A Phase 2 Randomized Trial of Sacituzumab Tirumotecan (MK2870) Alone and in Combination With Pembrolizumab in Ovarian Clear Cell Carcinoma Previously Exposed to Immunotherapy
Tufts Medical Center
Summary
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.
Description
The treatment plan consists of Sacituzumab tirumotecan administered at 4 mg/kg on days 1, 15, and 29 as a single agent (Arm 1) or in combination with pembrolizumab 400mg on day 1 (Arm 2). Each cycle will be 42 days. Treatment is administered for a maximum duration of two years on both arms. The interventions are summarized in Table 1.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: Type of Participant and Disease Characteristics 1. Has a histologically-confirmed diagnosis of pure OCCC. Patients with mixed histologies that include a clear cell component will not be eligible for this trial. 2. Has measurable disease per RECIST 1.1 as assessed by the local site investigator/ radiology. Lesions situated in a previously-irradiated area are considered measurable if progression has been shown in such lesions. 3. Patients must have received at least one prior platinum and taxane based chemotherapy regimen. Radiation therapy (including the use of chemotherap…
Interventions
- DrugSacituzumab tirumotecan
Sacituzumab tirumotecan
- DrugPembrolizumab
pembrolizumab
Location
- Tufts Medical CenterBoston, Massachusetts