An Investigational Immuno-therapy Study of BMS-986205 Com... | NCT03329846

NCT03329846

ID	Type	Description	Link
2017-002499-14	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nivolumab + Placebo	Active Comparator	Specified dose on specified day Participants will no longer receive BMS-986205 Placebo	Biological: Nivolumab Drug: Placebo
Nivolumab + BMS-986205	Experimental	Specified dose on specified day. Participants have the option to discontinue BMS-986205, and continue nivolumab monotherapy, at investigator discretion	Drug: BMS-986205 Biological: Nivolumab

Name	Type	Description	Arm Group Labels	Other Names
BMS-986205	Drug	specified dose on specified day	Nivolumab + BMS-986205

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Experiencing Adverse Events	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	From first dose to 30 days following last dose (up to approximately 25 months)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Angeles Clinic and Research Institute		Los Angeles	California	90025	United States
University Of Colorado

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source
Investigator Inquiry Form

Results Section

Participant Flow Module

ID	Title	Description
FG000	Nivolumab + BMS-986205	Nivolumab 480 mg IV Q4W + BMS-986205 100 mg PO QD
FG001	Nivolumab	Nivolumab 480 mg IV Q4W

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 25, 2018	Jun 18, 2021

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0004 BG0014 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0011 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants Experiencing Adverse Events

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

All treated participants

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Nivolumab + BMS-986205	Nivolumab 480 mg IV Q4W + BMS-986205 100 mg PO QD
OG001	Nivolumab	Nivolumab 480 mg IV Q4W

Units	Counts
Participants	OG00010 OG00110

Title

Denominators

Categories

Deaths

Title	Measurements
	OG0000 OG0010

Any cause SAEs (any grade)

Title	Measurements
	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Nivolumab + BMS-986205	Nivolumab 480 mg IV Q4W + BMS-986205 100 mg PO QD	1	10	4	10	10	10
EG001	Nivolumab	Nivolumab 480 mg IV Q4W	3	10	4	10	9	10

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk
Pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected10 at risk
Renal failure	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Ear pain	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk
Hypothyroidism	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Thyroiditis	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Dry eye	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Ocular discomfort	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk
Vitreous floaters	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk
Constipation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected10 at risk EG0011 affected10 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0012 affected10 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected10 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected10 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0005 affected10 at risk EG0014 affected10 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0012 affected10 at risk
Asthenia	General disorders	MedDRA 23.0	Systematic Assessment	EG0005 affected10 at risk EG0012 affected10 at risk
Chest discomfort	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Fatigue	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected10 at risk EG0012 affected10 at risk
Influenza like illness	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected10 at risk EG0011 affected10 at risk
Mucosal inflammation	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected10 at risk
Pain	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Pyrexia	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Hypersensitivity	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk
Conjunctivitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Herpes zoster	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0012 affected10 at risk
Nasopharyngitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected10 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0012 affected10 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Radiation injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Amylase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Blood bilirubin increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
C-reactive protein increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk
Lipase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Transaminases increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected10 at risk EG0012 affected10 at risk
Polydipsia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected10 at risk EG0010 affected10 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected10 at risk EG0013 affected10 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected10 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0012 affected10 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk
Dysgeusia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected10 at risk
Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0012 affected10 at risk
Lethargy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Neuralgia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Paraesthesia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Presyncope	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Tremor	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Anxiety	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Depressed mood	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Breast pain	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Pruritus genital	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0012 affected10 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected10 at risk EG0010 affected10 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected10 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk
Itching scar	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0012 affected10 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk
Sensitive skin	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Solar dermatitis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk
Hypertension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk
Hypotension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk

ID	Term
D008545	Melanoma
D012878	Skin Neoplasms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009380	Neoplasms, Nerve Tissue
D018326	Nevi and Melanomas
D009371	Neoplasms by Site
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	Nivolumab + BMS-986205	Nivolumab 480 mg IV Q4W + BMS-986205 100 mg PO QD
BG001	Nivolumab	Nivolumab 480 mg IV Q4W
BG002	Total	Total of all reporting groups