A Study of Nivolumab in Combination With Ipilimumab in Ch... | NCT03195478

Label	Type	Intervention Names
Nivo/Ipi Combination Therapy A	Experimental	Drug: Nivolumab Drug: Ipilimumab
Nivo/Ipi Combination Therapy B	Experimental	Drug: Nivolumab Drug: Ipilimumab
Nivo/Ipi Combination Therapy C	Experimental	Drug: Nivolumab Drug: Ipilimumab
Nivo/Ipi Combination Arm D	Experimental	Drug: Nivolumab Drug: Ipilimumab

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Drug	Specified dose on specified days	Nivo/Ipi Combination Arm D Nivo/Ipi Combination Therapy A Nivo/Ipi Combination Therapy B

Measure	Description	Time Frame
Number of Participants With Adverse Events (AEs) in Part 1.	Number of participants with Adverse events	From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)
Number of Participants With Serious Adverse Events (SAEs) in Part 1.	Number of participants with Adverse events	From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)
Number of Participants With Adverse Events Leading to Discontinuation in Part 1.	Number of participants with Adverse events	From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)
Number of Participants With Adverse Events Leading to Death in Part 1.	Number of participants with Adverse Events leading to death.	From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)
Number of Participants With Clinical Laboratory Abnormalities in Part 1.	Number of participants with clinical laboratory abnormalities.	From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)
BICR-Assessed ORR in Part 2	ORR is defined as the number of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) assessed by BICR, according to RECIST v1.1 criteria, divided by the number of treated subjects. The BOR is defined as the best response designation recorded between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. For purposes of analysis, if a subject receives one dose and discontinues the study without assessment or receives subsequent therapy prior to assessment, this participant will be counted in the denominator (as nonrespondent).

Measure	Description	Time Frame
Cmax - Maximum Observed Serum Concentration in Part 1.	Cmax - Maximum observed serum concentration in Part 1.	At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
Tmax - Time of Maximum Observed Serum Concentration in Part 1.

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

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0015		Beijing	Beijing Municipality	100021	China
Local Institution - 0001

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source

ID	Title	Description
FG000	Part 1: Arm A	NIVO 3 mg/kg Q2 + IPI 1 mg/kg Q6
FG001	Part 1: Arm B	NIVO 3 mg/kg Q3 + IPI 1 mg/kg Q3

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	Aug 22, 2022

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 (AEs) in Part 1.

Number of participants with Adverse events

All treated participants in Part 1

Posted

Count of Participants

Participants

From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)

ID	Title	Description
OG000	Part 1: Arm A	NIVO 3 mg/kg Q2 + IPI 1 mg/kg Q6
OG001	Part 1: Arm B	NIVO 3 mg/kg Q3 + IPI 1 mg/kg Q3
OG002	Part 1: Arm C	NIVO 1 mg/kg Q3 + IPI 3 mg/kg Q3

Units	Counts
Participants	OG0009 OG0019 OG0029

Title

Denominators

Categories

Title	Measurements
	OG0007 OG0019 OG0029

Primary

Number of Participants With Serious Adverse Events (SAEs) in Part 1.

Number of participants with Adverse events

All treated participants in Part 1

Posted

Count of Participants

Participants

From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)

ID	Title	Description
OG000	Part 1: Arm A	NIVO 3 mg/kg Q2 + IPI 1 mg/kg Q6
OG001	Part 1: Arm B	NIVO 3 mg/kg Q3 + IPI 1mg/kg Q3
OG002	Part 1: Arm C	NIVO 1 mg/kg Q3 + IPI 3 mg/kg Q3

Units	Counts
Participants	OG000

Primary

Number of Participants With Adverse Events Leading to Discontinuation in Part 1.

Number of participants with Adverse events

All treated participants in Part 1

Posted

Count of Participants

Participants

From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)

ID	Title	Description
OG000	Part 1: Arm A	NIVO 3 mg/kg Q2 + IPI 1 mg/kg Q6
OG001	Part 1: Arm B	NIVO 3 mg/kg Q3 + IPI 1mg/kg Q3
OG002	Part 1: Arm C	NIVO 1 mg/kg Q3 + IPI 3 mg/kg Q3

Units	Counts
Participants	OG000

Primary

Number of Participants With Adverse Events Leading to Death in Part 1.

Number of participants with Adverse Events leading to death.

