Ovarian Neoplasms
Conditions
Keywords
Open-label, Single-arm, Efficacy and Safety, Platinum-resistant ovarian cancer, Niraparib, dostarlimab
Brief summary
This is an open-label, single-arm Phase 2 study to evaluate the efficacy and safety of combination of niraparib and dostarlimab (TSR-042) in participants with advanced, relapsed, high-grade ovarian, fallopian tube, endometrioid, clear cell ovarian or primary peritoneal cancer without known breast cancer susceptibility gene (BRCA) mutation who have platinum-resistant disease and who have also been previously treated with bevacizumab.
Interventions
DRUGNiraparib
Niraparib is a potent, orally active poly (adenosine diphosphate-ribose) polymerase (PARP)-1 and PARP2 inhibitor being developed as a treatment for participants with tumors that harbor defects in the homologous recombination deoxyribonucleic acid (DNA) repair pathway or that are driven by PARP-mediated transcription factors.
DRUGDostarlimab
TSR-042 is a humanized monoclonal antibody that binds with high affinity to programmed cell death-1 (PD-1) resulting in inhibition of binding to programmed cell-death receptor ligands 1 and 2 (PD-L1 and PD-L2).
Sponsors
Gynecologic Oncology Group
Tesaro, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant must be female \>=18 years of age, able to understand the study procedures, and subsequently agreed to participate in the study by providing written informed consent. * Participants must have recurrent high-grade serous, endometrioid, or clear cell ovarian, fallopian tube, or primary peritoneal cancer. * Participants must be considered resistant to the last administered platinum therapy. * Participants must have completed at least 1 but no more than 3 prior lines of therapy for advanced or metastatic ovarian cancer. * Participants must have been previously treated with platinum-based regimen, taxane agent(s), and bevacizumab. * Participant has measurable disease according to RECIST v.1.1. * Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Participant has adequate organ function. * Females with childbearing potential have a serum pregnancy test that is negative 72 prior first dose and are not breastfeeding. Participant must also agree to abstain from activities that could result in pregnancy from enrollment through 180 days after the last dose of study treatment. * Participant must provide formalin fixed paraffin embedded (FFPE) tumor tissue block(s) with sufficient tumor content (as confirmed by the Sponsor's designated central laboratory) during screening to enable BRCA testing and PD-L1 testing. The use of slides created from paraffin-embedded tissue as opposed to FFPE blocks must be approved by the Sponsor. * Participant must agree to complete health-related quality of life (HRQoL) questionnaires throughout the study.
Exclusion criteria
* Participant who experienced disease progression within 3 months (12 weeks or 84 days) of first-line platinum therapy. * Participants with a known deleterious or suspected BRCA 1 or 2 mutation. * Participant has received prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent. * Participant has received prior therapy with a PARP-1/PARP-2 inhibitor. * Participant has a known hypersensitivity to dostarlimab (TSR-042), Niraparib, their components, or their excipients. * Participant has a known history of myelodysplastic syndrome or acute myeloid leukemia. * Participant has not recovered from prior chemotherapy induced adverse events. * Participant has a known diagnosis of immunodeficiency or is receiving systemic steroid therapy exceeding an equivalent of prednisone 10 mg daily or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. * Participant is currently participating in a treatment study or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment. * Participant has received prior systemic anticancer therapy including cytotoxic chemotherapy, hormonal therapy given with the intention to treat ovarian cancer, or biological therapy within 3 weeks of the first dose of study treatment. * Participant has received live vaccine within 14 days of planned start of study therapy * Participant has symptomatic uncontrolled brain or leptomeningeal metastases. (If investigator feels participant symptoms are not symptomatic, participants can undergo a scan to confirm for eligibility). * Participant had major surgery with 4 weeks of starting the first dose of the study treatment or participant has not recovered from any effects of any major surgery. * Participant has a known additional malignancy that progressed or required active treatment within the last 2 years. * Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active controlled infection. * Participant has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study. * Participant has known active hepatitis B (hepatitis B surface antigen reactive) or hepatitis C (hepatitis C virus ribonucleic acid, qualitative). * Participant with a known history of human immunodeficiency virus (HIV) are allowed if they meet all of the following criteria: 1. Cluster of differentiation 4 \>=350/microliter (μL) and viral load \<400 copies/milliliter (mL) 2. No history of acquired immunodeficiency syndrome-defining opportunistic infections within 12 months prior to enrollment 3. No history of HIV-associated malignancy for the past 5 years 4. Concurrent antiretroviral therapy as per the most current National Institutes of Health (NIH) Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV started \>4 weeks prior to study enrollment * Participant is immunocompromised. Participants with splenectomy are allowed. * Participant has an ongoing bowel obstruction or has other conditions that would lead to impaired absorption of oral niraparib. * Participant has active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) in Participants With Platinum-resistant Ovarian Cancer (PROC) | Up to approximately 22 months | 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. |
