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.
Age ≥18 years (at the time of informed consent).
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.
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.
Patients must have received at least one prior platinum and taxane-based chemotherapy regimen; maintenance treatment will not be counted as a separate regimen. Radiation therapy (including the use of chemotherapy as a radiosensitizer) will not count as a prior systemic regimen. There is otherwise no line limit for entry in to this trial.
None
Parallel
Sacituzumab tirumotecan
DrugSacituzumab tirumotecan
Pembrolizumab
Drugpembrolizumab
Objective response rate for sacituzumab tirumotecan alone and sacituzumab tirumotecan plus pembrolizumab, defined as the proportion of treated participants with a best overall response of complete response or partial response.
Responses will be confirmed by serial imaging (CT or MRI), conducted at least 4 weeks apart. Initial tumor scans at Screening must be performed within 28 days before randomization. The first on-study scan should be performed 6 weeks (42 days+7 days) from the date of randomization. Subsequent tumor scans should be performed every 12 weeks (84 days±7 days) or more frequently if clinically indicated for the first two years of treatment (Week 104). After Week 104 (±7 days), tumor scans should be performed every 16 weeks (112 days±7 days) until documentation of disease progression. Response will be evaluated by the investigator using RECIST 1.1 criteria, confirmed by repeat imaging performed at least 4 weeks after the initial documentation of response. Scans are to be performed until disease progression is identified by the investigator or until any of these conditions are met: * start of a new anticancer therapy * pregnancy * death * withdrawal of consent * the end of the study
Clinical benefit rate (Response+Stable disease at 6 months)
Clinical benefit rate is determined by confirmed resopnse or stable disease maintained for at least 6 months. Responses will be confirmed by serial imaging (CT or MRI), conducted at least 4 weeks apart. Initial tumor scans at Screening must be performed within 28 days before randomization. The first on-study scan should be performed 6 weeks (42 days+7 days) from the date of randomization. Subsequent tumor scans should be performed every 12 weeks (84 days±7 days) or more frequently if clinically indicated for the first two years of treatment (Week 104). After Week 104 (±7 days), tumor scans should be performed every 16 weeks (112 days±7 days) until documentation of disease progression. Scans are to be performed until disease progression is identified by the investigator or until any of these conditions are met: • start of a new anticancer therapy • pregnancy • death • withdrawal of consent • the end of the study
Toxicity of Treatment (Adverse Events)
All AEs, SAEs, and other reportable safety events that occur after the participant provides documented informed consent, but before intervention randomization, must be reported by the investigator if the participant is receiving placebo run-in or other run-in treatment, if the event causes the participant to be excluded from the study, or is the result of a protocol-specified intervention, including, but not limited to washout or discontinuation of usual therapy, diet, or a procedure. * All AEs (including those meeting serious criteria) from the time of intervention randomization through 90 days after cessation of study intervention must be reported by the investigator. * Pregnancies (as described in protocol section 8.4.1) * Any SAE brought to the attention of an investigator at any time outside the time specified above must be reported immediately to the Sponsor/Principal Investigator if the event is considered related to study intervention.
Progression-Free Survival (Time to progression of disease)
Disease progression event will be defined as progressive disease according to investigator RECIST 1.1 assessment or death. Responses will be confirmed by serial imaging (CT or MRI), conducted at least 4 weeks apart. Initial tumor scans at Screening must be performed within 28 days before randomization. The first on-study scan should be performed 6 weeks (42 days+7 days) from the date of randomization. Subsequent tumor scans should be performed every 12 weeks (84 days±7 days) or more frequently if clinically indicated for the first two years of treatment (Week 104). After Week 104 (±7 days), tumor scans should be performed every 16 weeks (112 days±7 days) until documentation of disease progression. Scans are to be performed until disease progression is identified by the investigator or until any of these conditions are met: * start of a new anticancer therapy * pregnancy * death * withdrawal of consent * the end of the study
Overall Survival (Time to death from any cause)
Participant survival follow-up status will be assessed approximately every 12 weeks to assess for survival status until death, withdrawal of consent, or the end of the study, whichever occurs first. The first survival follow-up assessment should be scheduled as described below: * For participants who discontinue treatment intervention and who will not enter Efficacy Follow-up, the first survival follow-up contact will be scheduled 12 weeks after the Discontinuation Visit and/or Safety Follow-up Visit (whichever is last). * For participants who completed assessments in Efficacy Follow-up, the first survival follow-up contact will be scheduled 12 weeks after the last efficacy assessment follow-up visit has been performed.
Click on the lead sponsor to view all of their trials.
