NCT07444619

A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young Adult Patients With Recurrent Soft Tissue Sarcomas

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

Summary

The goal of this study is to build on the experience of the SAINT trial by evaluating the safety and efficacy of the addition of pazopanib to their published chemotherapy regimen.

Detailed description

Primary Objectives: * To determine the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) of Pazopanib in combination with Trabectedin, Ipilimumab and Nivolumab. * To determine the safety and tolerance of Pazopanib when given in conjunction with Trabectedin, Ipilimumab and Nivolumab in pediatric and young adult patients with Recurrent STS. Secondary Objective: • To observe and record disease response (anti-tumor activity). Although the clinical benefit of the combination (Pazopanib when given in conjunction with Trabectedin, Ipilimumab and Nivolumab) has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief. Outcomes for disease response include Best OverallResponse (BOR), Duration of Response (DOR), and Progression-Free Survival (PFS) will be analyzed.

Conditions

• Soft Tissue Sarcomas

Interventions

Type	Name	Description
DRUG	Pazopanib	Given by mouth
DRUG	Trabectedin	Given by IV
DRUG	Ipilimumab	Given by IV
DRUG	Nivolumab	Given by IV

Timeline

• Start date: 2026-08-31
• Primary completion: 2031-12-31
• Completion: 2033-12-31
• First posted: 2026-03-03
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study