A Study of REGN2810 and Ipilimumab in Patients With Lung... | NCT03430063

NCT03430063

ID	Type	Description	Link
2017-003684-35	EudraCT Number

Status Module

Sponsor/Collaborators Module

Name	Class
Sanofi	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Intervention Names
SDREGN2810	Experimental	Drug: SDREGN2810
SDREGN2810/ipi	Experimental	Drug: SDREGN2810/ipi
HDREGN2810	Experimental	Drug: HDREGN2810

Name	Type	Description	Arm Group Labels	Other Names
SDREGN2810	Drug	Standard dose intravenous (IV) infusion	SDREGN2810

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective Response Rate (ORR) in Participants Whose Tumors Express Programmed Cell Death Ligand 1 (PD-L1) in <50% of Tumor Cells	ORR was 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 participants in the efficacy analysis set. BOR was defined as the best response recorded, as determined by a blinded Independent Review Committee (IRC) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) between the date of randomization and the date of the first objectively documented progression or the date of subsequent anti-cancer therapy, whichever came first. CR was defined as the disappearance of all target lesions (Any pathological lymph nodes [whether target or non-target] must have reduction in short axis to <10 mm [<1 cm]). PR was defined as having at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.	From date of randomization up to 41 months

Secondary Outcomes

Measure	Description	Time Frame
Overall Response Rate	Overall Response Rate was 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 participants in the efficacy analysis set. BOR was defined as the best response recorded, as determined by a blinded Independent Review Committee (IRC) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) between the date of randomization and the date of the first objectively documented progression or the date of subsequent anti-cancer therapy, whichever came first. CR was defined as the disappearance of all target lesions (Any pathological lymph nodes [whether target or non-target] must have reduction in short axis to <10 mm [<1 cm]). PR was defined as having at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Clinical Trial Management	Regeneron Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Regeneron Research Site		Phoenix	Arizona	85054	United States
Regeneron Research Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cemiplimab 350 mg Q3W	Participants received 350 mg of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
FG001	Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

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	May 1, 2018	Oct 10, 2022

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Safety analysis set (SAF) included all randomized participants who received any study drug; it is based on the treatment received (as treated).

Arm/Group Information

ID	Title	Description
BG000	Cemiplimab 350 mg Q3W	Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
BG001	Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W	Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks followed by ipilimumab 50 mg flat dose administered IV on Day 1 of every other treatment cycle (every 42 days or every 6 weeks [Q6W]) for up to 4 doses or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
BG002	Cemiplimab 1050 mg Q3W	Participants received 1050 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00062.4± 7.91 BG00168.5± 8.72 BG00268.1± 12.08 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0002 BG0014 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Number of Participants with PD-L1 Tumor Expression Levels of ≥50% of Tumor Cells

Number of participants with programmed death-ligand 1 (PD-L1) tumor expression levels of ≥50% of tumor cells is reported

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG0000 BG0010

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

Objective Response Rate (ORR) in Participants Whose Tumors Express Programmed Cell Death Ligand 1 (PD-L1) in <50% of Tumor Cells

ORR was 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 participants in the efficacy analysis set. BOR was defined as the best response recorded, as determined by a blinded Independent Review Committee (IRC) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) between the date of randomization and the date of the first objectively documented progression or the date of subsequent anti-cancer therapy, whichever came first. CR was defined as the disappearance of all target lesions (Any pathological lymph nodes [whether target or non-target] must have reduction in short axis to <10 mm [<1 cm]). PR was defined as having at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

SAF included all randomized participants who received any study drug; it is based on the treatment received (as treated).

Posted

Number

95% Confidence Interval

Percentage of participants

From date of randomization up to 41 months

ID	Title	Description
OG000	Cemiplimab 350 mg Q3W	Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
OG001	Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W	Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks followed by ipilimumab 50 mg flat dose administered IV on Day 1 of every other treatment cycle (every 42 days or every 6 weeks [Q6W]) for up to 4 doses or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
OG002	Cemiplimab 1050 mg Q3W	Participants received 1050 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.

Units	Counts
Participants	OG0008 OG00111 OG0028

Title

Denominators

Categories

Title	Measurements
	OG0000(0.0 to 36.9) OG00145.5(16.7 to 76.6) OG0020(0.0 to 36.9)

Secondary

Overall Response Rate

Overall Response Rate was 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 participants in the efficacy analysis set. BOR was defined as the best response recorded, as determined by a blinded Independent Review Committee (IRC) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) between the date of randomization and the date of the first objectively documented progression or the date of subsequent anti-cancer therapy, whichever came first. CR was defined as the disappearance of all target lesions (Any pathological lymph nodes [whether target or non-target] must have reduction in short axis to <10 mm [<1 cm]). PR was defined as having at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

SAF included all randomized participants who received any study drug; it is based on the treatment received (as treated).

Posted

Number

Percentage of participants

From date of randomization up to 41 months

ID	Title	Description
OG000	Cemiplimab 350 mg Q3W	Participants received 350 mg of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
OG001	Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W

Secondary

Overall Survival (OS) in Participants With Tumor PD-L1 Expression Levels <50% of Tumor Cells

OS was defined as the time from randomization to the date of death due to any cause. A participant who lost to follow-up was censored at the last date that the participant was known to be alive. OS was measured using Kaplan-Meier method.

SAF included all randomized participants who received any study drug; it is based on the treatment received (as treated).

Posted

Median

95% Confidence Interval

Months

Time from randomization to the date of death (up to 41 months)

ID	Title	Description
OG000	Cemiplimab 350 mg Q3W	Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
OG001	Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W	Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks followed by ipilimumab 50 mg flat dose administered IV on Day 1 of every other treatment cycle (every 42 days or every 6 weeks [Q6W]) for up to 4 doses or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
OG002	Cemiplimab 1050 mg Q3W

Secondary

Progression Free Survival (PFS) in Participants With Tumor PD-L1 Expression Levels <50% of Tumor Cells

PFS was defined as the time from randomization to the date of the first documented tumor progression, as determined by the IRC (based on RECIST 1.1 assessments) or death due to any cause, whichever occurred earlier. PFS was measured using Kaplan-Meier method.

SAF included all randomized participants who received any study drug; it is based on the treatment received (as treated).

Posted

Median

95% Confidence Interval

Months

Time from randomization up to the date of the first documented tumor progression or death (up to 41 months)

ID	Title	Description
OG000	Cemiplimab 350 mg Q3W	Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
OG001	Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W	Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks followed by ipilimumab 50 mg flat dose administered IV on Day 1 of every other treatment cycle (every 42 days or every 6 weeks [Q6W]) for up to 4 doses or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
OG002

Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Resulting in Death

Adverse event (AE): any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after the treatment start date. TEAEs included both serious and non-serious TEAEs. Number of participants with TEAEs, Serious TEAEs and TEAEs leading to death were reported.

SAF included all randomized participants who received any study drug; it is based on the treatment received (as treated).

Posted

Count of Participants

Participants

Up to 41 months

ID	Title	Description
OG000	Cemiplimab 350 mg Q3W	Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
OG001	Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W	Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks followed by ipilimumab 50 mg flat dose administered IV on Day 1 of every other treatment cycle (every 42 days or every 6 weeks [Q6W]) for up to 4 doses or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.

Secondary

Number of Participants With Laboratory Test Abnormalities of Grade 2 or Higher Severity Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grading System

The laboratory measurements included hematology, chemistry, electrolytes and liver function. NCI-CTCAE was graded according to the following scale: Grade 1 (Mild): Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 (Moderate): Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL); Grade 3 (Severe): Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL; Grade 4 (Life-threatening): Life-threatening consequences; urgent intervention indicated; Grade 5 (Death): Death related to AE.

SAF included all randomized participants who received any study drug; it is based on the treatment received (as treated).

