Trial Outcomes & Findings for Safety and Efficacy Study of Ulocuplumab and Nivolumab in Subjects With Solid Tumors (NCT NCT02472977)

NCT ID: NCT02472977

Last Updated: 2018-11-01

Results Overview

The number participants who experienced on-study AEs, SAEs, and AEs requiring immune modulating medication is reported.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

61 participants

Primary outcome timeframe

From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)

Results posted on

2018-11-01

Participant Flow

61 participants were enrolled; 41 participants entered the treatment period.

Participant milestones

Participant milestones
Measure	PAC DL1 (DLT) Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W	PAC DL-1 (Tot) Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W	SCLC (Tot) All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
Overall Study STARTED	6	27	8
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	6	27	8

Reasons for withdrawal

Reasons for withdrawal
Measure	PAC DL1 (DLT) Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W	PAC DL-1 (Tot) Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W	SCLC (Tot) All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
Overall Study Disease progression	4	25	6
Overall Study Withdrawal by Subject	0	1	0
Overall Study Study drug toxicity	2	0	2
Overall Study Subject request to discontinue treatment	0	1	0

Baseline Characteristics

All treated participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PAC DL1 (DLT) n=6 Participants Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W	PAC DL-1 (Tot) n=27 Participants Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W	SCLC (Tot) n=8 Participants All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W	Total n=41 Participants Total of all reporting groups
Age, Continuous	63.3 years STANDARD_DEVIATION 5.05 • n=5 Participants • All treated participants	61.9 years STANDARD_DEVIATION 7.93 • n=7 Participants • All treated participants	60.1 years STANDARD_DEVIATION 14.13 • n=5 Participants • All treated participants	61.7 years STANDARD_DEVIATION 8.94 • n=4 Participants • All treated participants
Sex: Female, Male Female	1 Participants n=5 Participants • All treated participants	14 Participants n=7 Participants • All treated participants	4 Participants n=5 Participants • All treated participants	19 Participants n=4 Participants • All treated participants
Sex: Female, Male Male	5 Participants n=5 Participants • All treated participants	13 Participants n=7 Participants • All treated participants	4 Participants n=5 Participants • All treated participants	22 Participants n=4 Participants • All treated participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants • All treated participants	1 Participants n=7 Participants • All treated participants	1 Participants n=5 Participants • All treated participants	2 Participants n=4 Participants • All treated participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants • All treated participants	22 Participants n=7 Participants • All treated participants	7 Participants n=5 Participants • All treated participants	35 Participants n=4 Participants • All treated participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • All treated participants	4 Participants n=7 Participants • All treated participants	0 Participants n=5 Participants • All treated participants	4 Participants n=4 Participants • All treated participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • All treated participants	0 Participants n=7 Participants • All treated participants	0 Participants n=5 Participants • All treated participants	0 Participants n=4 Participants • All treated participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants • All treated participants	0 Participants n=7 Participants • All treated participants	0 Participants n=5 Participants • All treated participants	0 Participants n=4 Participants • All treated participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • All treated participants	0 Participants n=7 Participants • All treated participants	0 Participants n=5 Participants • All treated participants	0 Participants n=4 Participants • All treated participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants • All treated participants	2 Participants n=7 Participants • All treated participants	1 Participants n=5 Participants • All treated participants	3 Participants n=4 Participants • All treated participants
Race (NIH/OMB) White	6 Participants n=5 Participants • All treated participants	25 Participants n=7 Participants • All treated participants	7 Participants n=5 Participants • All treated participants	38 Participants n=4 Participants • All treated participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • All treated participants	0 Participants n=7 Participants • All treated participants	0 Participants n=5 Participants • All treated participants	0 Participants n=4 Participants • All treated participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • All treated participants	0 Participants n=7 Participants • All treated participants	0 Participants n=5 Participants • All treated participants	0 Participants n=4 Participants • All treated participants

PRIMARY outcome

Timeframe: From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)

Population: All treated participants. Participants in the SCLC (Tot) Arm were not evaluated for Immune-mediated AEs

The number participants who experienced on-study AEs, SAEs, and AEs requiring immune modulating medication is reported.

Outcome measures

Outcome measures
Measure	PAC DL1 (DLT) n=6 Participants Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W	PAC DL-1 (Tot) n=27 Participants Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W	SCLC (Tot) n=8 Participants All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-mediated AEs Adverse Events	6 Participants	27 Participants	8 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-mediated AEs Serious Adverse Events	3 Participants	21 Participants	7 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-mediated AEs Immune-mediated AEs	1 Participants	3 Participants	—

PRIMARY outcome

Timeframe: From first dose until disease progression or treatment discontinuation (assessed up to January 2017, approximately 18 months)

Population: All treated participants in PAC arms. ORR data was not collected for SCLC arm.

ORR is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants. BOR is defined as the best response designation recorded between the first dose date and the date of progression per RECIST 1.1, or the date of subsequent anti-cancer therapy, whichever occurs first. CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD)=At least a 20% increase in the sum of diameters of target lesions, referencing the smallest sum on study, and an absolute increase of at least 5 mm, or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing the smallest sum diameters while on study.

Outcome measures

Outcome measures
Measure	PAC DL1 (DLT) n=6 Participants Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W	PAC DL-1 (Tot) n=27 Participants Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W	SCLC (Tot) All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
Objective Response Rate (ORR) Per RECIST 1.1 Criteria	0 Percentage of participants Interval 0.0 to 39.3	0 Percentage of participants Interval 0.0 to 10.5	—

PRIMARY outcome

Timeframe: From date of randomization to date of death (assessed up to study completion, approximately 18 months)

Population: OS data was not collected for any participants

If a Phase 2 comparative study is initiated and, for PAC only: Overall Survival is defined as the time from randomization to date of death due to any cause.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)

Population: All treated participants in PAC arms. Lab abnormality data was not collected for SCLC arm.

