TriangleNCT02657889 · STUDY IN CONTEXT
Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer
Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
DLTs are defined as: Any treatment-related Grade \>=3 non-hematologic clinical (non-laboratory) adverse event (AE); Any treatment-related Grade 3 or Grade 4 non-hematologic laboratory (lab) abnormality if Medical intervention is required to treat the participant or the abnormality leads to hospitalization or the abnormality persists for \>=7 days; Any treatment-related hematologic toxicity specifically defined as: Thrombocytopenia Grade 4 for \>=7 days, or Grade 3 or 4 associated with bleeding or requiring platelet transfusion, Neutropenia Grade 4 for \>=7 days, or Grade 3 or 4 associated with infection or febrile neutropenia, Anemia Grade 4, or Grade 3 or 4 requiring blood transfusion; Any treatment-related AE leading to niraparib dose interruption per the following criteria: A dose interruption for a non-DLT lab abnormality lasting \>=14 days, A dose in interruption per dose modification rules for non-hematologic AE leading to \<80 percent (%) of an intended dose being administered.
ORR is defined as the percentage of participants with a confirmed best overall response of Complete Response (CR) or Partial Response (PR), RECIST v1.1 for target lesions as assessed by the Investigator. CR is defined as disappearance of all target lesions, Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis; PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the Baseline sum diameters.
An adverse event was any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. TEAEs were any new AE that begins, or any pre-existing condition that worsens in severity, after at least 1 dose of study treatment has been administered.
An adverse event was any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. TEAEs were any new AE that begins, or any pre-existing condition that worsens in severity, after at least 1 dose of study treatment has been administered.
ORR by irRECIST is defined as the percentage of participants with a confirmed best overall response of CR or PR using irRECIST. Immune related complete response (irCR) is defined as at least two radiographic determinations of CR, at least 4 weeks apart and before Immune related progressive disease (irPD - defined as at least two consecutive radiographic determinations of progressive disease \[PD\] at least 4 weeks apart) at least 4 weeks apart. Immune related partial response (irPR) defined as at least two radiographic determinations of PR or better at least 4 weeks apart and before irPD (and not qualifying for an irCR).
DoR per RECIST v1.1 was defined as the time from first documented evidence of CR or PR until first documented disease progression per RECIST v1.1 based upon investigator assessment or death due to any cause, whichever occurs first, among participants who demonstrated CR or PR as the best overall response per RECIST v1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the Baseline sum diameters.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02657889
- trial label
- Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer
- applicability
- unclear
- applicability note
- Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 4
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02657889
- outcome key
- om-0000
- source section id
- NCT02657889-om-0000
- source outcome index
- 0
- endpoint
- Phase 1: Number of Participants Reporting Dose-Limiting Toxicities (DLTs)
- endpoint definition
- DLTs are defined as: Any treatment-related Grade \>=3 non-hematologic clinical (non-laboratory) adverse event (AE); Any treatment-related Grade 3 or Grade 4 non-hematologic laboratory (lab) abnormality if Medical intervention is required to treat the participant or the abnormality leads to hospitalization or the abnormality persists for \>=7 days; Any treatment-related hematologic toxicity specifically defined as: Thrombocytopenia Grade 4 for \>=7 days, or Grade 3 or 4 associated with bleeding or requiring platelet transfusion, Neutropenia Grade 4 for \>=7 days, or Grade 3 or 4 associated with infection or febrile neutropenia, Anemia Grade 4, or Grade 3 or 4 requiring blood transfusion; Any treatment-related AE leading to niraparib dose interruption per the following criteria: A dose interruption for a non-DLT lab abnormality lasting \>=14 days, A dose in interruption per dose modification rules for non-hematologic AE leading to \<80 percent (%) of an intended dose being administered.
- time origin
- During Cycle 1, ie, during the first 21 days of treatment
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- DLT Analysis Set comprised of all Phase 1 participants who completed the first cycle of therapy. The assessment of DLTs in Phase 1 included only those participants completing the first cycle of therapy, unless the participant discontinued study drug due to a DLT. Only those participants with data available at specified data point were analyzed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02657889
- outcome key
- om-0001
- source section id
- NCT02657889-om-0001
- source outcome index
- 1
- endpoint
- Phase 2: Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
- endpoint definition
- ORR is defined as the percentage of participants with a confirmed best overall response of Complete Response (CR) or Partial Response (PR), RECIST v1.1 for target lesions as assessed by the Investigator. CR is defined as disappearance of all target lesions, Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis; PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the Baseline sum diameters.
