| Primary | Objective Response Rate (ORR) in Participants With Platinum-resistant Ovarian Cancer (PROC) | ORR is defined as the percentage of participants who have achieved confirmed complete response (CR) or partial response (PR), as determined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria based on Investigator assessment and computed tomography (CT) scans were commonly used for tumor imaging. | Safety (SAF) Population: All participants who receive any amount of study treatment. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to approximately 22 months | | | | ID | Title | Description |
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| OG000 | Niraparib+Dostarlimab (TSR-042) | Participants with body weight ≥77 kg and platelet count ≥150,000/μL at baseline were administered Niraparib 300 mg QD and participants with body weight <77 kg or platelet count <150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until PD or toxicity. Dostarlimab (TSR-042) was administered as an IV infusion of 500 mg Q3W from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months. |
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| Primary | ORR in Participants With PROC Who Have Programmed Cell Death-ligand 1 (PD-L 1) Positive Status | ORR is defined as the percentage of participants who have achieved confirmed CR or PR, as determined by RECIST v1.1 criteria based on Investigator assessment and CT scans were commonly used for tumor imaging. PD-L1 is a ligand that binds to PD-L1 protein on tumor infiltrating T cells and renders the T cells inactive. Any PD-L1 positive tissue sample with combined positive score (vCPS) >=5% was used as specified cut-point for the assessment of PD-L1 positive patient subset with PROC. vCPS was defined as the percentage of tumor cells and immune cells staining positive within the total tumor area. | Data for participants with PD-L1 positive status in the SAF population are presented. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to approximately 22 months | | | | ID | Title | Description |
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| OG000 | Niraparib+Dostarlimab (TSR-042) | Participants with body weight ≥77 kg and platelet count ≥150,000/μL at baseline were administered Niraparib 300 mg QD and participants with body weight <77 kg or platelet count <150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until PD or toxicity. Dostarlimab (TSR-042) was administered as an IV infusion of 500 mg Q3W from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months. |
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| Secondary | Duration of Response (DOR) in Participants With PROC | DOR is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression or death by any cause in the absence of progression by RECIST v.1.1 based on Investigator assessment. | SAF Population. DOR has been summarized only for responders. | Posted | | Median | Full Range | Months | | Up to approximately 22 months | | | | ID | Title | Description |
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| OG000 | Niraparib+Dostarlimab (TSR-042) | Participants with body weight ≥77 kg and platelet count ≥150,000/μL at baseline were administered Niraparib 300 mg QD and participants with body weight <77 kg or platelet count <150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until PD or toxicity. Dostarlimab (TSR-042) was administered as an IV infusion of 500 mg Q3W from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months. |
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| Secondary | DOR in Participants With PROC Who Have PD-L 1 Positive Status | DOR is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression or death by any cause in the absence of progression by RECIST v.1.1 based on Investigator assessment. PD-L1 is a ligand that binds to PD-L1 protein on tumor infiltrating T cells and renders the T cells inactive. Any PD-L1 positive tissue sample with vCPS >=5% was used as specified cut-point for the assessment of PD-L1 patient subset with PROC. vCPS was defined as the percentage of tumor cells and immune cells staining positive within the total tumor area. | Data for participants with PD-L1 positive status in the SAF population are presented. DOR has been summarized only for responders. | Posted | | Median | Full Range | Months | | Up to approximately 22 months | | | | ID | Title | Description |
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| OG000 | Niraparib+Dostarlimab (TSR-042) | Participants with body weight ≥77 kg and platelet count ≥150,000/μL at baseline were administered Niraparib 300 mg QD and participants with body weight <77 kg or platelet count <150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until PD or toxicity. Dostarlimab (TSR-042) was administered as an IV infusion of 500 mg Q3W from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months. |
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| Secondary | Progression-free Survival (PFS) in Participants With PROC | PFS is defined as the time from the date of the first dose of study treatment to the earlier date of assessment of progression or death by any cause in the absence of progression by RECIST v.1.1 based on Investigator assessment. | | Posted | | Median | 95% Confidence Interval | Months | | Up to approximately 22 months | | | | ID | Title | Description |
