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NCT03355976 · ClinicalTrials.gov registry record · Phase 2
BrUOG 354 Nivolumab +/- Ipilimumab for Ovarian and Extra-renal Clear Cell Carcinomas
A Phase 2 study of Ovarian Cancer and Fallopian Tube Cancer, sponsored by Brown University.
- Active
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 4
- Study locations
NCT03355976: Active Phase 2 study of Ovarian Cancer and Fallopian Tube Cancer, sponsored by Brown University.
NCT03355976 is a Phase 2 study of Ovarian Cancer and Fallopian Tube Cancer that is active but no longer recruiting, run by Brown University. The registered enrollment target is 46 participants, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (94% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03355976, a Phase 2 study of Ovarian Cancer and Fallopian Tube Cancer, is active but no longer recruiting, sponsored by Brown University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
RECIST 1.1 and immune mediated RECIST. Confirmatory scans are required. Patients may remain on study post initial progression, but are required to be removed from treatment if they progress an additional 10%.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
Study Locations (4)
Rhode Island
- Rhode Island Hospital - Providence
- Women & Infants Hospital - Providence
- The Miriam Hospital - Providence
Illinois
- University of Illinois Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2018-04-30 |
| Est. Completion | 2026-03 |
| Phase | Phase 2 |
What the registry record for NCT03355976 still lists
NCT03355976 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (94% lower).
The record links to 5 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.
NCT03355976 reports a single indexed study location in Rhode Island, Illinois.
Frequently Asked Questions
What is clinical trial NCT03355976 about?
NCT03355976 is a clinical study titled "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) p...
What is the current status of trial NCT03355976?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2018-04-30. Estimated completion is 2026-03.
What conditions does trial NCT03355976 study?
This clinical trial studies the following conditions: Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Clear Cell Adenocarcinoma, Extra Renal Origin.
What interventions are being tested in trial NCT03355976?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG).
Who is sponsoring clinical trial NCT03355976?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03355976 being conducted?
This trial has 4 study locations across Illinois, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03355976's enrollment target sits among peer trials
46 217th of 322 higher than 105 of 322 other Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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