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Checkpoint Inhibitor

Nivolumab + Relatlimab for Colorectal Cancer

Phase 2
Recruiting
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
Cohort C: Prior surgical resection of primary tumor. Prospective biomarker evaluation not required
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Study Summary

This trial will test a new cancer treatment involving two drugs, nivolumab and relatlimab, in patients with colorectal cancer that has spread or is advanced and does not have changes in specific genes.

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.Check my eligibility
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.See study design
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 had surgery to remove my primary tumor.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohort A/B: Objective response rate (ORR)
Cohort C: Objective response rate (ORR)
Secondary outcome measures
Number of participants experiencing study drug-related toxicities

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
Relatlimab
2018
Completed Phase 2
~1110
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
555 Previous Clinical Trials
32,817 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,440 Total Patients Enrolled
Dung Le, MDPrincipal InvestigatorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
12 Previous Clinical Trials
575 Total Patients Enrolled

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03642067 — Phase 2
Colorectal Cancer Research Study Groups: Cohort A/B: Nivolumab and Relatlimab, Cohort C: Nivolumab and Relatlimab, Cohort C: Nivolumab and Relatlimab (co-administration)
Colorectal Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03642067 — Phase 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03642067 — Phase 2

Frequently Asked Questions

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

What ailments does Relatlimab generally target?

"Relatlimab is frequently administered to patients with malignant neoplasms. It can also be beneficial for those struggling with metastatic esophageal adenocarcinoma, squamous cell carcinoma, and unresectable melanomas."

Answered by AI

Has this trial been previously attempted in any similar formats?

"Research into Relatlimab initiated in 2012 when Ono Pharmaceutical Co. Ltd. launched a trial featuring 659 participants. After successfully passing Phase 1 & 2 clinical trials, today there are 719 active studies involving 2357 cities and 49 countries around the world."

Answered by AI

What is the enrollment quota for this research experiment?

"Affirmative, according to information supplied on clinicaltrials.gov, this medical study is currently recruiting volunteers. Initially posted in February 2019, the trial has recently been updated and seeks 96 patients from 2 distinct locations."

Answered by AI

Are there any openings for participation in this study currently?

"Based on the information found on clinicaltrials.gov, this survey is still looking for participants and was last updated in March of 2022. It has been posted since February 2019."

Answered by AI

Is there any potential harm associated with taking Relatlimab?

"Gleaned from the data we have, Relatlimab's safety was scored a 2 on our scale; this is due to it being in Phase 2 trials with some evidence of security but no evidence for efficacy."

Answered by AI

Has Relatlimab been the subject of previous experiments?

"At present, there are 82 Phase 3 clinical trials in progress for Relatlimab and 719 studies ongoing from around the world. Of these, many originate in Basel, BE; yet over forty-thousand other sites have contributed to Relatlimab research."

Answered by AI
~14 spots leftby Feb 2025