Study of Sacituzumab Tirumotecan with or without Pembrolizumab for Ovarian Clear Cell Cancer
This study is for women aged 18 and older with ovarian clear cell cancer that has spread (metastatic) or come back (recurrent), and who have already received anti-PD1 therapy. It tests Sacituzumab tirumotecan, a drug that targets cancer cells, either alone or combined with pembrolizumab, a drug that helps your immune system fight cancer. The study aims to see how many patients respond to these treatments (Overall Response Rate). You must have a confirmed diagnosis of pure ovarian clear cell cancer and measurable disease to join. The study is currently recruiting 50 participants.
- Study design
- This is a randomized study, meaning participants will be assigned by chance to receive either Sacituzumab tirumotecan alone or Sacituzumab tirumotecan with pembrolizumab. It plans to enroll 50 participants.
- What's involved
- Treatment involves Sacituzumab tirumotecan given on days 1, 15, and 29, and pembrolizumab (if in that arm) on day 1, every 42 days. Treatment can last up to two years, and scans will be done regularly to check for changes.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progress will be monitored until your disease gets worse, you start new cancer treatment, become pregnant, pass away, withdraw from the study, or the study ends, for up to ten years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Sacituzumab Tirumotecan +/- Pembrolizumab in I/O Exposed Metastatic or Recurrent Ovarian Clear Cell Cancer
At a glance
Conditions
NCT07718854
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Tufts Medical Center
Boston, Massachusettsstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
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Inclusion
What this trial measures
- 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.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.
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