Trial Outcomes & Findings for Study of Nivolumab in Combination With Gemcitabine/Cisplatin or Ipilimumab for Patients With Advanced Unresectable Biliary Tract Cancer (NCT NCT03101566)

Last Updated: 2022-10-28

Results Overview

The primary endpoint is PFS (Progression Free Survival) at 6 months following the initiation of treatment. Progression will be defined clinically or on imaging as per immune related response evaluation criteria in solid tumors (irRECIST) definition.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

75 participants

Primary outcome timeframe

6 Months

Results posted on

2022-10-28

Participant Flow

Participant milestones

Participant milestones
Measure	Gemcitabine + Cisplatin + Nivolumab Gemcitabine1000 mg/m2 IV and Cisplatin 25 mg/m2 IV on days 1 and 8 every 3 weeks + Nivolumab 360 mg IV on day 1 every 3 weeks for up to 8, 3-week cycles. Followed by Nivolumab alone at 240 mg IV every 2 weeks. Total duration no longer than 2 years of study treatment.	Nivolumab + Ipilimumab Nivolumab 240 mg IV on day 1 every 2 weeks + Ipilimumab 1 mg/kg IV on day 1 every 6 weeks; for up to 2 years in absence of disease progression.
Overall Study STARTED	37	38
Overall Study Received at Least One Dose of Protocol Therapy	35	33
Overall Study Assessed for Primary and Secondary Progression-free Survival	32	33
Overall Study COMPLETED	31	31
Overall Study NOT COMPLETED	6	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Nivolumab in Combination With Gemcitabine/Cisplatin or Ipilimumab for Patients With Advanced Unresectable Biliary Tract Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gemcitabine + Cisplatin + Nivolumab n=37 Participants Gemcitabine1000 mg/m2 IV and Cisplatin 25 mg/m2 IV on days 1 and 8 every 3 weeks + Nivolumab 360 mg IV on day 1 every 3 weeks for up to 8, 3-week cycles. Followed by Nivolumab alone at 240 mg IV every 2 weeks. Total duration no longer than 2 years of study treatment.	Nivolumab + Ipilimumab n=38 Participants Nivolumab 240 mg IV on day 1 every 2 weeks + Ipilimumab 1 mg/kg IV on day 1 every 6 weeks; for up to 2 years in absence of disease progression.	Total n=75 Participants Total of all reporting groups
Age, Continuous	59 years n=5 Participants	61 years n=7 Participants	60 years n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	20 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants	36 Participants n=7 Participants	67 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 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	0 Participants n=5 Participants	4 Participants n=7 Participants	4 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	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	28 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Disease status at enrollment locally advanced	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Disease status at enrollment metastatic	33 Participants n=5 Participants	34 Participants n=7 Participants	67 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Months

Outcome measures

Outcome measures
Measure	Gemcitabine + Cisplatin + Nivolumab n=32 Participants Gemcitabine1000 mg/m2 IV and Cisplatin 25 mg/m2 IV on days 1 and 8 every 3 weeks + Nivolumab 360 mg IV on day 1 every 3 weeks for up to 8, 3-week cycles. Followed by Nivolumab alone at 240 mg IV every 2 weeks. Total duration no longer than 2 years of study treatment.	Nivolumab + Ipilimumab n=33 Participants Nivolumab 240 mg IV on day 1 every 2 weeks + Ipilimumab 1 mg/kg IV on day 1 every 6 weeks; for up to 2 years in absence of disease progression.
The Percentage of Patients Alive and Without Progression at 6 Months Following the Initiation of Treatment	59.4 percentage of participants Interval 40.5 to 74.0	21.2 percentage of participants Interval 9.4 to 36.3

SECONDARY outcome

Timeframe: Patients will be followed until death, withdrawal from study, or until 2 years, whichever is earliest

The median time patients are alive without progression following the initiation of treatment wherein progression will be defined clinically or on imaging as per irRECIST criteria.

