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Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer (TOPACIO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02657889
Recruitment Status : Active, not recruiting
First Posted : January 18, 2016
Results First Posted : February 11, 2020
Last Update Posted : February 11, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Tesaro, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Triple Negative Breast Cancer
Ovarian Cancer
Breast Cancer
Metastatic Breast Cancer
Advanced Breast Cancer
Stage IV Breast Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Interventions Drug: niraparib
Biological: pembrolizumab
Enrollment 122
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase 1: Niraparib 200mg + Pembrolizumab Phase 1: Niraparib 300mg + Pembrolizumab Phase 2 OC: Niraparib 200mg + Pembrolizumab Phase 2 TNBC: Niraparib 200mg + Pembrolizumab
Hide Arm/Group Description Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle. Niraparib 300 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.

Ovarian Cancer:

Niraparib 200mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.

Triple Negative Breast Cancer:

Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.

Period Title: Overall Study
Started 7 7 53 55
Completed 0 0 0 0
Not Completed 7 7 53 55
Reason Not Completed
Death             5             2             20             34
Lost to Follow-up             2             0             1             2
Withdrawal by Subject             0             0             8             0
Ongoing in Study             0             5             24             19
Arm/Group Title Phase 1: Niraparib 200mg + Pembrolizumab Phase 1: Niraparib 300mg + Pembrolizumab Phase 2 OC: Niraparib 200mg + Pembrolizumab Phase 2 TNBC: Niraparib 200mg + Pembrolizumab Total
Hide Arm/Group Description Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle. Niraparib 300 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.

Ovarian Cancer:

Niraparib 200mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.

Triple Negative Breast Cancer:

Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.

Total of all reporting groups
Overall Number of Baseline Participants 7 7 53 55 122
Hide Baseline Analysis Population Description
The baseline analysis population consisted of all patients who received at least one dose of study medication.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 53 participants 55 participants 122 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  57.1%
4
  57.1%
37
  69.8%
47
  85.5%
92
  75.4%
>=65 years
3
  42.9%
3
  42.9%
16
  30.2%
8
  14.5%
30
  24.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 53 participants 55 participants 122 participants
Female
7
 100.0%
7
 100.0%
53
 100.0%
55
 100.0%
122
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 53 participants 55 participants 122 participants
Hispanic or Latino
1
  14.3%
0
   0.0%
3
   5.7%
3
   5.5%
7
   5.7%
Not Hispanic or Latino
6
  85.7%
6
  85.7%
50
  94.3%
51
  92.7%
113
  92.6%
Unknown or Not Reported
0
   0.0%
1
  14.3%
0
   0.0%
1
   1.8%
2
   1.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 53 participants 55 participants 122 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
3
   5.7%
2
   3.6%
5
   4.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
1
   1.9%
8
  14.5%
9
   7.4%
White
7
 100.0%
7
 100.0%
46
  86.8%
43
  78.2%
103
  84.4%
More than one race NA [1]  NA [1]  NA [1]  NA [1]  NA [2] 
Unknown or Not Reported
0
   0.0%
0
   0.0%
3
   5.7%
2
   3.6%
5
   4.1%
[1]
Data on multiple race categories not collected
[2]
Total not calculated because data are not available (NA) in one or more arms.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 7 participants 53 participants 55 participants 122 participants
7 7 53 55 122
1.Primary Outcome
Title Phase 1: Number of Subjects Reporting Dose-Limiting Toxicities (DLTs)
Hide Description

DLTs are defined as:

Any treatment-related Grade ≥ 3 non-hematologic clinical (non-laboratory) AE

Any treatment-related Grade 3 or Grade 4 non-hematologic lab abnormality if:

  • Medical intervention is required to treat the patient, 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 nonhematologic AE leading to < 80% of an intended dose being administered.
Time Frame During Cycle 1, ie, during the first 21 days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The assessment of DLTs in Phase 1 included only those patients completing the first cycle of therapy, unless the patient discontinued study drug due to a DLT.
Arm/Group Title Phase 1: Niraparib 200mg + Pembrolizumab Phase 1: Niraparib 300mg + Pembrolizumab
Hide Arm/Group Description:
Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
Niraparib 300 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
Overall Number of Participants Analyzed 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
1
  16.7%
1
  16.7%
2.Primary Outcome
Title Phase 2: Objective Response Rate (ORR)
Hide Description ORR is defined as the percentage of patients who achieved a best overall response of Complete Response (CR) or Partial Response (PR), per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions as assessed by the Investigator: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time Frame Up to 40 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on all patients who received at least one dose of study medication.
Arm/Group Title Phase 2 OC: Niraparib 200mg + Pembrolizumab Phase 2 TNBC: Niraparib 200mg + Pembrolizumab
Hide Arm/Group Description:

Ovarian Cancer:

Niraparib 200mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.

