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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 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.

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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.

Conditions Studied

Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma Clear Cell Adenocarcinoma Extra Renal Origin

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

FieldValue
Enrollment Target 46 participants
Start Date 2018-04-30
Est. Completion 2026-03
Phase Phase 2

Sponsor

Brown University

231 total trials

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What the Registry Record Tells You About NCT03355976

The ClinicalTrials.gov registry entry for NCT03355976 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (94% lower). The listed sponsor is Brown University, which has 231 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.