Posted

Count of Participants

Participants

Up to 41 months

ID	Title	Description
OG000	Cemiplimab 350 mg Q3W	Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.
OG001	Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W

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	Cemiplimab 350 mg Q3W	Participants received 350 mg of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.	3	8	1	8	7	8
EG001	Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W	Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks followed by ipilimumab 50 mg flat dose administered IV on Day 1 of every other treatment cycle (every 42 days or every 6 weeks [Q6W]) for up to 4 doses or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.	3	11	7	11	11	11
EG002	Cemiplimab 1050 mg Q3W	Participants received 1050 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.	4	8	4	8	8	8

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0014 events3 affected11 at risk EG0020 events0 affected8 at risk
Urinary tract infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Hypothyroidism	Endocrine disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Alanine aminotransferase increased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Dizziness	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Brain stem embolism	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected11 at risk EG0021 events1 affected8 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected11 at risk EG0021 events1 affected8 at risk
Hemiparesis	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected11 at risk EG0021 events1 affected8 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Bradypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected11 at risk EG0021 events1 affected8 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected11 at risk EG0021 events1 affected8 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected11 at risk EG0021 events1 affected8 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected11 at risk EG0021 events1 affected8 at risk
Angina unstable	Cardiac disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected11 at risk EG0021 events1 affected8 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected11 at risk EG0020 events0 affected8 at risk
Cyanosis	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected11 at risk EG0021 events1 affected8 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hypothyroidism	Endocrine disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0013 events3 affected11 at risk EG0020 events0 affected8 at risk
Hyperthyroidism	Endocrine disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0012 events2 affected11 at risk EG0022 events2 affected8 at risk
Hypophysitis	Endocrine disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0002 events2 affected8 at risk EG0013 events3 affected11 at risk EG0021 events1 affected8 at risk
Constipation	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0003 events3 affected8 at risk EG0015 events2 affected11 at risk EG0021 events1 affected8 at risk
Nausea	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0002 events2 affected8 at risk EG0012 events2 affected11 at risk EG0021 events1 affected8 at risk
Vomiting	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0003 events3 affected8 at risk EG0012 events2 affected11 at risk EG0020 events0 affected8 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Dry mouth	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Oral lichen planus	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Oral lichenoid reaction	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0012 events1 affected11 at risk EG0020 events0 affected8 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0003 events1 affected8 at risk EG0010 events0 affected11 at risk EG0020 events0 affected8 at risk
Pneumonia	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0013 events3 affected11 at risk EG0020 events0 affected8 at risk
Conjunctivitis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Nasopharyngitis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0021 events1 affected8 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Respiratory tract infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0012 events1 affected11 at risk EG0020 events0 affected8 at risk
Urinary tract infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Cellulitis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected11 at risk EG0021 events1 affected8 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected11 at risk EG0021 events1 affected8 at risk
Rhinitis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected11 at risk EG0021 events1 affected8 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0002 events1 affected8 at risk EG0013 events3 affected11 at risk EG0020 events0 affected8 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0001 events1 affected8 at risk EG0013 events3 affected11 at risk EG0021 events1 affected8 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0012 events2 affected11 at risk EG0020 events0 affected8 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0001 events1 affected8 at risk EG0012 events2 affected11 at risk EG0020 events0 affected8 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0012 events1 affected11 at risk EG0020 events0 affected8 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected11 at risk EG0020 events0 affected8 at risk
Fasciitis	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected11 at risk EG0020 events0 affected8 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected11 at risk EG0020 events0 affected8 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0002 events2 affected8 at risk EG0014 events3 affected11 at risk EG0022 events2 affected8 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0012 events2 affected11 at risk EG0020 events0 affected8 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0012 events2 affected11 at risk EG0021 events1 affected8 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0021 events1 affected8 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected11 at risk EG0025 events2 affected8 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected11 at risk EG0021 events1 affected8 at risk
Headache	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0001 events1 affected8 at risk EG0014 events2 affected11 at risk EG0020 events0 affected8 at risk
Dizziness	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0012 events1 affected11 at risk EG0020 events0 affected8 at risk