Triple Negative Breast Cancer:

Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.

Overall Number of Participants Analyzed 53 55
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
15.1
(7.7 to 25.6)
18.2
(10.2 to 28.9)
3.Secondary Outcome
Title To Evaluate the Safety and Tolerability of Combination Treatment With Niraparib and Pembrolizumab Using Common Terminology Criteria for Adverse Events (CTCAE, v4.03)
Hide Description Percentage of patients with at least 1 Treatment-Emergent Adverse Event. Refer to the adverse event tables for specific details.
Time Frame AEs were collected up to 90 days following the last dose of study treatment, where the median duration of treatment was 3 months.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on all patients who received at least one dose of study medication.
Arm/Group Title Phase 1: Niraparib 200mg + Pembrolizumab Phase 1: Niraparib 300mg + Pembrolizumab Phase 2 OC: Niraparib 200mg + Pembrolizumab Phase 2 TNBC: Niraparib 200mg + Pembrolizumab
Hide Arm/Group Description:
Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
Niraparib 300 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.

Ovarian Cancer:

Niraparib 200mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.

Triple Negative Breast Cancer:

Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.

Overall Number of Participants Analyzed 7 7 53 55
Measure Type: Count of Participants
Unit of Measure: Participants
7
 100.0%
7
 100.0%
53
 100.0%
55
 100.0%
4.Secondary Outcome
Title Phase 2: Overall Response Rate (ORR) as Measured by Immune-related RECIST (irRECIST)
Hide Description ORR by irRECIST is defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR) using immune-related RECIST criteria.
Time Frame Radiographic evaluations were conducted every 9 weeks while on study treatment (every 12 weeks after 1 year of scans) independent of cycle delays and/or dose interruptions, and/or at any time when progression of disease is suspected.
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected.
Arm/Group Title Phase 2 OC: Niraparib 200mg + Pembrolizumab Phase 2 TNBC: Niraparib 200mg + Pembrolizumab
Hide Arm/Group Description:

Ovarian Cancer:

Niraparib 200mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.

Triple Negative Breast Cancer:

Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Phase 2: Duration of Response (DOR)
Hide Description From first documentation of response (CR or PR) using RECIST (v1.1) as assessed by the investigator until time of first documented progression or death by any cause. No maximum timeframe was specified in the protocol.
Time Frame From first documentation of response (CR or PR) using RECIST (v1.1) as assessed by the Investigator until time of first documented progression.
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Phase 2: Disease Control Rate (DCR)
Hide Description DCR is defined as the percentage of patients who achieved a CR or PR or stable disease (SD) using RECIST (v1.1) as assessed by the Investigator.
Time Frame Up to 40 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on all patients who received at least one dose of study medication.
Arm/Group Title Phase 2 OC: Niraparib 200mg + Pembrolizumab Phase 2 TNBC: Niraparib 200mg + Pembrolizumab
Hide Arm/Group Description:

Ovarian Cancer:

Niraparib 200mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.

Triple Negative Breast Cancer:

Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.

Overall Number of Participants Analyzed 53 55
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
58.5
(46.3 to 70.0)
41.8
(30.5 to 53.8)
7.Secondary Outcome
Title Phase 2: Progression Free Survival (PFS)
Hide Description From date of first dose to the earlier date of assessment of progression or death by any cause in the absence of progression. No maximum timeframe was specified in the protocol.
Time Frame From date of first dose to the earlier date of assessment of progression of death by any cause in the absence of progression.
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Phase 2: Overall Survival (OS)
Hide Description Patients were followed off treatment every 90 days for survival status. Overall survival is defined as the time from first dose to the date of death by any cause. No maximum timeframe was specified in the protocol.
Time Frame From date of first dose to the date of death by any cause.
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Phase 1 and Phase 2: To Evaluate the Pharmacokinetics (PK) of Niraparib and Associated Major Metabolite M1 During Combination Treatment.
Hide Description Area Under the Curve (AUC), Minimum Concentration (Cmin), Maximum Concentration (Cmax), Clearance After Oral Administration (CL/F), Volume of Distribution After Oral Administration (Vz/F), AUC at Steady State (AUCss), Cmin at Steady State (Cmin,ss), Cmax at Steady State (Cmax,ss).
Time Frame Approximately 9 months
Outcome Measure Data Not Reported
Time Frame AEs were collected up to 90 days following the last dose of study treatment, where the median duration of treatment was 3 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase 1: Niraparib 200mg + Pembrolizumab Phase 1: Niraparib 300mg + Pembrolizumab Phase 2 OC: Niraparib 200mg + Pembrolizumab Phase 2 TNBC: Niraparib 200mg + Pembrolizumab
Hide Arm/Group Description Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle. Niraparib 300 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.

