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Using Genetic Profile to Determine the Treatment for Patients With Ovarian Cancer Who Previously Received a PARP-inhibitor | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Using Genetic Profile to Determine the Treatment for Patients With Ovarian Cancer Who Previously Received a PARP-inhibitor

Re-VOLVE: A Phase II Clinical Trial in Women With Ovarian Cancer Progressing Post-PARP Inhibitor With Treatment Adapted to Real-time Assessment of Evolving Genomic Resistance

NCT05065021•University Health Network, Toronto

View on ClinicalTrials.gov

Summary

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.

Detailed Description

Participants who join the study will first have samples of their blood and tumor tissue collected for biomarker testing. The testing will involve a method called "sequencing". This test will look for changes in the genes of your tumor. The results of the testing will be what is called the participant's molecular profile. All participants will first receive bevacizumab and niraparib for 3 cycles. A cycle will be 21-days in length. Once the participant's molecular profile has been determined, the study doctor will discuss the results with the participants and they may be referred to a genetic counsellor. Participants will then be assigned to a study cohort (group) and receive a combination of the study drugs based on the results of their genetic testing: * Cohort A: Participants who do not have the required gene changes will be assigned to receive niraparib, bevacizumab, and dostarlimab * Cohort B: Participants who have certain gene changes will receive paclitaxel, bevacizumab, and dostarlimab. * Cohort C: If the participant and the study doctor think that the participant is benefitting from the combination of bevacizumab and niraparib, or the molecular profile shows that bevacizumab and niraparib is the most suitable, the participant may continue to receive this drug combination. Participants will receive the study drug combination until disease worsening or they meet the criteria for discontinuation.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
•Histologically confirmed ovarian, fallopian tube or primary peritoneal cancer, high grade serous or high grade endometrioid histology subtype.
•Patients must have relapsed disease, either platinum-sensitive, resistant or refractory, with no limit to number of lines of prior systemic therapy.
•Radiographically documented disease progression within 28 days of registration.
•Patient must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
•Progression on any prior Poly (ADP-ribose) polymerase (PARP) inhibitor therapy, with no limit to number of prior lines of PARP inhibitors.
•Patients must have adequate bone marrow, renal and hepatic function within 7 days of registration
•Left ventricular ejection fraction (LVEF) \> 50% by echocardiograms or multigated acquisition (MUGA) scan within 28 days of registration.
•Patients are willing to undergo tumor biopsy pre-treatment (tissue at the time of progression on PARP inhibitor therapy).
•Availability of archival tissue (prior to PARP inhibitor therapy) for analysis.
+3 more criteria

Exclusion Criteria

•Treatment with an investigational (other than PARP inhibitor) drug within 30 days and treatment with PARP inhibitor within 14 days prior to the first dose of study medication.
•Major surgery within 4 weeks of registration or ongoing clinically significant post-surgical complications.
•Patients with current or are at high-risk of developing fistula, or any other gastrointestinal disorders likely to interfere with absorption of the study medication.
•Patients with current or history of bowel obstruction within the last 3 months.
•Untreated unstable brain or leptomeningeal metastases.
•Greater than +1 proteinuria on two consecutive dipsticks within 14 days of registration.
•Unresolved toxicity of \> grade 1 from previous anti-cancer therapy (including radiotherapy).
•.History of poorly controlled hypertension or resting blood pressure \>140/90 mmHg in the presence or absence of a stable regimen of anti-hypertensive therapy within 7 days of registration.
•Mean QTc \>470 msec in screening electrocardiograms within 7 days of registration or history of familial long QT syndrome.
•Any evidence of severe or uncontrolled diseases such as but not limited to unstable or uncompensated respiratory, cardiac, hepatic, renal disease or psychiatric illness/social situations that would limit compliance with study requirements.
+14 more criteria

Locations (1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Key Dates

Start Date

February 23, 2023

Primary Completion Date

June 6, 2025

Completion Date

June 6, 2025

Last Updated

January 17, 2024

Enrollment

ESTIMATED participants

Conditions

Ovarian CancerFallopian Tube CancerPrimary Peritoneal CancerHigh Grade Serous CancerHigh Grade Endometrioid Cancer

Interventions

Niraparib

DRUG

Dostarlimab

DRUG

Bevacizumab

DRUG

Paclitaxel

DRUG

Contacts

Stephanie Lheureux, M.D.

CONTACT

416-946-2818 stephanie.lheureux@uhn.ca

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 17, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Using Genetic Profile to Determine the Treatment for Patients With Ovarian Cancer Who Previously Received a PARP-inhibitor

Inclusion Criteria

Exclusion Criteria

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