All treated participants in Part 1

Posted

Count of Participants

Participants

From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)

ID	Title	Description
OG000	Part 1: Arm A	NIVO 3 mg/kg Q2 + IPI 1 mg/kg Q6
OG001	Part 1: Arm B	NIVO 3 mg/kg Q3 + IPI 1mg/kg Q3
OG002	Part 1: Arm C	NIVO 1 mg/kg Q3 + IPI 3 mg/kg Q3

Units	Counts
Participants	OG000

Primary

Number of Participants With Clinical Laboratory Abnormalities in Part 1.

Number of participants with clinical laboratory abnormalities.

All treated participants in Part 1

Posted

Count of Participants

Participants

From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)

ID	Title	Description
OG000	Part 1: Arm A	NIVO 3 mg/kg Q2 + IPI 1 mg/kg Q6
OG001	Part 1: Arm B	NIVO 3 mg/kg Q3 + IPI 1mg/kg Q3
OG002	Part 1: Arm C	NIVO 1 mg/kg Q3 + IPI 3 mg/kg Q3

Units	Counts
Participants	OG000

Primary

BICR-Assessed ORR in Part 2

ORR is defined as the number of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) assessed by BICR, according to RECIST v1.1 criteria, divided by the number of treated subjects.

The BOR is defined as the best response designation recorded between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. For purposes of analysis, if a subject receives one dose and discontinues the study without assessment or receives subsequent therapy prior to assessment, this participant will be counted in the denominator (as nonrespondent).

All treated participants in Part 2

Posted

Number

95% Confidence Interval

Percentage of Participants

between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first as assessed by BICR. (Approximately on average 3.21 Months)

ID	Title	Description
OG000	Part 2: Arm D	NIVO 3 mg/kg Q3 + IPI 1mg/kg Q3

Units	Counts
Participants

Secondary

Cmax - Maximum Observed Serum Concentration in Part 1.

Cmax - Maximum observed serum concentration in Part 1.

PK Evaluable Population in Part 1

Posted

Geometric Mean

Geometric Coefficient of Variation

ug/mL

At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

ID	Title	Description
OG000	Part 1: Arm A	NIVO 3 mg/kg Q2 + IPI 1 mg/kg Q6
OG001	Part 1: Arm B	NIVO 3 mg/kg Q3 + IPI 1 mg/kg Q3
OG002	Part 1: Arm C	NIVO 1 mg/kg Q3 + IPI 3 mg/kg Q3

Units	Counts
Participants	OG000

Secondary

Tmax - Time of Maximum Observed Serum Concentration in Part 1.

Tmax - Time of maximum observed serum concentration in Part 1.

PK Evaluable Population in Part 1

Posted

Median

Full Range

Hours

At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

ID	Title	Description
OG000	Part 1: Arm A	NIVO 3 mg/kg Q2 + IPI 1 mg/kg Q6
OG001	Part 1: Arm B	NIVO 3 mg/kg Q3 + IPI 1 mg/kg Q3
OG002	Part 1: Arm C	NIVO 1 mg/kg Q3 + IPI 3 mg/kg Q3

Units	Counts
Participants	OG000

Secondary

AUC(0-T) - Area Under the Plasma Concentration-time Curve in Part 1.

AUC(0-T) - Area under the plasma concentration-time curve from time zero to the last time of the last quantifiable concentration. in Part 1.

PK Evaluable Population in Part 1

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ug/mL

At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

ID	Title	Description
OG000	Part 1: Arm A	NIVO 3 mg/kg Q2 + IPI 1 mg/kg Q6
OG001	Part 1: Arm B	NIVO 3 mg/kg Q3 + IPI 1 mg/kg Q3
OG002	Part 1: Arm C	NIVO 1 mg/kg Q3 + IPI 3 mg/kg Q3

Units	Counts
Participants	OG000

Secondary

AUC(TAU) - Area Under the Concentration-time Curve in One Dosing Interval in Part 1.

AUC(TAU) - Area under the concentration-time curve in one dosing interval in Part 1.

PK Evaluable Population in Part 1. Inadequate PK Sampling for arm A ipilimumab treatment, so no data was collected

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ug/mL

At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

ID	Title	Description
OG000	Part 1: Arm A	NIVO 3 mg/kg Q2 + IPI 1 mg/kg Q6
OG001	Part 1: Arm B	NIVO 3 mg/kg Q3 + IPI 1 mg/kg Q3
OG002	Part 1: Arm C	NIVO 1 mg/kg Q3 + IPI 3 mg/kg Q3

Units	Counts
Participants

Secondary

Ceoinf - Serum Concentration Achieved at the End of Study Drug Infusion in Part 1.

