BrUOG 354 Nivolumab +/- Ipilimumab for Ovarian and Extra-renal Clear Cell Carcinomas

Preclinical and early-phase clinical data suggest that immune modulation represents a treatment strategy that is worthy of further investigation in relapsed epithelial ovarian cancer. One method by which tumor cells may evade immune surveillance is by activation of the programmed cell death (PD-1) pathway, mediated by expression of PD-1 on the surface of T lymphocytes, which conveys an inhibitory signal after binding to its ligand PD-L1 on the surface of tumor cells. Nivolumab and Ipilimumab have shown activity as monotherapies in solid tumors and very early data suggest that nivolumab may be particularly active for ovarian clear cell carcinoma.(Hamanishi et al., 2015). Given the uniformly poor prognosis for patients with clear cell carcinoma in general, we are interested in formally evaluating this agent in all extra-renal clear cell carcinomas.

NCT Number	NCT03355976
Lead Sponsor	Brown University Collaborators: Bristol-Myers Squibb, Rhode Island Hospital, The Miriam Hospital, Women and Infants Hospital of Rhode Island
Conditions	Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Extra Renal Origin, Clear Cell Adenocarcinoma
Enrollment	46 participants
Start Date	2018-04-30
Primary Completion	2026-06 (estimated)
Study Completion	2026-09 (estimated)
Updated on ClinicalTrials.gov	2026-04-02