| ORR in Participants With PROC Who Have Programmed Cell Death-ligand 1 (PD-L 1) Positive Status | Up to approximately 22 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) in Participants With PROC | Up to approximately 22 months | 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. |
| PFS in Participants With PROC Who Have PD-L 1 Positive Status | Up to approximately 22 months | 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. |
| Overall Survival (OS) in Participants With PROC | Up to approximately 22 months | OS is defined as the time from the date of the first dose of study treatment to the date of death by any cause. |
| OS in Participants With PROC Who Have PD-L 1 Positive Status | Up to approximately 22 months | 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. |
| Disease Control Rate (DCR) in Participants With PROC | Up to approximately 22 months | 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. |
| DCR in Participants With PROC Who Have PD-L 1 Positive Status | Up to approximately 22 months | 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. |
| ORR in Participants With PROC Based on Independent Review Committee (IRC) Assessment | Up to approximately 22 months | 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. |
| ORR in Participants With PROC Who Have PD-L 1 Positive Status Based on IRC Assessment | Up to approximately 22 months | 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. |
| DOR in Participants With PROC Based on IRC Assessment | Up to approximately 22 months | 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. |
| DOR in Participants With PROC Who Have PD-L 1 Positive Status Based on IRC Assessment | Up to approximately 22 months | 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. |
| PFS in Participants With PROC Based on IRC Assessment | Up to approximately 22 months | 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. |
| Duration of Response (DOR) in Participants With PROC | Up to approximately 22 months | 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. |
| DCR in Participants With PROC Based on IRC Assessment | Up to approximately 22 months | 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. |
| DCR in Participants With PROC Who Have PD-L 1 Positive Status Based on IRC Assessment | Up to approximately 22 months | 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. |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-emergent Adverse Events (TEAEs) and Adverse Event of Special Interest (AESI) | Up to approximately 27 months | 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. |
| Number of Participants With Grade Shift From Baseline in Hematology | Up to approximately 27 months | 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. |
| Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Up to approximately 27 months | 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. |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Up to approximately 27 months | 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. |
| Change From Baseline in Pulse Rate | Up to approximately 27 months | 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. |
| Change From Baseline in Temperature | Up to approximately 27 months | 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. |
| Change From Baseline in Prothrombin International Normalized Ratio | Baseline and up to approximately 27 months | 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. |
| Change in Baseline in Activated Partial Thromboplastin Time | Baseline and up to approximately 27 months | 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. |
| Change From Baseline in Thyrotropin | Baseline and up to approximately 27 months | 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. |
| PFS in Participants With PROC Who Have PD-L 1 Positive Status Based on IRC Assessment | Up to approximately 22 months | 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. |
| DOR in Participants With PROC Who Have PD-L 1 Positive Status | Up to approximately 22 months | 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. |
Countries
United States
Participant flow
Recruitment details
From October 2019 until September 2020, 72 participants were screened and 41 participants were enrolled (31 screen failures)
Pre-assignment details
This study was terminated as the interim analysis of the primary endpoint met the prespecified futility criteria.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 22 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Sponsor Decision to Terminate Study | 11 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Niraparib+Dostarlimab (TSR-042) |
|---|---|
| Age, Continuous | 62.9 YEARS STANDARD_DEVIATION 10.59 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants |
| Race/Ethnicity, Customized Unknown | 3 Participants |
| Race/Ethnicity, Customized White | 32 Participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 22 / 41 |
| other Total, other adverse events | 41 / 41 |
| serious Total, serious adverse events | 23 / 41 |
Outcome results
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.
