Phase II trial with three independent strata to independently assess the effects of the association of pembrolizumab and cabozantinib in advanced sarcomas.
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.
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,
Parallel
Association of pembrolizumab + cabozantinib
DrugA treatment cycle consists of 3 weeks. Pembrolizumab will be administered intraveinously on day 1 every 3 weeks (200 mg). Cabozantinib will be administered per os, once daily (40 mg), and given on a continuous basis.
Assessment of the efficacy of pembrolizumab and cabozantinib (independently for each stratum)
Efficacy will be assessed in terms of non-progression rate at 6 months and is defined as the proportion of patients with complete response (CR), or partial response (PR), or stable disease (SD) at 6 months from the start of the treatment, based on RECIST 1.1 criteria.
Best overall response, independently for each stratum
Best overall response is defined as the best response across all time points (RECIST 1.1). The best overall response is determined once all the data for the patient is known (RECIST 1.1).
1-year progression-free survival, independently for each stratum
Progression-free survival is defined as the delay between the start date of treatment and the date of progression (as per RECIST 1.1) or death (from any cause), whichever occurs first.
1-year overall survival, independently for each stratum
Overall survival is defined as the delay between the start date of treatment and the date of death (of any cause).
Safety profile, independently for each stratum: Common Terminology Criteria for Adverse Events version 5
Toxicity graded using the Common Terminology Criteria for Adverse Events version 5.
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