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

First listed

Jul 31, 2018

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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