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
M.D. Anderson Cancer Center
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.
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,…
Eligibility
- Age range
- 1–30 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: All Recurrent STS are eligible for enrollment. All laboratory studies will need to be complete within 7 days prior to initiating protocol therapy. All imaging studies will need to be done within 28 days prior to starting treatment. 1. Age: Patients must be \> 1 year of age and . 30 years of age at time of initiation of protocol therapy. 2. Diagnosis: Patients have a histologically or radiographically confirmed relapsed or refractory STS. 3. Disease Status: Patients must have evaluable disease. a. Patients may have CNS metastases at study entry, if they are previously…
Interventions
- DrugPazopanib
Given by mouth
- DrugTrabectedin
Given by IV
- DrugIpilimumab
Given by IV
- DrugNivolumab
Given by IV
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas