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RECRUITINGPHASE2

Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas

NCT05182164•Institut Bergonié

Summary

Phase II trial with three independent strata to independently assess the effects of the association of pembrolizumab and cabozantinib in advanced sarcomas.

Detailed Description

3 independent, multicenter, prospective, signel-arm phase II trial, based on 2-stage Simon's optimal design, will be conducted in parallel to assess the efficacy of pembrolizumab + cabozantinib, in distinct populations of sarcomas: * stratum 1: advanced undiffenrentiated pleomorphic sarcoma * stratum 2: advanced osteosarcoma * stratum 3: advanced ewing sarcoma

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histology: undifferentiated pleomorphic sarcoma (stratum 1), bone osteosarcoma (stratum 2), bone or extraskeletal or Ewing sarcoma (stratum 3),
•2. Advanced non resectable / metastatic disease,
•3. Recurrent disease or progression after standard therapy,
•4. Documented progression according to RECIST criteria.
•5. Have provided tissue of a tumor lesion from \< 3 months old archival tissue sample obtained on locally advanced disease, or metastatis with no subsequent treatment since or from a newly obtained core or excisional biopsy,
•6. No more of three previous lines of systemic therapy for advanced disease,
•7. Age ≥ 18 years,
•8. Eastern Cooperative Oncology Group ≤ 1,
•9. Measurable disease according to RECIST v1.1 outside any previously irradiated field. At least one site of disease must be uni-dimensionally ≥ 10 mm,
•10. Life expectancy \> 3 months,
+10 more criteria

Exclusion Criteria

•1. Previous treatment with Pembrolizumab or Cabozantinib,
•2. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumabor any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways),
•3. Evidence of progressive or symptomatic central nervous system or leptomeningeal metastases,
•4. Men or women of childbearing potential who are not using an effective method of contraception; women who are pregnant or breast feeding, men or women who are planning to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment,
•5. Participation to a study involving a medical or therapeutic intervention in the last 21 days,
•6. Previous enrolment in the present study,
•7. Patient unable to follow and comply with the study procedures because of any geographical, familial, social or psychological reasons,
•8. Patient unable to swallow,
•9. Known hypersensitivity to any involved study drug or of its formulation components,
•10. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy is not considered a form of systemic treatment and is allowed.
+14 more criteria

Locations (10)

Institut Bergonie

Bordeaux, France

Centre Georges François Leclerc

Dijon, France

Centre Oscar Lambret

Lille, France

Centre Leon Berard

Lyon, France

Institut Paoli Calmettes

Marseille, France

Hôpital La Timone

Marseille, France

Institut Curie

Paris, France

Institut de Cancérologie de l'Ouest - Site René Gauducheau

Saint-Herblain, France

IUCT Oncopole

Toulouse, France

Institut Gustave Roussy

Villejuif, France

Key Dates

Start Date

April 25, 2022

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2027

Last Updated

October 7, 2025

Enrollment

119

ESTIMATED participants

Conditions

Soft Tissue Sarcoma AdultAdvanced Soft-tissue SarcomaEwing SarcomaOsteosarcomaUndifferentiated Pleomorphic Sarcoma

Interventions

Association of pembrolizumab + cabozantinib

DRUG

Contacts

Maud TOULMONDE, MD

CONTACT

+33556333333 m.toulmonde@bordeaux.unicancer.fr

Simone MATHOULIN-PELISSIER, MD, PhD

CONTACT

s.mathoulin@bordeaux.unicancer.fr

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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: October 7, 2025Data 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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Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas

Inclusion Criteria

Exclusion Criteria

Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors

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