Ovarian Cancer:

Niraparib 200mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.

Triple Negative Breast Cancer:

Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.

All-Cause Mortality
Phase 1: Niraparib 200mg + Pembrolizumab Phase 1: Niraparib 300mg + Pembrolizumab Phase 2 OC: Niraparib 200mg + Pembrolizumab Phase 2 TNBC: Niraparib 200mg + Pembrolizumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/7 (71.43%)   2/7 (28.57%)   20/53 (37.74%)   34/55 (61.82%) 
Hide Serious Adverse Events
Phase 1: Niraparib 200mg + Pembrolizumab Phase 1: Niraparib 300mg + Pembrolizumab Phase 2 OC: Niraparib 200mg + Pembrolizumab Phase 2 TNBC: Niraparib 200mg + Pembrolizumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/7 (85.71%)   4/7 (57.14%)   20/53 (37.74%)   22/55 (40.00%) 
Blood and lymphatic system disorders         
Anemia * 1  1/7 (14.29%)  0/7 (0.00%)  1/53 (1.89%)  1/55 (1.82%) 
Febrile neutropenia * 1  0/7 (0.00%)  0/7 (0.00%)  1/53 (1.89%)  0/55 (0.00%) 
Leukopenia * 1  0/7 (0.00%)  0/7 (0.00%)  1/53 (1.89%)  0/55 (0.00%) 
Neutropenia * 1  1/7 (14.29%)  0/7 (0.00%)  1/53 (1.89%)  0/55 (0.00%) 
Pancytopenia * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  0/55 (0.00%) 
Thrombocytopenia * 1  1/7 (14.29%)  3/7 (42.86%)  2/53 (3.77%)  3/55 (5.45%) 
Cardiac disorders         
Cardiac failure congestive * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  1/55 (1.82%) 
Cardiac tamponade * 1  0/7 (0.00%)  0/7 (0.00%)  1/53 (1.89%)  0/55 (0.00%) 
Pericardial effusion * 1  0/7 (0.00%)  0/7 (0.00%)  2/53 (3.77%)  1/55 (1.82%) 
Tachycardia * 1  0/7 (0.00%)  0/7 (0.00%)  1/53 (1.89%)  1/55 (1.82%) 
Endocrine disorders         
Adrenal insufficiency * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  1/55 (1.82%) 
Gastrointestinal disorders         
Abdominal distension * 1  1/7 (14.29%)  0/7 (0.00%)  0/53 (0.00%)  0/55 (0.00%) 
Abdominal pain * 1  2/7 (28.57%)  0/7 (0.00%)  1/53 (1.89%)  0/55 (0.00%) 
Ascites * 1  1/7 (14.29%)  0/7 (0.00%)  0/53 (0.00%)  0/55 (0.00%) 
Colitis * 1  1/7 (14.29%)  0/7 (0.00%)  0/53 (0.00%)  0/55 (0.00%) 
Constipation * 1  0/7 (0.00%)  0/7 (0.00%)  4/53 (7.55%)  0/55 (0.00%) 
Intestinal perforation * 1  0/7 (0.00%)  0/7 (0.00%)  1/53 (1.89%)  0/55 (0.00%) 
Nausea * 1  2/7 (28.57%)  1/7 (14.29%)  2/53 (3.77%)  0/55 (0.00%) 
Obstruction gastric * 1  1/7 (14.29%)  0/7 (0.00%)  0/53 (0.00%)  0/55 (0.00%) 
Pancreatitis acute * 1  0/7 (0.00%)  0/7 (0.00%)  1/53 (1.89%)  0/55 (0.00%) 
Small intestinal obstruction * 1  1/7 (14.29%)  0/7 (0.00%)  5/53 (9.43%)  0/55 (0.00%) 
Vomiting * 1  1/7 (14.29%)  0/7 (0.00%)  4/53 (7.55%)  0/55 (0.00%) 
General disorders         
Asthenia * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  1/55 (1.82%) 
Chills * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  1/55 (1.82%) 
Fatigue * 1  0/7 (0.00%)  0/7 (0.00%)  1/53 (1.89%)  2/55 (3.64%) 
Malaise * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  1/55 (1.82%) 
Non-cardiac chest pain * 1  0/7 (0.00%)  0/7 (0.00%)  1/53 (1.89%)  0/55 (0.00%) 
Oedema peripheral * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  1/55 (1.82%) 
Pyrexia * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  3/55 (5.45%) 
Hepatobiliary disorders         
Bile duct stenosis * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  1/55 (1.82%) 
