Trial Outcomes & Findings for Niraparib + Ipilimumab or Nivolumab in Progression Free Pancreatic Adenocarcinoma After Platinum-Based Chemotherapy (NCT NCT03404960)

NCT ID: NCT03404960

Last Updated: 2025-10-10

Results Overview

The PFS6 rate will be estimated using the Kaplan-Meier method, and the 95% confidence interval will be estimated from the Kaplan-Meier curve. The null hypothesis is that the PFS6 rate in this population of subjects is 44%. Progressive disease is defined as at least a 20% increase in the sum of all the longest diameter (LD) of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. The appearance of one or more new lesions is also considered progression. Target lesions assessed according to RECIST v1.1.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 104 participants
• Primary outcome timeframe: 6 months after initiation of study therapy
• Results posted on: 2025-10-10

Participant Flow

104 subjects enrolled. 11 failed eligibility criteria. 2 withdrew consent. 91 randomly assigned and included in the safety analysis.

Participant milestones

Measure	Niraparib + Nivolumab (Arm A) Niraparib + Nivolumab: Niraparib 200mg PO daily on days 1-28 of each 28-day cycle. Nivolumab 480mg IV day 1 of each cycle.	Niraparib + Ipilimumab (Arm B) Niraparib + Ipilimumab: Niraparib 200mg PO daily on days 1-21 of each 21-day cycle. Ipilimumab 3mg/kg IV day 1 of each cycle, for the first 4 cycles only.
Overall Study STARTED	46	45
Overall Study COMPLETED	44	40
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Measure	Niraparib + Nivolumab (Arm A) Niraparib + Nivolumab: Niraparib 200mg PO daily on days 1-28 of each 28-day cycle. Nivolumab 480mg IV day 1 of each cycle.	Niraparib + Ipilimumab (Arm B) Niraparib + Ipilimumab: Niraparib 200mg PO daily on days 1-21 of each 21-day cycle. Ipilimumab 3mg/kg IV day 1 of each cycle, for the first 4 cycles only.
Overall Study Adverse Event	0	2
Overall Study Rapidly declined before 1st follow-up scan	0	2
Overall Study Bowel obstruction	0	1
Overall Study Incorrect pathological diagnosis on internal review	2	0

Baseline Characteristics

Niraparib + Ipilimumab or Nivolumab in Progression Free Pancreatic Adenocarcinoma After Platinum-Based Chemotherapy

Baseline characteristics by cohort

Measure	Arm A n=44 Participants Niraparib + Nivolumab Niraparib + Nivolumab: Niraparib 200mg PO daily on days 1-28 of each 28-day cycle. Nivolumab 480mg IV day 1 of each cycle.	Arm B n=40 Participants Niraparib + Ipilimumab Niraparib + Ipilimumab: Niraparib 200mg PO daily on days 1-21 of each 21-day cycle. Ipilimumab 3mg/kg IV day 1 of each cycle, for the first 4 cycles only.	Total n=84 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	23 Participants n=7 Participants	41 Participants n=5 Participants
Age, Categorical >=65 years	26 Participants n=5 Participants	17 Participants n=7 Participants	43 Participants n=5 Participants
Age, Continuous	68 years n=5 Participants	64 years n=7 Participants	66 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	20 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	20 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants	37 Participants n=7 Participants	75 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	44 participants n=5 Participants	40 participants n=7 Participants	84 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months after initiation of study therapy

Population: The efficacy population will consist of all patients who received at least one dose of study treatment and had a least one post-treatment assessment of response by RECIST v.1.1.

The PFS6 rate will be estimated using the Kaplan-Meier method, and the 95% confidence interval will be estimated from the Kaplan-Meier curve. The null hypothesis is that the PFS6 rate in this population of subjects is 44%.

Progressive disease is defined as at least a 20% increase in the sum of all the longest diameter (LD) of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. The appearance of one or more new lesions is also considered progression.

Target lesions assessed according to RECIST v1.1.

