NCT05182164 Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas
| NCT ID | NCT05182164 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institut Bergonié |
| Condition | Soft Tissue Sarcoma Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 119 participants |
| Start Date | 2022-04-25 |
| Primary Completion | 2026-12 |
Trial Parameters
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Brief Summary
Phase II trial with three independent strata to independently assess the effects of the association of pembrolizumab and cabozantinib in advanced sarcomas.
Eligibility Criteria
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, 11. Participant must have advanced disease and must not be a candidate for other approved therapeutic regimen known to