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TerminatedNCT03955471MOONSTONEUpdated Sep 10, 2022Results posted

Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Participants With Platinum Resistant Ovarian Cancer

A Phase 2 interventional study of Niraparib and Dostarlimab in Ovarian Neoplasms, sponsored by Tesaro, Inc.. Terminated at 27 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-10.

Sponsored by Tesaro, Inc. · Phase 2, Interventional, and Treatment

Why this study was terminated
The study will not resume based on the results of a planned interim analysis that showed futility
Phase
Phase 2
Study type
Interventional
Enrollment
41
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Ovarian Neoplasms

Keywords

  • Open-label
  • Single-arm
  • Efficacy and Safety
  • Platinum-resistant ovarian cancer
  • Niraparib
  • dostarlimab
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 41 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Tesaro, Inc. is the lead sponsor of 32 studies on the registry; none are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 12 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts 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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    Niraparib+Dostarlimab (TSR-042)

    Participants with body weight ≥77 kilogram (kg) and platelet count ≥150,000/microliter (μL) at baseline were administered Niraparib 300 milligram (mg) once daily (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 Progressive disease (PD) or toxicity. Dostarlimab (TSR-042) was administered as an intravenous (IV) infusion of 500 mg once every three weeks (Q3W) from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab (TSR-042) 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.

    Drug: Niraparib · Drug: Dostarlimab

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.

    Also known as: ZEJULA

  • 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).

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

07

Results

Posted Sep 10, 2022

Participant flow

From October 2019 until September 2020, 72 participants were screened and 41 participants were enrolled (31 screen failures)

Participant flow — Overall Study
MilestoneNiraparib+Dostarlimab (TSR-042)
Started41
Completed1
Not completed40
Withdrew: Death22
Withdrew: Lost to follow-up1
Withdrew: Withdrawal by subject6
Withdrew: Sponsor decision to terminate study11

Outcome measures

PrimaryObjective 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
Reported as:
Number · Percentage of Participants
Objective Response Rate (ORR) in Participants With Platinum-resistant Ovarian Cancer (PROC)
Percentage of ParticipantsNiraparib+Dostarlimab (TSR-042)
Objective Response Rate (ORR) in Participants With Platinum-resistant Ovarian Cancer (PROC)7.3 (1.5 to 19.9)
PrimaryORR 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
Reported as:
Number · Percentage of Participants
ORR in Participants With PROC Who Have Programmed Cell Death-ligand 1 (PD-L 1) Positive Status
Percentage of ParticipantsNiraparib+Dostarlimab (TSR-042)
ORR in Participants With PROC Who Have Programmed Cell Death-ligand 1 (PD-L 1) Positive Status7.7 (0.2 to 36)
SecondaryDuration 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
Reported as:
Median · Months
Duration of Response (DOR) in Participants With PROC
MonthsNiraparib+Dostarlimab (TSR-042)
Duration of Response (DOR) in Participants With PROC3.8 (3 to 9.2)
SecondaryDOR 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
Reported as:
Median · Months
DOR in Participants With PROC Who Have PD-L 1 Positive Status
MonthsNiraparib+Dostarlimab (TSR-042)
DOR in Participants With PROC Who Have PD-L 1 Positive StatusNA (3.8 to NA)
SecondaryProgression-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
Reported as:
Median · Months
Progression-free Survival (PFS) in Participants With PROC
MonthsNiraparib+Dostarlimab (TSR-042)
Progression-free Survival (PFS) in Participants With PROC2.1 (1.97 to 2.23)
SecondaryPFS 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
Reported as:
Median · Months
PFS in Participants With PROC Who Have PD-L 1 Positive Status
MonthsNiraparib+Dostarlimab (TSR-042)
PFS in Participants With PROC Who Have PD-L 1 Positive Status2.22 (1.64 to NA)
SecondaryOverall 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
Reported as:
Median · Months
Overall Survival (OS) in Participants With PROC
MonthsNiraparib+Dostarlimab (TSR-042)
Overall Survival (OS) in Participants With PROC10.61 (7.26 to 13.44)
SecondaryOS 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
Reported as:
Median · Months
OS in Participants With PROC Who Have PD-L 1 Positive Status
MonthsNiraparib+Dostarlimab (TSR-042)
OS in Participants With PROC Who Have PD-L 1 Positive StatusNA (7.26 to NA)
SecondaryDisease 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
Reported as:
Number · Percentage of Participants
Disease Control Rate (DCR) in Participants With PROC
Percentage of ParticipantsNiraparib+Dostarlimab (TSR-042)
Disease Control Rate (DCR) in Participants With PROC29.3 (16.1 to 45.5)
SecondaryDCR 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
Reported as:
Number · Percentage of Participants
DCR in Participants With PROC Who Have PD-L 1 Positive Status
Percentage of ParticipantsNiraparib+Dostarlimab (TSR-042)
DCR in Participants With PROC Who Have PD-L 1 Positive Status38.5 (13.9 to 68.4)
SecondaryORR 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