Time frame: Up to approximately 22 months
Population: Safety (SAF) Population: All participants who receive any amount of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Niraparib+Dostarlimab (TSR-042) | Objective Response Rate (ORR) in Participants With Platinum-resistant Ovarian Cancer (PROC) | 7.3 Percentage of Participants |
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.
Time frame: Up to approximately 22 months
Population: Data for participants with PD-L1 positive status in the SAF population are presented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Niraparib+Dostarlimab (TSR-042) | ORR in Participants With PROC Who Have Programmed Cell Death-ligand 1 (PD-L 1) Positive Status | 7.7 Percentage of Participants |
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.
Time frame: Baseline and up to approximately 27 months
Population: SAF Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Niraparib+Dostarlimab (TSR-042) | Change From Baseline in Prothrombin International Normalized Ratio | Day 2 | 0.2 Ratio |
| Niraparib+Dostarlimab (TSR-042) | Change From Baseline in Prothrombin International Normalized Ratio | Day 41 | 0.3 Ratio |
| Niraparib+Dostarlimab (TSR-042) | Change From Baseline in Prothrombin International Normalized Ratio | Day 52 | 0.7 Ratio |
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.
Time frame: Up to approximately 27 months
Population: SAF Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niraparib+Dostarlimab (TSR-042) | Change From Baseline in Pulse Rate | min change post baseline | 1 Beats per minute | Standard Deviation 13.77 |
| Niraparib+Dostarlimab (TSR-042) | Change From Baseline in Pulse Rate | max change post baseline | 20.5 Beats per minute | Standard Deviation 14.71 |
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.
Time frame: Up to approximately 27 months
Population: SAF Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niraparib+Dostarlimab (TSR-042) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, max change post baseline | 10.6 Millimeters of mercury | Standard Deviation 10.07 |
| Niraparib+Dostarlimab (TSR-042) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, min change post baseline | -5.8 Millimeters of mercury | Standard Deviation 11.87 |
| Niraparib+Dostarlimab (TSR-042) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, max change post baseline | 16.5 Millimeters of mercury | Standard Deviation 23.01 |
| Niraparib+Dostarlimab (TSR-042) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, min change post baseline | -12.5 Millimeters of mercury | Standard Deviation 24.61 |
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.
Time frame: Up to approximately 27 months
Population: SAF Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niraparib+Dostarlimab (TSR-042) | Change From Baseline in Temperature | max change post baseline | 0.31 Degrees Celsius | Standard Deviation 0.421 |
| Niraparib+Dostarlimab (TSR-042) | Change From Baseline in Temperature | min change post baseline | -0.35 Degrees Celsius | Standard Deviation 0.422 |
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.
Time frame: Baseline and up to approximately 27 months
Population: SAF Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niraparib+Dostarlimab (TSR-042) | Change From Baseline in Thyrotropin | Cycle 5 Day 1 | 8.074 Milliunits per liter (mU/L) | Standard Deviation 19.737 |
| Niraparib+Dostarlimab (TSR-042) | Change From Baseline in Thyrotropin | Cycle 7 Day 1 | 12.79 Milliunits per liter (mU/L) | Standard Deviation 23.24 |
| Niraparib+Dostarlimab (TSR-042) | Change From Baseline in Thyrotropin | Cycle 9 Day 1 | 2.596 Milliunits per liter (mU/L) | — |
| Niraparib+Dostarlimab (TSR-042) | Change From Baseline in Thyrotropin | Cycle 11 Day 1 | 2.517 Milliunits per liter (mU/L) | — |
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.
