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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nivolumab — DRUG
  Patients will receive treatment every 28 days for up to 2 years. Nivolumab will be administered IV on day 1 (28 day cycle).
• Relatlimab — DRUG
  Patients will receive treatment every 28 days up to 2 years. Relatlimab will be administered IV on day 1 (28 day cycle).
• Nivolumab — DRUG
  Patients will receive treatment every 28 days for up to 2 years. Nivolumab will be administered IV on day 1 (28 day cycle).
• Relatlimab — DRUG
  Patients will receive treatment every 28 days up to 2 years. Relatlimab will be administered IV on day 1 (28 day cycle).
• Nivolumab — DRUG
  Patients will receive treatment every 28 days for up to 2 years. Nivolumab will be administered IV on day 1 (28 day cycle).
• Relatlimab — DRUG
  Patients will receive treatment every 28 days up to 2 years. Relatlimab will be administered IV on day 1 (28 day cycle).

Study Details

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.

Key Dates

Start date

Nov 16, 2018

Status verified

Mar 2026

Primary completion

Oct 31, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

38 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) [ Time Frame: 4 years ]

Locations (2)

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