Cholecystitis * 1  1/7 (14.29%)  0/7 (0.00%)  0/53 (0.00%)  0/55 (0.00%) 
Infections and infestations         
Device related infection * 1  0/7 (0.00%)  0/7 (0.00%)  1/53 (1.89%)  0/55 (0.00%) 
Gastroenteritis viral * 1  0/7 (0.00%)  0/7 (0.00%)  1/53 (1.89%)  0/55 (0.00%) 
Lung infection * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  1/55 (1.82%) 
Neutropenic sepsis * 1  0/7 (0.00%)  0/7 (0.00%)  1/53 (1.89%)  0/55 (0.00%) 
Pneumonia * 1  0/7 (0.00%)  0/7 (0.00%)  1/53 (1.89%)  2/55 (3.64%) 
Stoma site infection * 1  0/7 (0.00%)  0/7 (0.00%)  1/53 (1.89%)  0/55 (0.00%) 
Injury, poisoning and procedural complications         
Femur fracture * 1  0/7 (0.00%)  0/7 (0.00%)  1/53 (1.89%)  0/55 (0.00%) 
Procedural pneumothorax * 1  1/7 (14.29%)  0/7 (0.00%)  0/53 (0.00%)  0/55 (0.00%) 
Investigations         
Amylase increased * 1  0/7 (0.00%)  0/7 (0.00%)  1/53 (1.89%)  1/55 (1.82%) 
Aspartate aminotransferase increased * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  1/55 (1.82%) 
Blood alkaline phosphatase increased * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  2/55 (3.64%) 
Blood bilirubin increased * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  1/55 (1.82%) 
Blood creatinine increased * 1  0/7 (0.00%)  0/7 (0.00%)  1/53 (1.89%)  0/55 (0.00%) 
Liver function test increased * 1  0/7 (0.00%)  0/7 (0.00%)  1/53 (1.89%)  1/55 (1.82%) 
Platelet count decreased * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  1/55 (1.82%) 
Metabolism and nutrition disorders         
Dehydration * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  1/55 (1.82%) 
Failure to thrive * 1  0/7 (0.00%)  0/7 (0.00%)  2/53 (3.77%)  0/55 (0.00%) 
Hyperglycaemia * 1  1/7 (14.29%)  0/7 (0.00%)  1/53 (1.89%)  0/55 (0.00%) 
Hyperkalaemia * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  1/55 (1.82%) 
Musculoskeletal and connective tissue disorders         
Back pain * 1  1/7 (14.29%)  0/7 (0.00%)  0/53 (0.00%)  0/55 (0.00%) 
Pain in extremity * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  0/55 (0.00%) 
Pathological fracture * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  1/55 (1.82%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Malignant pleural effusion * 1  1/7 (14.29%)  0/7 (0.00%)  0/53 (0.00%)  1/55 (1.82%) 
Metastases to central nervous system * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  1/55 (1.82%) 
Nervous system disorders         
Cerebral haemorrhage * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  1/55 (1.82%) 
Dizziness * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  1/55 (1.82%) 
Encephalopathy * 1  0/7 (0.00%)  0/7 (0.00%)  1/53 (1.89%)  0/55 (0.00%) 
Headache * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  3/55 (5.45%) 
Psychiatric disorders         
Mental status changes * 1  1/7 (14.29%)  0/7 (0.00%)  1/53 (1.89%)  1/55 (1.82%) 
Renal and urinary disorders         
Acute kidney injury * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  3/55 (5.45%) 
Respiratory, thoracic and mediastinal disorders         
Acute respiratory distress syndrome * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  1/55 (1.82%) 
Dyspnoea * 1  0/7 (0.00%)  1/7 (14.29%)  2/53 (3.77%)  1/55 (1.82%) 
