Trial Outcomes & Findings for An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma (NCT NCT03329846)

NCT ID: NCT03329846

Last Updated: 2021-07-09

Results Overview

Number of participants experiencing different types of Adverse Events, including Death, Any cause Adverse Events (AEs), Drug-related AEs, Any cause Serious Adverse Events (SAEs), Drug-related SAEs, SAEs leading to discontinuation, and Drug-related Non-serious AEs leading to discontinuation

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 20 participants
• Primary outcome timeframe: From first dose to 30 days following last dose (up to approximately 25 months)
• Results posted on: 2021-07-09

Participant Flow

20 participants were randomized and treated.

Participant milestones

Measure	Nivolumab + BMS-986205 Nivolumab 480 mg IV Q4W + BMS-986205 100 mg PO QD	Nivolumab Nivolumab 480 mg IV Q4W
Overall Study STARTED	10	10
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	8	9

Reasons for withdrawal

Measure	Nivolumab + BMS-986205 Nivolumab 480 mg IV Q4W + BMS-986205 100 mg PO QD	Nivolumab Nivolumab 480 mg IV Q4W
Overall Study Disease progression	4	6
Overall Study Study drug toxicity	1	0
Overall Study Participant request to discontinue treatment	0	1
Overall Study Participant withdrew consent	1	0
Overall Study Other reasons	2	2

Baseline Characteristics

An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma

Baseline characteristics by cohort

Measure	Nivolumab + BMS-986205 n=10 Participants Nivolumab 480 mg IV Q4W + BMS-986205 100 mg PO QD	Nivolumab n=10 Participants Nivolumab 480 mg IV Q4W	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	4 Participants n=7 Participants	8 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	1 Participants n=7 Participants	1 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose to 30 days following last dose (up to approximately 25 months)

Population: All treated participants

Number of participants experiencing different types of Adverse Events, including Death, Any cause Adverse Events (AEs), Drug-related AEs, Any cause Serious Adverse Events (SAEs), Drug-related SAEs, SAEs leading to discontinuation, and Drug-related Non-serious AEs leading to discontinuation

Outcome measures

Measure	Nivolumab + BMS-986205 n=10 Participants Nivolumab 480 mg IV Q4W + BMS-986205 100 mg PO QD	Nivolumab n=10 Participants Nivolumab 480 mg IV Q4W
Number of Participants Experiencing Adverse Events Any cause AEs (any grade)	10 Participants	9 Participants
Number of Participants Experiencing Adverse Events Deaths	0 Participants	0 Participants
Number of Participants Experiencing Adverse Events Any cause SAEs (any grade)	3 Participants	3 Participants
Number of Participants Experiencing Adverse Events Drug-related SAEs (any grade)	1 Participants	0 Participants
Number of Participants Experiencing Adverse Events SAEs leading to discontinuation	1 Participants	0 Participants
Number of Participants Experiencing Adverse Events Drug-related AEs (any grade)	9 Participants	7 Participants
Number of Participants Experiencing Adverse Events Drug-Related Non-serious AEs leading to discontinuation	0 Participants	0 Participants

Adverse Events

Nivolumab + BMS-986205

Serious events: 4 serious events

Other events: 10 other events

Deaths: 1 deaths

Nivolumab

Serious events: 4 serious events

Other events: 9 other events

Deaths: 3 deaths

Serious adverse events

Measure	Nivolumab + BMS-986205 n=10 participants at risk Nivolumab 480 mg IV Q4W + BMS-986205 100 mg PO QD	Nivolumab n=10 participants at risk Nivolumab 480 mg IV Q4W
Gastrointestinal disorders Constipation	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Gastrointestinal disorders Vomiting	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Infections and infestations Gastroenteritis viral	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Infections and infestations Lower respiratory tract infection	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Infections and infestations Pneumonia	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Renal and urinary disorders Renal failure	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.

