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 statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Pazopanib

    Drug

    Given by mouth

  • Trabectedin

    Drug

    Given by IV

  • Ipilimumab

    Drug

    Given by IV

  • Nivolumab

    Drug

    Given by IV

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: Phase I Dose Escalation: Treatment with Pazopanib + Trabectedin + Ipilimumab + NivolumabExperimental treatment 4 interventions

Trial outcomes

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

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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