Checkpoint Inhibitor

Relatlimab for Tumors

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

Life expectancy of greater than 3 months.

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up4 years

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Microsatellite Instability-High Tumors
Microsatellite Instability-High Solid Tumors

Eligibility Criteria

Inclusion Criteria

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

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You are expected to live for at least three more months.

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

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

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 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

Not yet FDA approved

Nivolumab

FDA approved

0 / 1Eligibility criteria met

Find a site

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

547 Previous Clinical Trials

32,658 Total Patients Enrolled

1 Trials studying Tumors

2 Patients Enrolled for Tumors

Bristol-Myers SquibbIndustry Sponsor

2,576 Previous Clinical Trials

4,033,783 Total Patients Enrolled

11 Trials studying Tumors

2,092 Patients Enrolled for Tumors

National Cancer Institute (NCI)NIH

13,412 Previous Clinical Trials

41,239,024 Total Patients Enrolled

3 Trials studying Tumors

1,244 Patients Enrolled for Tumors

Dung Le, MDPrincipal Investigator

Johns Hopkins Medical Institution

12 Previous Clinical Trials

667 Total Patients Enrolled

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.