Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers

What is the Purpose of this Study?

The purpose of this study is to evaluate how the combination of the drugs nivolumab and relatlimab might work in people with advanced cancer that is “microsatellite instability high” (MSI-H). Microsatellite instability is a marker in the tumor tissue that suggests abnormalities in the tumor that result in deficient repair of the DNA and whose cancer has grown on a previous immunotherapy. Tumors that are MSI-H have a defect in repair of DNA. Another goal of the study is to learn more about the safety of these drugs. All participants will receive the same drugs. Nivolumab and relatlimab are human antibodies made in the laboratory. An antibody is a type of protein normally made in the body by immune cells that helps protect the body against foreign matter. Nivolumab and relatlimab attach to and block proteins that are found on different cells of the immune system and may stop these immune cells from being shut down, allowing them to help the body destroy cancer cells. The use of nivolumab and relatlimab in this study is experimental.

Eligibility

* 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

Inclusion 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.

Exclusion Criteria:

* 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.

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Where can I participate?

Cedars-Sinai Cancer at SOCC : Abrahm Levi

More about this Clinical Trial

What is the full name of this clinical trial?

EIIT-J18102: Phase 2 Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-1 Inhibition

Study Details

Disease Type/Condition

Unknown Sites

Principal Investigator

Hendifar, Andrew

Co-Investigators

Arsen Osipov, Jun Gong, Kamya Sankar

Age Group

Adult

Phase

IRB Number

STUDY00003199

ClinicalTrials.gov ID

NCT03607890

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

Name

Abrahm Levi

Abrahm.Levi@cshs.org