Phase II Study of Sacituzumab Govitecan for Recurrent or Metastatic Salivary Gland Cancers
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT05884320
This clinical trial is testing whether the drug sacituzumab govitecan can help control salivary gland cancer that has returned or spread to other parts of the body.
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Program Overview
The aim of this study is to find out if sacituzumab govitecan can effectively manage salivary gland cancer that has come back or spread. Researchers will also look at how long the treatment works, how long patients live without the cancer getting worse, and overall survival rates. The safety of the drug will also be assessed. Additionally, the study will explore biological markers that might predict how well patients respond to the treatment.
Description
This study is focused on patients with recurrent or metastatic (R/M) salivary gland cancers. It is divided into two groups:
- Cohort 1: Patients with adenoid cystic carcinoma (ACC) who have either not received treatment before or have had previous treatments.
- Cohort 2: Patients with other types of salivary gland cancers, such as salivary duct carcinoma (SDC), adenocarcinoma not otherwise specified (NOS), or mucoepidermoid carcinoma (MEC), who have had up to three lines of chemotherapy.
The study will measure how long the treatment works, how long patients live without the cancer getting worse, and overall survival rates. Safety and potential side effects will also be monitored. Researchers will explore biological markers that might predict how well patients respond to the treatment.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older with confirmed recurrent or metastatic salivary gland cancer.
- Cancer cannot be treated with surgery or radiotherapy aimed at curing it.
- Cancer must be measurable by scans.
- Good overall health with a performance status of 0 or 1.
- Willing to provide informed consent.
- Meet specific blood and organ function criteria, including:
- Hemoglobin level of at least 9 g/dL.
- Neutrophil count of at least 1 x 10^9/mL.
- Platelet count of at least 100 x 10^9/mL.
- Creatinine clearance of at least 30 mL/min.
- Liver function tests within specified limits.
- Women of childbearing potential must use two effective forms of birth control during and for 90 days after treatment.
- Men must agree to use contraception during and for 90 days after treatment.
Cohort 1 Specific Criteria:
- Patients with ACC who are either new to treatment or have had previous treatments.
- Cancer progression within 6 months.
Cohort 2 Specific Criteria:
- Patients with SDC, adenocarcinoma NOS, or MEC who have had up to three lines of chemotherapy.
- Patients with HER2-positive tumors must have tried HER2-targeted therapy or have a reason not to use it.
Exclusion Criteria
- Recent radiation therapy within 2 weeks before joining the study.
- Active brain disease unless stable and treated.
- Dependence on frequent blood transfusions.
- Recent cancer treatments within 4 weeks before starting the study drug.
- Participation in another clinical trial.
- History of other cancers unless treated and inactive for at least 1 year.
- Active infections requiring treatment within 10 days before starting the study drug.
- Serious medical conditions that increase risk, such as recent heart attack or uncontrolled diabetes.
- Pregnant or breastfeeding women.
- Allergies to study drugs or their components.
- Recent live-virus vaccination within 30 days before treatment.
- High-dose steroid use within 2 weeks before treatment.
- Cognitive impairment affecting consent.
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