Dyspnoea exertional * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  1/55 (1.82%) 
Hypoxia * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  3/55 (5.45%) 
Pleural effusion * 1  0/7 (0.00%)  1/7 (14.29%)  1/53 (1.89%)  4/55 (7.27%) 
Pneumonia aspiration * 1  1/7 (14.29%)  0/7 (0.00%)  0/53 (0.00%)  0/55 (0.00%) 
Pneumonitis * 1  1/7 (14.29%)  0/7 (0.00%)  0/53 (0.00%)  0/55 (0.00%) 
Pneumothorax * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  0/55 (0.00%) 
Pulmonary embolism * 1  1/7 (14.29%)  0/7 (0.00%)  1/53 (1.89%)  1/55 (1.82%) 
Respiratory failure * 1  0/7 (0.00%)  0/7 (0.00%)  1/53 (1.89%)  1/55 (1.82%) 
Skin and subcutaneous tissue disorders         
Decubitus ulcer * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  0/55 (0.00%) 
Rash pruritic * 1  0/7 (0.00%)  0/7 (0.00%)  1/53 (1.89%)  0/55 (0.00%) 
Vascular disorders         
Embolism * 1  1/7 (14.29%)  0/7 (0.00%)  0/53 (0.00%)  1/55 (1.82%) 
Hypotension * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  1/55 (1.82%) 
Orthostatic hypotension * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  1/55 (1.82%) 
1
Term from vocabulary, MedDRA (20.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase 1: Niraparib 200mg + Pembrolizumab Phase 1: Niraparib 300mg + Pembrolizumab Phase 2 OC: Niraparib 200mg + Pembrolizumab Phase 2 TNBC: Niraparib 200mg + Pembrolizumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/7 (100.00%)   7/7 (100.00%)   52/53 (98.11%)   54/55 (98.18%) 
Blood and lymphatic system disorders         
Anaemia * 1  5/7 (71.43%)  5/7 (71.43%)  19/53 (35.85%)  23/55 (41.82%) 
Leukocytosis * 1  1/7 (14.29%)  0/7 (0.00%)  0/53 (0.00%)  0/55 (0.00%) 
Lymphopenia * 1  1/7 (14.29%)  1/7 (14.29%)  0/53 (0.00%)  2/55 (3.64%) 
Neutropenia * 1  1/7 (14.29%)  1/7 (14.29%)  4/53 (7.55%)  3/55 (5.45%) 
Thrombocytopenia * 1  1/7 (14.29%)  4/7 (57.14%)  14/53 (26.42%)  13/55 (23.64%) 
Cardiac disorders         
Diastolic dysfunction * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  0/55 (0.00%) 
Tachycardia * 1  2/7 (28.57%)  1/7 (14.29%)  2/53 (3.77%)  2/55 (3.64%) 
Endocrine disorders         
Hyperthyroidism * 1  0/7 (0.00%)  0/7 (0.00%)  1/53 (1.89%)  3/55 (5.45%) 
Hypothyroidism * 1  2/7 (28.57%)  0/7 (0.00%)  7/53 (13.21%)  6/55 (10.91%) 
Eye disorders         
Cataract * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  0/55 (0.00%) 
Dry eye * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  0/55 (0.00%) 
Lacrimation increased * 1  0/7 (0.00%)  2/7 (28.57%)  0/53 (0.00%)  0/55 (0.00%) 
Ocular hyperaemia * 1  0/7 (0.00%)  1/7 (14.29%)  1/53 (1.89%)  1/55 (1.82%) 
Vision blurred * 1  0/7 (0.00%)  2/7 (28.57%)  1/53 (1.89%)  0/55 (0.00%) 
Gastrointestinal disorders         
Abdominal discomfort * 1  0/7 (0.00%)  0/7 (0.00%)  3/53 (5.66%)  0/55 (0.00%) 
Abdominal distension * 1  3/7 (42.86%)  0/7 (0.00%)  5/53 (9.43%)  3/55 (5.45%) 
Abdominal pain * 1  3/7 (42.86%)  0/7 (0.00%)  15/53 (28.30%)  7/55 (12.73%) 
Abdominal pain upper * 1  1/7 (14.29%)  1/7 (14.29%)  3/53 (5.66%)  2/55 (3.64%) 
Ascites * 1  1/7 (14.29%)  0/7 (0.00%)  5/53 (9.43%)  0/55 (0.00%) 
Colitis * 1  1/7 (14.29%)  0/7 (0.00%)  0/53 (0.00%)  0/55 (0.00%) 
Constipation * 1  5/7 (71.43%)  2/7 (28.57%)  28/53 (52.83%)  24/55 (43.64%) 
