A Study to Compare Nivolumab Administered Subcutaneously... | NCT05297565

ID	Type	Description	Link
2021-003208-42	EudraCT Number
U1111-1266-6116	Registry Identifier	WHO

Status Module

Label	Type	Description	Intervention Names
Arm A: Subcutaneous Nivolumab	Experimental		Biological: Nivolumab/rHuPH20
Arm B: Intravenous Nivolumab	Active Comparator		Biological: Nivolumab

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab/rHuPH20	Biological	Specified dose on specified days	Arm A: Subcutaneous Nivolumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events	An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.	From first dose to 100 days post last dose (Approximately up to 14 Months)
Number of Participants With Serious Adverse Events	A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: Results in death. Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe). Requires inpatient hospitalization or causes prolongation of existing hospitalization.	From first dose to 100 days post last dose (Approximately up to 14 Months)
Number of Participants With Treatment Related Adverse Events	An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom or disease.	From first dose to 100 days post last dose (Approximately up to 14 Months)
Number of Participants With Treatment Related Serious Adverse Events	A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: Results in death. Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe). Requires inpatient hospitalization or causes prolongation of existing hospitalization.

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0004		Fort Wayne	Indiana	46804	United States
Local Institution - 0044

Label	URL
BMS Clinical Trial Information	View source
FDA Safety Alerts and Recalls	View source
BMS Clinical Trial Patient Recruiting

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Arm A	Nivo SC (BMS-986298) 600 mg with 8,000 U of rHuPH20 administered via 2 sequential injections Q2W. Nivo SC will be administered in-clinic through cycle 5, Day 1.
FG001	Arm B

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	May 25, 2023

ID	Title	Description
BG000	Arm A	Nivo SC (BMS-986298) 600 mg with 8,000 U of rHuPH20 administered via 2 sequential injections Q2W. Nivo SC will be administered in-clinic through cycle 5, Day 1.
BG001	Arm B	Nivo IV (BMS-936558) 240 mg Q2W for Cycles 1 through 4. Nivo IV 480 mg Q4W Cycle 5 onwards for up to total of 52 weeks. All dosing will be performed in-clinic.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0006 BG0018 BG00214

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 With Adverse Events

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.

An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.

All Treated Participants

Posted

Number

Participants

From first dose to 100 days post last dose (Approximately up to 14 Months)

ID	Title	Description
OG000	Arm A	Nivo SC (BMS-986298) 600 mg with 8,000 U of rHuPH20 administered via 2 sequential injections Q2W. Nivo SC will be administered in-clinic through cycle 5, Day 1.
OG001	Arm B	Nivo IV (BMS-936558) 240 mg Q2W for Cycles 1 through 4. Nivo IV 480 mg Q4W Cycle 5 onwards for up to total of 52 weeks. All dosing will be performed in-clinic.

Units	Counts
Participants	OG0006 OG0018

Title

Denominators

Categories

Any Grade

Title	Measurements
	OG0006 OG0018

Grade 3 to 4

Title	Measurements
	OG000

Primary

Number of Participants With Serious Adverse Events

A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:

Results in death.
Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe).
Requires inpatient hospitalization or causes prolongation of existing hospitalization.

All Treated Participants

Posted

Number

Participants

From first dose to 100 days post last dose (Approximately up to 14 Months)

ID	Title	Description
OG000	Arm A	Nivo SC (BMS-986298) 600 mg with 8,000 U of rHuPH20 administered via 2 sequential injections Q2W. Nivo SC will be administered in-clinic through cycle 5, Day 1.
OG001	Arm B	Nivo IV (BMS-936558) 240 mg Q2W for Cycles 1 through 4. Nivo IV 480 mg Q4W Cycle 5 onwards for up to total of 52 weeks. All dosing will be performed in-clinic.

Units	Counts
Participants

Primary

Number of Participants With Treatment Related Adverse Events

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment.

An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom or disease.

All Treated Participants

Posted

Number

Participants

From first dose to 100 days post last dose (Approximately up to 14 Months)

ID	Title	Description
OG000	Arm A	Nivo SC (BMS-986298) 600 mg with 8,000 U of rHuPH20 administered via 2 sequential injections Q2W. Nivo SC will be administered in-clinic through cycle 5, Day 1.
OG001	Arm B	Nivo IV (BMS-936558) 240 mg Q2W for Cycles 1 through 4. Nivo IV 480 mg Q4W Cycle 5 onwards for up to total of 52 weeks. All dosing will be performed in-clinic.