Outcome measures

Outcome measures
Measure	Gemcitabine + Cisplatin + Nivolumab n=35 Participants Gemcitabine1000 mg/m2 IV and Cisplatin 25 mg/m2 IV on days 1 and 8 every 3 weeks + Nivolumab 360 mg IV on day 1 every 3 weeks for up to 8, 3-week cycles. Followed by Nivolumab alone at 240 mg IV every 2 weeks. Total duration no longer than 2 years of study treatment.	Nivolumab + Ipilimumab n=33 Participants Nivolumab 240 mg IV on day 1 every 2 weeks + Ipilimumab 1 mg/kg IV on day 1 every 6 weeks; for up to 2 years in absence of disease progression.
Median Progression Free Survival Time	6.6 months Interval 3.4 to 7.7	3.9 months Interval 2.3 to 4.5

SECONDARY outcome

Timeframe: Patients will be followed until death, withdrawal from study, or until 2 years, whichever is earliest

The median overall survival time following the initiation of treatment.

Outcome measures

Outcome measures
Measure	Gemcitabine + Cisplatin + Nivolumab n=32 Participants Gemcitabine1000 mg/m2 IV and Cisplatin 25 mg/m2 IV on days 1 and 8 every 3 weeks + Nivolumab 360 mg IV on day 1 every 3 weeks for up to 8, 3-week cycles. Followed by Nivolumab alone at 240 mg IV every 2 weeks. Total duration no longer than 2 years of study treatment.	Nivolumab + Ipilimumab n=33 Participants Nivolumab 240 mg IV on day 1 every 2 weeks + Ipilimumab 1 mg/kg IV on day 1 every 6 weeks; for up to 2 years in absence of disease progression.
Median Overall Survival Time	10.6 months Interval 6.4 to 24.5	8.2 months Interval 5.8 to 16.9

SECONDARY outcome

Timeframe: Up to two years

Overall Response Rate will be determined as per the combined RECIST v1.1 and irRECIST criteria

Outcome measures

Outcome measures
Measure	Gemcitabine + Cisplatin + Nivolumab n=33 Participants Gemcitabine1000 mg/m2 IV and Cisplatin 25 mg/m2 IV on days 1 and 8 every 3 weeks + Nivolumab 360 mg IV on day 1 every 3 weeks for up to 8, 3-week cycles. Followed by Nivolumab alone at 240 mg IV every 2 weeks. Total duration no longer than 2 years of study treatment.	Nivolumab + Ipilimumab n=32 Participants Nivolumab 240 mg IV on day 1 every 2 weeks + Ipilimumab 1 mg/kg IV on day 1 every 6 weeks; for up to 2 years in absence of disease progression.
Overall Response Rate (ORR)	22.9 percentage of patients Interval 10.4 to 40.1	3.0 percentage of patients Interval 0.1 to 15.8

