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Sacituzumab Tirumotecan +/- Pembrolizumab in I/O Exposed Metastatic or Recurrent Ovarian Clear Cell Cancer

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 years 5 months later Mar 2032 → Sep 2036
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Tufts Medical Center

Record History

  1. Primary and study completion pushed from Mar 2032 to Sep 2036 Primary endpoint(s) modified · Recruitment opened · Start date: Jun 2026 to Sep 2026 · 4 more Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Recruitment opened
    • Start date: Jun 2026 to Sep 2026
    • Eligibility criteria shortened, about 45 words
    • Secondary endpoints revised (4)
    • Study description expanded, about 559 words
    • Site details revised
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a phase II, two-arm, noncomparative screening study of Sacituzumab tirumotecan, an intravenous antibody-drug conjugate (ADC) that targets Trop-1, administered alone or in combination with pembrolizumab, a monoclonal antibody to PD-1 in patients with relapsed clear cell cancers that originated in the ovary, fallopian tube or peritoneal cavity, inclusive of endometriosis (collectively referred to as OCCC throughout the protocol) after previous treatment with anti-PD1 therapy. The regimens will be evaluated separately, and the study is not designed or powered to compare the regimens.
Trial Details
NCT Number NCT07718854
Lead Sponsor Tufts Medical Center
Conditions Ovarian Clear Cell Carcinoma, Metastatic Ovarian Cancer, Recurrent Ovarian Clear Cell Adenocarcinoma
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov