RecruitingPhase 2

Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas

France119 participantsStarted 2022-04-25

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Histology: undifferentiated pleomorphic sarcoma (stratum 1), bone osteosarcoma (stratum 2), bone or extraskeletal or Ewing sarcoma (stratum 3),
✓. Advanced non resectable / metastatic disease,
✓. Recurrent disease or progression after standard therapy,
✓. Documented progression according to RECIST criteria.
✓. 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,
✓. No more of three previous lines of systemic therapy for advanced disease,
✓. Age ≥ 18 years,
✓. Eastern Cooperative Oncology Group ≤ 1,

Exclusion criteria

✕. Previous treatment with Pembrolizumab or Cabozantinib,
✕. 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),
✕. Evidence of progressive or symptomatic central nervous system or leptomeningeal metastases,
✕. 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,
✕. Participation to a study involving a medical or therapeutic intervention in the last 21 days,
✕. Previous enrolment in the present study,
✕. Patient unable to follow and comply with the study procedures because of any geographical, familial, social or psychological reasons,
✕. Patient unable to swallow,

What they're measuring

Assessment of the efficacy of pembrolizumab and cabozantinib (independently for each stratum)

Timeframe: 6 months

Trial details

NCT IDNCT05182164

SponsorInstitut Bergonié

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Maud TOULMONDE, MD

+33556333333 m.toulmonde@bordeaux.unicancer.fr

View on ClinicalTrials.gov More Soft Tissue Sarcoma Adult trials