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

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Johns Hopkins Medicine

Status and phase

Enrolling
Phase 2

Conditions

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

Treatments

Drug: Nivolumab
Drug: Relatlimab

Study type

Interventional

Funder types

Other
Industry
NIH

Identifiers

NCT03607890
J18102
P50CA062924 (U.S. NIH Grant/Contract)
IRB00173534 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

42 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

42 participants in 3 patient groups

Cohort 1: Nivolumab and Relatlimab
Experimental group
Description:
480mg/160mg (co-administered)
Treatment:
Drug: Relatlimab
Drug: Nivolumab
Cohort 2: Nivolumab and Relatlimab
Experimental group
Description:
480mg/960mg or 480mg/160mg (sequential administration)
Treatment:
Drug: Relatlimab
Drug: Nivolumab
Cohort 3: Nivolumab and Relatlimab
Experimental group
Description:
480mg/480mg (sequential administration)
Treatment:
Drug: Relatlimab
Drug: Nivolumab

Trial contacts and locations

1

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Central trial contact

Colleen Apostal, RN; Joann Santmyer, RN

Data sourced from clinicaltrials.gov

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