Maintenance Treatment With Bevacizumab and Atezolizumab for Ovarian Cancer

NCT04510584 | Withdrawn Phase 2 DMC

• 2 other identifiers: HEARTBEAT-OV20-5562
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Endometrioid Tumor; Fallopian Tube Cancer; Primary Peritoneal Cancer; TP53 Mutation

Outcome Measures

Primary Outcomes (1)

• Number of participants where increase in circulating deoxyribonucleic acid (ctDNA) level is related to progression

  3 months

Secondary Outcomes (7)

• Disease free survival rate

  6 months

• Disease free survival rate

  12 months

• Progression free survival rate

  1 year

• Progression free survival rate

  2 years

• Number of participants with disease free survival with change from detectable to undetectable TP53 ctDNA

  6 months

Study Arms (1)

Atezolizumab and Bevacizumab

EXPERIMENTAL

A cycle will be every 3 weeks. Atezolizumab will be given intravenously (by vein) at a dose of 1200 mg once every cycle. Bevacizumab will be given intravenously at a dose of 15 mg/kg once every cycle. Up to 17 cycles of study treatment may be given. Participants may be able to receive the study treatment for more than 17 cycles if the participants and the study doctor thinks that they are benefiting.

Drug: Atezolizumab; Drug: Bevacizumab

Interventions

Atezolizumab DRUG

Atezolizumab is a humanized immunoglobulin (IgG1) monoclonal antibody that targets programmed death-ligand 1 (PD-L1) on tumor-infiltrating immune cells (ICs) or tumor cells (TCs) and prevents interaction with the programmed death-1 (PD-1) receptor and B7.1 (CD80), both of which function as inhibitory receptors expressed on T cells and other immune cells.

Also known as: TECENTRIQ

Atezolizumab and Bevacizumab

Bevacizumab DRUG

Bevacizumab is a recombinant humanized IgG1 monoclonal antibody that binds VEGF, a secreted factor that stimulates angiogenesis. Bevacizumab prevents the interaction of VEGF with its receptors and neutralizes the biological activity of VEGF.

Also known as: AVASTIN

Atezolizumab and Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Following completion of platinum-based chemotherapy, patients must have residual disease detectable by TP53 ctDNA
• May have received prior PARP-inhibitor therapy or prior bevacizumab.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2
• Patients must have a life expectancy ≥16 weeks
• Patients must have normal organ and marrow function

You may not qualify if:

• 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:
• Major surgical procedure or significant traumatic injury within 28 days prior to Day 1 therapy, or open biopsy within 28 days prior to Day 1 therapy
• Anticipation of need for major surgical procedures during the course of the study
• Significant vascular disease within 6 months prior to Day 1
• Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because of the possible increased risk of bleeding if treatment with antiangiogenic agents is provided.
• Inadequately controlled hypertension, history of cerebrovascular accident, myocardial infarction or unstable angina, serious or inadequately controlled cardiac arrhythmia within 6 months.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms

Interventions

atezolizumab; Bevacizumab

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Stephanie Lheureux, M.D.

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2020
• First Posted: August 12, 2020
• Study Start: July 16, 2021
• Primary Completion: February 22, 2023
• Study Completion: February 22, 2023
• Last Updated: June 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)