Outcome measures

Measure	Niraparib + Nivolumab (Arm A) n=44 Participants Niraparib + Nivolumab: Niraparib 200mg PO daily on days 1-28 of each 28-day cycle. Nivolumab 480mg IV day 1 of each cycle.	Niraparib + Ipilimumab (Arm B) n=40 Participants Niraparib + Ipilimumab: Niraparib 200mg PO daily on days 1-21 of each 21-day cycle. Ipilimumab 3mg/kg IV day 1 of each cycle, for the first 4 cycles only.
Rate of Progression-free Survival at 6 Months (PFS6)	20.6 percentage of participants with PFS Interval 8.3 to 32.9	59.6 percentage of participants with PFS Interval 44.3 to 74.9

SECONDARY outcome

Timeframe: From first restaging assessment through completion of study treatment (maximum 42 months)

Population: The efficacy population consisted of all patients who received at least one dose of study treatment and had at least one post-treatment assessment of response by RECIST.

The proportion of patients who achieve a complete or partial response, as determined by RECIST

Outcome measures

Measure	Niraparib + Nivolumab (Arm A) n=44 Participants Niraparib + Nivolumab: Niraparib 200mg PO daily on days 1-28 of each 28-day cycle. Nivolumab 480mg IV day 1 of each cycle.	Niraparib + Ipilimumab (Arm B) n=40 Participants Niraparib + Ipilimumab: Niraparib 200mg PO daily on days 1-21 of each 21-day cycle. Ipilimumab 3mg/kg IV day 1 of each cycle, for the first 4 cycles only.
Objective Response Rate (ORR) Per RECIST v.1.1 as Assessed by Radiology Review	7.7 Percentage of participants Interval 1.5 to 19.5	15.4 Percentage of participants Interval 5.9 to 30.5

SECONDARY outcome

Timeframe: Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first

Population: The efficacy population consisted of all patients who received at least one dose of study treatment and had at least one post-treatment assessment of response by RECIST.

Start of treatment to death due to any cause or last patient contact alive.

Outcome measures

Measure	Niraparib + Nivolumab (Arm A) n=44 Participants Niraparib + Nivolumab: Niraparib 200mg PO daily on days 1-28 of each 28-day cycle. Nivolumab 480mg IV day 1 of each cycle.	Niraparib + Ipilimumab (Arm B) n=40 Participants Niraparib + Ipilimumab: Niraparib 200mg PO daily on days 1-21 of each 21-day cycle. Ipilimumab 3mg/kg IV day 1 of each cycle, for the first 4 cycles only.
Overall Survival (OS)	13.2 Months Interval 8.1 to 16.7	17.3 Months Interval 12.8 to 21.9

Adverse Events

Niraparib + Nivolumab (Arm A)

Serious events: 20 serious events

Other events: 46 other events

Deaths: 7 deaths

Niraparib + Ipilimumab (Arm B)

