Trial Outcomes & Findings for Niraparib and Dostarlimab for the Treatment of Germline or Somatic BRCA1/2 and PALB2 Mutated Metastatic Pancreatic Cancer (NCT NCT04493060)
NCT ID: NCT04493060
Last Updated: 2025-08-07
Results Overview
Will be assessed using the standard immune-modified Response Evaluation Criteria in Solid Tumors (iRECIST) criteria.
COMPLETED
PHASE2
22 participants
At 12 weeks
2025-08-07
Participant Flow
Participant milestones
| Measure |
Treatment (Niraparib, Dostarlimab)
Patients receive niraparib PO QD on days 1-21. Patients also receive dostarlimab IV over 30 minutes on day 1 Q3W for cycles 1-4 and Q6W for subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.\>\> \>\> Dostarlimab: Given IV\>\>
\>\> Niraparib: Given PO
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One patient did not give information on mismatch repair status
Baseline characteristics by cohort
| Measure |
Treatment (Niraparib, Dostarlimab)
n=18 Participants
Patients receive niraparib PO QD on days 1-21. Patients also receive dostarlimab IV over 30 minutes on day 1 Q3W for cycles 1-4 and Q6W for subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.\>\> \>\> Dostarlimab: Given IV\>\>
\>\> Niraparib: Given PO
|
|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 8.49 • n=18 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
|
Number of Prior Treatment(s)
1
|
3 Participants
n=18 Participants
|
|
Number of Prior Treatment(s)
2
|
7 Participants
n=18 Participants
|
|
Number of Prior Treatment(s)
3+
|
8 Participants
n=18 Participants
|
|
Mismatch Repair Status
Deficient
|
2 Participants
n=17 Participants • One patient did not give information on mismatch repair status
|
|
Mismatch Repair Status
Proficient
|
15 Participants
n=17 Participants • One patient did not give information on mismatch repair status
|
|
Deleterious Mutation
BRCA 1
|
5 Participants
n=18 Participants
|
|
Deleterious Mutation
BRCA 2
|
12 Participants
n=18 Participants
|
|
Deleterious Mutation
PALB2
|
1 Participants
n=18 Participants
|
|
Platinum Tx Exposure
Yes
|
16 Participants
n=18 Participants
|
|
Platinum Tx Exposure
No
|
2 Participants
n=18 Participants
|
|
Refractory To Cancer Tx
Yes
|
5 Participants
n=18 Participants
|
|
Refractory To Cancer Tx
No
|
13 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: At 12 weeksWill be assessed using the standard immune-modified Response Evaluation Criteria in Solid Tumors (iRECIST) criteria.
Outcome measures
| Measure |
Treatment (Niraparib, Dostarlimab)
n=18 Participants
Patients receive niraparib PO QD on days 1-21. Patients also receive dostarlimab IV over 30 minutes on day 1 Q3W for cycles 1-4 and Q6W for subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.\>\> \>\> Dostarlimab: Given IV\>\>
\>\> Niraparib: Given PO
|
|---|---|
|
Disease Control Rate at 12 Weeks (DCR12)
No Success
|
13 Participants
|
|
Disease Control Rate at 12 Weeks (DCR12)
Success
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 4 years and 5 monthsThe confirmed response rate (by iRECIST ) will be assessed.
