mucin (CPM) positive colorectal cancer Experimental Treatment 2 Interventions

Participants were pre-screened for CPM score. The CPM score integrates the percent of PD-L1 expression at the tumor interface and the percent of acellular mucin in the tumor area (\[%PD-L1 + % acellular mucin\]/2) using each participant's primary tumor tissue. A CPM score cutoff of greater than or equal to 15% was used to determine CPM positivity. Participants received 480mg Nivolumab and 160mg Relatlimab.

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

Approved in United States as Opdivo for:

• Advanced or metastatic gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma
• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Hepatocellular carcinoma
• Esophageal squamous cell carcinoma

Approved in European Union as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Approved in Canada as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Approved in Switzerland as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

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

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

Bristol-Myers Squibb

Chief Medical Officer since 2024

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