Serious events: 15 serious events

Other events: 44 other events

Deaths: 5 deaths

Serious adverse events

Measure	Niraparib + Nivolumab (Arm A) n=46 participants at risk Niraparib + Nivolumab: Niraparib 200mg PO daily on days 1-28 of each 28-day cycle. Nivolumab 480mg IV day 1 of each cycle.	Niraparib + Ipilimumab (Arm B) n=45 participants at risk Niraparib + Ipilimumab: Niraparib 200mg PO daily on days 1-21 of each 21-day cycle. Ipilimumab 3mg/kg IV day 1 of each cycle, for the first 4 cycles only.
Vascular disorders Hypertension	2.2% 1/46 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	0.00% 0/45 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Renal and urinary disorders Other: Passing gallbladder obstruction	2.2% 1/46 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	0.00% 0/45 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.3% 2/46 • Number of events 2 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/46 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/46 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	4.4% 2/45 • Number of events 2 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Cardiac disorders Myocardial infarction	2.2% 1/46 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	0.00% 0/45 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal pain	4.3% 2/46 • Number of events 2 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	0.00% 0/45 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Gastrointestinal disorders Ascites	2.2% 1/46 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	0.00% 0/45 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Gastrointestinal disorders Colitis	0.00% 0/46 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/46 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Gastrointestinal disorders Gastric hemorrhage	2.2% 1/46 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	0.00% 0/45 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Gastrointestinal disorders Obstruction gastric	2.2% 1/46 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	0.00% 0/45 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Gastrointestinal disorders Pancreatitis	2.2% 1/46 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	0.00% 0/45 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/46 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
General disorders Fever	2.2% 1/46 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Hepatobiliary disorders Other: Acute cholangitis	0.00% 0/46 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Infections and infestations Biliary tract infection	2.2% 1/46 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	0.00% 0/45 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Infections and infestations Sepsis	2.2% 1/46 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Investigations Blood bilirubin increased	4.3% 2/46 • Number of events 2 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	0.00% 0/45 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Investigations Platelet count decreased	2.2% 1/46 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	4.4% 2/45 • Number of events 2 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/46 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/46 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Nervous system disorders Dysarthria	2.2% 1/46 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	0.00% 0/45 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Nervous system disorders Stroke	2.2% 1/46 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	0.00% 0/45 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Psychiatric disorders Confusion	2.2% 1/46 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	0.00% 0/45 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Psychiatric disorders Suicide attempt	2.2% 1/46 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	0.00% 0/45 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/46 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.

