RECRUITING

Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor

Conditions

Refractory MSI - H Solid Tumors Prior of PD-(L) 1 Therapy MSI-H Tumors Relatlimab Nivolumab Immunotherapy Anti - PD-1 Anti - LAG-3 Antibodies MSI MMR deficient Microsatellite instability

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the safety and clinical activity of nivolumab and relatlimab in patients with microsatellite instability high (MSI-H) solid tumors refractory to prior PD-(L)1 therapy.

Official Title

Phase 2 Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor

Quick Facts

Study Start:2018-11-16

Study Completion:2025-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03607890

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age ≥18 years. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Have metastatic or locally advanced mismatch repair deficient/MSI-H disease. * Patients must have received prior PD-1/PD-L1 inhibitor therapy * Patients with the presence of at least one measurable lesion. * Life expectancy of greater than 3 months. * Patients must have adequate organ and marrow function defined by study - specified laboratory tests. * Documented left ventricular ejection fraction (LVEF) ≥ 50% - 6 month prior to drug administration. * Must use acceptable form of birth control while on study. * Ability to understand and willingness to sign a written informed consent document.	* Known history or evidence of brain metastases. * Require any antineoplastic therapy. * History of prior treatment with anti-LAG3. * Had chemotherapy, radiation, or steroids within 14 days prior to study treatment. * Had any investigational cytotoxic drug within 4 weeks prior to study treatment. * Have received any investigational drugs, a live vaccine, any allergen hyposensitization therapy, growth factors or major surgery within 28 days prior to study treatment. * Major surgery * Hypersensitivity reaction to any monoclonal antibody. * Has an active known or suspected autoimmune disease. * Has a diagnosis of immunodeficiency. * Prior tissue or organ allograft or allogeneic bone marrow transplantation. * Requires daily supplemental oxygen * History of interstitial lung disease. * Significant heart disease * History of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent. * Infection with HIV or hepatitis B or C at screening. * Has an active infection. * Unable to have blood drawn. * Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Prior life-threatening toxicity to anti-PD-1, anti-PD-L1, anti-PD-L2,or anti-CTLA4 * Woman who are pregnant or breastfeeding.

Inclusion Criteria

Exclusion Criteria

* Age ≥18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Have metastatic or locally advanced mismatch repair deficient/MSI-H disease.
* Patients must have received prior PD-1/PD-L1 inhibitor therapy
* Patients with the presence of at least one measurable lesion.
* Life expectancy of greater than 3 months.
* Patients must have adequate organ and marrow function defined by study - specified laboratory tests.
* Documented left ventricular ejection fraction (LVEF) ≥ 50% - 6 month prior to drug administration.
* Must use acceptable form of birth control while on study.
* Ability to understand and willingness to sign a written informed consent document.

* Known history or evidence of brain metastases.
* Require any antineoplastic therapy.
* History of prior treatment with anti-LAG3.
* Had chemotherapy, radiation, or steroids within 14 days prior to study treatment.
* Had any investigational cytotoxic drug within 4 weeks prior to study treatment.
* Have received any investigational drugs, a live vaccine, any allergen hyposensitization therapy, growth factors or major surgery within 28 days prior to study treatment.
* Major surgery
* Hypersensitivity reaction to any monoclonal antibody.
* Has an active known or suspected autoimmune disease.
* Has a diagnosis of immunodeficiency.
* Prior tissue or organ allograft or allogeneic bone marrow transplantation.
* Requires daily supplemental oxygen
* History of interstitial lung disease.
* Significant heart disease
* History of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent.
* Infection with HIV or hepatitis B or C at screening.
* Has an active infection.
* Unable to have blood drawn.
* Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Prior life-threatening toxicity to anti-PD-1, anti-PD-L1, anti-PD-L2,or anti-CTLA4
* Woman who are pregnant or breastfeeding.

Contacts and Locations

Study Contact

Colleen Apostal, RN

CONTACT

410-614-3644

GIClinicaltrials@jhmi.edu

Joann Santmyer, RN

CONTACT

410-614-3644

GIClinicaltrials@jhmi.edu

Principal Investigator

Dung Le, MD

PRINCIPAL_INVESTIGATOR

Johns Hopkins Medical Institution

Study Locations (Sites)

Cedars Sinai Medical Center

Los Angeles, California, 90048

United States

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231

United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Dung Le, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins Medical Institution

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-11-16

Study Completion Date2025-10

Study Record Updates

Study Start Date2018-11-16

Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

Relatlimab
Nivolumab
Immunotherapy
Anti - PD-1
Anti - LAG-3
Antibodies
MSI
MMR deficient
Microsatellite instability

Additional Relevant MeSH Terms

Refractory MSI - H Solid Tumors Prior of PD-(L) 1 Therapy
MSI-H Tumors