No measurements were reported for this outcome.

SecondaryORR 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

No measurements were reported for this outcome.

SecondaryDOR 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

No measurements were reported for this outcome.

SecondaryDOR 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

No measurements were reported for this outcome.

SecondaryPFS 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

No measurements were reported for this outcome.

SecondaryPFS 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

No measurements were reported for this outcome.

SecondaryDCR 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

No measurements were reported for this outcome.

SecondaryDCR 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

No measurements were reported for this outcome.

SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-emergent Adverse Events (TEAEs) and Adverse Event of Special Interest (AESI)
ParticipantsNiraparib+Dostarlimab (TSR-042)
AEs41
SAEs23
TEAE41
AESIs2
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Grade Shift From Baseline in Hematology
ParticipantsNiraparib+Dostarlimab (TSR-042)
Hemoglobin, Grade 0 to Grade 33
Hemoglobin, Grade 1 to Grade 35
Hemoglobin, Grade 2 to Grade 31
Hemoglobin, Grade 3 to Grade 30
Hemoglobin, Grade 4 to Grade 30
Hemoglobin, Grade 0 to Grade 40
Hemoglobin, Grade 1 to Grade 40
Hemoglobin, Grade 2 to Grade 40
Hemoglobin, Grade 3 to Grade 40
Hemoglobin, Grade 4 to Grade 40
Leukocytes, Grade 0 to Grade 30
Leukocytes, Grade 1 to Grade 30
Leukocytes, Grade 2 to Grade 30
Leukocytes, Grade 3 to Grade 30
Leukocytes, Grade 4 to Grade 30
Leukocytes, Grade 0 to Grade 40
Leukocytes, Grade 1 to Grade 40
Leukocytes, Grade 2 to Grade 40
Leukocytes, Grade 3 to Grade 40
Leukocytes, Grade 4 to Grade 40
Lymphocytes, Grade 0 to Grade 35
Lymphocytes, Grade 1 to Grade 33
Lymphocytes, Grade 2 to Grade 33
Lymphocytes, Grade 3 to Grade 30
Lymphocytes, Grade 4 to Grade 30
Lymphocytes, Grade 0 to Grade 41
Lymphocytes, Grade 1 to Grade 40
Lymphocytes, Grade 2 to Grade 40
Lymphocytes, Grade 3 to Grade 40
Lymphocytes, Grade 4 to Grade 40
Neutrophil Count, Grade 0 to Grade 31
Neutrophil Count, Grade 1 to Grade 30
Neutrophil Count, Grade 2 to Grade 30
Neutrophil Count, Grade 3 to Grade 30
Neutrophil Count, Grade 4 to Grade 30
Neutrophil Count, Grade 0 to Grade 41
Neutrophil Count, Grade 1 to Grade 40
Neutrophil Count, Grade 2 to Grade 40
Neutrophil Count, Grade 3 to Grade 40
Neutrophil Count, Grade 4 to Grade 40
Platelets, Grade 0 to Grade 34
Platelets, Grade 1 to Grade 31
Platelets, Grade 2 to Grade 30
Platelets, Grade 3 to Grade 30
Platelets, Grade 4 to Grade 30
Platelets, Grade 0 to Grade 44
Platelets, Grade 1 to Grade 40
Platelets, Grade 2 to Grade 40
Platelets, Grade 3 to Grade 40
Platelets, Grade 4 to Grade 40
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Grade Shift From Baseline in Plasma Chemistry
ParticipantsNiraparib+Dostarlimab (TSR-042)
ALT, Grade 0 to Grade 33
ALT, Grade 1 to Grade 30
ALT, Grade 2 to Grade 30