Time frame: Baseline and up to approximately 27 months
Population: SAF Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Niraparib+Dostarlimab (TSR-042) | Change in Baseline in Activated Partial Thromboplastin Time | Day 2 | 1 Second |
| Niraparib+Dostarlimab (TSR-042) | Change in Baseline in Activated Partial Thromboplastin Time | Day 41 | 16.9 Second |
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.
Time frame: Up to approximately 22 months
Population: Data was not collected as IRC assessment was not utilized due to study termination
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.
Time frame: Up to approximately 22 months
Population: Data for participants with PD-L1 positive status in the SAF population are presented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Niraparib+Dostarlimab (TSR-042) | DCR in Participants With PROC Who Have PD-L 1 Positive Status | 38.5 Percentage of Participants |
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.
Time frame: Up to approximately 22 months
Population: Data was not collected as IRC assessment was not utilized due to study termination
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.
Time frame: Up to approximately 22 months
Population: SAF Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Niraparib+Dostarlimab (TSR-042) | Disease Control Rate (DCR) in Participants With PROC | 29.3 Percentage of Participants |
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.
Time frame: Up to approximately 22 months
Population: Data was not collected as IRC assessment was not utilized due to study termination
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.
Time frame: Up to approximately 22 months
Population: Data for participants with PD-L1 positive status in the SAF population are presented. DOR has been summarized only for responders.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Niraparib+Dostarlimab (TSR-042) | DOR in Participants With PROC Who Have PD-L 1 Positive Status | NA Months |
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.
Time frame: Up to approximately 22 months
Population: Data was not collected as IRC assessment was not utilized due to study termination
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.
Time frame: Up to approximately 22 months
Population: SAF Population. DOR has been summarized only for responders.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Niraparib+Dostarlimab (TSR-042) | Duration of Response (DOR) in Participants With PROC | 3.8 Months |
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.
Time frame: Up to approximately 27 months
Population: SAF Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-emergent Adverse Events (TEAEs) and Adverse Event of Special Interest (AESI) | AEs | 41 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-emergent Adverse Events (TEAEs) and Adverse Event of Special Interest (AESI) | SAEs | 23 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-emergent Adverse Events (TEAEs) and Adverse Event of Special Interest (AESI) | TEAE | 41 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-emergent Adverse Events (TEAEs) and Adverse Event of Special Interest (AESI) | AESIs | 2 Participants |
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.
Time frame: Up to approximately 27 months
Population: SAF Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Leukocytes, Grade 1 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Leukocytes, Grade 4 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Lymphocytes, Grade 3 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Hemoglobin, Grade 0 to Grade 3 | 3 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Hemoglobin, Grade 1 to Grade 3 | 5 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Hemoglobin, Grade 2 to Grade 3 | 1 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Hemoglobin, Grade 3 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Hemoglobin, Grade 4 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Hemoglobin, Grade 0 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Hemoglobin, Grade 1 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Hemoglobin, Grade 2 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Hemoglobin, Grade 3 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Hemoglobin, Grade 4 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Leukocytes, Grade 0 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Leukocytes, Grade 2 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Leukocytes, Grade 3 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Leukocytes, Grade 4 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Leukocytes, Grade 0 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Leukocytes, Grade 1 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Leukocytes, Grade 2 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Leukocytes, Grade 3 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Lymphocytes, Grade 0 to Grade 3 | 5 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Lymphocytes, Grade 1 to Grade 3 | 3 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Lymphocytes, Grade 2 to Grade 3 | 3 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Lymphocytes, Grade 3 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Lymphocytes, Grade 4 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Lymphocytes, Grade 0 to Grade 4 | 1 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Lymphocytes, Grade 1 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Lymphocytes, Grade 2 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Lymphocytes, Grade 4 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Neutrophil Count, Grade 0 to Grade 3 | 1 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Neutrophil Count, Grade 1 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Neutrophil Count, Grade 2 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Neutrophil Count, Grade 3 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Neutrophil Count, Grade 4 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Neutrophil Count, Grade 0 to Grade 4 | 1 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Neutrophil Count, Grade 1 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Neutrophil Count, Grade 2 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Neutrophil Count, Grade 3 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Neutrophil Count, Grade 4 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Platelets, Grade 0 to Grade 3 | 4 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Platelets, Grade 1 to Grade 3 | 1 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Platelets, Grade 2 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Platelets, Grade 3 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Platelets, Grade 4 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Platelets, Grade 0 to Grade 4 | 4 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Platelets, Grade 1 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Platelets, Grade 2 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Platelets, Grade 3 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Hematology | Platelets, Grade 4 to Grade 4 | 0 Participants |
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.
