Tufts Medical Center
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.
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. To avoid the possibility of inappropriate or excessive accrual, an exact Simon minimax two-stage design will guide each arm. Confirmed responses will be determined by investigator-assessed RECIST 1.1 imaging, with the first tumor assessment at Week 6, followed b…
Inclusion Criteria An individual is eligible for inclusion in the study if the individual meets all of the following criteria: Type of Participant and Disease Characteristics 1. Age ≥18 years (at the time of informed consent). 2. 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. 3. 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 suc…
Sacituzumab tirumotecan
pembrolizumab
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