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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Tufts Medical Center
Study ID
NCT07718854
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Metastatic Ovarian Cancer
  • Ovarian Clear Cell Carcinoma
  • Recurrent Ovarian Clear Cell Adenocarcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sacituzumab tirumotecan — DRUG
    Sacituzumab tirumotecan
  • Pembrolizumab — DRUG
    pembrolizumab

Study Details

This is a phase II randomized 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.

Key Dates

First listed
Jul 22, 2026
Start date
Jun 30, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2032
Completion
Mar 31, 2032

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sacituzumab tirumotecan + Pembrolizumab
    Sacituzumab tirumotecan will be administered at a dose of 4 mg/kg by IV infusion on Days 1, 15, and 29 of each 42-day (6 week) cycle. Pembrolizumab is administered at a dose of 400 mg by IV infusion on Day 1 of each 42-Day cycle. Pembrolizumab is administered prior to premedications for - and infusion of - Sacituzumab.
  • Experimental: Sacituzumab tirumotecan
    Sacituzumab tirumotecan will be administered at a dose of 4 mg/kg by IV infusion on Days 1, 15, and 29 of each 42-day (6 week) cycle.

Primary Outcome Measure

Overall Response Rate (ORR). [ Time Frame: First scan collected within 28 days prior to randomization, then according to the schedule above until disease progression, new anticancer therapy, pregnancy, death, withdrawal of consent, or the end of the study, whichever occurs first, up to ten years. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Tufts Medical CenterBostonMassachusetts02111
Neely Center for Clinical Cancer Research
[email protected]
617-636-5000
Don S Dizon, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Tufts Medical Center· Boston, MA

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