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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07444619
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Soft Tissue Sarcomas

Eligibility Criteria

Sex
ALL
Age
1 Year - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Pazopanib — DRUG
    Given by mouth
  • Trabectedin — DRUG
    Given by IV
  • Ipilimumab — DRUG
    Given by IV
  • Nivolumab — DRUG
    Given by IV

Study Details

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.

Key Dates

Start date
Aug 31, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2031
Completion
Dec 31, 2033

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas M. D. Anderson Cancer CenterHoustonTexas77030
Brandon D Brown, MD
[email protected]
713-563-9478
Brandon D Brown, MD (PRINCIPAL_INVESTIGATOR)

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By research site
The University of Texas M. D. Anderson Cancer Center· Houston, TX

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