Adverse Events

Gemcitabine + Cisplatin + Nivolumab

Serious events: 25 serious events

Other events: 34 other events

Deaths: 22 deaths

Nivolumab + Ipilimumab

Serious events: 23 serious events

Other events: 28 other events

Deaths: 23 deaths

Serious adverse events

Other adverse events

Additional Information

Vaibhav Sahai, MBBS, MS

University of Michigan Rogel Cancer Center

Phone: 734-936-4991

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Gemcitabine + Cisplatin + Nivolumab n=35 participants at risk Gemcitabine1000 mg/m2 IV and Cisplatin 25 mg/m2 IV on days 1 and 8 every 3 weeks + Nivolumab 360 mg IV on day 1 every 3 weeks for up to 8, 3-week cycles. Followed by Nivolumab alone at 240 mg IV every 2 weeks. Total duration no longer than 2 years of study treatment.	Nivolumab + Ipilimumab n=33 participants at risk Nivolumab 240 mg IV on day 1 every 2 weeks + Ipilimumab 1 mg/kg IV on day 1 every 6 weeks; for up to 2 years in absence of disease progression.
Blood and lymphatic system disorders Leukocytosis	2.9% 1/35 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	0.00% 0/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Cardiac disorders Paroxysmal atrial tachycardia	2.9% 1/35 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	0.00% 0/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Gastrointestinal disorders Abdominal distension	2.9% 1/35 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	3.0% 1/33 • Number of events 2 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Gastrointestinal disorders Abdominal pain	14.3% 5/35 • Number of events 5 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	9.1% 3/33 • Number of events 3 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Gastrointestinal disorders Ascites	2.9% 1/35 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	0.00% 0/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Gastrointestinal disorders Constipation	2.9% 1/35 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	0.00% 0/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Gastrointestinal disorders Enterocolitis	2.9% 1/35 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	0.00% 0/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Gastrointestinal disorders Nausea	2.9% 1/35 • Number of events 2 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	3.0% 1/33 • Number of events 2 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	2.9% 1/35 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	3.0% 1/33 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
General disorders Fever	11.4% 4/35 • Number of events 4 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	3.0% 1/33 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Hepatobiliary disorders Bile duct stenosis	5.7% 2/35 • Number of events 2 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	3.0% 1/33 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Hepatobiliary disorders Cholecystitis	5.7% 2/35 • Number of events 3 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	3.0% 1/33 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Hepatobiliary disorders Hepatobiliary disorders - Other	2.9% 1/35 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	3.0% 1/33 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Infections and infestations Infections and infestations - Other	8.6% 3/35 • Number of events 4 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	9.1% 3/33 • Number of events 4 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Infections and infestations Sepsis	11.4% 4/35 • Number of events 6 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	6.1% 2/33 • Number of events 3 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Infections and infestations Small intestine infection	2.9% 1/35 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	0.00% 0/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Investigations Alanine aminotransferase increased	2.9% 1/35 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	0.00% 0/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Investigations Aspartate aminotransferase increased	2.9% 1/35 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	0.00% 0/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Investigations Blood bilirubin increased	2.9% 1/35 • Number of events 3 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	12.1% 4/33 • Number of events 4 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Metabolism and nutrition disorders Dehydration	2.9% 1/35 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	6.1% 2/33 • Number of events 2 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Metabolism and nutrition disorders Hypercalcemia	2.9% 1/35 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	0.00% 0/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Metabolism and nutrition disorders Hyperkalemia	2.9% 1/35 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	0.00% 0/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other	14.3% 5/35 • Number of events 5 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	18.2% 6/33 • Number of events 6 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Nervous system disorders Nervous system disorders - Other, specify	2.9% 1/35 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	0.00% 0/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Nervous system disorders Syncope	2.9% 1/35 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	0.00% 0/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Psychiatric disorders Confusion	2.9% 1/35 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	3.0% 1/33 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Renal and urinary disorders Acute kidney injury	2.9% 1/35 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	0.00% 0/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.9% 1/35 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	0.00% 0/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.7% 2/35 • Number of events 2 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	0.00% 0/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Surgical and medical procedures Surgical and medical procedures - Other, specify	2.9% 1/35 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	0.00% 0/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Vascular disorders Hypotension	2.9% 1/35 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	3.0% 1/33 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Vascular disorders Thromboembolic event	8.6% 3/35 • Number of events 3 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	3.0% 1/33 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Blood and lymphatic system disorders Anemia	0.00% 0/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	3.0% 1/33 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Cardiac disorders Myocardial infarction	0.00% 0/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	3.0% 1/33 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Cardiac disorders Sinus tachycardia	0.00% 0/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	3.0% 1/33 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Endocrine disorders Adrenal insufficiency	0.00% 0/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	3.0% 1/33 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Gastrointestinal disorders Colitis	0.00% 0/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	3.0% 1/33 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Gastrointestinal disorders Colonic perforation	0.00% 0/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	3.0% 1/33 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Gastrointestinal disorders Diarrhea	0.00% 0/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	6.1% 2/33 • Number of events 2 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Gastrointestinal disorders Vomiting	0.00% 0/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	3.0% 1/33 • Number of events 1 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.