ALT, Grade 3 to Grade 30
ALT, Grade 4 to Grade 30
ALT, Grade 0 to Grade 41
ALT, Grade 1 to Grade 40
ALT, Grade 2 to Grade 40
ALT, Grade 3 to Grade 40
ALT, Grade 4 to Grade 40
Alb, Grade 0 to Grade 31
Alb, Grade 1 to Grade 30
Alb, Grade 2 to Grade 30
Alb, Grade 3 to Grade 30
Alb, Grade 4 to Grade 30
Alb, Grade 0 to Grade 40
Alb, Grade 1 to Grade 40
Alb, Grade 2 to Grade 40
Alb, Grade 3 to Grade 40
Alb, Grade 4 to Grade 40
ALP, Grade 0 to Grade 33
ALP, Grade 1 to Grade 31
ALP, Grade 2 to Grade 31
ALP, Grade 3 to Grade 30
ALP, Grade 4 to Grade 30
ALP, Grade 0 to Grade 40
ALP, Grade 1 to Grade 41
ALP, Grade 2 to Grade 40
ALP, Grade 3 to Grade 40
ALP, Grade 4 to Grade 40
Amylase, Grade 0 to Grade 30
Amylase, Grade 1 to Grade 30
Amylase, Grade 2 to Grade 30
Amylase, Grade 3 to Grade 30
Amylase, Grade 4 to Grade 30
Amylase, Grade 0 to Grade 40
Amylase, Grade 1 to Grade 40
Amylase, Grade 2 to Grade 40
Amylase, Grade 3 to Grade 40
Amylase, Grade 4 to Grade 40
AST, Grade 0 to Grade 34
AST, Grade 1 to Grade 31
AST, Grade 2 to Grade 30
AST, Grade 3 to Grade 30
AST, Grade 4 to Grade 30
AST, Grade 0 to Grade 40
AST, Grade 1 to Grade 40
AST, Grade 2 to Grade 40
AST, Grade 3 to Grade 40
AST, Grade 4 to Grade 40
TB, Grade 0 to Grade 31
TB, Grade 1 to Grade 30
TB, Grade 2 to Grade 30
TB, Grade 3 to Grade 30
TB, Grade 4 to Grade 30
TB, Grade 0 to Grade 41
TB, Grade 1 to Grade 40
TB, Grade 2 to Grade 40
TB, Grade 3 to Grade 40
TB, Grade 4 to Grade 40
Creatinine, Grade 0 to Grade 31
Creatinine, Grade 1 to Grade 30
Creatinine, Grade 2 to Grade 30
Creatinine, Grade 3 to Grade 30
Creatinine, Grade 4 to Grade 30
Creatinine, Grade 0 to Grade 40
Creatinine, Grade 1 to Grade 40
Creatinine, Grade 2 to Grade 40
Creatinine, Grade 3 to Grade 40
Creatinine, Grade 4 to Grade 40
Glucose high, Grade 0 to Grade 30
Glucose high, Grade 1 to Grade 33
Glucose high, Grade 2 to Grade 30
Glucose high, Grade 3 to Grade 31
Glucose high, Grade 4 to Grade 30
Glucose high, Grade 0 to Grade 40
Glucose high, Grade 1 to Grade 40
Glucose high, Grade 2 to Grade 40
Glucose high, Grade 3 to Grade 40
Glucose high, Grade 4 to Grade 40
Glucose low, Grade 0 to Grade 30
Glucose low, Grade 1 to Grade 30
Glucose low, Grade 2 to Grade 30
Glucose low, Grade 3 to Grade 30
Glucose low, Grade 4 to Grade 30
Glucose low, Grade 0 to Grade 40
Glucose low, Grade 1 to Grade 40
Glucose low, Grade 2 to Grade 40
Glucose low, Grade 3 to Grade 40
Glucose low, Grade 4 to Grade 40
Magnesium high, Grade 0 to Grade 31
Magnesium high, Grade 1 to Grade 30
Magnesium high, Grade 2 to Grade 30
Magnesium high, Grade 3 to Grade 30
Magnesium high, Grade 4 to Grade 30
Magnesium high, Grade 0 to Grade 40
Magnesium high, Grade 1 to Grade 40
Magnesium high, Grade 2 to Grade 40
Magnesium high, Grade 3 to Grade 40
Magnesium high, Grade 4 to Grade 40
Magnesium low, Grade 0 to Grade 30
Magnesium low, Grade 1 to Grade 30
Magnesium low, Grade 2 to Grade 30
Magnesium low, Grade 3 to Grade 31
Magnesium low, Grade 4 to Grade 30
Magnesium low, Grade 0 to Grade 40
Magnesium low, Grade 1 to Grade 40
Magnesium low, Grade 2 to Grade 40