Dysarthria	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0001 events1 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Dysgeusia	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Presyncope	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Cauda equina syndrome	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected11 at risk EG0021 events1 affected8 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected11 at risk EG0021 events1 affected8 at risk
Insomnia	Psychiatric disorders	MedDRA (24.1)	Systematic Assessment	EG0001 events1 affected8 at risk EG0012 events2 affected11 at risk EG0020 events0 affected8 at risk
Nervousness	Psychiatric disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0013 events2 affected11 at risk EG0020 events0 affected8 at risk
Anxiety	Psychiatric disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0002 events1 affected8 at risk EG0013 events3 affected11 at risk EG0021 events1 affected8 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0012 events2 affected11 at risk EG0020 events0 affected8 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0021 events1 affected8 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Lichen planus	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0012 events1 affected11 at risk EG0020 events0 affected8 at risk
Skin odour abnormal	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Umbilical erythema	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Cataract	Eye disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Eyelid ptosis	Eye disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Vision blurred	Eye disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Mucosal inflammation	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0015 events3 affected11 at risk EG0020 events0 affected8 at risk
Asthenia	General disorders	MedDRA (24.1)	Systematic Assessment	EG0002 events2 affected8 at risk EG0015 events2 affected11 at risk EG0020 events0 affected8 at risk
Non-cardiac chest pain	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0012 events1 affected11 at risk EG0021 events1 affected8 at risk
Pain	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Fatigue	General disorders	MedDRA (24.1)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected11 at risk EG0022 events2 affected8 at risk
Infusion site extravasation	General disorders	MedDRA (24.1)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected11 at risk EG0020 events0 affected8 at risk
Oedema	General disorders	MedDRA (24.1)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected11 at risk EG0020 events0 affected8 at risk
Oedema peripheral	General disorders	MedDRA (24.1)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected11 at risk EG0020 events0 affected8 at risk
Pyrexia	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected11 at risk EG0021 events1 affected8 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Alanine aminotransferase increased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0012 events2 affected11 at risk EG0021 events1 affected8 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0021 events1 affected8 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Blood lactic acid increased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Blood thyroid stimulating hormone decreased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Blood thyroid stimulating hormone increased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0001 events1 affected8 at risk EG0011 events1 affected11 at risk EG0021 events1 affected8 at risk
Lipase increased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0021 events1 affected8 at risk
Blood creatinine increased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected11 at risk EG0022 events2 affected8 at risk
Blood urea increased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected11 at risk EG0021 events1 affected8 at risk
Platelet count decreased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected11 at risk EG0020 events0 affected8 at risk
Transaminases increased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected11 at risk EG0020 events0 affected8 at risk
Weight decreased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected11 at risk EG0021 events1 affected8 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0004 events4 affected8 at risk EG0016 events3 affected11 at risk EG0024 events3 affected8 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected11 at risk EG0020 events0 affected8 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected11 at risk EG0021 events1 affected8 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected11 at risk EG0021 events1 affected8 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected11 at risk EG0020 events0 affected8 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected11 at risk EG0021 events1 affected8 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0001 events1 affected8 at risk EG0011 events1 affected11 at risk EG0022 events2 affected8 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected11 at risk EG0020 events0 affected8 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected11 at risk EG0021 events1 affected8 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected11 at risk EG0022 events2 affected8 at risk
Deafness	Ear and labyrinth disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Ear pain	Ear and labyrinth disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Vestibular disorder	Ear and labyrinth disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Contrast media reaction	Immune system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Pruritus genital	Reproductive system and breast disorders	MedDRA (24.1)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected11 at risk EG0020 events0 affected8 at risk
Palpitations	Cardiac disorders	MedDRA (24.1)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected11 at risk EG0020 events0 affected8 at risk
Lymphoedema	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected11 at risk EG0020 events0 affected8 at risk

All participants' tumors had PD-L1 expression levels of <50% at baseline. Therefore, the results do not present efficacy for participants with PD-L1 expression levels of ≥50% of tumor cells versus all participants.

Certain Agreements

ID	Term
C000627974	cemiplimab
D000074324	Ipilimumab

Ancestor Terms

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

Participants received 350 mg of cemiplimab IV infusion on Day 1 of Q3W for up to 108 weeks followed by ipilimumab 50 mg flat dose administered IV on Day 1 of every other treatment cycle (every 42 days or every 6 weeks [Q6W]) for up to 4 doses or until progression of disease or unacceptable toxicity, withdrawal of consent, death, initiation of another anti-cancer treatment.