NCT06683755

Phase I/IIa Dose Finding Study of Triplet Regimen of Relatlimab Ipilimumab and NIvolumab in First Line Therapy of Metastatic Melanoma (TRINITY)

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the recommended Phase IIa dose (RP2D) of the triplet combination. To determine the safety and efficacy of the combination at the RP2D.

Detailed description

Primary Objectives: Phase I: Primary Objective of the Phase I portion is to determine the recommended Phase IIa dose (RP2D) of ipilimumab in combination with nivolumab and relatlimab in the first line treatment of patients with metastatic melanoma. Phase IIa: Primary Objective of the Phase IIa portion is to determine the preliminary clinical efficacy of ipilimumab at the RP2D in combination with nivolumab and relatlimab in the first line treatment of patients with metastatic melanoma as determined by overall response rate (ORR) according to RECIST 1.1. Secondary Objectives: 1. Phase I: To assess the overall response rates by RECIST 1.1 (as assessed by Investigator/site designated radiologist). 2. Phase IIa: To determine the safety and tolerability of the triplet combination. 3. To assess the progression free survival (PFS), and overall survival for patients treated with the triplet combination 4. Assess the PFS and ORR to subsequent therapies in the second and third line setting. 5. Evaluate the pharmacodynamic effects of the combination in tumor tissues obtained at baseline (archival and/or fresh tissue), on treatment, and at time of progression. 6. Peripheral blood assays to assess for immunologic changes and immune cell subsets

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Nivolumab	Given by IV
DRUG	Relatlimab	Given by IV
DRUG	Ipilimumab	Given by IV

Timeline

• Start date: 2025-05-01
• Primary completion: 2030-08-16
• Completion: 2032-08-16
• First posted: 2024-11-12
• Last updated: 2024-11-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study