Sacituzumab + Cisplatin for Ovarian and Uterine Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This is an open-label, Phase 1 study with a dose expansion cohort of Sacituzumab Govitecan in Combination with Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer. The goal of the study is to determine the optimal dose of sacituzumab govitecan for use in combination with cisplatin for treatment of epithelial ovarian and endometrial cancers.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications, but it does mention that ongoing therapy with any prohibited medications is not allowed. It's best to discuss your current medications with the trial team to see if they are compatible with the study requirements.
What safety data exists for Sacituzumab and Cisplatin in humans?
Cisplatin, also known as CDDP, has been used in various cancer treatments and is known to cause side effects like nausea, vomiting, and blood-related issues such as neutropenia (low white blood cell count) and thrombocytopenia (low platelet count). It can also cause kidney problems and hearing loss. Sacituzumab, marketed as Trodelvy, is generally used for breast cancer, but specific safety data for its combination with Cisplatin in ovarian and uterine cancer is not provided in the available research.12345
How is the drug Sacituzumab + Cisplatin different from other treatments for ovarian and uterine cancer?
Sacituzumab govitecan is unique because it is an antibody-drug conjugate (a targeted therapy that combines an antibody with a drug) that specifically targets the Trop-2 protein on cancer cells, delivering the chemotherapy drug SN-38 directly to them. This targeted approach is different from traditional chemotherapy, which affects both cancerous and healthy cells.678910
What data supports the effectiveness of the drug combination Sacituzumab and Cisplatin for ovarian and uterine cancer?
Cisplatin, a component of the treatment, has shown effectiveness in combination with other drugs like paclitaxel for improving survival rates in advanced ovarian cancer. Additionally, antibody-drug conjugates, like Sacituzumab, have shown promise in treating some cancers, suggesting potential benefits when combined with Cisplatin.1112131415
Who Is on the Research Team?
Amy D. Tiersten
Principal Investigator
Icahn School of Medicine at Mount Sinai Division of Hematology and Medical Oncology
Are You a Good Fit for This Trial?
This trial is for women aged 18+ with recurrent ovarian or endometrial cancer that's sensitive to platinum-based chemo, showing progression more than 6 months after the last dose. Participants must have a WHO performance status of 0-1 and measurable disease. They should not have severe diseases, be pregnant/nursing, or have had certain treatments recently.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Safety Run-in
Safety run-in phase utilizing a 3+3 design with dose de-escalation if toxicity is observed
Dose Expansion Cohort
Evaluate the preliminary efficacy and tolerability of the experimental regimen
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cisplatin
- Sacituzumab
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
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Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor