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Not Yet RecruitingNCT07504588

Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy

A Randomized Phase II Trial of Sacituzumab Govitecan (SG) and Bevacizumab Versus Standard of Care Carboplatin, Pegylated Liposomal Doxorubicin (PLD) and Bevacizumab in Patients With Platinum-Sensitive Ovarian Cancer That Has Progressed on Prior Maintenance PARP Inhibitor Therapy

Status
Not Yet Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
87 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II trial compares the effect of sacituzumab govitecan and bevacizumab to standard care (carboplatin, pegylated liposomal doxorubicin, and bevacizumab) in patients with ovarian cancer that has come back after an initial response to platinum therapy (platinum-sensitive), that has progressed after poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor maintenance therapy (recurrent), and that has a mutation in the BRCA1 or BRCA2 genes or is homologous recombination deficient. Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a drug called govitecan. Sacituzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as TROP2 receptors, and delivers govitecan to kill them. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. Giving sacituzumab govitecan and bevacizumab may kill more tumor cells than standard care (carboplatin, pegylated liposomal doxorubicin, and bevacizumab) in patients with recurrent platinum-sensitive ovarian cancers that have BRCA1/2 mutations or homologous recombination deficiency.

Detailed description

PRIMARY OBJECTIVE: I. To assess the clinical activity of sacituzumab govitecan (sacituzumab govitecan-hziy \[SG\]) and bevacizumab (or an anti-VEGF antibody biosimilar) compared to standard of care carboplatin, pegylated liposomal doxorubicin hydrochloride (pegylated liposomal doxorubicin \[PLD\]) and bevacizumab (or an anti-VEGF antibody biosimilar), as measured by progression-free survival, in patients with platinum-sensitive ovarian cancer that has progressed while receiving first-line PARP inhibitor maintenance therapy. SECONDARY OBJECTIVES: I. To assess additional measures of clinical activity, including overall response rate and duration of response, of SG and bevacizumab compared to standard of care carboplatin, PLD and bevacizumab in patients with recurrent platinum-sensitive ovarian cancer. II. To assess the safety of SG and bevacizumab in patients with recurrent platinum-sensitive ovarian cancer. EXPLORATORY OBJECTIVES: I. To correlate clinical activity of SG and bevacizumab with TROP2 expression and tumor-specific cell-free deoxyribonucleic acid (cfDNA). II. To assess time to first subsequent therapy or death (TFST). III. To assess time to second subsequent therapy or death (TSST). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive carboplatin intravenously (IV) on day 1, PLD IV on day 1 (or gemcitabine IV on days 1 and 8), and bevacizumab (or anti-VEGF antibody biosimilar) IV on days 1 and 15 of each cycle. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. After 6-10 cycles, patients proceed to maintenance therapy. ARM II: Patients receive SG IV on days 1 and 8 and bevacizumab (or anti-VEGF antibody biosimilar) IV on day 1 of each cycle. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. After 6-10 cycles, patients proceed to maintenance therapy. MAINTENANCE: Patients receive bevacizumab (or anti-VEGF antibody biosimilar) IV on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients in Arm I also undergo echocardiography (ECHO) at screening and all patients undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) and collection of blood samples throughout the trial. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Conditions

Interventions

TypeNameDescription
BIOLOGICALAnti-VEGF Monoclonal AntibodyGiven IV
BIOLOGICALBevacizumabGiven IV
PROCEDUREBiospecimen CollectionUndergo collection of blood samples
DRUGCarboplatinGiven IV
PROCEDUREComputed TomographyUndergo CT
PROCEDUREEchocardiography TestUndergo ECHO
DRUGGemcitabineGiven IV
PROCEDUREMagnetic Resonance ImagingUndergo MRI
DRUGPegylated Liposomal Doxorubicin HydrochlorideGiven IV
BIOLOGICALSacituzumab GovitecanGiven IV

Timeline

Start date
2026-09-10
Primary completion
2029-04-12
Completion
2029-04-12
First posted
2026-04-01
Last updated
2026-04-13

Regulatory

Source: ClinicalTrials.gov record NCT07504588. Inclusion in this directory is not an endorsement.