Time frame: Up to approximately 27 months
Population: SAF Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | TB, Grade 4 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Magnesium high, Grade 2 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Magnesium low, Grade 3 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | ALT, Grade 0 to Grade 3 | 3 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | ALT, Grade 1 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | ALT, Grade 2 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | ALT, Grade 3 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | ALT, Grade 4 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | ALT, Grade 0 to Grade 4 | 1 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | ALT, Grade 1 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | ALT, Grade 2 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | ALT, Grade 3 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | ALT, Grade 4 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Alb, Grade 0 to Grade 3 | 1 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Alb, Grade 1 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Alb, Grade 2 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Alb, Grade 3 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Alb, Grade 4 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Alb, Grade 0 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Alb, Grade 1 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Alb, Grade 2 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Alb, Grade 3 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Alb, Grade 4 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | ALP, Grade 0 to Grade 3 | 3 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | ALP, Grade 1 to Grade 3 | 1 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | ALP, Grade 2 to Grade 3 | 1 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | ALP, Grade 3 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | ALP, Grade 4 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | ALP, Grade 0 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | ALP, Grade 1 to Grade 4 | 1 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | ALP, Grade 2 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | ALP, Grade 3 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | ALP, Grade 4 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Amylase, Grade 0 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Amylase, Grade 1 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Amylase, Grade 2 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Amylase, Grade 3 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Amylase, Grade 4 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Amylase, Grade 0 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Amylase, Grade 1 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Amylase, Grade 2 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Amylase, Grade 3 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Amylase, Grade 4 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | AST, Grade 0 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | AST, Grade 0 to Grade 3 | 4 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | AST, Grade 1 to Grade 3 | 1 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | AST, Grade 2 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | AST, Grade 3 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | AST, Grade 4 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | AST, Grade 1 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | AST, Grade 2 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | AST, Grade 3 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | AST, Grade 4 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | TB, Grade 0 to Grade 3 | 1 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | TB, Grade 1 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | TB, Grade 2 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | TB, Grade 3 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | TB, Grade 4 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | TB, Grade 0 to Grade 4 | 1 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | TB, Grade 1 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | TB, Grade 2 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Creatinine, Grade 0 to Grade 3 | 1 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | TB, Grade 3 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Creatinine, Grade 1 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Creatinine, Grade 2 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Creatinine, Grade 3 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Creatinine, Grade 4 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Creatinine, Grade 0 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Creatinine, Grade 1 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Creatinine, Grade 2 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Creatinine, Grade 3 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Creatinine, Grade 4 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Glucose high, Grade 0 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Glucose high, Grade 1 to Grade 3 | 3 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Glucose high, Grade 2 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Glucose high, Grade 3 to Grade 3 | 1 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Glucose high, Grade 4 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Glucose high, Grade 0 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Glucose high, Grade 1 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Glucose high, Grade 2 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Glucose high, Grade 3 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Glucose high, Grade 4 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Glucose low, Grade 0 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Glucose low, Grade 1 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Glucose low, Grade 2 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Glucose low, Grade 3 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Glucose low, Grade 4 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Glucose low, Grade 0 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Glucose low, Grade 1 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Glucose low, Grade 2 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Glucose low, Grade 3 