Sacituzumab Tirumotecan +/- Pembrolizumab for Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for women aged 18+ with a confirmed diagnosis of pure ovarian clear cell cancer that has come back or spread after at least one prior chemo and immune therapy. Participants must have measurable disease, good organ function, not be pregnant or breastfeeding, and meet other health requirements.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Sacituzumab tirumotecan alone or in combination with pembrolizumab in 42-day cycles for up to two years
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for disease progression and survival status
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- Sacituzumab tirumotecan
Trial Overview
The study tests sacituzumab tirumotecan (a targeted antibody-drug) given by IV alone or combined with pembrolizumab (an immunotherapy), in people whose ovarian clear cell cancer returned after previous treatments. The two regimens are studied separately.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tufts Medical Center
Lead Sponsor
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