Trial of Relatlimab, Nivolumab, and Ipilimumab in Patients With Asymptomatic and Symptomatic Melanoma Brain Metastases

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT06712927
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — DRUG
    1 mg/kg of Ipilimumab will be administered via IV every 8 weeks. Participants will be assigned to Cohort A or B as per eligibility criteria. No randomization or blinding will occur
  • Nivolumab + Relatlimab FDC — DRUG
    Relatlimab 160mg + Nivo 480mg will be administered via IV every 4 weeks. Participants will be assigned to Cohort A or B as per eligibility criteria. No randomization or blinding will occur

Study Details

This is a multicenter, phase II trial of relatlimab (rela), nivolumab (nivo), and ipilimumab (ipi) in patients with asymptomatic and symptomatic melanoma brain metastases.

Key Dates

Start date
Aug 6, 2025
Status verified
May 2026
Primary completion
Nov 30, 2026
Completion
Feb 28, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: Asymptomatic
  • Experimental: Cohort B: Symptomatic

Primary Outcome Measure

Intracranial clinical benefit rate [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304
Divya Divya Pathak
650-492-3674
Phuong Q Pham
Allison Betof, MD, Phd (PRINCIPAL_INVESTIGATOR)

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