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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age1-30
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

Age: Patients must be > 1 year of age and . 30 years of age at time of initiation of protocol therapy.

Diagnosis: Patients have a histologically or radiographically confirmed relapsed or refractory STS.

Disease Status: Patients must have evaluable disease.

Performance Level: Karnofsky . 50% for patients > 16 years old, and Lansky . 50 for patients 1-16 years old. (See Appendix I)

Disqualifiers

Significant organ dysfunction, not meeting inclusion criteria.

Pediatric subjects who are considered wards of some entity.

Pregnancy or Breast-Feeding Pregnant or breast-feeding woman will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies.

Growth factor: Growth factors that support platelet or white cell number or function must not have been administered within the past 7 days.

Trial design

Treatments tested in this trial

  • Pazopanib
  • Trabectedin
  • Ipilimumab
  • Nivolumab

Treatment groups

18 Participants
are divided into 1 treatment group

Sponsors and collaborators