Diarrhoea * 1  2/7 (28.57%)  2/7 (28.57%)  15/53 (28.30%)  12/55 (21.82%) 
Dry mouth * 1  1/7 (14.29%)  0/7 (0.00%)  4/53 (7.55%)  4/55 (7.27%) 
Dyspepsia * 1  1/7 (14.29%)  2/7 (28.57%)  5/53 (9.43%)  2/55 (3.64%) 
Gastrooesophageal reflux disease * 1  1/7 (14.29%)  0/7 (0.00%)  4/53 (7.55%)  2/55 (3.64%) 
Nausea * 1  4/7 (57.14%)  4/7 (57.14%)  32/53 (60.38%)  34/55 (61.82%) 
Noninfective gingivitis * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  0/55 (0.00%) 
Stomatitis * 1  1/7 (14.29%)  0/7 (0.00%)  3/53 (5.66%)  4/55 (7.27%) 
Toothache * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  0/55 (0.00%) 
Vomiting * 1  4/7 (57.14%)  2/7 (28.57%)  20/53 (37.74%)  12/55 (21.82%) 
General disorders         
Asthenia * 1  0/7 (0.00%)  0/7 (0.00%)  3/53 (5.66%)  1/55 (1.82%) 
Chills * 1  0/7 (0.00%)  0/7 (0.00%)  3/53 (5.66%)  2/55 (3.64%) 
Fatigue * 1  4/7 (57.14%)  3/7 (42.86%)  32/53 (60.38%)  30/55 (54.55%) 
Local swelling * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  0/55 (0.00%) 
Oedema peripheral * 1  3/7 (42.86%)  1/7 (14.29%)  2/53 (3.77%)  4/55 (7.27%) 
Pain * 1  0/7 (0.00%)  0/7 (0.00%)  2/53 (3.77%)  3/55 (5.45%) 
Peripheral swelling * 1  0/7 (0.00%)  1/7 (14.29%)  4/53 (7.55%)  1/55 (1.82%) 
Pyrexia * 1  0/7 (0.00%)  0/7 (0.00%)  7/53 (13.21%)  4/55 (7.27%) 
Infections and infestations         
Conjunctivitis * 1  1/7 (14.29%)  0/7 (0.00%)  1/53 (1.89%)  0/55 (0.00%) 
Eye infection * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  0/55 (0.00%) 
Laryngitis * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  0/55 (0.00%) 
Pneumonia * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  4/55 (7.27%) 
Sinusitis * 1  0/7 (0.00%)  0/7 (0.00%)  2/53 (3.77%)  3/55 (5.45%) 
Upper respiratory tract infection * 1  0/7 (0.00%)  1/7 (14.29%)  1/53 (1.89%)  5/55 (9.09%) 
Urinary tract infection * 1  0/7 (0.00%)  0/7 (0.00%)  7/53 (13.21%)  9/55 (16.36%) 
Injury, poisoning and procedural complications         
Contusion * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  0/55 (0.00%) 
Fall * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  1/55 (1.82%) 
Overdose * 1  0/7 (0.00%)  0/7 (0.00%)  3/53 (5.66%)  3/55 (5.45%) 
Investigations         
Alanine aminotransferase increased * 1  0/7 (0.00%)  0/7 (0.00%)  8/53 (15.09%)  10/55 (18.18%) 
Amylase increased * 1  0/7 (0.00%)  0/7 (0.00%)  3/53 (5.66%)  2/55 (3.64%) 
Anticoagulation drug level increased * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  0/55 (0.00%) 
Aspartate aminotransferase increased * 1  1/7 (14.29%)  1/7 (14.29%)  8/53 (15.09%)  14/55 (25.45%) 
Blood alkaline phosphatase decreased * 1  1/7 (14.29%)  0/7 (0.00%)  0/53 (0.00%)  0/55 (0.00%) 
Blood alkaline phosphatase increased * 1  2/7 (28.57%)  0/7 (0.00%)  6/53 (11.32%)  9/55 (16.36%) 
Blood creatinine increased * 1  0/7 (0.00%)  0/7 (0.00%)  4/53 (7.55%)  4/55 (7.27%) 
Creatinine renal clearance increased * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  0/55 (0.00%) 
Electrocardiogram QT prolonged * 1  0/7 (0.00%)  0/7 (0.00%)  1/53 (1.89%)  3/55 (5.45%) 
Lymphocyte count decreased * 1  1/7 (14.29%)  1/7 (14.29%)  2/53 (3.77%)  10/55 (18.18%) 
Neutrophil count decreased * 1  0/7 (0.00%)  0/7 (0.00%)  7/53 (13.21%)  6/55 (10.91%) 
Platelet count decreased * 1  0/7 (0.00%)  2/7 (28.57%)  7/53 (13.21%)  9/55 (16.36%) 
