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,
Institut Bergonié
Lead sponsor
Ipsen
Collaborator
MSD France
Collaborator