- time origin
- Up to 40 weeks
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full Analysis Set comprised of all Phase 2 participants who received any amount of study treatment. Only those participants with data available at specified time points were analyzed. .
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02657889
- outcome key
- om-0002
- source section id
- NCT02657889-om-0002
- source outcome index
- 2
- endpoint
- Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
- endpoint definition
- An adverse event was any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. TEAEs were any new AE that begins, or any pre-existing condition that worsens in severity, after at least 1 dose of study treatment has been administered.
- time origin
- Up to a maximum of 22 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety Analysis Set comprised of all participants who received any amount of study treatment in Phase 1 or Phase 2. Only those participants with data available at specified time points were analyzed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02657889
- outcome key
- om-0003
- source section id
- NCT02657889-om-0003
- source outcome index
- 3
- endpoint
- Phase 2: Number of Participants With TEAEs
- endpoint definition
- An adverse event was any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. TEAEs were any new AE that begins, or any pre-existing condition that worsens in severity, after at least 1 dose of study treatment has been administered.
- time origin
- Up to a maximum of 54 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety Analysis Set. Only those participants with data available at specified time points were analyzed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02657889
- outcome key
- om-0004
- source section id
- NCT02657889-om-0004
- source outcome index
- 4
- endpoint
- Phase 2: Overall Response Rate (ORR) as Measured by Immune-related RECIST (irRECIST)
- endpoint definition
- ORR by irRECIST is defined as the percentage of participants with a confirmed best overall response of CR or PR using irRECIST. Immune related complete response (irCR) is defined as at least two radiographic determinations of CR, at least 4 weeks apart and before Immune related progressive disease (irPD - defined as at least two consecutive radiographic determinations of progressive disease \[PD\] at least 4 weeks apart) at least 4 weeks apart. Immune related partial response (irPR) defined as at least two radiographic determinations of PR or better at least 4 weeks apart and before irPD (and not qualifying for an irCR).
- time origin
- Up to a maximum of 54 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full Analysis Set. IrRECIST data were invalid due to errors in the collection approach. Hence, data for this outcome measure were not reported. This decision was documented in the final Statistical Analysis Plan (SAP) (Version 2, 21-March-2019) and approved before database lock which occurred on 22-October-2021.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02657889
- outcome key
- om-0005
- source section id
- NCT02657889-om-0005
- source outcome index
- 5
- endpoint
- Phase 2: Duration of Response (DOR) as Measured by RECIST v1.1
- endpoint definition
- DoR per RECIST v1.1 was defined as the time from first documented evidence of CR or PR until first documented disease progression per RECIST v1.1 based upon investigator assessment or death due to any cause, whichever occurs first, among participants who demonstrated CR or PR as the best overall response per RECIST v1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the Baseline sum diameters.