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| OG000 | Niraparib+Dostarlimab (TSR-042) | Participants with body weight ≥77 kg and platelet count ≥150,000/μL at baseline were administered Niraparib 300 mg QD and participants with body weight <77 kg or platelet count <150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until PD or toxicity. Dostarlimab (TSR-042) was administered as an IV infusion of 500 mg Q3W from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months. |
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| Secondary | PFS in Participants With PROC Who Have PD-L 1 Positive Status | PFS is defined as the time from the date of the first dose of study treatment to the earlier date of assessment of progression or death by any cause in the absence of progression by RECIST v.1.1 based on Investigator assessment. PD-L1 is a ligand that binds to PD-L1 protein on tumor infiltrating T cells and renders the T cells inactive. Any PD-L1 positive tissue sample with a vCPS >=5% was used as specified cut-point for the assessment of PD-L1 positive patient subset with PROC. vCPS was defined as the percentage of tumor cells and immune cells staining positive within the total tumor area. | Data for participants with PD-L1 positive status in the SAF population are presented. | Posted | | Median | 95% Confidence Interval | Months | | Up to approximately 22 months | | | | ID | Title | Description |
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| OG000 | Niraparib+Dostarlimab (TSR-042) | Participants with body weight ≥77 kg and platelet count ≥150,000/μL at baseline were administered Niraparib 300 mg QD and participants with body weight <77 kg or platelet count <150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until PD or toxicity. Dostarlimab (TSR-042) was administered as an IV infusion of 500 mg Q3W from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months. |
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| Secondary | Overall Survival (OS) in Participants With PROC | OS is defined as the time from the date of the first dose of study treatment to the date of death by any cause. | | Posted | | Median | 95% Confidence Interval | Months | | Up to approximately 22 months | | | | ID | Title | Description |
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| OG000 | Niraparib+Dostarlimab (TSR-042) | Participants with body weight ≥77 kg and platelet count ≥150,000/μL at baseline were administered Niraparib 300 mg QD and participants with body weight <77 kg or platelet count <150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until PD or toxicity. Dostarlimab (TSR-042) was administered as an IV infusion of 500 mg Q3W from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months. |
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| Secondary | OS in Participants With PROC Who Have PD-L 1 Positive Status | OS is defined as the time from the date of the first dose of study treatment to the date of death by any cause. PD-L1 is a ligand that binds to PD-L1 protein on tumor infiltrating T cells and renders the T cells inactive. Any PD-L1 positive tissue sample with vCPS >=5% was used as specified cut-point for the assessment of PD-L1 positive patient subset with PROC. vCPS was defined as the percentage of tumor cells and immune cells staining positive within the total tumor area. | Data for participants with PD-L1 positive status in the SAF population are presented. | Posted | | Median | 95% Confidence Interval | Months | | Up to approximately 22 months | | | | ID | Title | Description |
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| OG000 | Niraparib+Dostarlimab (TSR-042) | Participants with body weight ≥77 kg and platelet count ≥150,000/μL at baseline were administered Niraparib 300 mg QD and participants with body weight <77 kg or platelet count <150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until PD or toxicity. Dostarlimab (TSR-042) was administered as an IV infusion of 500 mg Q3W from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months. |
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| Secondary | Disease Control Rate (DCR) in Participants With PROC | DCR is defined as the percentage of participants who have achieved best overall response (BOR) of CR, PR, or stable disease (SD) per RECIST v.1.1 based on the investigator's assessment. | | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to approximately 22 months | | | | ID | Title | Description |
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| OG000 | Niraparib+Dostarlimab (TSR-042) | Participants with body weight ≥77 kg and platelet count ≥150,000/μL at baseline were administered Niraparib 300 mg QD and participants with body weight <77 kg or platelet count <150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until PD or toxicity. Dostarlimab (TSR-042) was administered as an IV infusion of 500 mg Q3W from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months. |
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| Secondary | DCR in Participants With PROC Who Have PD-L 1 Positive Status | DCR is defined as the percentage of participants who have achieved BOR of CR, PR, or SD per RECIST v.1.1 based on the investigator's assessment. PD-L1 is a ligand that binds to PD-L1 protein on tumor infiltrating T cells and renders the T cells inactive. Any PD-L1 positive tissue sample with vCPS >=5% was used as specified cut-point for the assessment of PD-L1 positive patient subset with PROC. vCPS was defined as the percentage of tumor cells and immune cells staining positive within the total tumor area. | Data for participants with PD-L1 positive status in the SAF population are presented. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to approximately 22 months | | | | ID | Title | Description |
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| OG000 | Niraparib+Dostarlimab (TSR-042) | Participants with body weight ≥77 kg and platelet count ≥150,000/μL at baseline were administered Niraparib 300 mg QD and participants with body weight <77 kg or platelet count <150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until PD or toxicity. Dostarlimab (TSR-042) was administered as an IV infusion of 500 mg Q3W from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months. |
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| Secondary | ORR in Participants With PROC Based on Independent Review Committee (IRC) Assessment | ORR is defined as the percentage of participants who have achieved confirmed CR or PR per RECIST v1.1 based on the independent review committee assessment. | Data was not collected as IRC assessment was not utilized due to study termination. | Posted | | | | | | Up to approximately 22 months | | | | ID | Title | Description |
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| OG000 | Niraparib+Dostarlimab (TSR-042) | Participants with body weight ≥77 kg and platelet count ≥150,000/μL at baseline were administered Niraparib 300 mg QD and participants with body weight <77 kg or platelet count <150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until PD or toxicity. Dostarlimab (TSR-042) was administered as an IV infusion of 500 mg Q3W from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months. |
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| Secondary | ORR in Participants With PROC Who Have PD-L 1 Positive Status Based on IRC Assessment | ORR is defined as the percentage of participants who have achieved confirmed CR or PR per RECIST v1.1 based on the independent review committee assessment. PD-L1 is a ligand that binds to PD-L1 protein on tumor infiltrating T cells and renders the T cells inactive. Any PD-L1 positive tissue sample with a vCPS >=5% was used as specified cut-point for the assessment of PD-L1 positive patient subset with PROC. vCPS was defined as the percentage of tumor cells and immune cells staining positive within the total tumor area. | Data was not collected as IRC assessment was not utilized due to study termination | Posted | | | | | | Up to approximately 22 months | | | | ID | Title | Description |
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| OG000 | Niraparib+Dostarlimab (TSR-042) | Participants with body weight ≥77 kg and platelet count ≥150,000/μL at baseline were administered Niraparib 300 mg QD and participants with body weight <77 kg or platelet count <150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until PD or toxicity. Dostarlimab (TSR-042) was administered as an IV infusion of 500 mg Q3W from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months. |
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| Secondary | DOR in Participants With PROC Based on IRC Assessment | DOR is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression or death by any cause in the absence of progression by RECIST v.1.1 based on Independent Review Committee assessment. | Data was not collected as IRC assessment was not utilized due to study termination | Posted | | | | | | Up to approximately 22 months | | | | ID | Title | Description |
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| OG000 | Niraparib+Dostarlimab (TSR-042) | Participants with body weight ≥77 kg and platelet count ≥150,000/μL at baseline were administered Niraparib 300 mg QD and participants with body weight <77 kg or platelet count <150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until PD or toxicity. Dostarlimab (TSR-042) was administered as an IV infusion of 500 mg Q3W from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months. |
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| Secondary | DOR in Participants With PROC Who Have PD-L 1 Positive Status Based on IRC Assessment | DOR is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression or death by any cause in the absence of progression by RECIST v.1.1 based on Independent Review Committee assessment. PD-L1 is a ligand that binds to PD-L1 protein on tumor infiltrating T cells and renders the T cells inactive. Any PD-L1 positive tissue sample with a vCPS >=5% was used as specified cut-point for the assessment of PD-L1 positive patient subset with PROC. vCPS was defined as the percentage of tumor cells and immune cells staining positive within the total tumor area. | Data was not collected as IRC assessment was not utilized due to study termination | Posted | | | | | | Up to approximately 22 months | | | | ID | Title | Description |
