Maintenance Treatment With Bevacizumab and Atezolizumab for Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT04510584|
Recruitment Status : Not yet recruiting
First Posted : August 12, 2020
Last Update Posted : August 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Endometrioid Tumor Fallopian Tube Cancer Primary Peritoneal Cancer TP53 Mutation||Drug: Atezolizumab Drug: Bevacizumab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Halting Early Advancement of Residual Disease by Treatment With Bevacizumab and Atezolizumab in Ovarian Cancer|
|Estimated Study Start Date :||September 28, 2020|
|Estimated Primary Completion Date :||September 28, 2023|
|Estimated Study Completion Date :||September 28, 2023|
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.
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.
Other Name: TECENTRIQ
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.
Other Name: AVASTIN
- Number of participants where increase in circulating deoxyribonucleic acid (ctDNA) level is related to progression [ Time Frame: 3 months ]
- Disease free survival rate [ Time Frame: 6 months ]
- Disease free survival rate [ Time Frame: 12 months ]
- Progression free survival rate [ Time Frame: 1 year ]
- Progression free survival rate [ Time Frame: 2 years ]
- Number of participants with disease free survival with change from detectable to undetectable TP53 ctDNA [ Time Frame: 6 months ]
- Number of participants with disease free survival with change from detectable to undetectable TP53 ctDNA [ Time Frame: 12 months ]
- Number of participants with adverse events [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510584
|Contact: Stephanie Lheureux, M.D.||firstname.lastname@example.org|
|Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Stephanie Lheureux, M.D. 416-946-2818|
|Principal Investigator: Stephanie Lheureux, M.D.|
|Principal Investigator:||Stephanie Lheureux, M.D.||Princess Margaret Cancer Centre|