Genetic Profile-Guided Therapy for Ovarian Cancer
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have taken an investigational drug (other than a PARP inhibitor) within 30 days or a PARP inhibitor within 14 days before starting the study treatment.
What data supports the effectiveness of the drug combination including Niraparib for ovarian cancer?
Is niraparib safe for use in humans?
How is the drug Niraparib unique in treating ovarian cancer?
Niraparib is unique because it is a PARP inhibitor that can be used as maintenance therapy for ovarian cancer patients who have responded to platinum-based chemotherapy, regardless of their BRCA mutation or homologous recombination deficiency status. This makes it a versatile option for patients with limited maintenance treatment choices.457811
What is the purpose of this trial?
The purpose of this research study is to see how useful it is to look at biomarkers in the blood and tumor tissue of participants with ovarian, fallopian tube or primary peritoneal cancer who have previously received treatment with a drug called a PARP inhibitor, and using the results to determine the best treatment for these participants. Biomarkers are molecules such as genes (molecules that contain instructions for the development and function of cells in the body) and proteins that may be used to see how well a body responds to certain treatments.
Research Team
Stephanie Lheureux
Principal Investigator
Princess Margaret Cancer Centre
Eligibility Criteria
This trial is for patients with ovarian, fallopian tube, or primary peritoneal cancer who have relapsed after PARP inhibitor therapy. They must have a good heart function, measurable disease by RECIST 1.1 criteria, and proper organ function. Women of childbearing potential need to use effective contraception and not breastfeed during the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Biomarker Testing
Blood and tumor tissue samples are collected for biomarker testing to determine the participant's molecular profile
Initial Treatment
Participants receive bevacizumab and niraparib for 3 cycles, each cycle being 21 days
Cohort-Specific Treatment
Participants are assigned to a cohort based on genetic testing results and receive a combination of study drugs until disease progression or discontinuation criteria are met
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Bevacizumab
- Dostarlimab
- Niraparib
- Paclitaxel
Niraparib is already approved in European Union, United States, Canada for the following indications:
- Maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy
- Maintenance treatment of adults with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy
- Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
- Treatment of adults with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status
- Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor
GlaxoSmithKline
Industry Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School