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| OG000 | Niraparib+Dostarlimab (TSR-042) | Participants with body weight ≥77 kg and platelet count ≥150,000/μL at baseline were administered Niraparib 300 mg QD and participants with body weight <77 kg or platelet count <150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until PD or toxicity. Dostarlimab (TSR-042) was administered as an IV infusion of 500 mg Q3W from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months. |
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| Secondary | PFS in Participants With PROC Based on IRC Assessment | PFS is defined as the time from the date of the first dose of study treatment to the earlier date of assessment of progression or death by any cause in the absence of progression by RECIST v.1.1 based on Independent Review Committee Assessment. | Data was not collected as IRC assessment was not utilized due to study termination | Posted | | | | | | Up to approximately 22 months | | | | ID | Title | Description |
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| OG000 | Niraparib+Dostarlimab (TSR-042) | Participants with body weight ≥77 kg and platelet count ≥150,000/μL at baseline were administered Niraparib 300 mg QD and participants with body weight <77 kg or platelet count <150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until PD or toxicity. Dostarlimab (TSR-042) was administered as an IV infusion of 500 mg Q3W from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months. |
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| Secondary | PFS in Participants With PROC Who Have PD-L 1 Positive Status Based on IRC Assessment | PFS is defined as the time from the date of the first dose of study treatment to the earlier date of assessment of progression or death by any cause in the absence of progression by RECIST v.1.1 based on IRC Assessment. PD-L1 is a ligand that binds to PD-L1 protein on tumor infiltrating T cells and renders the T cells inactive. Any PD-L1 positive tissue sample with a vCPS >=5% was used as specified cut-point for the assessment of PD-L1 positive patient subset with PROC. vCPS was defined as the percentage of tumor cells and immune cells staining positive within the total tumor area. | Data was not collected as IRC assessment was not utilized due to study termination | Posted | | | | | | Up to approximately 22 months | | | | ID | Title | Description |
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| OG000 | Niraparib+Dostarlimab (TSR-042) | Participants with body weight ≥77 kg and platelet count ≥150,000/μL at baseline were administered Niraparib 300 mg QD and participants with body weight <77 kg or platelet count <150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until PD or toxicity. Dostarlimab (TSR-042) was administered as an IV infusion of 500 mg Q3W from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months. |
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| Secondary | DCR in Participants With PROC Based on IRC Assessment | DCR is defined as the percentage of participants who have achieved BOR of CR, PR, or SD per RECIST v.1.1 based on IRC Assessment. | Data was not collected as IRC assessment was not utilized due to study termination | Posted | | | | | | Up to approximately 22 months | | | | ID | Title | Description |
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| OG000 | Niraparib+Dostarlimab (TSR-042) | Participants with body weight ≥77 kg and platelet count ≥150,000/μL at baseline were administered Niraparib 300 mg QD and participants with body weight <77 kg or platelet count <150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until PD or toxicity. Dostarlimab (TSR-042) was administered as an IV infusion of 500 mg Q3W from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months. |
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| Secondary | DCR in Participants With PROC Who Have PD-L 1 Positive Status Based on IRC Assessment | DCR is defined as the percentage of participants who have achieved BOR of CR, PR, or SD per RECIST v.1.1 based on Independent Review Committee Assessment. PD-L1 is a ligand that binds to PD-L1 protein on tumor infiltrating T cells and renders the T cells inactive. Any PD-L1 positive tissue sample with vCPS >=5% was used as specified cut-point for the assessment of PD-L1 positive patient subset with PROC. vCPS was defined as the percentage of tumor cells and immune cells staining positive within the total tumor area. | Data was not collected as IRC assessment was not utilized due to study termination | Posted | | | | | | Up to approximately 22 months | | | | ID | Title | Description |