Ceoinf - Serum concentration achieved at the end of study drug infusion in Part 1.

PK Evaluable Population in Part 1

Posted

Geometric Mean

Geometric Coefficient of Variation

ug/mL

At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

ID	Title	Description
OG000	Part 1: Arm A	NIVO 3 mg/kg Q2 + IPI 1 mg/kg Q6
OG001	Part 1: Arm B	NIVO 3 mg/kg Q3 + IPI 1 mg/kg Q3
OG002	Part 1: Arm C	NIVO 1 mg/kg Q3 + IPI 3 mg/kg Q3

Units	Counts
Participants	OG000

Secondary

Ctau - Concentration at the End of Dosing Interval in Part 1.

Ctau - Concentration at the end of dosing interval in Part 1. The Ctau is equivilant to the CTrough at these time points.

PK Evaluable Population in Part 1

Posted

Geometric Mean

Geometric Coefficient of Variation

ug/mL

At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

ID	Title	Description
OG000	Part 1: Arm A	NIVO 3 mg/kg Q2 + IPI 1 mg/kg Q6
OG001	Part 1: Arm B	NIVO 3 mg/kg Q3 + IPI 1 mg/kg Q3
OG002	Part 1: Arm C	NIVO 1 mg/kg Q3 + IPI 3 mg/kg Q3

Units	Counts
Participants	OG000

Secondary

CLT - Total Body Clearance in Part 1.

CLT - Total body clearance in Part 1.

PK Evaluable Population in Part 1 with CLT data collected, Inadequate PK Sampling for arm A nivo/ipilimumab treatment, so no data was collected

Posted

Geometric Mean

Geometric Coefficient of Variation

mL/h

At Cycle 3 Day 1 for Arm A, Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

ID	Title	Description
OG000	Part 1: Arm A	NIVO 3 mg/kg Q2 + IPI 1 mg/kg Q6
OG001	Part 1: Arm B	NIVO 3 mg/kg Q3 + IPI 1 mg/kg Q3
OG002	Part 1: Arm C	NIVO 1 mg/kg Q3 + IPI 3 mg/kg Q3

Units	Counts
Participants	OG000

Secondary

Css-avg - Average Concentration Over a Dosing Interval (AUC(TAU)/Tau) in Part 1.

Css-avg - Average concentration over a dosing interval (AUC(TAU)/tau) in Part 1.

PK Evaluable Population in Part 1. Inadequate PK Sampling for arm A ipilimumab treatment, so no data was collected

Posted

Geometric Mean

Geometric Coefficient of Variation

ug/mL

At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

ID	Title	Description
OG000	Part 1: Arm A	NIVO 3 mg/kg Q2 + IPI 1 mg/kg Q6
OG001	Part 1: Arm B	NIVO 3 mg/kg Q3 + IPI 1 mg/kg Q3
OG002	Part 1: Arm C	NIVO 1 mg/kg Q3 + IPI 3 mg/kg Q3

Units	Counts
Participants

Secondary

AI - Accumulation Index in Part 1.

AI - Accumulation index; ratio of an exposure measure at steady-state to that after the first dose (exposure measure includes AUC (TAU) in Part 1.

Here SS = Steady State Here FD = First Dose

PK Evaluable Population in Part 1. Inadequate PK Sampling for arm A nivo/ipilimumab treatment, so no data was collected

Posted

Geometric Mean

Geometric Coefficient of Variation

ratio of AUC(Tau) at SS vs FD

At Cycle 3 Day 1 for Arm A, Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

ID	Title	Description
OG000	Part 1: Arm A	NIVO 3 mg/kg Q2 + IPI 1 mg/kg Q6
OG001	Part 1: Arm B	NIVO 3 mg/kg Q3 + IPI 1 mg/kg Q3
OG002	Part 1: Arm C	NIVO 1 mg/kg Q3 + IPI 3 mg/kg Q3

Units	Counts
Participants

Secondary

T-HALFeff - Effective Elimination Half-life in Part 1.

T-HALFeff - Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (exposure measure includes AUC(TAU), Cmax, or Ctau) in Part 1.