Other adverse events

Measure	Niraparib + Nivolumab (Arm A) n=46 participants at risk Niraparib + Nivolumab: Niraparib 200mg PO daily on days 1-28 of each 28-day cycle. Nivolumab 480mg IV day 1 of each cycle.	Niraparib + Ipilimumab (Arm B) n=45 participants at risk Niraparib + Ipilimumab: Niraparib 200mg PO daily on days 1-21 of each 21-day cycle. Ipilimumab 3mg/kg IV day 1 of each cycle, for the first 4 cycles only.
Skin and subcutaneous tissue disorders Rash maculo-papular	4.3% 2/46 • Number of events 2 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	13.3% 6/45 • Number of events 8 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Other: Rash	10.9% 5/46 • Number of events 7 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	11.1% 5/45 • Number of events 7 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Blood and lymphatic system disorders Anemia	21.7% 10/46 • Number of events 30 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	44.4% 20/45 • Number of events 41 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Cardiac disorders Palpitations	0.00% 0/46 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	6.7% 3/45 • Number of events 3 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal distension	6.5% 3/46 • Number of events 4 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal pain	39.1% 18/46 • Number of events 26 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	26.7% 12/45 • Number of events 15 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Gastrointestinal disorders Constipation	15.2% 7/46 • Number of events 7 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	15.6% 7/45 • Number of events 7 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Gastrointestinal disorders Diarrhea	13.0% 6/46 • Number of events 9 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	26.7% 12/45 • Number of events 17 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Gastrointestinal disorders Dry mouth	2.2% 1/46 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	6.7% 3/45 • Number of events 6 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/46 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	6.7% 3/45 • Number of events 3 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Gastrointestinal disorders Mucositis oral	4.3% 2/46 • Number of events 2 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	6.7% 3/45 • Number of events 3 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Gastrointestinal disorders Nausea	34.8% 16/46 • Number of events 20 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	44.4% 20/45 • Number of events 25 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Gastrointestinal disorders Vomiting	15.2% 7/46 • Number of events 12 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	17.8% 8/45 • Number of events 12 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
General disorders Chills	6.5% 3/46 • Number of events 4 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	8.9% 4/45 • Number of events 4 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
General disorders Fatigue	28.3% 13/46 • Number of events 18 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	57.8% 26/45 • Number of events 40 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
General disorders Fever	17.4% 8/46 • Number of events 10 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	22.2% 10/45 • Number of events 11 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
General disorders Pain	19.6% 9/46 • Number of events 13 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	8.9% 4/45 • Number of events 4 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Infections and infestations Urinary tract infection	6.5% 3/46 • Number of events 4 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	2.2% 1/45 • Number of events 2 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Investigations Alanine aminotransferase increased	21.7% 10/46 • Number of events 25 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	44.4% 20/45 • Number of events 30 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Investigations Alkaline phosphatase increased	30.4% 14/46 • Number of events 27 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	37.8% 17/45 • Number of events 20 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Investigations Aspartate aminotransferase increased	26.1% 12/46 • Number of events 33 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	48.9% 22/45 • Number of events 37 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Investigations Blood bilirubin increased	15.2% 7/46 • Number of events 13 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	11.1% 5/45 • Number of events 6 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Investigations Creatinine increased	10.9% 5/46 • Number of events 8 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	20.0% 9/45 • Number of events 13 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Investigations Neutrophil count decreased	17.4% 8/46 • Number of events 14 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	15.6% 7/45 • Number of events 13 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Investigations Platelet count decreased	39.1% 18/46 • Number of events 41 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	46.7% 21/45 • Number of events 43 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Investigations Thyroid stimulating hormone increased	2.2% 1/46 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	6.7% 3/45 • Number of events 4 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Investigations Weight loss	10.9% 5/46 • Number of events 5 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	13.3% 6/45 • Number of events 6 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Investigations White blood cell decreased	6.5% 3/46 • Number of events 8 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	8.9% 4/45 • Number of events 11 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Metabolism and nutrition disorders Anorexia	10.9% 5/46 • Number of events 6 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	13.3% 6/45 • Number of events 8 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/46 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	8.9% 4/45 • Number of events 5 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypocalcemia	8.7% 4/46 • Number of events 6 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	11.1% 5/45 • Number of events 10 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypokalemia	8.7% 4/46 • Number of events 6 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	11.1% 5/45 • Number of events 7 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypomagnesemia	17.4% 8/46 • Number of events 8 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	24.4% 11/45 • Number of events 16 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyponatremia	21.7% 10/46 • Number of events 17 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	24.4% 11/45 • Number of events 17 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypophosphatemia	6.5% 3/46 • Number of events 5 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	13.0% 6/46 • Number of events 11 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	15.6% 7/45 • Number of events 9 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	15.2% 7/46 • Number of events 7 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	17.8% 8/45 • Number of events 10 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Nervous system disorders Dizziness	6.5% 3/46 • Number of events 3 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	4.4% 2/45 • Number of events 2 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Nervous system disorders Dysgeusia	6.5% 3/46 • Number of events 3 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Nervous system disorders Headache	15.2% 7/46 • Number of events 10 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	13.3% 6/45 • Number of events 8 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Psychiatric disorders Insomnia	15.2% 7/46 • Number of events 7 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	4.4% 2/45 • Number of events 2 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	8.7% 4/46 • Number of events 4 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	13.3% 6/45 • Number of events 8 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	13.0% 6/46 • Number of events 8 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	8.9% 4/45 • Number of events 4 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/46 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	6.7% 3/45 • Number of events 3 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Pruritus	4.3% 2/46 • Number of events 3 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	11.1% 5/45 • Number of events 7 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/46 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	8.9% 4/45 • Number of events 5 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Vascular disorders Hot flashes	6.5% 3/46 • Number of events 4 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	8.9% 4/45 • Number of events 4 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.
Vascular disorders Hypertension	13.0% 6/46 • Number of events 12 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.	11.1% 5/45 • Number of events 12 • Adverse events were assessed from 6 months after initiation of study therapy. All-Cause Mortality was from Cycle 1 Day 1 until death, loss to follow-up, withdrawal of consent or until 5 years have passed, whichever occurs first. The safety population consisted of all patients who received at least one dose of study treatment.

Additional Information

Regulatory Lead

University of Pennsylvania

Phone: 215-662-4484

Email: psom-ind-ide@pobox.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place