Other adverse events

Measure	Nivolumab + BMS-986205 n=10 participants at risk Nivolumab 480 mg IV Q4W + BMS-986205 100 mg PO QD	Nivolumab n=10 participants at risk Nivolumab 480 mg IV Q4W
Ear and labyrinth disorders Ear pain	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Endocrine disorders Hyperthyroidism	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Endocrine disorders Hypothyroidism	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Endocrine disorders Thyroiditis	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Eye disorders Dry eye	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Eye disorders Ocular discomfort	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Eye disorders Vitreous floaters	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Gastrointestinal disorders Abdominal distension	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Gastrointestinal disorders Abdominal pain	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Gastrointestinal disorders Constipation	20.0% 2/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Gastrointestinal disorders Diarrhoea	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	20.0% 2/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Gastrointestinal disorders Dry mouth	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Gastrointestinal disorders Dyspepsia	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Gastrointestinal disorders Nausea	50.0% 5/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	40.0% 4/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Gastrointestinal disorders Proctalgia	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Gastrointestinal disorders Stomatitis	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Gastrointestinal disorders Vomiting	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	20.0% 2/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
General disorders Asthenia	50.0% 5/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	20.0% 2/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
General disorders Chest discomfort	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
General disorders Fatigue	20.0% 2/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	20.0% 2/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
General disorders Influenza like illness	20.0% 2/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
General disorders Mucosal inflammation	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
General disorders Pain	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
General disorders Pyrexia	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Immune system disorders Hypersensitivity	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Infections and infestations Conjunctivitis	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Infections and infestations Herpes zoster	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Infections and infestations Lower respiratory tract infection	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	20.0% 2/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Infections and infestations Nasopharyngitis	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Infections and infestations Upper respiratory tract infection	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Infections and infestations Urinary tract infection	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Infections and infestations Viral upper respiratory tract infection	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Injury, poisoning and procedural complications Infusion related reaction	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	20.0% 2/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Injury, poisoning and procedural complications Procedural pain	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Injury, poisoning and procedural complications Radiation injury	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Investigations Amylase increased	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Investigations Blood bilirubin increased	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Investigations C-reactive protein increased	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Investigations Lipase increased	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Investigations Transaminases increased	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Metabolism and nutrition disorders Decreased appetite	30.0% 3/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	20.0% 2/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Metabolism and nutrition disorders Polydipsia	20.0% 2/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Musculoskeletal and connective tissue disorders Arthralgia	20.0% 2/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	30.0% 3/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Musculoskeletal and connective tissue disorders Bone pain	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Musculoskeletal and connective tissue disorders Flank pain	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	20.0% 2/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Musculoskeletal and connective tissue disorders Pain in jaw	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Musculoskeletal and connective tissue disorders Trigger finger	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Nervous system disorders Dysgeusia	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Nervous system disorders Headache	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	20.0% 2/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Nervous system disorders Lethargy	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Nervous system disorders Neuralgia	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Nervous system disorders Paraesthesia	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Nervous system disorders Presyncope	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Nervous system disorders Tremor	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Psychiatric disorders Anxiety	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Psychiatric disorders Depressed mood	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Renal and urinary disorders Urinary incontinence	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Reproductive system and breast disorders Breast pain	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Reproductive system and breast disorders Pelvic pain	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Reproductive system and breast disorders Pruritus genital	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Respiratory, thoracic and mediastinal disorders Cough	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	20.0% 2/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Respiratory, thoracic and mediastinal disorders Dyspnoea	20.0% 2/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Skin and subcutaneous tissue disorders Itching scar	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	20.0% 2/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Skin and subcutaneous tissue disorders Rash macular	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Skin and subcutaneous tissue disorders Sensitive skin	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Skin and subcutaneous tissue disorders Skin lesion	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Skin and subcutaneous tissue disorders Solar dermatitis	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Vascular disorders Hypertension	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.
Vascular disorders Hypotension	10.0% 1/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.	0.00% 0/10 • All-cause mortality was assessed from first dose to approximately 300 days following last dose. Serious adverse events and non-serious adverse events above 5% were assessed from first dose to 100 days following last dose.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: Clinical.Trials@bms.com

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