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| OG000 | Niraparib+Dostarlimab (TSR-042) | Participants with body weight ≥77 kg and platelet count ≥150,000/μL at baseline were administered Niraparib 300 mg QD and participants with body weight <77 kg or platelet count <150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until PD or toxicity. Dostarlimab (TSR-042) was administered as an IV infusion of 500 mg Q3W from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months. |
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| Secondary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-emergent Adverse Events (TEAEs) and Adverse Event of Special Interest (AESI) | An AE is any untoward medical occurrence in a patient administered with a medicinal product and that does which may or may not have a causal relationship with this treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. TEAEs are any event that occurred between first dose of study drug up to 22 months, which were absent before treatment or that had worsened relative to pretreatment state. AESI were any AE (serious or non-serious) that is of scientific and medical concern specific to the study treatment, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was done. | | Posted | | Count of Participants | | Participants | | Up to approximately 27 months | | | | ID | Title | Description |
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| OG000 | Niraparib+Dostarlimab (TSR-042) | Participants with body weight ≥77 kg and platelet count ≥150,000/μL at baseline were administered Niraparib 300 mg QD and participants with body weight <77 kg or platelet count <150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until PD or toxicity. Dostarlimab (TSR-042) was administered as an IV infusion of 500 mg Q3W from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months. |
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| Secondary | Number of Participants With Grade Shift From Baseline in Hematology | Blood samples were collected for the analysis of hematology parameters and each parameter was graded according to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.3. Grade 0: Normal, Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as the most recent measurement prior to the first administration of study treatment. Data has been presented for the number of participants with hematology grade shifts from baseline grade to grade 3 and 4 for each parameter. | | Posted | | Count of Participants | | Participants | | Up to approximately 27 months | | | | ID | Title | Description |
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| OG000 | Niraparib+Dostarlimab (TSR-042) | Participants with body weight ≥77 kg and platelet count ≥150,000/μL at baseline were administered Niraparib 300 mg QD and participants with body weight <77 kg or platelet count <150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until PD or toxicity. Dostarlimab (TSR-042) was administered as an IV infusion of 500 mg Q3W from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months. |
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| Secondary | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Blood samples were collected and the clinical chemistry parameters assessed were Albumin (Alb), alanine aminotransferase (ALT), amylase, aspartate aminotransferase (AST), alkaline phosphatase (ALP), sodium, total bilirubin (TB), creatinine, glucose, magnesium and potassium. The Grade shift post baseline data of each parameter from Grade 0 through Grade 4 was based on the CTCAE version 4.03, grading scale, as per intensity, namely Grade 0: Normal, Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as the most recent measurement prior to the first administration of study treatment. Data has been presented for the number of participants with plasma chemistry grade shifts from baseline grade to grade 3 and 4 for each parameter. | | Posted | | Count of Participants | | Participants | | Up to approximately 27 months | | | | ID | Title | Description |
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| OG000 | Niraparib+Dostarlimab (TSR-042) | Participants with body weight ≥77 kg and platelet count ≥150,000/μL at baseline were administered Niraparib 300 mg QD and participants with body weight <77 kg or platelet count <150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until PD or toxicity. Dostarlimab (TSR-042) was administered as an IV infusion of 500 mg Q3W from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months. |
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| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline was defined as the most recent measurement prior to the first administration of study treatment. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. The minimum (min) and maximum (max) change from baseline values have been reported. | | Posted | | Mean | Standard Deviation | Millimeters of mercury | | Up to approximately 27 months | | | | ID | Title | Description |
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| OG000 | Niraparib+Dostarlimab (TSR-042) | Participants with body weight ≥77 kg and platelet count ≥150,000/μL at baseline were administered Niraparib 300 mg QD and participants with body weight <77 kg or platelet count <150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until PD or toxicity. Dostarlimab (TSR-042) was administered as an IV infusion of 500 mg Q3W from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months. |
