Study Comparing Sacituzumab Govitecan and Bevacizumab to Standard Chemotherapy for Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Therapy

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT07504588

Provider View

This clinical trial is testing a new treatment combination of sacituzumab govitecan and bevacizumab against the usual chemotherapy for ovarian cancer that has returned after responding to platinum therapy and progressed after PARP inhibitor maintenance. The study focuses on patients with specific genetic mutations or deficiencies.

Patient Parameters

Program Overview

This study is exploring whether a new combination of treatments, sacituzumab govitecan and bevacizumab, can be more effective than the standard chemotherapy in treating ovarian cancer that has come back after initial treatment. The cancer must have responded to platinum-based therapy and then progressed after maintenance therapy with PARP inhibitors. The study targets patients with certain genetic mutations or deficiencies, such as BRCA1/2 mutations or homologous recombination deficiency.

Description

The main goal of this study is to see if the combination of sacituzumab govitecan and bevacizumab can help patients live longer without their cancer getting worse, compared to the standard treatment of carboplatin, pegylated liposomal doxorubicin, and bevacizumab. Researchers will also look at how well the new treatment works overall, how long it lasts, and its safety.

Patients will be randomly assigned to one of two groups:

  • Group 1: Will receive the standard treatment of carboplatin, pegylated liposomal doxorubicin, and bevacizumab. This treatment is given through an IV on specific days of a 21-day cycle, repeated for 6-10 cycles.

  • Group 2: Will receive sacituzumab govitecan and bevacizumab. This treatment is also given through an IV on specific days of a 21-day cycle, repeated for 6-10 cycles.

After completing the initial cycles, patients will continue with maintenance therapy using bevacizumab.

Throughout the study, patients will undergo various tests, including heart scans, CT or MRI scans, and blood tests, to monitor their health and the treatment's effects. After finishing the study treatment, patients will have follow-up visits every few months for up to five years.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with high-grade serous or endometrioid epithelial ovarian cancer, including fallopian tube, ovarian, and primary peritoneal cancer.
  • Cancer must have returned at least 6 months after the last platinum-based treatment.
  • Cancer must have progressed during first-line PARP inhibitor maintenance therapy.
  • Must have BRCA1/2 mutations or homologous recombination deficiency.
  • Cancer must be measurable or non-measurable by specific criteria.
  • No previous treatment with topoisomerase-I inhibitors.
  • No other cancer treatments within 4 weeks before joining the study.
  • Last PARP inhibitor dose must be at least 3 weeks before joining the study.
  • Treated brain metastases are allowed if stable and not requiring steroids.
  • Age 18 or older.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Not pregnant or nursing.
  • Meet specific blood count and organ function criteria.
  • No active infections or recent major surgeries.
  • No history of allergic reactions to study drugs.

Locations

FACILITYZIPCITYSTATE
Mercy Hospital Springfield65804SpringfieldMissouri

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.