Study on Sacituzumab Govitecan and Cisplatin for Treating Recurrent Ovarian and Endometrial Cancer Sensitive to Platinum

Sponsor: Icahn School of Medicine at Mount Sinai

Sponsor score: 0

ClinicalTrials ID:NCT06040970

This clinical trial is testing a new combination of drugs, sacituzumab govitecan and cisplatin, to find the best dose for treating ovarian and endometrial cancers that have returned and are sensitive to platinum-based treatments.

Patient Parameters

Parameter	Options

Program Overview

The purpose of this study is to determine the best dose of sacituzumab govitecan when used with cisplatin for treating ovarian and endometrial cancers that have come back and respond to platinum-based chemotherapy. The study will involve two groups of patients, one with ovarian cancer and the other with endometrial cancer, to evaluate the safety and effectiveness of this drug combination.

Description

This study is divided into two phases. In the first phase, researchers will test different doses of sacituzumab govitecan combined with cisplatin to find the safest and most effective dose for patients with ovarian and endometrial cancers. This phase will involve a small group of patients to ensure the treatment is safe.

In the second phase, the study will expand to include more patients to further evaluate how well the treatment works and how well patients tolerate it. The goal is to see if this combination can help control the cancer and improve patient outcomes.

Participants will receive the treatment until their cancer progresses, they experience unacceptable side effects, or they choose to stop. The study will closely monitor patients for any side effects and the overall response to the treatment.

Eligibility Criteria

Inclusion Criteria

Diagnosed with epithelial ovarian or endometrial cancer.
Cancer has returned and is sensitive to platinum-based chemotherapy, meaning it progressed more than 6 months after the last platinum treatment.
Female, aged 18 years or older.
Good overall health with a performance status of 0 or 1, indicating full activity or some restriction in strenuous activities.
Have at least one tumor that can be measured by scans.
Adequate blood counts and organ function, including:
- Hemoglobin of at least 8.5 g/dL.
- Neutrophil count of at least 1500/mm3.
- Platelet count of at least 100,000/μL.
- Normal liver and kidney function as indicated by specific blood tests.
Women of childbearing potential must agree to use effective contraception during the study and for 6 months after treatment.
Ability to understand and sign a written informed consent.

Exclusion Criteria

Have received any investigational drugs or treatments from another study within 28 days before starting this study.
Have had other chemotherapy or cancer treatments within 14 days before starting this study.
Have had major surgery within 4 weeks before starting this study.
Have unresolved side effects from previous treatments greater than grade 1, except for hair loss.
Have severe or uncontrolled medical conditions, including active infections like hepatitis B, C, or HIV.
Have known allergies to the study drugs or their components.
Have significant nerve damage or gastrointestinal issues.
Are pregnant or breastfeeding.
Have a history of significant heart or lung disease within 6 months before starting the study.
Have a history of significant bleeding or gastrointestinal issues within 6 months before starting the study.
Have other medical or psychiatric conditions that could interfere with the study.
Have previously received sacituzumab govitecan or similar drugs.
Have active inflammatory bowel disease or gastrointestinal perforation within 6 months before starting the study.
Require ongoing treatment with prohibited medications.
Have active brain metastases or cancer in the brain lining.
Have another active cancer, unless it has been completely treated and inactive for 3 years.
Have received a live vaccine within 30 days before starting the study.
Have a serious infection requiring treatment.

Locations

FACILITY	ZIP	CITY	STATE
Icahn School of Medicine at Mount Sinai Division of Hematology and Medical Oncology	10029	New York	New York

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