PK Evaluable Population in Part 1. Inadequate PK Sampling for arm A nivo/ipilimumab treatment, so no data was collected

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours

At Cycle 3 Day 1 for Arm A, Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

ID	Title	Description
OG000	Part 1: Arm A	NIVO 3 mg/kg Q2 + IPI 1 mg/kg Q6
OG001	Part 1: Arm B	NIVO 3 mg/kg Q3 + IPI 1 mg/kg Q3
OG002	Part 1: Arm C	NIVO 1 mg/kg Q3 + IPI 3 mg/kg Q3

Units	Counts
Participants

Secondary

Number of Participants With Nivolumab Anti Drug Antibodies in Part 1.

Number of participants with nivolumab Anti Drug Antibodies in Part 1.

All Treated Subjects with Baseline and at Least One Post-baseline Evaluable ADA Assessment (Part 1)

Posted

Count of Participants

Participants

At baseline and from first dose to last dose (Approximately on average of Arm A 24.54 weeks, Arm B 76 weeks, Arm C 92.5 Weeks)

ID	Title	Description
OG000	Part 1: Arm A	NIVO 3 mg/kg Q2 + IPI 1 mg/kg Q6
OG001	Part 1: Arm B	NIVO 3 mg/kg Q3 + IPI 1 mg/kg Q3
OG002	Part 1: Arm C	NIVO 1 mg/kg Q3 + IPI 3 mg/kg Q3

Units	Counts
Participants	OG000

Secondary

Number of Participants With Ipilimumab Anti Drug Antibodies in Part 1.

Number of participants with Ipilimumab Anti Drug Antibodies in Part 1.

All Treated Subjects with Baseline and at Least One Post-baseline Evaluable ADA Assessment (Part 1)

Posted

Count of Participants

Participants

At baseline and from first dose to last dose (Approximately on average of Arm A 24.54 weeks, Arm B 76 weeks, Arm C 92.5 Weeks)

ID	Title	Description
OG000	Part 1: Arm A	NIVO 3 mg/kg Q2 + IPI 1 mg/kg Q6
OG001	Part 1: Arm B	NIVO 3 mg/kg Q3 + IPI 1 mg/kg Q3
OG002	Part 1: Arm C	NIVO 1 mg/kg Q3 + IPI 3 mg/kg Q3

Units	Counts
Participants	OG000

Secondary

Investigator-Assessed ORR in Part 2

ORR is defined as the number of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) assessed by Investigator, according to RECIST v1.1 criteria, divided by the number of treated subjects.

All treated participants in Part 2

Posted

Number

95% Confidence Interval

Percentage of Participants

ID	Title	Description
OG000	Part 2: Arm D	NIVO 3 mg/kg Q3 + IPI 1mg/kg Q3

Units	Counts
Participants

Secondary

Investigator-Assessed Disease Control Rate (DCR) in Part 2

The percentage of participants whose BOR is confirmed CR or confirmed PR or stable disease (SD) for at least 12 weeks as per investigator.

All treated participants in Part 2

Posted

Number

95% Confidence Interval

Percentage of Participants

between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 as assessed by the Investigator. (Approximately on average 5 Months)

ID	Title	Description
OG000	Part 2: Arm D	NIVO 3 mg/kg Q3 + IPI 1mg/kg Q3

Units	Counts
Participants	OG000

Secondary

BICR-Assessed Disease Control Rate (DCR) in Part 2

The percentage of participants whose BOR is confirmed CR or confirmed PR or stable disease (SD) for at least 12 weeks as per BICR.

All treated participants in Part 2

Posted

Number

95% Confidence Interval

Percentage of Participants

Approximately 5.92 Months

ID	Title	Description
OG000	Part 2: Arm D	NIVO 3 mg/kg Q3 + IPI 1mg/kg Q3

Units	Counts
Participants	OG0009

Secondary

BICR-Assessed Duration of Response (DOR) in Part 2

The time between the date of first confirmed response to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause, whichever occurs first as per BICR.

All confirmed responders per BICR in Part 2

Posted

Median

95% Confidence Interval

Months

From first dose to 100 days post last dose (approximately 102 weeks)

ID	Title	Description
OG000	Part 2: Arm D	NIVO 3 mg/kg Q3 + IPI 1mg/kg Q3

Units	Counts
Participants	OG0007

Secondary

Investigator-Assessed Duration of Response (DOR) in Part 2

The time between the date of first confirmed response to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause, whichever occurs first as per investigator.

