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| ID | Type | Description | Link |
|---|---|---|---|
| 21-5915 | Other Identifier | University Health Network |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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:
Participants will receive the study drug combination until disease worsening or they meet the criteria for discontinuation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initial/Cohort C | Experimental | Niraparib by mouth (orally), once a day, every day. Bevacizumab, by vein (intravenously), once every 3 weeks for up to 1 year, then every 6 weeks. |
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| Cohort A | Experimental | Niraparib by mouth (orally), once a day, every day. Bevacizumab, by vein (intravenously), once every 3 weeks for up to 1 year, then every 6 weeks. Dostarlimab, by vein (intravenously), once every 3 weeks for 4 doses, then every 6 weeks afterwards. |
|
| Cohort B | Experimental | Paclitaxel, by vein (intravenously), once a week. Bevacizumab, by vein (intravenously), once every 3 weeks for up to 1 year, then every 6 weeks. Dostarlimab, by vein (intravenously), once every 3 weeks for 4 doses, then every 6 weeks afterwards. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niraparib | Drug | Niraparib works by blocking poly(ADP-ribose) polymerases (PARP) 1 and PARP 2 from working. PARP 1 and PARP 2 are proteins that are involved in cell growth, cell survival, and cell death, including cancer cells. It is believed that blocking PARP1 and PARP 2 from working will slow or stop the growth of cancer cells. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants that achieve biomarker-guided treatment | 3 years | |
| Response rate percentage | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate for Cohort A | 3 years | |
| Overall response rate for Cohort B | 3 years | |
| Overall response rate for initial cohort/Cohort C |
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Inclusion Criteria:
Exclusion Criteria:
.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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Lheureux, M.D. | Contact | 416-946-2818 | stephanie.lheureux@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Stephanie Lheureux, M.D. | Princess Margaret Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
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| Dostarlimab | Drug | Dostarlimab is 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. Dostarlimab attaches to PD-1 and inhibits the interaction of PD-L1 and PD-L2 with PD-1. |
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| Bevacizumab | Drug | Bevacizumab is a chemotherapy drug commonly used for the treatment of various cancers. |
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| Paclitaxel | Drug | Paclitaxel is a chemotherapy drug commonly used for the treatment of various cancers. |
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| 3 years |
| Progression-free survival rate for initial cohort/Cohort C | 3 years |
| Progression-free survival rate for initial cohort/Cohort A | 3 years |
| Progression-free survival rate for initial cohort/Cohort B | 3 years |
| CA125 response rate for initial cohort/Cohort C | 3 years |
| CA125 response rate for Cohort A | 3 years |
| CA125 response rate for Cohort B | 3 years |
| Disease control rate for initial cohort/Cohort C | 3 years |
| Disease control rate for Cohort A | 3 years |
| Disease control rate for Cohort B | 3 years |
| Percentage of participants with adverse events in the initial cohort/Cohort C | 3 years |
| Percentage of participants with adverse events in Cohort A | 3 years |
| Percentage of participants with adverse events in Cohort B | 3 years |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
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| ID | Term |
|---|---|
| C545685 | niraparib |
| C000719628 | dostarlimab |
| D000068258 | Bevacizumab |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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