Trial · NCT03955471
Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Participants With Platinum Resistant Ovarian Cancer
NCT03955471, Phase 2, Terminated, Tesaro, Inc.; results first posted 2022-09-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Participants With Platinum Resistant Ovarian Cancer. Trials, record NCT03955471. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03955471
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Participants With Platinum Resistant Ovarian Cancer
- NCT number
- NCT03955471
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- Tesaro, Inc.
- Conditions
- Ovarian Neoplasms
- Interventions
- Niraparib, Dostarlimab
- First posted
- 2019-05-20
- Last updated
- 2022-09-10
- Results first posted
- 2022-09-10
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) in Participants With Platinum-resistant Ovarian Cancer (PROC) | Up to approximately 22 months | Safety (SAF) Population: All participants who receive any amount of study treatment. | Percentage of Participants | NUMBER |
| PRIMARY | ORR in Participants With PROC Who Have Programmed Cell Death-ligand 1 (PD-L 1) Positive Status | Up to approximately 22 months | Data for participants with PD-L1 positive status in the SAF population are presented. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) in Participants With PROC | Up to approximately 22 months | SAF Population. DOR has been summarized only for responders. | Months | MEDIAN |
| SECONDARY | DOR in Participants With PROC Who Have PD-L 1 Positive Status | Up to approximately 22 months | Data for participants with PD-L1 positive status in the SAF population are presented. DOR has been summarized only for responders. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) in Participants With PROC | Up to approximately 22 months | SAF Population | Months | MEDIAN |
| SECONDARY | PFS in Participants With PROC Who Have PD-L 1 Positive Status | Up to approximately 22 months | Data for participants with PD-L1 positive status in the SAF population are presented. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) in Participants With PROC | Up to approximately 22 months | SAF Population | Months | MEDIAN |
| SECONDARY | OS in Participants With PROC Who Have PD-L 1 Positive Status | Up to approximately 22 months | Data for participants with PD-L1 positive status in the SAF population are presented. | Months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) in Participants With PROC | Up to approximately 22 months | SAF Population | Percentage of Participants | NUMBER |
| SECONDARY | DCR in Participants With PROC Who Have PD-L 1 Positive Status | Up to approximately 22 months | Data for participants with PD-L1 positive status in the SAF population are presented. | Percentage of Participants | NUMBER |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group231
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) in Participants With Platinum-resistant Ovarian Cancer (PROC) | Niraparib+Dostarlimab (TSR-042) | 7.3 | 95% Confidence Interval 1.5 to 19.9 | Percentage of Participants | |
| ORR in Participants With PROC Who Have Programmed Cell Death-ligand 1 (PD-L 1) Positive Status | Niraparib+Dostarlimab (TSR-042) | 7.7 | 95% Confidence Interval 0.2 to 36 | Percentage of Participants | |
| Duration of Response (DOR) in Participants With PROC | Niraparib+Dostarlimab (TSR-042) | 3.8 | Full Range 3 to 9.2 | Months | |
| DOR in Participants With PROC Who Have PD-L 1 Positive Status | Niraparib+Dostarlimab (TSR-042) | NA | Full Range 3.8 to NA | Months | |
| Progression-free Survival (PFS) in Participants With PROC | Niraparib+Dostarlimab (TSR-042) | 2.1 | 95% Confidence Interval 1.97 to 2.23 | Months | |
| PFS in Participants With PROC Who Have PD-L 1 Positive Status | Niraparib+Dostarlimab (TSR-042) | 2.22 | 95% Confidence Interval 1.64 to NA | Months | |
| Overall Survival (OS) in Participants With PROC | Niraparib+Dostarlimab (TSR-042) | 10.61 | 95% Confidence Interval 7.26 to 13.44 | Months | |
| OS in Participants With PROC Who Have PD-L 1 Positive Status | Niraparib+Dostarlimab (TSR-042) | NA | 95% Confidence Interval 7.26 to NA | Months | |
| Disease Control Rate (DCR) in Participants With PROC | Niraparib+Dostarlimab (TSR-042) | 29.3 | 95% Confidence Interval 16.1 to 45.5 | Percentage of Participants | |
| DCR in Participants With PROC Who Have PD-L 1 Positive Status | Niraparib+Dostarlimab (TSR-042) | 38.5 | 95% Confidence Interval 13.9 to 68.4 | Percentage of Participants |
1 to 10 of 231Source ClinicalTrials.gov
See all 231 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Niraparib+Dostarlimab (TSR-042) | 41 | |
| Overall Study | COMPLETED | Niraparib+Dostarlimab (TSR-042) | 1 | |
| Overall Study | NOT COMPLETED | Niraparib+Dostarlimab (TSR-042) | 40 |
Source ClinicalTrials.gov
Adverse events75
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Niraparib+Dostarlimab (TSR-042) | 18 | 41 | 63 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Niraparib+Dostarlimab (TSR-042) | 7 | 41 | 11 |
| other | Palpitations | Cardiac disorders | Niraparib+Dostarlimab (TSR-042) | 5 | 41 | 5 |
| other | Sinus tachycardia | Cardiac disorders | Niraparib+Dostarlimab (TSR-042) | 4 | 41 | 4 |
| other | Tachycardia | Cardiac disorders | Niraparib+Dostarlimab (TSR-042) | 3 | 41 | 3 |
| other | Hypothyroidism | Endocrine disorders | Niraparib+Dostarlimab (TSR-042) | 6 | 41 | 7 |
| other | Nausea | Gastrointestinal disorders | Niraparib+Dostarlimab (TSR-042) | 24 | 41 | 35 |
| other | Vomiting | Gastrointestinal disorders | Niraparib+Dostarlimab (TSR-042) | 19 | 41 | 28 |
| other | Abdominal pain | Gastrointestinal disorders | Niraparib+Dostarlimab (TSR-042) | 15 | 41 | 24 |
| other | Constipation | Gastrointestinal disorders | Niraparib+Dostarlimab (TSR-042) | 15 | 41 | 18 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Niraparib+Dostarlimab (TSR-042) | 22 | 41 |
| Total, other adverse events | Niraparib+Dostarlimab (TSR-042) | 41 | 41 |
| Total, serious adverse events | Niraparib+Dostarlimab (TSR-042) | 23 | 41 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37890345 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03955471
GET https://conductscience.org/api/trials/v1/NCT03955471/registered?page=2