Maintenance Treatment With Bevacizumab and Atezolizumab for Ovarian Cancer

Sponsor
University Health Network, Toronto
Study ID
NCT04510584
Phase
PHASE2
Status
Withdrawn

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jul 16, 2021
Status verified
Jun 2023
Primary completion
Feb 22, 2023
Completion
Feb 22, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab and Bevacizumab
    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.

Primary Outcome Measure

Number of participants where increase in circulating deoxyribonucleic acid (ctDNA) level is related to progression [ Time Frame: 3 months ]

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