Troponin increased * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  0/55 (0.00%) 
Weight decreased * 1  1/7 (14.29%)  1/7 (14.29%)  8/53 (15.09%)  3/55 (5.45%) 
White blood cell count decreased * 1  1/7 (14.29%)  1/7 (14.29%)  4/53 (7.55%)  6/55 (10.91%) 
Metabolism and nutrition disorders         
Decreased appetite * 1  2/7 (28.57%)  3/7 (42.86%)  17/53 (32.08%)  14/55 (25.45%) 
Dehydration * 1  1/7 (14.29%)  3/7 (42.86%)  6/53 (11.32%)  6/55 (10.91%) 
Hyperglycaemia * 1  0/7 (0.00%)  1/7 (14.29%)  5/53 (9.43%)  5/55 (9.09%) 
Hypoalbuminaemia * 1  3/7 (42.86%)  0/7 (0.00%)  1/53 (1.89%)  2/55 (3.64%) 
Hypocalcaemia * 1  1/7 (14.29%)  0/7 (0.00%)  1/53 (1.89%)  4/55 (7.27%) 
Hypokalaemia * 1  3/7 (42.86%)  1/7 (14.29%)  6/53 (11.32%)  6/55 (10.91%) 
Hypomagnesaemia * 1  3/7 (42.86%)  1/7 (14.29%)  7/53 (13.21%)  5/55 (9.09%) 
Hyponatraemia * 1  4/7 (57.14%)  3/7 (42.86%)  6/53 (11.32%)  6/55 (10.91%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  1/7 (14.29%)  0/7 (0.00%)  7/53 (13.21%)  9/55 (16.36%) 
Back pain * 1  1/7 (14.29%)  1/7 (14.29%)  8/53 (15.09%)  8/55 (14.55%) 
Flank pain * 1  0/7 (0.00%)  0/7 (0.00%)  3/53 (5.66%)  3/55 (5.45%) 
Muscular weakness * 1  0/7 (0.00%)  2/7 (28.57%)  2/53 (3.77%)  3/55 (5.45%) 
Musculoskeletal chest pain * 1  0/7 (0.00%)  1/7 (14.29%)  2/53 (3.77%)  3/55 (5.45%) 
Musculoskeletal pain * 1  0/7 (0.00%)  0/7 (0.00%)  2/53 (3.77%)  5/55 (9.09%) 
Myalgia * 1  0/7 (0.00%)  0/7 (0.00%)  7/53 (13.21%)  3/55 (5.45%) 
Neck pain * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  3/55 (5.45%) 
Pain in extremity * 1  1/7 (14.29%)  1/7 (14.29%)  1/53 (1.89%)  6/55 (10.91%) 
Nervous system disorders         
Ataxia * 1  1/7 (14.29%)  0/7 (0.00%)  0/53 (0.00%)  0/55 (0.00%) 
Dizziness * 1  2/7 (28.57%)  1/7 (14.29%)  6/53 (11.32%)  6/55 (10.91%) 
Dysgeusia * 1  1/7 (14.29%)  3/7 (42.86%)  4/53 (7.55%)  6/55 (10.91%) 
Headache * 1  2/7 (28.57%)  2/7 (28.57%)  14/53 (26.42%)  14/55 (25.45%) 
Neuropathy peripheral * 1  0/7 (0.00%)  0/7 (0.00%)  3/53 (5.66%)  4/55 (7.27%) 
Peripheral sensory neuropathy * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  1/55 (1.82%) 
Psychiatric disorders         
Anxiety * 1  0/7 (0.00%)  3/7 (42.86%)  3/53 (5.66%)  6/55 (10.91%) 
Confusional state * 1  1/7 (14.29%)  1/7 (14.29%)  0/53 (0.00%)  0/55 (0.00%) 
Depression * 1  1/7 (14.29%)  0/7 (0.00%)  1/53 (1.89%)  0/55 (0.00%) 
Insomnia * 1  2/7 (28.57%)  3/7 (42.86%)  11/53 (20.75%)  13/55 (23.64%) 
Renal and urinary disorders         
Acute kidney injury * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  3/55 (5.45%) 
Chronic kidney disease * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  0/55 (0.00%) 
Costovertebral angle tenderness * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  0/55 (0.00%) 
Haematuria * 1  1/7 (14.29%)  0/7 (0.00%)  1/53 (1.89%)  0/55 (0.00%) 
Proteinuria * 1  1/7 (14.29%)  0/7 (0.00%)  2/53 (3.77%)  1/55 (1.82%) 
Reproductive system and breast disorders         
Breast tenderness * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  0/55 (0.00%) 
Pelvic pain * 1  1/7 (14.29%)  0/7 (0.00%)  1/53 (1.89%)  0/55 (0.00%) 
Vaginal haemorrhage * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  1/55 (1.82%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  1/7 (14.29%)  2/7 (28.57%)  9/53 (16.98%)  18/55 (32.73%) 
