drugset / Trial / NCT07718854

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

NCT07718854 ↗

Phase 2 Recruiting 50 enrolled Tufts Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2026-09
Primary completion
2036-09
Completion
2036-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody 400 mg Intravenous
Subject Sacituzumab Tirumotecan Other / unclassified 4 mg/kg Intravenous