Magnesium low, Grade 3 to Grade 40
Magnesium low, Grade 4 to Grade 40
Potassium high, Grade 0 to Grade 30
Potassium high, Grade 1 to Grade 30
Potassium high, Grade 2 to Grade 30
Potassium high, Grade 3 to Grade 30
Potassium high, Grade 4 to Grade 30
Potassium high, Grade 0 to Grade 40
Potassium high, Grade 1 to Grade 40
Potassium high, Grade 2 to Grade 40
Potassium high, Grade 3 to Grade 40
Potassium high, Grade 4 to Grade 40
Potassium low, Grade 0 to Grade 33
Potassium low, Grade 1 to Grade 31
Potassium low, Grade 2 to Grade 30
Potassium low, Grade 3 to Grade 30
Potassium low, Grade 4 to Grade 30
Potassium low, Grade 0 to Grade 40
Potassium low, Grade 1 to Grade 40
Potassium low, Grade 2 to Grade 40
Potassium low, Grade 3 to Grade 40
Potassium low, Grade 4 to Grade 40
Sodium high, Grade 0 to Grade 30
Sodium high, Grade 1 to Grade 30
Sodium high, Grade 2 to Grade 30
Sodium high, Grade 3 to Grade 30
Sodium high, Grade 4 to Grade 30
Sodium high, Grade 0 to Grade 40
Sodium high, Grade 1 to Grade 40
Sodium high, Grade 2 to Grade 40
Sodium high, Grade 3 to Grade 40
Sodium high, Grade 4 to Grade 40
Sodium low, Grade 0 to Grade 34
Sodium low, Grade 1 to Grade 37
Sodium low, Grade 2 to Grade 30
Sodium low, Grade 3 to Grade 30
Sodium low, Grade 4 to Grade 30
Sodium low, Grade 0 to Grade 40
Sodium low, Grade 1 to Grade 40
Sodium low, Grade 2 to Grade 40
Sodium low, Grade 3 to Grade 40
Sodium low, Grade 4 to Grade 40
SecondaryChange 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
Reported as:
Mean · Millimeters of mercury
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Millimeters of mercuryNiraparib+Dostarlimab (TSR-042)
DBP, max change post baseline10.6 ± 10.07
DBP, min change post baseline-5.8 ± 11.87
SBP, max change post baseline16.5 ± 23.01
SBP, min change post baseline-12.5 ± 24.61
SecondaryChange 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
Reported as:
Mean · Beats per minute
Change From Baseline in Pulse Rate
Beats per minuteNiraparib+Dostarlimab (TSR-042)
max change post baseline20.5 ± 14.71
min change post baseline1 ± 13.77
SecondaryChange 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
Reported as:
Mean · Degrees Celsius
Change From Baseline in Temperature
Degrees CelsiusNiraparib+Dostarlimab (TSR-042)
max change post baseline0.31 ± 0.421
min change post baseline-0.35 ± 0.422
SecondaryChange 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
Reported as:
Mean · Ratio
Change From Baseline in Prothrombin International Normalized Ratio
RatioNiraparib+Dostarlimab (TSR-042)
Day 20.2
Day 410.3
Day 520.7
SecondaryChange 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
Reported as:
Mean · Second
Change in Baseline in Activated Partial Thromboplastin Time
SecondNiraparib+Dostarlimab (TSR-042)
Day 21
Day 4116.9
SecondaryChange 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
Reported as:
Mean · Milliunits per liter (mU/L)
Change From Baseline in Thyrotropin
Milliunits per liter (mU/L)Niraparib+Dostarlimab (TSR-042)
Cycle 5 Day 18.074 ± 19.737
Cycle 7 Day 112.79 ± 23.240
Cycle 9 Day 12.596
Cycle 11 Day 12.517

