Clinical Trials /

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

NCT03607890

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: J18102
  • SECONDARY ID: IRB00173534
  • NCT ID: NCT03607890

Conditions

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

Interventions

DrugSynonymsArms
Nivolumabanti-PD-1, OPDIVONivolumab and Relatlimab
RelatlimabBMS-986016Nivolumab and Relatlimab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Nivolumab and RelatlimabExperimental
  • Nivolumab
  • Relatlimab

Eligibility Criteria

        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

          -  Have disease progression.

          -  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.

          -  Have received any investigational drugs, a live vaccine, any allergen
             hyposensitization therapy, growth factors or major surgery within 28 days prior to
             study treatment.

          -  Hypersensitivity reaction to any monoclonal antibody.

          -  Has uncontrolled intercurrent acute or chronic medical illness.

          -  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.
      
Maximum Eligible Age:100 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time Frame:4 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Number of participants experiencing study drug-related toxicities
Time Frame:4 years
Safety Issue:
Description:
Measure:Overall survival (OS) using RECIST 1.1
Time Frame:4 years
Safety Issue:
Description:
Measure:Progression free survival (PFS) using RECIST 1.1
Time Frame:4 years
Safety Issue:
Description:
Measure:Disease control rate (DCR) using RECIST 1.1
Time Frame:4 years
Safety Issue:
Description:
Measure:Best overall response (BOR) using RECIST 1.1
Time Frame:4 years
Safety Issue:
Description:
Measure:Duration of response (DOR) using RECIST 1.1
Time Frame:4 years
Safety Issue:
Description:
Measure:Duration of clinical benefit (DCB) using RECIST 1.1
Time Frame:4 years
Safety Issue:
Description:
Measure:Time to objective response (TTOR) using RECIST 1.1
Time Frame:4 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Trial Keywords

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

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