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Glucose low, Grade 4 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Magnesium high, Grade 0 to Grade 3 | 1 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Magnesium high, Grade 1 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Magnesium high, Grade 0 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Magnesium high, Grade 3 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Magnesium high, Grade 4 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Magnesium high, Grade 1 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Magnesium high, Grade 2 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Magnesium high, Grade 3 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Magnesium high, Grade 4 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Magnesium low, Grade 0 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Magnesium low, Grade 1 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Magnesium low, Grade 2 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Magnesium low, Grade 3 to Grade 3 | 1 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Magnesium low, Grade 4 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Magnesium low, Grade 0 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Magnesium low, Grade 1 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Magnesium low, Grade 2 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Magnesium low, Grade 4 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Potassium high, Grade 0 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Potassium high, Grade 1 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Potassium high, Grade 2 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Potassium high, Grade 3 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Potassium high, Grade 4 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Potassium high, Grade 0 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Potassium high, Grade 1 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Potassium high, Grade 2 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Potassium high, Grade 3 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Potassium high, Grade 4 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Potassium low, Grade 0 to Grade 3 | 3 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Potassium low, Grade 1 to Grade 3 | 1 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Potassium low, Grade 2 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Potassium low, Grade 3 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Potassium low, Grade 4 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Potassium low, Grade 0 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Potassium low, Grade 1 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Potassium low, Grade 2 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Potassium low, Grade 3 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Potassium low, Grade 4 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Sodium high, Grade 0 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Sodium high, Grade 1 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Sodium high, Grade 2 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Sodium high, Grade 3 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Sodium high, Grade 4 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Sodium high, Grade 0 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Sodium high, Grade 1 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Sodium high, Grade 2 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Sodium high, Grade 3 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Sodium high, Grade 4 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Sodium low, Grade 0 to Grade 3 | 4 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Sodium low, Grade 1 to Grade 3 | 7 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Sodium low, Grade 2 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Sodium low, Grade 3 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Sodium low, Grade 4 to Grade 3 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Sodium low, Grade 0 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Sodium low, Grade 1 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Sodium low, Grade 2 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Sodium low, Grade 3 to Grade 4 | 0 Participants |
| Niraparib+Dostarlimab (TSR-042) | Number of Participants With Grade Shift From Baseline in Plasma Chemistry | Sodium low, Grade 4 to Grade 4 | 0 Participants |
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.
Time frame: Up to approximately 22 months
Population: Data was not collected as IRC assessment was not utilized due to study termination.
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.
Time frame: Up to approximately 22 months
Population: Data was not collected as IRC assessment was not utilized due to study termination
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.
Time frame: Up to approximately 22 months
Population: Data for participants with PD-L1 positive status in the SAF population are presented.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Niraparib+Dostarlimab (TSR-042) | OS in Participants With PROC Who Have PD-L 1 Positive Status | NA Months |
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.
Time frame: Up to approximately 22 months
Population: SAF Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Niraparib+Dostarlimab (TSR-042) | Overall Survival (OS) in Participants With PROC | 10.61 Months |
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.
Time frame: Up to approximately 22 months
Population: Data was not collected as IRC assessment was not utilized due to study termination
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.
Time frame: Up to approximately 22 months
Population: Data for participants with PD-L1 positive status in the SAF population are presented.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Niraparib+Dostarlimab (TSR-042) | PFS in Participants With PROC Who Have PD-L 1 Positive Status | 2.22 Months |
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.
Time frame: Up to approximately 22 months
Population: Data was not collected as IRC assessment was not utilized due to study termination
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.
Time frame: Up to approximately 22 months
Population: SAF Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Niraparib+Dostarlimab (TSR-042) | Progression-free Survival (PFS) in Participants With PROC | 2.1 Months |