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BrUOG 354 Nivolumab +/- Ipilimumab for Ovarian and Extra-renal Clear Cell Carcinomas
NCT03355976 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03355976
The ClinicalTrials.gov registry entry for NCT03355976 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brown University, which has 268 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03355976 reports 4 study locations spanning 2 distinct geographic areas — top geographies include Rhode Island, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03355976?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03355976?
This trial is sponsored by Brown University, which has 268 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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