Outcome measures
| Measure |
Treatment (Niraparib, Dostarlimab)
n=18 Participants
Patients receive niraparib PO QD on days 1-21. Patients also receive dostarlimab IV over 30 minutes on day 1 Q3W for cycles 1-4 and Q6W for subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.\>\> \>\> Dostarlimab: Given IV\>\>
\>\> Niraparib: Given PO
|
|---|---|
|
Objective Response Rate (ORR)
|
0 Participants
|
SECONDARY outcome
Timeframe: From the end of study treatment to receiving the next treatment, assessed up to 5 yearsTTNT will be estimated using the Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From study entry to death from any cause, assessed up to 4 years and 5 monthsOS will be estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Niraparib, Dostarlimab)
n=18 Participants
Patients receive niraparib PO QD on days 1-21. Patients also receive dostarlimab IV over 30 minutes on day 1 Q3W for cycles 1-4 and Q6W for subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.\>\> \>\> Dostarlimab: Given IV\>\>
\>\> Niraparib: Given PO
|
|---|---|
|
Overall Survival (OS)
|
27.9 months
Interval 27.3 to
Not enough events to calculate upper bound
|
SECONDARY outcome
Timeframe: From the first documented date of confirmed response (complete response [CR] or partial response [PR]) to the date at which progression is first documented, assessed up to 5 yearsPopulation: Since 0 responses, Time to and duration of confirmed response is Not Applicable. We didn't have a single confirmed response.
Will be assessed using the Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From study entry to the first of either disease progression or death from any cause, assessed up to 4 years and 5 monthsPFS will be estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Niraparib, Dostarlimab)
n=18 Participants
Patients receive niraparib PO QD on days 1-21. Patients also receive dostarlimab IV over 30 minutes on day 1 Q3W for cycles 1-4 and Q6W for subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.\>\> \>\> Dostarlimab: Given IV\>\>
\>\> Niraparib: Given PO
|
|---|---|
|
Progression-free Survival (PFS)
|
16.4 months
Interval 13.6 to
Not enough events to calculate upper bound
|
SECONDARY outcome
Timeframe: Up to 4 years and 5 monthsThe maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The frequency and percentage of grade 3+ adverse events will be estimated. Will also assess AEs at least possibly related to treatment as well.
Outcome measures
| Measure |
Treatment (Niraparib, Dostarlimab)
n=18 Participants
Patients receive niraparib PO QD on days 1-21. Patients also receive dostarlimab IV over 30 minutes on day 1 Q3W for cycles 1-4 and Q6W for subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.\>\> \>\> Dostarlimab: Given IV\>\>
\>\> Niraparib: Given PO
|
|---|---|
|
Incidence of Adverse Events (AEs)
Any Grade 3 or Higher
|
15 Participants
|
|
Incidence of Adverse Events (AEs)
Any Grade 4 or Higher
|
3 Participants
|
|
Incidence of Adverse Events (AEs)
Grade 5
|
2 Participants
|
|
Incidence of Adverse Events (AEs)
Hematologic Grade 3 or Higher
|
9 Participants
|
|
Incidence of Adverse Events (AEs)
Hematologic Grade 4 or Higher
|
1 Participants
|
|
Incidence of Adverse Events (AEs)
Hematologic Grade 5
|
0 Participants
|
|
Incidence of Adverse Events (AEs)
Non-Hematologic Grade 3 or Higher
|
12 Participants
|
|
Incidence of Adverse Events (AEs)
Non-Hematologic Grade 4 or Higher
|
2 Participants
|
|
Incidence of Adverse Events (AEs)
Non-Hematologic Grade 5
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsDue to the limited sample size, these analyses will be hypothesis generating and descriptive in nature. Descriptive statistics will be summarized and the blood and tissue marker data will be correlated with clinical endpoints (response, DCR12, duration of response, OS, PFS, adverse events, etc.). For time-to-event data, the Kaplan-Meier method will be used. For categorical data, will use the Fisher's exact test. For marker data used to predict binary outcomes (i.e. response versus \[vs\]. no response), will use logistic regression models.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 5 yearsDue to the limited sample size, these analyses will be hypothesis generating and descriptive in nature. Descriptive statistics will be summarized and the blood and tissue marker data will be correlated with clinical endpoints (response, DCR12, duration of response, OS, PFS, adverse events, etc.). For time-to-event data, the Kaplan-Meier method will be used. For categorical data, will use the Fisher's exact test. For marker data used to predict binary outcomes (i.e. response vs. no response), will use logistic regression models.