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Checkpoint Inhibitor

Nivolumab + Relatlimab for Advanced 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
Age ≥18 years.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Study Summary

This trial is testing a new combination drug treatment for patients with MSI-H solid tumors who have not responded to other PD-(L)1 treatments.

Who is the study for?
Adults with advanced cancers that have high microsatellite instability and didn't respond to previous PD-1/PD-L1 inhibitor therapy. Participants must be in good physical condition, have at least one measurable lesion, proper organ and marrow function, no severe allergies to monoclonal antibodies or history of certain diseases like interstitial lung disease or brain metastases.Check my eligibility
What is being tested?
The trial is testing the combination of Nivolumab and Relatlimab for effectiveness and safety in patients whose tumors are resistant to prior therapies targeting PD-(L)1 proteins. It aims to see if this new treatment can help control cancer growth.See study design
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation in various organs, infusion-related responses, increased risk of infections due to a weakened immune system, fatigue, possible heart issues related to drug administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My organ and bone marrow functions meet the study's requirements.
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I have previously been treated with PD-1/PD-L1 inhibitors.
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My cancer is advanced and has a specific genetic feature (MSI-H or mismatch repair deficient).

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
Objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Secondary outcome measures
Number of participants experiencing study drug-related toxicities

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3: Nivolumab and RelatlimabExperimental Treatment2 Interventions
480mg/480mg (sequential administration)
Group II: Cohort 2: Nivolumab and RelatlimabExperimental Treatment2 Interventions
480mg/960mg or 480mg/160mg (sequential administration)
Group III: Cohort 1: 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
557 Previous Clinical Trials
32,858 Total Patients Enrolled
1 Trials studying Tumors
2 Patients Enrolled for Tumors
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,472 Total Patients Enrolled
12 Trials studying Tumors
2,128 Patients Enrolled for Tumors
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,599 Total Patients Enrolled
3 Trials studying Tumors
1,244 Patients Enrolled for Tumors

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03607890 — Phase 2
Tumors Research Study Groups: Cohort 2: Nivolumab and Relatlimab, Cohort 1: Nivolumab and Relatlimab, Cohort 3: Nivolumab and Relatlimab
Tumors Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03607890 — Phase 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03607890 — Phase 2

Frequently Asked Questions

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

Is Nivolumab a danger to people when used as directed?

"While there is some data supporting Nivolumab's safety, it is only from a Phase 2 trial, so it received a score of 2."

Answered by AI

What are the main benefits of Nivolumab?

"Nivolumab is most often used as a cancer treatment, but it can also be used to manage unresectable melanoma, squamous cell carcinoma, metastatic esophageal adenocarcinoma, and other conditions."

Answered by AI

Have similar investigations been conducted before this one?

"749 clinical trials for Nivolumab are ongoing in 2348 cities across 50 nations. The first study began a decade ago in 2010 and, after completing Phase 1 drug approval, ended with 127 participants. To date, 249 similar studies have been completed."

Answered by AI

Are there other investigational treatments that use Nivolumab?

"At the moment, there are 749 different clinical trials ongoing that involve the use of Nivolumab. Out of those, 82 have reached Phase 3. The great majority of these studies are based in Zürich, BE; however, there are 40408 total locations running Nivolumab trials."

Answered by AI

How many people fit the requirements to participate in this clinical trial?

"Yes, according to the listing on clinicaltrials.gov, this trial is still looking for patients. The study was first posted on November 16th, 2018 and was most recently updated on August 30th, 2020. They are currently 42 participants needed from 1 site."

Answered by AI

Are new enrollees still being sought for this program?

"That is correct, the information hosted on clinicaltrials.gov does state that this particular trial is currently looking for patients to enroll. The date the trial was first posted was November 16th, 2018 with the most recent edit being made on August 30th, 2022. They are only 42 participants needed at a single location."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor
2018. "Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03607890.
~3 spots leftby Oct 2024
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