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| Secondary | Change From Baseline in Pulse Rate | Baseline was defined as the most recent measurement prior to the first administration of study treatment. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. The minimum (min) and maximum (max) change from baseline values have been reported. | | Posted | | Mean | Standard Deviation | Beats per minute | | Up to approximately 27 months | | | | ID | Title | Description |
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| OG000 | Niraparib+Dostarlimab (TSR-042) | Participants with body weight ≥77 kg and platelet count ≥150,000/μL at baseline were administered Niraparib 300 mg QD and participants with body weight <77 kg or platelet count <150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until PD or toxicity. Dostarlimab (TSR-042) was administered as an IV infusion of 500 mg Q3W from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months. |
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| Secondary | Change From Baseline in Temperature | Baseline was defined as the most recent measurement prior to the first administration of study treatment. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. The minimum (min) and maximum (max) change from baseline values have been reported. | | Posted | | Mean | Standard Deviation | Degrees Celsius | | Up to approximately 27 months | | | | ID | Title | Description |
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| OG000 | Niraparib+Dostarlimab (TSR-042) | Participants with body weight ≥77 kg and platelet count ≥150,000/μL at baseline were administered Niraparib 300 mg QD and participants with body weight <77 kg or platelet count <150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until PD or toxicity. Dostarlimab (TSR-042) was administered as an IV infusion of 500 mg Q3W from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months. |
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| Secondary | Change From Baseline in Prothrombin International Normalized Ratio | Blood samples were collected to evaluate Prothrombin International Normalized Ratio (INR). Baseline was defined as the most recent measurement prior to the first administration of study treatment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | SAF Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Mean | Standard Deviation | Ratio | | Baseline and up to approximately 27 months | | | | ID | Title | Description |
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| OG000 | Niraparib+Dostarlimab (TSR-042) | Participants with body weight ≥77 kg and platelet count ≥150,000/μL at baseline were administered Niraparib 300 mg QD and participants with body weight <77 kg or platelet count <150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until PD or toxicity. Dostarlimab (TSR-042) was administered as an IV infusion of 500 mg Q3W from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months. |
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| Secondary | Change in Baseline in Activated Partial Thromboplastin Time | Blood samples were planned to be collected to evaluate activated partial thromboplastin time (APTT). Baseline was defined as the most recent measurement prior to the first administration of study treatment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | SAF Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Mean | Standard Deviation | Second | | Baseline and up to approximately 27 months | | | | ID | Title | Description |
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| OG000 | Niraparib+Dostarlimab (TSR-042) | Participants with body weight ≥77 kg and platelet count ≥150,000/μL at baseline were administered Niraparib 300 mg QD and participants with body weight <77 kg or platelet count <150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until PD or toxicity. Dostarlimab (TSR-042) was administered as an IV infusion of 500 mg Q3W from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months. |
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| Secondary | Change From Baseline in Thyrotropin | Blood samples were collected to evaluate thyrotropin at indicated time points. Baseline was defined as the most recent measurement prior to the first administration of study treatment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | SAF Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Mean | Standard Deviation | Milliunits per liter (mU/L) | | Baseline and up to approximately 27 months | | | | ID | Title | Description |
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| OG000 | Niraparib+Dostarlimab (TSR-042) | Participants with body weight ≥77 kg and platelet count ≥150,000/μL at baseline were administered Niraparib 300 mg QD and participants with body weight <77 kg or platelet count <150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until PD or toxicity. Dostarlimab (TSR-042) was administered as an IV infusion of 500 mg Q3W from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months. |
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