All confirmed responders per investigator in Part 2

Posted

Median

95% Confidence Interval

Months

From first dose to 100 days post last dose (approximately 102 weeks)

ID	Title	Description
OG000	Part 2: Arm D	NIVO 3 mg/kg Q3 + IPI 1mg/kg Q3

Units	Counts
Participants	OG0006

Secondary

BICR-Assessed Progression Free Survival (PFS) in Part 2

The time between the date of first confirmed response to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause, whichever occurs first as per BICR.

All Treated participtants in Part 2

Posted

Median

95% Confidence Interval

Months

From first dose to 100 days post last dose (approximately 102 weeks)

ID	Title	Description
OG000	Part 2: Arm D	NIVO 3 mg/kg Q3 + IPI 1mg/kg Q3

Units	Counts
Participants	OG0009

Secondary

Investigator-Assessed Progression Free Survival (PFS) in Part 2

The time between the date of first confirmed response to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause, whichever occurs first as per investigator.

All Treated participtants in Part 2

Posted

Median

95% Confidence Interval

Months

From first dose to 100 days post last dose (approximately 102 weeks)

ID	Title	Description
OG000	Part 2: Arm D	NIVO 3 mg/kg Q3 + IPI 1mg/kg Q3

Units	Counts
Participants	OG0009

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG0004 affected9 at risk EG0016 affected9 at risk EG0022 affected9 at risk EG0033 affected9 at risk
Leukocytosis	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected9 at risk EG0021 affected9 at risk EG003
Leukopenia	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0014 affected9 at risk EG0020 affected9 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Neutropenia	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0012 affected9 at risk EG0020 affected9 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0022 affected9 at risk EG003
Cardiac failure	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Palpitations	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Sinus bradycardia	Cardiac disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Supraventricular tachycardia	Cardiac disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Autoimmune thyroiditis	Endocrine disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Goitre	Endocrine disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Hyperthyroidism	Endocrine disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0024 affected9 at risk EG003
Hypothyroidism	Endocrine disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0013 affected9 at risk EG0023 affected9 at risk EG003
Thyroiditis subacute	Endocrine disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected9 at risk EG003
Abdominal distension	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0012 affected9 at risk EG0023 affected9 at risk EG003
Abdominal pain	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Constipation	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0012 affected9 at risk EG0022 affected9 at risk EG003
Diarrhoea	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0012 affected9 at risk EG0023 affected9 at risk EG003
Dry mouth	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0021 affected9 at risk EG003
Gastritis erosive	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Gastrointestinal obstruction	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Haematochezia	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected9 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Nausea	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected9 at risk EG0022 affected9 at risk EG003
Toothache	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected9 at risk EG003
Vomiting	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0023 affected9 at risk EG003
Asthenia	General disorders	26.1	Systematic Assessment	EG0002 affected9 at risk EG0012 affected9 at risk EG0023 affected9 at risk EG003
Face oedema	General disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Fatigue	General disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Generalised oedema	General disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Malaise	General disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected9 at risk EG003
Mass	General disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Nodule	General disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Oedema peripheral	General disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Pain	General disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Pyrexia	General disorders	26.1	Systematic Assessment	EG0005 affected9 at risk EG0012 affected9 at risk EG0026 affected9 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Liver injury	Hepatobiliary disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected9 at risk EG003
Bronchitis	Infections and infestations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
COVID-19	Infections and infestations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Gastroenteritis	Infections and infestations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Helicobacter infection	Infections and infestations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Influenza	Infections and infestations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Orchitis	Infections and infestations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Pneumonia	Infections and infestations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Pneumonia fungal	Infections and infestations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Upper respiratory tract infection	Infections and infestations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Face injury	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Neck injury	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Alanine aminotransferase increased	Investigations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0013 affected9 at risk EG0024 affected9 at risk EG003
Amylase increased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Anti-thyroid antibody increased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Aspartate aminotransferase increased	Investigations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0013 affected9 at risk EG0024 affected9 at risk EG003
Bacterial test positive	Investigations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Bilirubin conjugated decreased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected9 at risk EG003
Bilirubin conjugated increased	Investigations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0012 affected9 at risk EG0023 affected9 at risk EG003
Blood albumin decreased	Investigations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Blood alkaline phosphatase increased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Blood bilirubin increased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0012 affected9 at risk EG0022 affected9 at risk EG003
