Comparing Treatment with Sacituzumab Govitecan and Bevacizumab to Chemotherapy and Bevacizumab for Recurrent Ovarian Cancer After PARP Inhibitor Maintenance Therapy
Treatment
Phase 2 study for platinum-sensitive ovarian cancer that has progressed after PARP inhibitor
Clinicaltrials.gov identifier:NCT07504588
Study Contact Information:
Principal Investigator: Rebecca L Porter, NRG Oncology
Email: [email protected]
About the Study
This is a Phase II 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 ovarian cancer that has progressed after maintenance therapy. The study is open to people whose tumor has a mutation in the or genes or has a known as or HRD-positive.
Trodelvy is a type of 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 ovarian cancers.
This Study is Open To:
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 maintenance with a .
- Most have either an inherited or tumor or mutation (found by genetic testing or tumor testing) or positive for a called HRD-positive.
- Most have completed the last dose of treatment at least 3 weeks before study registration.
This Study is NOT Open To:
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.
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 of their heart at screening and all patients undergo CT and/or 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 .
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:
- 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.
Study Contact Information:
Principal Investigator: Rebecca L Porter, NRG Oncology
Email: [email protected]
Locations:
Arkansas
City: Fayetteville RECRUITING
Facility: Highlands Oncology Group - Fayetteville
Contact Info:
[email protected]
479-872-8100
Ewa M. Matczak
City: Rogers RECRUITING
Facility: Highlands Oncology Group - Rogers
Contact Info:
[email protected]
479-872-8130
Ewa M. Matczak
City: Springdale RECRUITING
Facility: Highlands Oncology Group
Contact Info:
[email protected]
479-872-8130
Ewa M. Matczak
Idaho
City: Coeur d'Alene RECRUITING
Facility: Kootenai Health - Coeur d'Alene
Contact Info:
[email protected]
406-969-6060
John M. Schallenkamp
City: Post Falls RECRUITING
Facility: Kootenai Clinic Cancer Services - Post Falls
Contact Info:
[email protected]
406-969-6060
John M. Schallenkamp
City: Sandpoint RECRUITING
Facility: Kootenai Clinic Cancer Services - Sandpoint
Contact Info:
[email protected]
406-969-6060
John M. Schallenkamp
Missouri
City: Springfield RECRUITING
Facility: Mercy Hospital Springfield
Contact Info:
417-269-4520
Jay W. Carlson
Montana
City: Billings RECRUITING
Facility: Billings Clinic Cancer Center
Contact Info:
[email protected]
800-996-2663
John M. Schallenkamp
City: Missoula RECRUITING
Facility: Community Medical Center
Contact Info:
[email protected]
406-969-6060
John M. Schallenkamp
Treatment
Phase 2 study for platinum-sensitive ovarian cancer that has progressed after PARP inhibitor
Clinicaltrials.gov identifier:NCT07504588
Study Contact Information:
Principal Investigator: Rebecca L Porter, NRG Oncology
Email: [email protected]