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 (NCT07444619)

🧪 Interventions in This Study

• Pazopanib (DRUG)
• Trabectedin (DRUG)
• Ipilimumab (DRUG)
• Nivolumab (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. 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.
2. Age: Patients must be \> 1 year of age and . 30 years of age at time of initiation of protocol therapy.
3. Diagnosis: Patients have a histologically or radiographically confirmed relapsed or refractory STS.
4. Disease Status: Patients must have evaluable disease. a. Patients may have CNS metastases at study entry, if they are previously treated or stable (defined by not requiring initiation or the need for increased steroids for 7 days).
5. Performance Level: Karnofsky . 50% for patients \> 16 years old, and Lansky . 50 for patients 1-16 years old. (See Appendix I)
6. 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. a. Patients must be fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. Delayed toxicities from chemotherapy (e.g. requiring electrolyte replacement, alopecia) will be permitted as long as they are stable or improving and approved by the study PI. i. Hematopoietic growth factor: At least 7 days must have elapsed since the last administration of filgrastim, or 14 days since administration of pegfilgrastim. ii. XRT: At least 7 days since the last dose of local palliative radiation therapy. Greater than 6 months must have elapsed since the last day of treatment if given total body irradiation, craniospinal irradiation. iii. Autologous or Allogenic Stem Cell Transplant: Complete resolution of graft versus host disease and no current need for immunosuppressive medication. Greater than 3 months must have elapsed since engraftment and no longer requiring transfusion of platelets or injection of colony stimulating factors.
7. 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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• The University of Texas M. D. Anderson Cancer Center — Houston, Texas

📞 Contact the Study Coordinator

Phone: (713) 563-9478

Email: bdbrown4@mdanderson.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Soft Tissue Sarcomas

• Hypofractionated Radiotherapy Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas — Nashville, Tennessee

Explore by condition: All Soft Tissue Sarcomas clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.