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Maintenance Treatment With Bevacizumab and Atezolizumab for Ovarian Cancer | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

Maintenance Treatment With Bevacizumab and Atezolizumab for Ovarian Cancer

Halting Early Advancement of Residual Disease by Treatment With Bevacizumab and Atezolizumab in Ovarian Cancer

NCT04510584•University Health Network, Toronto

Summary

This study is being done to look at the combination of the drugs atezolizumab and bevacizumab as a maintenance treatment (treatment given after the main treatment to keep the cancer from coming back or worsening) following standard therapy in patients with high grade ovarian, fallopian tube, or primary peritoneal cancer with a mutation (change) in a gene called TP53. Genes are molecules in the body that are made up of deoxyribonucleic acid (DNA) and control how the body's cells behave.

Detailed Description

Atezolizumab and bevacizumab are a type of drug called a monoclonal antibody. Antibodies are proteins that are naturally found in the blood stream that fight infections. A monoclonal antibody is a special kind of antibody that is created in a laboratory that seeks out specific proteins in the body that may be involved in cancers to stop tumor growth. When tumor cells start to die, broken down pieces of the tumor's DNA gets released into the blood stream, called circulating tumor DNA (ctDNA). Looking at ctDNA may be useful in determining whether the cancer is responding to treatment. The purpose of this research study is to see whether looking at tumor DNA circulating in the bloodstream can help to determine which patients may respond to atezolizumab and bevacizumab and whether this drug combination is useful, when given as a maintenance treatment for patients with TP53 mutant ovarian, fallopian tube, or primary peritoneal cancer.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Pre-screening:
•Patients must have histologically confirmed TP53-mutant high grade serous or high grade endometrioid ovarian, fallopian tube, primary peritoneal cancer.
•Ability to understand and the willingness to sign a written Pre-screening Informed consent document.
•Patients must be receiving standard therapy for recurrent disease and have completed 3 cycles of platinum-based chemotherapy, with clinical benefit (in opinion of investigator). Patients with stable disease (in opinion of investigator) after 3 cycles of chemotherapy will also be eligible for pre-screening. There is no limitation on the number of prior lines of therapy. May have received prior PARP-inhibitor therapy or prior bevacizumab or biosimilar.
•Formalin fixed, paraffin embedded (FFPE) tumour sample from the primary cancer must be available.
•Eastern Cooperative Oncology Group (ECOG) performance status ≤2
•Patients must have a life expectancy ≥16 weeks
•Main Study:
•Patients must have histologically confirmed TP53-mutant high grade serous or high grade endometrioid ovarian, fallopian tube, primary peritoneal cancer.
•Must have completed standard therapy for recurrent disease including at least 4 cycles of platinum-based chemotherapy with no clinical and radiographic evidence of disease progression on the post-treatment scan or a rising CA-125 level, following completion of standard therapy. Patients with stable disease and in response (as per Investigators opinion) following completion of chemotherapy will also be eligible for this study. There is no limitation on the number of prior lines of therapy.
+12 more criteria

Exclusion Criteria

•Pre-screening:
•History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab, or atezolizumab
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active severe infection, symptomatic congestive heart failure, or psychiatric illness/social situations that (in the opinion of Investigator) would limit compliance with study requirements.
•History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to day 1.
•Main Study:
•Patients who are receiving any other investigational agents or on-going chemotherapy.
•History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab, or atezolizumab
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active severe infection, symptomatic congestive heart failure, or psychiatric illness/social situations that (in the opinion of Investigator) would limit compliance with study requirements.
•History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to day 1.
•Invasive procedures defined as follows:
+24 more criteria

Locations (1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Key Dates

Start Date

July 16, 2021

Primary Completion Date

February 22, 2023

Completion Date

February 22, 2023

Last Updated

June 6, 2023

Conditions

Ovarian Endometrioid TumorFallopian Tube CancerPrimary Peritoneal CancerTP53 Mutation

Interventions

Atezolizumab

DRUG

Bevacizumab

DRUG

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RECRUITINGPHASE3

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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: June 6, 2023Data 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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Maintenance Treatment With Bevacizumab and Atezolizumab for Ovarian Cancer

Inclusion Criteria

Exclusion Criteria

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)

Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Cytoreductive Surgery

An Automated Personalized Physical Activity Intervention to Improve Immune Function and Clinical Outcomes in Stage II-IV Ovarian, Primary Peritoneal or Fallopian Tube Cancer and Newly Diagnosed Endometrial Cancer, Life on the Go 3 Study

A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab

Study of AVZO-021 in Patients With Advanced Solid Tumors