The number of participants who experienced on-study Grade 3 or 4 laboratory abnormalities (without Grade 3 or 4 abnormality at baseline) was reported for each arm.

Outcome measures

Outcome measures
Measure	PAC DL1 (DLT) n=6 Participants Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W	PAC DL-1 (Tot) n=27 Participants Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W	SCLC (Tot) All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
Number of Participants With Laboratory Abnormalities Increased lymphocytes	1 Participants	2 Participants	—
Number of Participants With Laboratory Abnormalities Decreased platelet count	1 Participants	2 Participants	—
Number of Participants With Laboratory Abnormalities Hemoglobin	1 Participants	1 Participants	—
Number of Participants With Laboratory Abnormalities Leukocytes	0 Participants	1 Participants	—
Number of Participants With Laboratory Abnormalities Neutrophils	0 Participants	0 Participants	—
Number of Participants With Laboratory Abnormalities Platelet Count	1 Participants	2 Participants	—
Number of Participants With Laboratory Abnormalities Alanine Aminotransferase	0 Participants	3 Participants	—
Number of Participants With Laboratory Abnormalities Alkaline Phosphatase	1 Participants	11 Participants	—
Number of Participants With Laboratory Abnormalities Aspartate Aminotransferase	0 Participants	5 Participants	—
Number of Participants With Laboratory Abnormalities Bilirubin	0 Participants	1 Participants	—
Number of Participants With Laboratory Abnormalities Creatine	0 Participants	0 Participants	—
Number of Participants With Laboratory Abnormalities Hypernatremia	0 Participants	0 Participants	—
Number of Participants With Laboratory Abnormalities Hyponatremia	1 Participants	3 Participants	—
Number of Participants With Laboratory Abnormalities Hypermagnesemia	0 Participants	0 Participants	—
Number of Participants With Laboratory Abnormalities Hypomagnesemia	0 Participants	0 Participants	—
Number of Participants With Laboratory Abnormalities Hypercalcemia	0 Participants	0 Participants	—
Number of Participants With Laboratory Abnormalities Hypocalcemia	0 Participants	0 Participants	—
Number of Participants With Laboratory Abnormalities Hyperkalemia	0 Participants	1 Participants	—
Number of Participants With Laboratory Abnormalities Hypokalemia	0 Participants	0 Participants	—
Number of Participants With Laboratory Abnormalities Amylase	1 Participants	0 Participants	—
Number of Participants With Laboratory Abnormalities Lipase	1 Participants	1 Participants	—

PRIMARY outcome

Timeframe: From first dose to date of last dose plus 30 days

Population: Electrocardiogram data was not collected for any participants

The number of participants experiencing electrocardiogram abnormalities was reported for each arm

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose to date of progression (assessed up to January 2017, approximately 18 months)

Population: PFS data was not collected for any participants

Progression-free survival is defined as the time from first dosing date to the date of the first documented tumor progression, as determined by the investigator according to RECIST 1.1 criteria, or death due to any cause, whichever occurs first. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. PFS was not assessed for this study due to the small number of participants.

Outcome measures

Outcome data not reported

Adverse Events

PAC DL1 (DLT)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 3 deaths

PAC DL-1 (Tot)

Serious events: 21 serious events

Other events: 26 other events

Deaths: 16 deaths

SCLC (Tot)

Serious events: 7 serious events

Other events: 8 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: [email protected]

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER

Measure	PAC DL1 (DLT) n=6 participants at risk Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W	PAC DL-1 (Tot) n=27 participants at risk Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W	SCLC (Tot) n=8 participants at risk All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
Gastrointestinal disorders Ascites	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	3.7% 1/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	3.7% 1/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
General disorders Asthenia	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	3.7% 1/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
General disorders Fatigue	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	3.7% 1/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
General disorders Gait disturbance	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	3.7% 1/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
General disorders Pyrexia	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	7.4% 2/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
Hepatobiliary disorders Bile duct obstruction	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	3.7% 1/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
Infections and infestations Biliary tract infection	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	3.7% 1/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
Infections and infestations Diverticulitis	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	3.7% 1/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
Infections and infestations Infection	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	3.7% 1/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
Infections and infestations Sepsis	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	3.7% 1/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	12.5% 1/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
Investigations Blood bilirubin increased	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	3.7% 1/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
Investigations C-reactive protein increased	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	3.7% 1/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
Investigations Neutrophil count decreased	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	3.7% 1/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
Metabolism and nutrition disorders Failure to thrive	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	12.5% 1/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	3.7% 1/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	12.5% 1/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	3.7% 1/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	50.0% 3/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	59.3% 16/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	37.5% 3/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
Nervous system disorders Cerebrovascular accident	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	3.7% 1/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
Nervous system disorders Presyncope	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	3.7% 1/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
Psychiatric disorders Agitation	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	3.7% 1/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
Psychiatric disorders Mental status changes	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	3.7% 1/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	3.7% 1/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	12.5% 1/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	7.4% 2/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	12.5% 1/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	3.7% 1/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	12.5% 1/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
Vascular disorders Aortic aneurysm	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	12.5% 1/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
Vascular disorders Embolism	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	7.4% 2/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)
Vascular disorders Haematoma	0.00% 0/6 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	0.00% 0/27 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)	12.5% 1/8 • From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 months)