Other adverse events
Measure	Gemcitabine + Cisplatin + Nivolumab n=35 participants at risk Gemcitabine1000 mg/m2 IV and Cisplatin 25 mg/m2 IV on days 1 and 8 every 3 weeks + Nivolumab 360 mg IV on day 1 every 3 weeks for up to 8, 3-week cycles. Followed by Nivolumab alone at 240 mg IV every 2 weeks. Total duration no longer than 2 years of study treatment.	Nivolumab + Ipilimumab n=33 participants at risk Nivolumab 240 mg IV on day 1 every 2 weeks + Ipilimumab 1 mg/kg IV on day 1 every 6 weeks; for up to 2 years in absence of disease progression.
Gastrointestinal disorders Abdominal pain	40.0% 14/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	33.3% 11/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Gastrointestinal disorders Ascites	2.9% 1/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	15.2% 5/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Gastrointestinal disorders Bloating	5.7% 2/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	3.0% 1/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Gastrointestinal disorders Constipation	37.1% 13/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	30.3% 10/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Gastrointestinal disorders Diarrhea	37.1% 13/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	24.2% 8/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Gastrointestinal disorders Dyspepsia	0.00% 0/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	6.1% 2/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Gastrointestinal disorders Dysphagia	5.7% 2/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	3.0% 1/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Gastrointestinal disorders Flatulence	8.6% 3/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	3.0% 1/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Gastrointestinal disorders Gastritis	5.7% 2/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	0.00% 0/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Gastrointestinal disorders Gastroesophageal reflux disease	2.9% 1/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	9.1% 3/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Gastrointestinal disorders Mucositis oral	5.7% 2/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	0.00% 0/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Gastrointestinal disorders Nausea	51.4% 18/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	27.3% 9/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Gastrointestinal disorders Vomiting	28.6% 10/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	15.2% 5/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
General disorders Chills	8.6% 3/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	6.1% 2/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
General disorders Edema limbs	22.9% 8/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	24.2% 8/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
General disorders Fatigue	42.9% 15/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	48.5% 16/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Blood and lymphatic system disorders Anemia	45.7% 16/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	15.2% 5/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Cardiac disorders Sinus tachycardia	5.7% 2/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	0.00% 0/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Ear and labyrinth disorders Tinnitus	8.6% 3/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	0.00% 0/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Endocrine disorders Hypothyroidism	2.9% 1/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	9.1% 3/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Eye disorders Papilledema	5.7% 2/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	0.00% 0/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
General disorders Fever	20.0% 7/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	12.1% 4/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
General disorders Flu like symptoms	2.9% 1/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	9.1% 3/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
General disorders Infusion related reaction	0.00% 0/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	6.1% 2/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
General disorders Non-cardiac chest pain	11.4% 4/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	0.00% 0/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
General disorders Pain	20.0% 7/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	15.2% 5/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	2.9% 1/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	6.1% 2/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Infections and infestations Infections and infestations - Other, specify	11.4% 4/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	12.1% 4/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Injury, poisoning and procedural complications Fall	2.9% 1/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	6.1% 2/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Investigations Alanine aminotransferase increased	22.9% 8/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	15.2% 5/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Investigations Alkaline phosphatase increased	20.0% 7/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	18.2% 6/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Investigations Aspartate aminotransferase increased	14.3% 5/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	12.1% 4/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Investigations Blood bilirubin increased	5.7% 2/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	18.2% 6/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Investigations Creatinine increased	8.6% 3/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	9.1% 3/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Investigations Investigations - Other, specify	0.00% 0/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	6.1% 2/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Investigations Lipase increased	5.7% 2/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	3.0% 1/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Investigations Lymphocyte count decreased	11.4% 4/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	6.1% 2/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Investigations Neutrophil count decreased	40.0% 14/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	0.00% 0/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Investigations Platelet count decreased	31.4% 11/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	0.00% 0/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.
Investigations Weight gain	2.9% 1/35 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.	6.1% 2/33 • Data on adverse events was collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment. Any serious adverse event that occured more than 100 days after the last study treatment and is considered related to the study treatment or intervention is also reported.