Adverse events

Collected over All cause mortality, non-SAEs and SAEs were collected from Day 1 up to approximately 27 months.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Niraparib+Dostarlimab (TSR-042)22/41 (53.7%)23/41 (56.1%)41/41 (100%)
Most frequent serious events
Showing 10 of 30
Most frequent serious events
EventNiraparib+Dostarlimab (TSR-042)
ThrombocytopeniaBlood and lymphatic system disorders3/41
Small intestinal obstructionGastrointestinal disorders3/41
DyspnoeaRespiratory, thoracic and mediastinal disorders3/41
AnaemiaBlood and lymphatic system disorders2/41
Intestinal obstructionGastrointestinal disorders2/41
VomitingGastrointestinal disorders2/41
Blood bilirubin increasedInvestigations2/41
Pleural effusionRespiratory, thoracic and mediastinal disorders2/41
TachycardiaCardiac disorders1/41
Abdominal painGastrointestinal disorders1/41
Most frequent other events
Showing 10 of 45
Most frequent other events
EventNiraparib+Dostarlimab (TSR-042)
NauseaGastrointestinal disorders24/41
VomitingGastrointestinal disorders19/41
AnaemiaBlood and lymphatic system disorders18/41
FatigueGeneral disorders18/41
Abdominal painGastrointestinal disorders15/41
ConstipationGastrointestinal disorders15/41
DiarrhoeaGastrointestinal disorders11/41
Platelet count decreasedInvestigations11/41
Blood creatinine increasedInvestigations10/41
Blood alkaline phosphatase increasedInvestigations10/41

Baseline characteristics

Age, Continuous
Age, Continuous(YEARS)Niraparib+Dostarlimab (TSR-042)
Mean62.9 ± 10.59
Sex: Female, Male
Sex: Female, Male(Participants)Niraparib+Dostarlimab (TSR-042)
Female41
Male0
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Niraparib+Dostarlimab (TSR-042)
American Indian or Alaska Native1
Asian2
Black or African American3
Unknown3
White32
08

Study locations

27 sites
  • GSK Investigational Site
    Scottsdale, Arizona 85258, United States
  • GSK Investigational Site
    Duarte, California 91010, United States
  • GSK Investigational Site
    Newport Beach, California 92663, United States
  • GSK Investigational Site
    Orange, California 92868, United States
  • GSK Investigational Site
    Solvang, California 93463, United States
  • GSK Investigational Site
    Deerfield Beach, Florida 33442, United States
  • GSK Investigational Site
    Miami, Florida 33136, United States
  • GSK Investigational Site
    Orlando, Florida 32804, United States
  • GSK Investigational Site
    Tampa, Florida 33612, United States
  • GSK Investigational Site
    Iowa City, Iowa 52242-1009, United States
  • GSK Investigational Site
    Boston, Massachusetts 02114, United States
  • GSK Investigational Site
    Boston, Massachusetts 02215, United States
  • GSK Investigational Site
    Burlington, Massachusetts 01805, United States
  • GSK Investigational Site
    Minneapolis, Minnesota 55404, United States
  • GSK Investigational Site
    Jackson, Mississippi 39216, United States
  • GSK Investigational Site
    New York, New York 10022, United States
  • GSK Investigational Site
    Durham, North Carolina 27710, United States
  • GSK Investigational Site
    Cleveland, Ohio 44106, United States
  • GSK Investigational Site
    Cleveland, Ohio 44124, United States
  • GSK Investigational Site
    Eugene, Oregon 97401, United States
  • GSK Investigational Site
    Providence, Rhode Island 02905, United States
  • GSK Investigational Site
    Chattanooga, Tennessee 37403, United States
  • GSK Investigational Site
    Germantown, Tennessee 38138, United States
  • GSK Investigational Site
    Austin, Texas 78731, United States
  • GSK Investigational Site
    Fort Worth, Texas 76104, United States
  • GSK Investigational Site
    San Antonio, Texas 78229, United States
  • GSK Investigational Site
    Charlottesville, Virginia 22903, United States
09

References and documents

Study documents

  • Study protocol · Dec 15, 2021
  • Statistical analysis plan · Oct 29, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03955471
Lead sponsor
Tesaro, Inc.
Collaborators
Gynecologic Oncology Group
Responsible party
Sponsor
First posted
May 20, 2019
Start date
Oct 3, 2019
Primary completion
Aug 18, 2021
Completion
Jan 12, 2022
Results posted
Sep 10, 2022
Last update
Sep 10, 2022

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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