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 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2025-1035NCI-2026-01398
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Soft Tissue Sarcomas

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (1)

Phase I Dose Escalation: Treatment with Pazopanib + Trabectedin + Ipilimumab + Nivolumab

EXPERIMENTAL

Participants will begiven: * Ipilimumab 1 mg/kg IV q9 weeks * Trabectedin 1.2 mg/m² IV over 3h q3 weeks * Nivolumab 3 mg/kg IV q3 weeks * Pazopanib dose levels * Escalating Pazopanib x 200mg (100 mg/m2/day for pediatric) PO daily per 7-day intervals until dose level continuation dose. * For pediatric participants, mg/m2/day dose will be calculated and the lower of fixed versus BSA-based dose will be used * Given tablet size of 200mg, dosing will be averaged over 7-day period * 200mg qD x 7d (level 0); 400mg qD (level 1) x 7d; 600mg qD (level 2) x 7d; 800mg qD (level 3) * 100mg/m2/day 7d (level 0); 200mg/m2/day 7d (level 1), 300mg/m2/day 7d (level 2), 400mg/m2/day (level 3) * Pre-phase with Trabectedin + Pazopanib \& Delay 1st Ipi/Nivo

Drug: Pazopanib; Drug: Trabectedin; Drug: Ipilimumab; Drug: Nivolumab

Interventions

Pazopanib DRUG

Given by mouth

Also known as: Votrient

Phase I Dose Escalation: Treatment with Pazopanib + Trabectedin + Ipilimumab + Nivolumab

Trabectedin DRUG

Given by IV

Also known as: Yondelis

Phase I Dose Escalation: Treatment with Pazopanib + Trabectedin + Ipilimumab + Nivolumab

Ipilimumab DRUG

Given by IV

Also known as: Yervoy

Phase I Dose Escalation: Treatment with Pazopanib + Trabectedin + Ipilimumab + Nivolumab

Nivolumab DRUG

Given by IV

Also known as: Opdivo

Phase I Dose Escalation: Treatment with Pazopanib + Trabectedin + Ipilimumab + Nivolumab

Eligibility Criteria

• Age: 1 Year - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.
• 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).
• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• Concomitant Medications:
• 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)
• Anti-cancer Agents: Patients who are currently receiving other anti-cancer agents. (Please refer to section 4.1, Prior Therapy)
• Medication Allergy:
• i. Allergy or intolerance to agents on this protocol: Trabectedin. Pazopanib, Ipilimumab or Nivolumab e. Infection: Patients who have uncontrolled infection, positive blood cultures within the past 48 hours, or receiving treatment for Clostridium difficile infection.
• Known history of human immunodeficiency virus (HIV) infection
• Known active infection of hepatitis B or Hepatitis C virus

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Sarcoma

Interventions

pazopanib; Trabectedin; Ipilimumab; Nivolumab

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Brandon D Brown, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brandon D Brown, MD

CONTACT

(713) 563-9478; bdbrown4@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 3, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2033
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

US (1)