A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) i… (NCT07444619) | Clinical Trial Compass
Not Yet RecruitingPhase 1
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
United States18 participantsStarted 2026-08-31
Plain-language 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.
Who can participate
Age range1 Year – 30 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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)
✓. Prior Therapy: Patients may have received prior therapy including single-agent pazopanib or trabectedin. Patients may not have previously been treated with combination therapy of pazopanib and trabectedin.
✓. Organ Function Requirements a. Bone Marrow Function: i. Peripheral absolute neutrophil count (ANC) . 750/ƒÊL ii. Platelet count . 75,000/ƒÊL (no platelet transfusion within 7 days prior to obtaining laboratory result) b. Adequate Renal Function: i. Creatinine clearance or glomerular filtration rate . 70ml/min/1.73m2 (calculated or measured as appropriate for age and level of concern by treating MD) c. Adequate Liver Function: i. Total bilirubin . 1.5x upper limit of normal (ULN) for age ii. SGPT (ALT) . 3 x ULN iii. Serum albumin . 2gm/dL Due to the risk of hepatic injury, including fatal hepatic failure, temozolomide should not be administered if total bilirubin is \>2.0 mg/dl or SGPT(ALT)\> 3 x ULN.
Exclusion criteria
✕. Growth factor: Growth factors that support platelet or white cell number or function must not have been administered within the past 7 days.
✕. Investigational Drugs: Patients who are currently receiving another investigational drug. (Please refer to section 4.1, Prior Therapy)
What they're measuring
1
Safety and Adverse Events (AEs)
Timeframe: Through study completion; an average of 1 year