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Soft Tissue SarcomasPhase 1NCT07444619

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

A Phase 1 study testing Pazopanib, Trabectedin and Ipilimumab in people with Soft Tissue Sarcomas, run by M.D. Anderson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 30 years
Conditions the study is for
Soft Tissue Sarcomas
What is being tested?
Pazopanib, Trabectedin and Ipilimumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
12 Jun 2026to 31 Dec 2033
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.
  • 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)
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  • 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.
  • 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.

Who cannot join

  • 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.
  • 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)
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  • Anti-cancer Agents: Patients who are currently receiving other anti-cancer agents. (Please refer to section 4.1, Prior Therapy)
  • Medication Allergy:
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Brandon D Brown, MD contact

(713) 563-9478

bdbrown4@mdanderson.org

United States1 site, 1 recruiting

  • The University of Texas M. D. Anderson Cancer Center

    Houston, Texas, 77030

    Brandon D Brown, MD, 713-563-9478, bdbrown4@mdanderson.org

    Brandon D Brown, MD

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Primary Objectives:

  • To determine the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) of Pazopanib in combination with Trabectedin, Ipilimumab and Nivolumab.
  • To determine the safety and tolerance of Pazopanib when given in conjunction with Trabectedin, Ipilimumab and Nivolumab in pediatric and young adult patients with Recurrent STS.

Secondary Objective:

  • To observe and record disease response (anti-tumor activity). Although the clinical benefit of the combination (Pazopanib when given in conjunction with Trabectedin, Ipilimumab and Nivolumab) has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief. Outcomes for disease response include Best OverallResponse (BOR), Duration of Response (DOR), and Progression-Free Survival (PFS) will be analyzed.
Being tested
Pazopanib, Trabectedin, Ipilimumab, Nivolumab
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PazopanibDrug

    Also called Votrient

    Given by mouth

  • TrabectedinDrug

    Also called Yondelis

    Given by IV

  • IpilimumabDrug

    Also called Yervoy

    Given by IV

  • NivolumabDrug

    Also called Opdivo

    Given by IV

Study groups in NCT07444619
Study groupRoleWhat they receive
Phase I Dose Escalation: Treatment with Pazopanib + Trabectedin + Ipilimumab + NivolumabExperimentalParticipants 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
Receives: Drug: Pazopanib; Drug: Trabectedin; Drug: Ipilimumab; Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Through study completion; an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2026
  2. Study start12 Jun 2026
  3. Primary completion31 Dec 2031 (estimated)
  4. Study completion31 Dec 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07444619
Sponsor's protocol ID
2025-1035
Other IDs
NCI-2026-01398
Status last verified
Aug 2026
First submitted
26 Feb 2026
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pazopanib, Trabectedin and Ipilimumab in people with Soft Tissue Sarcomas, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Brandon D Brown, MD ((713) 563-9478, bdbrown4@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07444619.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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