Trials / Active Not Recruiting
Active Not RecruitingNCT03355976
BrUOG 354 Nivolumab +/- Ipilimumab for Ovarian and Extra-renal Clear Cell Carcinomas
BrUOG 354: A Phase II Randomized Trial of Nivolumab +/- Ipilimumab for Ovarian and Extra-renal Clear Cell Carcinomas
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Brown University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Ovarian Cancer
- Fallopian Tube Cancer
- Primary Peritoneal Carcinoma
- Extra Renal Origin
- Clear Cell Adenocarcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nivolumab | 240mg flat dose every 2 weeks |
| DRUG | Ipilimumab | Ipilimumab 1mg/kg every 6 weeks |
Timeline
- Start date
- 2018-04-30
- Primary completion
- 2026-06-01
- Completion
- 2026-09-01
- First posted
- 2017-11-29
- Last updated
- 2026-04-02
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03355976. Inclusion in this directory is not an endorsement.