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsDue to the limited sample size, these analyses will be hypothesis generating and descriptive in nature. Descriptive statistics will be summarized and the blood and tissue marker data will be correlated with clinical endpoints (response, DCR12, duration of response, OS, PFS, adverse events, etc.). For time-to-event data, the Kaplan-Meier method will be used. For categorical data, will use the Fisher's exact test. For marker data used to predict binary outcomes (i.e. response vs. no response), will use logistic regression models.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsDue to the limited sample size, these analyses will be hypothesis generating and descriptive in nature. Descriptive statistics will be summarized and the blood and tissue marker data will be correlated with clinical endpoints (response, DCR12, duration of response, OS, PFS, adverse events, etc.). For time-to-event data, the Kaplan-Meier method will be used. For categorical data, will use the Fisher's exact test. For marker data used to predict binary outcomes (i.e. response vs. no response), will use logistic regression models.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 5 yearsDue to the limited sample size, these analyses will be hypothesis generating and descriptive in nature. Descriptive statistics will be summarized and the blood and tissue marker data will be correlated with clinical endpoints (response, DCR12, duration of response, OS, PFS, adverse events, etc.). For time-to-event data, the Kaplan-Meier method will be used. For categorical data, will use the Fisher's exact test. For marker data used to predict binary outcomes (i.e. response vs. no response), will use logistic regression models.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 5 yearsDue to the limited sample size, these analyses will be hypothesis generating and descriptive in nature. Descriptive statistics will be summarized and the blood and tissue marker data will be correlated with clinical endpoints (response, DCR12, duration of response, OS, PFS, adverse events, etc.). For time-to-event data, the Kaplan-Meier method will be used. For categorical data, will use the Fisher's exact test. For marker data used to predict binary outcomes (i.e. response vs. no response), will use logistic regression models.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Niraparib, Dostarlimab)
Serious adverse events
| Measure |
Treatment (Niraparib, Dostarlimab)
n=20 participants at risk
Niraparib: Given PO
|
|---|---|
|
Cardiac disorders
Asystole
|
5.0%
1/20 • Number of events 1 • Up to 4 years and 5 months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
5.0%
1/20 • Number of events 1 • Up to 4 years and 5 months
|
Other adverse events
| Measure |
Treatment (Niraparib, Dostarlimab)
n=20 participants at risk
Niraparib: Given PO
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
95.0%
19/20 • Number of events 59 • Up to 4 years and 5 months
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
5.0%
1/20 • Number of events 1 • Up to 4 years and 5 months
|
|
Endocrine disorders
Hypothyroidism
|
20.0%
4/20 • Number of events 11 • Up to 4 years and 5 months
|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
1/20 • Number of events 5 • Up to 4 years and 5 months
|
|
Gastrointestinal disorders
Abdominal pain
|
15.0%
3/20 • Number of events 4 • Up to 4 years and 5 months
|
|
Gastrointestinal disorders
Ascites
|
5.0%
1/20 • Number of events 6 • Up to 4 years and 5 months
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Number of events 1 • Up to 4 years and 5 months
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
5/20 • Number of events 6 • Up to 4 years and 5 months
|
|
Gastrointestinal disorders
Duodenal obstruction
|
5.0%
1/20 • Number of events 1 • Up to 4 years and 5 months
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
5.0%
1/20 • Number of events 1 • Up to 4 years and 5 months
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
1/20 • Number of events 2 • Up to 4 years and 5 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
10.0%
2/20 • Number of events 2 • Up to 4 years and 5 months
|
|
Gastrointestinal disorders
Nausea
|
15.0%
