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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Jun 2026 → Oct 2026
See other at-risk trials from Brown University

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jun 2026 to Oct 2026
    • Study completion pushed from Sep 2026 to Dec 2026
    v18
  2. Primary completion date: Jan 2026 to Jun 2026
    • Study completion date: Mar 2026 to Sep 2026
    v17
  3. Primary completion date: Jul 2025 to Jan 2026
    • Study completion date: Oct 2025 to Mar 2026
    v16
  4. Primary completion date: Mar 2025 to Jul 2025
    • Study completion date: Jun 2025 to Oct 2025
    v15
  5. Primary completion date: Jun 2024 to Mar 2025
    • Study completion date: Dec 2025 to Jun 2025
    v14
Show 12 earlier versionsHide 12 earlier versions
  1. Primary completion date: Jun 2023 to Jun 2024v13
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 62 to confirmed 46
    • Site details revised at 4 of 4 sites
    v12
  3. Primary completion date: Dec 2022 to Jun 2023
    • Study completion date: Dec 2024 to Dec 2025
    v11
  4. Site contacts updated at 1 of 4 sitesv10
  5. Lead sponsor: Don Dizon to Brown University
    • Primary completion date: Dec 2021 to Dec 2022
    • Study completion date: Feb 2023 to Dec 2024
    • Collaborators: 5 to 4
    v9
  6. Study sites: 3 to 4v8
  7. Primary completion date: Feb 2021 to Dec 2021v7
  8. Primary completion date: Feb 2020 to Feb 2021
    • Study completion date: Feb 2022 to Feb 2023
    v6
  9. Study sites: 2 to 3
    • Eligibility criteria expanded, about 15 words
    • Collaborators: 4 to 5
    v5
  10. Eligibility criteria shortened, about 12 wordsv4
  11. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 2018 to Apr 30, 2018
    • Site details revised at 2 of 2 sites
    v3
  12. Study title shortened, about 6 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Brown University
80 trials monitored
See 9 trials at risk
Ovarian Cancer
1,336 trials monitored
See 90 trials at risk
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.
Trial Details
NCT Number NCT03355976
Lead Sponsor Brown University
Collaborators: Bristol-Myers Squibb, Rhode Island Hospital, The Miriam Hospital, Women and Infants Hospital of Rhode Island
Conditions
(from sponsor)		 Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Extra Renal Origin, Clear Cell Adenocarcinoma
Related terms Adenocarcinoma, Clear Cell, Fallopian Tube Neoplasms, Ovarian Neoplasms, Recurrence
Enrollment 46 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov