Ovarian Cancer Clinical Trial
Official title:
To Assess the Tolerance of Intraperitoneal (IP) Nivolumab After Extensive Debulking Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Ovarian Carcinoma, Through a Phase Ib/II Study Including Patients at 3 Dose-levels for Nivolumab
Spread pattern, the lack of alternative treatments, and emerging data on the activity of
anti-Programmed death ligand 1 (PDL1) targeted checkpoint inhibitor therapy in gynecological
cancers provide the rationale for this investigation.
Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) are likely to increase the
tumor-antigen expression and the mutational load. As a result, it would be interesting to
combine this approach with immunotherapy. Moreover, Intraperitoneal (IP) infusion will
directly target the peritoneal cavity and potentially enhance the immune response. Indeed
some recent papers indicate that the peritoneum could be considered as a lymphoid organ,
involving "milky spots", thus able to produce a better immune response when immunotherapy is
given by IP route rather than intravenous (IV) route.
The investigating team in Lyon, France is one of the major groups for HIPEC research in
Europe (Pr O. Glehen et al) - Reference center for the tumors of the peritoneum (French
National Cancer Institute).
The aim of this study is to assess in this I/II phase study, the feasibility of extensive
debulking surgery and HIPEC followed by Intraperitoneal (IP) nivolumab dose escalation in
patients with advanced ovarian carcinoma.
n/a
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