3/20 • Number of events 4 • Up to 4 years and 5 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
5.0%
1/20 • Number of events 1 • Up to 4 years and 5 months
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
3/20 • Number of events 4 • Up to 4 years and 5 months
|
|
General disorders
Fatigue
|
85.0%
17/20 • Number of events 52 • Up to 4 years and 5 months
|
|
General disorders
Fever
|
5.0%
1/20 • Number of events 1 • Up to 4 years and 5 months
|
|
General disorders
Gait disturbance
|
5.0%
1/20 • Number of events 1 • Up to 4 years and 5 months
|
|
General disorders
Pain
|
65.0%
13/20 • Number of events 42 • Up to 4 years and 5 months
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
5.0%
1/20 • Number of events 1 • Up to 4 years and 5 months
|
|
Infections and infestations
Abdominal infection
|
5.0%
1/20 • Number of events 5 • Up to 4 years and 5 months
|
|
Infections and infestations
Anorectal infection
|
5.0%
1/20 • Number of events 1 • Up to 4 years and 5 months
|
|
Infections and infestations
Sepsis
|
10.0%
2/20 • Number of events 2 • Up to 4 years and 5 months
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
4/20 • Number of events 6 • Up to 4 years and 5 months
|
|
Investigations
Alkaline phosphatase increased
|
5.0%
1/20 • Number of events 2 • Up to 4 years and 5 months
|
|
Investigations
Aspartate aminotransferase increased
|
30.0%
6/20 • Number of events 9 • Up to 4 years and 5 months
|
|
Investigations
Blood bilirubin increased
|
10.0%
2/20 • Number of events 2 • Up to 4 years and 5 months
|
|
Investigations
Creatinine increased
|
25.0%
5/20 • Number of events 19 • Up to 4 years and 5 months
|
|
Investigations
Lymphocyte count decreased
|
25.0%
5/20 • Number of events 13 • Up to 4 years and 5 months
|
|
Investigations
Neutrophil count decreased
|
10.0%
2/20 • Number of events 4 • Up to 4 years and 5 months
|
|
Investigations
Platelet count decreased
|
40.0%
8/20 • Number of events 20 • Up to 4 years and 5 months
|
|
Investigations
Weight loss
|
5.0%
1/20 • Number of events 3 • Up to 4 years and 5 months
|
|
Investigations
White blood cell decreased
|
10.0%
2/20 • Number of events 4 • Up to 4 years and 5 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
55.0%
11/20 • Number of events 21 • Up to 4 years and 5 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.0%
1/20 • Number of events 1 • Up to 4 years and 5 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.0%
1/20 • Number of events 1 • Up to 4 years and 5 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.0%
1/20 • Number of events 1 • Up to 4 years and 5 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.0%
1/20 • Number of events 1 • Up to 4 years and 5 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.0%
1/20 • Number of events 1 • Up to 4 years and 5 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
5.0%
1/20 • Number of events 2 • Up to 4 years and 5 months
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • Number of events 4 • Up to 4 years and 5 months
|
|
Nervous system disorders
Encephalopathy
|
5.0%
1/20 • Number of events 1 • Up to 4 years and 5 months
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Number of events 1 • Up to 4 years and 5 months
|
|
Psychiatric disorders
Confusion
|
5.0%
1/20 • Number of events 2 • Up to 4 years and 5 months
|
|
Psychiatric disorders
Delirium
|
5.0%
1/20 • Number of events 1 • Up to 4 years and 5 months
|
|
Renal and urinary disorders
Acute kidney injury
|
5.0%
1/20 • Number of events 1 • Up to 4 years and 5 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
5.0%
1/20 • Number of events 1 • Up to 4 years and 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
5/20 • Number of events 7 • Up to 4 years and 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.0%
1/20 • Number of events 2 • Up to 4 years and 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.0%
1/20 • Number of events 1 • Up to 4 years and 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.0%
1/20 • Number of events 2 • Up to 4 years and 5 months
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
5.0%
1/20 • Number of events 4 • Up to 4 years and 5 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
10.0%
2/20 • Number of events 3 • Up to 4 years and 5 months
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • Number of events 5 • Up to 4 years and 5 months
|
|
Vascular disorders
Thromboembolic event
|
5.0%
1/20 • Number of events 1 • Up to 4 years and 5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place