- time origin
- Up to a maximum of 54 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full Analysis Set. Only those participants with data available at specified time point were analyzed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02657889
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Phase 1: Niraparib 200 mg + Pembrolizumab
- regimen
- Participants received Niraparib 200 milligrams (mg) orally once daily from Days 1 to 21 and Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02657889-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02657889
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Phase 1: Niraparib 300 mg + Pembrolizumab
- regimen
- Participants received Niraparib 300 mg orally once daily from Days 1 to 21 and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02657889-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02657889
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Phase 2 OC: Niraparib 200mg + Pembrolizumab
- regimen
- Participants with Ovarian Cancer (OC) received recommended phase 2 dose (RP2D) of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
- analyzed count
- 53
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02657889-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02657889
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Phase 2 TNBC: Niraparib 200mg + Pembrolizumab
- regimen
- Participants with Triple Negative Breast Cancer (TNBC) received RP2D of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
- analyzed count
- 55
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02657889-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02657889
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Phase 1: Niraparib 200 mg + Pembrolizumab
- regimen
- Participants received Niraparib 200 milligrams (mg) orally once daily from Days 1 to 21 and Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02657889-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02657889
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Phase 1: Niraparib 300 mg + Pembrolizumab
- regimen
- Participants received Niraparib 300 mg orally once daily from Days 1 to 21 and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02657889-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02657889
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Phase 2 OC: Niraparib 200 mg + Pembrolizumab
- regimen
- Participants with Ovarian Cancer (OC) received recommended phase 2 dose (RP2D) of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
- analyzed count
- 53
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02657889-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02657889
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Phase 2 TNBC: Niraparib 200 mg + Pembrolizumab
- regimen
- Participants with Triple Negative Breast Cancer (TNBC) received RP2D of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
- analyzed count
- 55
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02657889-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02657889
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Phase 2 OC: Niraparib 200mg + Pembrolizumab
- regimen
- Participants with Ovarian Cancer (OC) received recommended phase 2 dose (RP2D) of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02657889-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02657889
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Phase 2 TNBC: Niraparib 200mg + Pembrolizumab
- regimen
- Participants with Triple Negative Breast Cancer (TNBC) received RP2D of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02657889-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02657889
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Phase 2 OC: Niraparib 200 mg + Pembrolizumab
- regimen
- Participants with Ovarian Cancer (OC) received recommended phase 2 dose (RP2D) of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02657889-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02657889
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Phase 2 TNBC: Niraparib 200 mg + Pembrolizumab
- regimen
- Participants with Triple Negative Breast Cancer (TNBC) received RP2D of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02657889-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02657889
- harm key
- EG000
- source section id
- NCT02657889-ae
- event group key
- EG000
- event group label
- Phase 1: Niraparib 200 mg + Pembrolizumab
- serious affected
- 6
- serious at risk
- 7
- other affected
- 7
- other at risk
- 7
- frequency threshold
- 5
- collection period
- All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAEs) were collected up to a maximum of 22 months in Phase 1 and up to a maximum of 54 months in Phase 2 of the study
- event definition
- All-cause mortality, SAE and non-SAE were collected in Safety analysis set which comprised of all participants who received any amount of study treatment in Phase 1 or Phase 2.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02657889
- harm key
- EG001
- source section id
- NCT02657889-ae
- event group key
- EG001
- event group label
- Phase 1: Niraparib 300 mg + Pembrolizumab
- serious affected
- 4
- serious at risk
- 7
- other affected
- 7
- other at risk
- 7
- frequency threshold
- 5
- collection period
- All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAEs) were collected up to a maximum of 22 months in Phase 1 and up to a maximum of 54 months in Phase 2 of the study
- event definition
- All-cause mortality, SAE and non-SAE were collected in Safety analysis set which comprised of all participants who received any amount of study treatment in Phase 1 or Phase 2.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02657889
- harm key
- EG002
- source section id
- NCT02657889-ae
- event group key
- EG002
- event group label
- Phase 2 OC: Niraparib 200 mg + Pembrolizumab
- serious affected
- 22
- serious at risk
- 53
- other affected
- 52
- other at risk
- 53
- frequency threshold
- 5
- collection period
- All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAEs) were collected up to a maximum of 22 months in Phase 1 and up to a maximum of 54 months in Phase 2 of the study
- event definition
- All-cause mortality, SAE and non-SAE were collected in Safety analysis set which comprised of all participants who received any amount of study treatment in Phase 1 or Phase 2.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02657889
- harm key
- EG003
- source section id
- NCT02657889-ae
- event group key
- EG003
- event group label
- Phase 2 TNBC: Niraparib 200 mg + Pembrolizumab
- serious affected
- 24
- serious at risk
- 55
- other affected
- 54
- other at risk
- 55
- frequency threshold
- 5
- collection period
- All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAEs) were collected up to a maximum of 22 months in Phase 1 and up to a maximum of 54 months in Phase 2 of the study
- event definition
- All-cause mortality, SAE and non-SAE were collected in Safety analysis set which comprised of all participants who received any amount of study treatment in Phase 1 or Phase 2.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice