What side effects are associated with this type of intervention?

Common treatments for colorectal cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy often causes side effects like nausea, vomiting, diarrhea, fatigue, and increased risk of infection. Targeted therapies, such as bevacizumab, can lead to hypertension, bleeding, and gastrointestinal perforations. Immunotherapies, including PD-1 inhibitors like Nivolumab, can cause immune-related adverse events such as colitis, hepatitis, pneumonitis, and endocrinopathies. The combination of Nivolumab and Relatlimab (a LAG-3 inhibitor) may have similar immune-related side effects, though specific data on this combination's side effect profile is still being studied.

What prior FDA approvals exist?

For the treatment of colorectal cancer, the FDA has approved several immunotherapy drugs, including PD-1 inhibitors. Nivolumab, a PD-1 inhibitor, has been approved for use in patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan. Pembrolizumab, another PD-1 inhibitor, is also approved for MSI-H or dMMR colorectal cancer. These approvals highlight the role of immunotherapy in treating specific genetic profiles of colorectal cancer.

What other types of research exist?

Promising novel alternatives for colorectal cancer treatment in 2024 include combination therapies involving pembrolizumab (a PD-1 inhibitor) with lenvatinib (a VEGF receptor inhibitor), as well as ongoing trials exploring the efficacy of other immune checkpoint inhibitors like avelumab (a PD-L1 inhibitor). Additionally, emerging therapies targeting different pathways, such as tyrosine kinase inhibitors combined with anti-VEGF therapies, are also being investigated and may offer new options for patients.

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Checkpoint Inhibitor

Nivolumab + Relatlimab for Colorectal Cancer

Phase 2

Waitlist Available

Led By Dung Le, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status 0 or 1

Must have received at least one chemotherapy regimen

Must not have

Has an active infection

Unable to have blood drawn

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

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 the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include immune-related reactions such as inflammation in various organs, skin issues, hormone gland problems like thyroid disorders, infusion reactions during drug administration, fatigue and possible allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I have undergone at least one chemotherapy treatment.

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I have tissue samples from my initial cancer surgery available.

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My colorectal cancer is advanced but not responsive to immunotherapy.

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My primary cancer lesion has a high PD-L1/Mucin score.

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My cancer's PD-L1/Mucin score is below 15%.

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I am 18 years old or older.

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My organ and bone marrow functions meet the study's requirements.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have an infection.

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I cannot have blood drawn for medical reasons.

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I have been treated with specific immune therapies before.

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I have been diagnosed with an immune system disorder.

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I have had a tissue, organ, or bone marrow transplant from another person.

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I have a serious health condition that is not under control.

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I do not have HIV or hepatitis B or C.

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I have a history of lung scarring or fibrosis.

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I need extra oxygen every day.

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I have a serious heart condition.

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I haven't had encephalitis, meningitis, or uncontrolled seizures in the last year.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I am not pregnant or breastfeeding.

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I haven't had chemotherapy, radiation, or steroids in the last 14 days.

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I need treatment to stop my cancer cells from growing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cohort A/B: Objective response rate (ORR)

Cohort C: Objective response rate (ORR)

Secondary study objectives

Number of participants experiencing study drug-related toxicities

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort C: Nivolumab and Relatlimab (co-administration)Experimental Treatment2 Interventions

480mg/160mg (co-administration)

Group II: Cohort C: Nivolumab and RelatlimabExperimental Treatment2 Interventions

480mg/ 960mg or 480mg/480mg (sequential administration)

Group III: Cohort A/B: Nivolumab and RelatlimabExperimental Treatment2 Interventions

480mg/160mg (co-administered)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

Relatlimab

2019

Completed Phase 2

~1150

0 / 23Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for colorectal cancer include immune checkpoint inhibitors such as PD-1 inhibitors (e.g., nivolumab) and LAG-3 inhibitors (e.g., relatlimab). PD-1 inhibitors work by blocking the programmed cell death protein 1 (PD-1) pathway, which cancer cells exploit to evade immune detection. By inhibiting this pathway, PD-1 inhibitors enhance the immune system's ability to recognize and attack cancer cells. LAG-3 inhibitors target the lymphocyte-activation gene 3 (LAG-3) protein, which also plays a role in downregulating immune responses. Blocking LAG-3 can further boost the immune system's activity against cancer cells. These mechanisms are crucial for colorectal cancer patients as they offer a way to harness the body's own immune system to fight the cancer, potentially leading to better outcomes and prolonged survival.

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