Comparing Treatment with Sacituzumab Govitecan and Bevacizumab to Chemotherapy and Bevacizumab for Recurrent Ovarian Cancer After PARP Inhibitor Maintenance Therapy

About the Study

This is a Phase II randomized study that compares the effect of combining the medications sacituzumab govitecan (Trodelvy) plus bevacizumab (Avastin) to standard of care chemotherapy plus bevacizumab in people with platinum-sensitive ovarian cancer that has progressed after PARP inhibitor maintenance therapy. The study is open to people whose tumor has a mutation in the BRCA1 or BRCA2 genes or has a biomarker known as homologous recombination deficiency or HRD-positive.  

Trodelvy is a type of targeted therapy known as an antibody-drug conjugate. It combines an antibody and chemotherapy that works to deliver the chemotherapy directly to the cancer cells. The drug bevacizumab slows down the creation of blood vessels in the tumor cells which can slow its growth. 

This study will look at whether sacituzumab govitecan and bevacizumab is more effective at killing cancer cells than standard chemotherapy care in patients with recurrent platinum-sensitive ovarian cancers.

What the Study Involves

Participants will be selected by chance to participate in Group 1 or Group 2 of the study. 

All participants will undergo an ultrasound of their heart at screening and all patients undergo CT and/or MRI scans and collection of blood samples throughout the trial.

Group 1: Standard chemotherapy and bevacizumab 

•  Participants receive carboplatin by IV injection (injection in their vein) on day 1, PLD IV on day 1 (or gemcitabine IV on days 1 and 8), and bevacizumab IV on days 1 and 15 of each cycle. 
• Cycles repeat every 21 days for 6-10 cycles until their cancer gets worse or they have side effects that require stopping the medication.
•  After 6-10 cycles, patients proceed to maintenance therapy.

Group 2: Sacituzumab govitecan (SG) and bevacizumab

• Participants receive SG by IV injection (injection in their vein) on days 1 and 8 and bevacizumab IV on day 1 of each cycle. 
• Cycles repeat every 21 days for 6-10 cycles until their cancer gets worse or they have side effects that require stopping the medication.
• After 6-10 cycles, patients proceed to maintenance therapy.

Maintenance: 

• Patients receive bevacizumab IV on day 1 of each cycle. Cycles repeat every 21 days until their cancer gets worse or they have side effects that require stopping the medication.
• After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

People ages 18 years or older may be eligible if all of the following applies:

• Participants must have a diagnosis of ovarian cancer.
• Disease must be platinum sensitive.
• Cancer must have gotten worse during first-line maintenance with a PARP inhibitor. 
• Most have either an inherited or tumor BRCA1 or BRCA2 mutation (found by genetic testing or tumor testing) or positive for a biomarker called HRD-positive.
• Most have completed the last dose of PARP inhibitor treatment at least 3 weeks before study registration.

People cannot join if they:

• Have received other treatments for their disease progression since completing PARP inhibitors.
• Need to have surgery to remove the tumor during the study period. 
• Are receiving treatment with any other type of therapy. 
• Have a history or current symptoms of heart disease.
• Have uncontrolled high blood pressure.
• Have had major surgery within 3 weeks prior to study entry.