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NOT_YET_RECRUITINGPHASE2

Phase 2 Trial of Zanzalintinib and Pembrolizumab in Select Subtypes of Advanced/Metastatic Soft-tissue Sarcoma

NCT07283731•M.D. Anderson Cancer Center

Summary

To learn if zanzalintinib and pembrolizumab can help to control select subtypes of advanced/metastatic soft-tissue sarcoma (UPS, MFS, HGPS, and HGUS

Detailed Description

Primary Objectives 1\. To estimate the progression free survival (PFS), defined as the time from enrollment to time of first event (progressive disease per RECIST v.1.1 criteria or death from any cause) after receiving zanzalintinib and pembrolizumab or date of last contact for participants without an event Secondary Objectives 1. To estimate the progression free rate (progressive disease per RECIST v.1.1 criteria70 or death from any cause after first drug) at 6 months and 1 year 2. To estimate the overall response rate (ORR) as measured by RECIST v1.1 a 3. To describe the toxicity of zanzalintinib and pembrolizumab, defined by the rate of Grade 3 or higher adverse events by CTCAE v5 criteria

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Eligibility Criteria
•Participants must have histologically or cytologically confirmed undifferentiated pleomorphic sarcoma (UPS), myxofibrosarcoma (MFS), high grade pleomorphic (HGPS) or undifferentiated sarcoma (HGUS).
•Participant ≥ 18 years of age. Because no dosing or adverse event data are currently available on the use of zanzalintinib in combination with pembrolizumab in participants \<18 years of age, children are excluded from this study.
•ECOG performance status ≤2 (Karnofsky ≥60%).
•Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam.
•At least 4 weeks since prior chemotherapy.
•At least 2 weeks since radiation therapy for bone metastases, any other radiation therapy within 4 weeks before first dose of study treatment. At least 6 weeks since systemic treatment with radionuclides before first dose of study treatment.
•Participants must have adequate organ and marrow function as defined below within 14 days before first dose of study treatment:
•absolute neutrophil count ≥1,500/mcL without granulocyte colony-stimulating factor support within 2 weeks of screening laboratory sample collection.
•platelets ≥100,000/mcL without transfusion within 2 weeks of screening laboratory sample collection.
+26 more criteria

Exclusion Criteria

•Prior treatment with immune checkpoint inhibitors (ICIs)
•Prior treatment with zanzalintinib
•Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.
•Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia.
•Participants who are receiving any other investigational agents, as well as cytotoxic or biological systemic anticancer therapy including investigational treatments within 4 weeks of initiating study treatment are excluded.
•Concomitant anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin inhibitors) and platelet inhibitors (eg, clopidogrel).
•* Allowed anticoagulants are the following:
•1. Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).
•2. Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.
•Note: Subjects must have discontinued oral anticoagulants within 3 days or 5 half-lives prior to first dose of study treatment, whichever is longer.
+39 more criteria

Locations (1)

MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

June 2, 2026

Primary Completion Date

November 1, 2028

Completion Date

November 1, 2030

Last Updated

February 17, 2026

Enrollment

ESTIMATED participants

Conditions

Phase 2ZanzalintinibPembrolizumabAdvanced/MetastaticSoft-Tissue Sarcoma

Interventions

Zanzalintinib

DRUG

Pembrolizumab

DRUG

Contacts

Michael S Nakazawa, MD

CONTACT

(713) 410-3409 msnakazawa@mdanderson.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase 2 Trial of Zanzalintinib and Pembrolizumab in Select Subtypes of Advanced/Metastatic Soft-tissue Sarcoma

Inclusion Criteria

Exclusion Criteria

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