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ACTIVE NOT RECRUITING
NCT03355976
PHASE2

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

Sponsor: Brown University

View on ClinicalTrials.gov

Summary

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.

Official title: BrUOG 354: A Phase II Randomized Trial of Nivolumab +/- Ipilimumab for Ovarian and Extra-renal Clear Cell Carcinomas

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2018-04-30

Completion Date

2026-09

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

DRUG

Nivolumab

240mg flat dose every 2 weeks

DRUG

Ipilimumab

Ipilimumab 1mg/kg every 6 weeks

Locations (4)

University of Illinois Chicago

Chicago, Illinois, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Women & Infants Hospital

Providence, Rhode Island, United States

The Miriam Hospital

Providence, Rhode Island, United States