Units	Counts
Participants	OG000

Primary

Number of Participants With Treatment Related Serious Adverse Events

A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:

Results in death.
Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe).
Requires inpatient hospitalization or causes prolongation of existing hospitalization.

All Treated Participants

Posted

Number

Participants

From first dose to 100 days post last dose (Approximately up to 14 Months)

ID	Title	Description
OG000	Arm A	Nivo SC (BMS-986298) 600 mg with 8,000 U of rHuPH20 administered via 2 sequential injections Q2W. Nivo SC will be administered in-clinic through cycle 5, Day 1.
OG001	Arm B	Nivo IV (BMS-936558) 240 mg Q2W for Cycles 1 through 4. Nivo IV 480 mg Q4W Cycle 5 onwards for up to total of 52 weeks. All dosing will be performed in-clinic.

Units	Counts
Participants

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Hypothyroidism	Endocrine disorders	26.1	Systematic Assessment	EG0001 affected6 at risk EG0011 affected8 at risk
Abdominal discomfort	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Colitis	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Diarrhoea	Gastrointestinal disorders	26.1	Systematic Assessment	EG0003 affected6 at risk EG0011 affected8 at risk
Dry mouth	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected6 at risk EG0012 affected8 at risk
Dyspepsia	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Gastrointestinal toxicity	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Nausea	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected6 at risk EG0011 affected8 at risk
Tongue pruritus	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Administration site reaction	General disorders	26.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Asthenia	General disorders	26.1	Systematic Assessment	EG0004 affected6 at risk EG0011 affected8 at risk
Device related thrombosis	General disorders	26.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Fatigue	General disorders	26.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Impaired healing	General disorders	26.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Injection site pain	General disorders	26.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Mucosal inflammation	General disorders	26.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Puncture site erythema	General disorders	26.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Puncture site inflammation	General disorders	26.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Puncture site pain	General disorders	26.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Puncture site pruritus	General disorders	26.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Pyrexia	General disorders	26.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Anal abscess	Infections and infestations	26.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Body tinea	Infections and infestations	26.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Bronchiolitis	Infections and infestations	26.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
COVID-19	Infections and infestations	26.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Conjunctivitis	Infections and infestations	26.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Diverticulitis	Infections and infestations	26.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Gastrointestinal viral infection	Infections and infestations	26.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Influenza	Infections and infestations	26.1	Systematic Assessment	EG0001 affected6 at risk EG0012 affected8 at risk
Nasopharyngitis	Infections and infestations	26.1	Systematic Assessment	EG0002 affected6 at risk EG0011 affected8 at risk
Oral herpes	Infections and infestations	26.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Sinusitis	Infections and infestations	26.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Urinary tract infection	Infections and infestations	26.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Multiple injuries	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Skin laceration	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Blood bilirubin increased	Investigations	26.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Blood glucose increased	Investigations	26.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Haemoglobin decreased	Investigations	26.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Lipase increased	Investigations	26.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Platelet count decreased	Investigations	26.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Dehydration	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Hypokalaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0001 affected6 at risk EG0011 affected8 at risk
Groin pain	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Muscle contracture	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Dizziness	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected6 at risk EG0011 affected8 at risk
Headache	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected6 at risk EG0011 affected8 at risk
Anxiety	Psychiatric disorders	26.1	Systematic Assessment	EG0000 affected6 at risk EG0013 affected8 at risk
Insomnia	Psychiatric disorders	26.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Renal colic	Renal and urinary disorders	26.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Menstrual disorder	Reproductive system and breast disorders	26.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Catarrh	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Cough	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0003 affected6 at risk EG0011 affected8 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Drug eruption	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Eczema nummular	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Erythema	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0001 affected6 at risk EG0011 affected8 at risk
Pruritus	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0002 affected6 at risk EG0012 affected8 at risk
Rash	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0000 affected6 at risk EG0012 affected8 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0000 affected6 at risk EG0012 affected8 at risk
Hypertension	Vascular disorders	26.1	Systematic Assessment	EG0000 affected6 at risk EG0014 affected8 at risk
Lymphoedema	Vascular disorders	26.1	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 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	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm A	Nivo SC (BMS-986298) 600 mg with 8,000 U of rHuPH20 administered via 2 sequential injections Q2W. Nivo SC will be administered in-clinic through cycle 5, Day 1.	0	6	0	6	6	6
EG001	Arm B	Nivo IV (BMS-936558) 240 mg Q2W for Cycles 1 through 4. Nivo IV 480 mg Q4W Cycle 5 onwards for up to total of 52 weeks. All dosing will be performed in-clinic.	0	8	0	8	8	8