Nivolumab + Relatlimab for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two drugs, nivolumab (Opdivo) and relatlimab (Opdualag), to determine their safety and effectiveness for people with advanced colorectal cancer that hasn't spread. Researchers aim to assess how these drugs perform across different cancer types, based on specific tumor features. Individuals with metastatic or locally advanced colorectal cancer who have undergone at least one round of chemotherapy might qualify. The trial organizes participants into groups based on cancer characteristics, but all receive the same treatment. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had chemotherapy, radiation, steroids, or any cytotoxic drugs within 14 to 28 days before starting the study treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using nivolumab and relatlimab together has generally been safe in past studies. One study found that the side effects were similar to those known for each drug when used alone. Patients with certain types of colorectal cancer mostly tolerated the combination well. However, another study found that using these two drugs together can increase the risk of serious treatment-related side effects.
These results present a mixed view of safety. On one hand, the combination has been safe for some patients. On the other hand, there is a greater chance of more severe side effects compared to using nivolumab alone. Patients should consider these factors and discuss them with their healthcare providers when thinking about joining a clinical trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Nivolumab and Relatlimab for colorectal cancer because they target the immune system in a novel way. Unlike traditional chemotherapy, which directly attacks cancer cells, this combination uses immune checkpoint inhibitors to enhance the body's own immune response against the tumor. Nivolumab blocks the PD-1 pathway, and Relatlimab targets the LAG-3 protein, both of which can suppress the immune system's ability to fight cancer. By inhibiting these checkpoints, the treatment can potentially unleash a more robust and targeted attack on cancer cells, offering hope for improved outcomes in patients.
What evidence suggests that nivolumab and relatlimab could be effective for colorectal cancer?
Research has shown that using nivolumab and relatlimab together can help treat some types of cancer. For instance, in patients with melanoma, this combination allowed many to go over 10 months without their cancer worsening. However, in patients with microsatellite stable (MSS) colorectal cancer, the results have been less positive. A recent study in this group did not achieve its main goals, indicating limited effectiveness for MSS colorectal cancer. This trial will explore the effectiveness of nivolumab and relatlimab in different cohorts of colorectal cancer patients, including those with CPM positive, CPM negative, and those without biomarker evaluation. These findings suggest that while the treatment works well for some cancers, it may not be as effective for others, such as MSS colorectal cancer.16789
Who Is on the Research Team?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Nivolumab and Relatlimab based on their CPM score
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
3
Treatment groups
Experimental Treatment
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).
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.
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:
- 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
- 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
- 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
- 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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
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
Citations
Nivolumab plus relatlimab in patients with previously ...
Conclusions: Nivolumab plus relatlimab provided durable clinical benefit and was well tolerated in previously treated patients with MSI-H/dMMR ...
2.
news.bms.com
news.bms.com/news/details/2025/Bristol-Myers-Squibb-Provides-Update-on-Phase-3-RELATIVITY-098-Trial/default.aspxBristol Myers Squibb Provides Update on Phase 3 ...
The safety profile of Opdualag observed in this analysis was consistent with the known profiles of nivolumab and relatlimab. “We are ...
BMS Ends Phase 3 Trial of Nivolumab and Relatlimab in ...
The phase 3 RELATIVITY-123 trial in metastatic microsatellite stable colorectal cancer is not expected to meet its primary end point upon completion and is ...
4.
onclive.com
onclive.com/view/futility-analysis-ends-nivolumab-and-relatlimab-evaluation-in-pretreated-mss-mcrcFutility Analysis Ends Nivolumab and Relatlimab ...
The phase 3 RELATIVITY-123 trial evaluating the fixed-dose combination of nivolumab and relatlimab in patients with microsatellite stable metastatic colorectal ...
Advanced Melanoma Clinical Trial Results
In the primary analysis at 13.2 months, half of the patients on Opdualag went 10.1 months without melanoma growing, spreading, or getting worse. Standard ...
Nivolumab plus relatlimab in patients with previously ...
Nivolumab plus relatlimab provided durable clinical benefit and was well tolerated in previously treated patients with MSI-H/dMMR metastatic CRC ...
Safety profile of nivolumab-relatlimab in cancer patients
Compared with nivolumab monotherapy, therapy with nivolumab-relatlimab was associated with a significantly increased risk of high-grade TRAEs, and some ...
Neoadjuvant nivolumab and relatlimab in locally advanced ...
Our results show that neoadjuvant nivolumab/relatlimab induces high rates of pathologic responses and that further investigation of this treatment in larger ...
NCT05328908 | A Study of Nivolumab-relatlimab Fixed ...
The purpose of this study is to evaluate relatlimab in combination with nivolumab, administered as a fixed-dose combination (nivolumab-relatlimab FDC, ...
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