Dyspnoea * 1  3/7 (42.86%)  4/7 (57.14%)  11/53 (20.75%)  20/55 (36.36%) 
Dyspnoea exertional * 1  1/7 (14.29%)  1/7 (14.29%)  2/53 (3.77%)  2/55 (3.64%) 
Epistaxis * 1  0/7 (0.00%)  2/7 (28.57%)  0/53 (0.00%)  1/55 (1.82%) 
Hypoxia * 1  1/7 (14.29%)  0/7 (0.00%)  0/53 (0.00%)  2/55 (3.64%) 
Nasal congestion * 1  0/7 (0.00%)  1/7 (14.29%)  2/53 (3.77%)  5/55 (9.09%) 
Oropharyngeal pain * 1  2/7 (28.57%)  0/7 (0.00%)  2/53 (3.77%)  1/55 (1.82%) 
Pleural effusion * 1  1/7 (14.29%)  0/7 (0.00%)  3/53 (5.66%)  3/55 (5.45%) 
Pleuritic pain * 1  1/7 (14.29%)  0/7 (0.00%)  0/53 (0.00%)  0/55 (0.00%) 
Productive cough * 1  0/7 (0.00%)  0/7 (0.00%)  2/53 (3.77%)  3/55 (5.45%) 
Pulmonary hypertension * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  0/55 (0.00%) 
Upper-airway cough syndrome * 1  1/7 (14.29%)  0/7 (0.00%)  1/53 (1.89%)  0/55 (0.00%) 
Skin and subcutaneous tissue disorders         
Dermatitis contact * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  1/55 (1.82%) 
Dry skin * 1  1/7 (14.29%)  2/7 (28.57%)  1/53 (1.89%)  2/55 (3.64%) 
Erythema * 1  0/7 (0.00%)  1/7 (14.29%)  2/53 (3.77%)  1/55 (1.82%) 
Night sweats * 1  1/7 (14.29%)  0/7 (0.00%)  1/53 (1.89%)  2/55 (3.64%) 
Onychoclasis * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  0/55 (0.00%) 
Onychomadesis * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  0/55 (0.00%) 
Photosensitivity reaction * 1  1/7 (14.29%)  1/7 (14.29%)  1/53 (1.89%)  2/55 (3.64%) 
Pruritus * 1  0/7 (0.00%)  1/7 (14.29%)  9/53 (16.98%)  4/55 (7.27%) 
Rash * 1  1/7 (14.29%)  1/7 (14.29%)  6/53 (11.32%)  7/55 (12.73%) 
Rash maculo-papular * 1  0/7 (0.00%)  0/7 (0.00%)  2/53 (3.77%)  3/55 (5.45%) 
Skin lesion * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  0/55 (0.00%) 
Vascular disorders         
Hot flush * 1  0/7 (0.00%)  1/7 (14.29%)  0/53 (0.00%)  7/55 (12.73%) 
Hypertension * 1  0/7 (0.00%)  0/7 (0.00%)  5/53 (9.43%)  4/55 (7.27%) 
Lymphoedema * 1  0/7 (0.00%)  0/7 (0.00%)  0/53 (0.00%)  3/55 (5.45%) 
1
Term from vocabulary, MedDRA (20.0)
*
Indicates events were collected by non-systematic assessment
This study is ongoing. Study visit and data collection activities are still being performed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Neither Institution nor Investigator will submit for publication or public disclosure any publication or disclosure based on the results of the Study until after the first to occur of (a) publication of the Multi-Center Clinical Trial results; (b) notification by Sponsor that the Multi-Center Clinical Trial submission is no longer planned; or (c) the eighteen (18) month anniversary of the completion or early termination of the Multi-Center Clinical Trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nathan Buerstatte
Organization: TESARO/GSK
Phone: 781-257-2344
EMail: nathan.x.buerstatte@gsk.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Tesaro, Inc.
ClinicalTrials.gov Identifier: NCT02657889    
Other Study ID Numbers: 3000-PN162-01-001
First Submitted: January 8, 2016
First Posted: January 18, 2016
Results First Submitted: December 17, 2019
Results First Posted: February 11, 2020
Last Update Posted: February 11, 2020