Blood bilirubin unconjugated increased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Blood calcium decreased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected9 at risk EG003
Blood chloride decreased	Investigations	26.1	Systematic Assessment	EG0002 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Blood creatine phosphokinase MB increased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected9 at risk EG003
Blood creatine phosphokinase increased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0013 affected9 at risk EG0024 affected9 at risk EG003
Blood creatinine increased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Blood glucose increased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected9 at risk EG003
Blood lactate dehydrogenase increased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Blood pH increased	Investigations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Blood potassium decreased	Investigations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected9 at risk EG0020 affected9 at risk EG003
Blood sodium decreased	Investigations	26.1	Systematic Assessment	EG0002 affected9 at risk EG0011 affected9 at risk EG0021 affected9 at risk EG003
Blood thyroid stimulating hormone increased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Electrocardiogram QT prolonged	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Gamma-glutamyltransferase increased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Haematocrit decreased	Investigations	26.1	Systematic Assessment	EG0002 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Haemoglobin decreased	Investigations	26.1	Systematic Assessment	EG0002 affected9 at risk EG0010 affected9 at risk EG0022 affected9 at risk EG003
Lipase increased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected9 at risk EG003
Neutrophil count decreased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0013 affected9 at risk EG0020 affected9 at risk EG003
Neutrophil count increased	Investigations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Occult blood positive	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Oxygen saturation decreased	Investigations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
PCO2 increased	Investigations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
PO2 decreased	Investigations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Platelet count decreased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0021 affected9 at risk EG003
Prealbumin decreased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Protein total decreased	Investigations	26.1	Systematic Assessment	EG0002 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Protein urine present	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0012 affected9 at risk EG0021 affected9 at risk EG003
Red blood cell count decreased	Investigations	26.1	Systematic Assessment	EG0003 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Red blood cells urine positive	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0022 affected9 at risk EG003
Thyroid hormones increased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Thyroxine free decreased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Troponin I increased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected9 at risk EG003
Urinary occult blood positive	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Urine output decreased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0022 affected9 at risk EG003
Weight decreased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0024 affected9 at risk EG003
Weight increased	Investigations	26.1	Systematic Assessment	EG0002 affected9 at risk EG0012 affected9 at risk EG0020 affected9 at risk EG003
White blood cell count decreased	Investigations	26.1	Systematic Assessment	EG0000 affected9 at risk EG0012 affected9 at risk EG0020 affected9 at risk EG003
White blood cell count increased	Investigations	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0003 affected9 at risk EG0012 affected9 at risk EG0024 affected9 at risk EG003
Hyperalbuminaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Hypermagnesaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Hypernatraemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Hypochloraemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0002 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Hypoproteinaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0002 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected9 at risk EG0020 affected9 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Dizziness	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0012 affected9 at risk EG0021 affected9 at risk EG003
Essential tremor	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Headache	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected9 at risk EG003
Hypoaesthesia	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Bipolar I disorder	Psychiatric disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Insomnia	Psychiatric disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Chronic kidney disease	Renal and urinary disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Oliguria	Renal and urinary disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected9 at risk EG003
Proteinuria	Renal and urinary disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0014 affected9 at risk EG0021 affected9 at risk EG003
Renal impairment	Renal and urinary disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0003 affected9 at risk EG0010 affected9 at risk EG0023 affected9 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0004 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0011 affected9 at risk EG0020 affected9 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0003 affected9 at risk EG0010 affected9 at risk EG0022 affected9 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003
Sputum discoloured	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0011 affected9 at risk EG0020 affected9 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0013 affected9 at risk EG0025 affected9 at risk EG003
Rash	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0002 affected9 at risk EG0011 affected9 at risk EG0022 affected9 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Skin discolouration	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0000 affected9 at risk EG0010 affected9 at risk EG0021 affected9 at risk EG003
Venous thrombosis limb	Vascular disorders	26.1	Systematic Assessment	EG0001 affected9 at risk EG0010 affected9 at risk EG0020 affected9 at risk EG003

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	Part 1: Arm A	NIVO 3 mg/kg Q2 + IPI 1 mg/kg Q6
BG001	Part 1: Arm B	NIVO 3 mg/kg Q3 + IPI 1 mg/kg Q3
BG002	Part 1: Arm C	NIVO 1 mg/kg Q3 + IPI 3 mg/kg Q3
BG003	Part 2: Arm D	NIVO 3 mg/kg Q3 + IPI 1mg/kg Q3
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part 1: Arm A	NIVO 3 mg/kg Q2 + IPI 1 mg/kg Q6	2	9	4	9	7	9
EG001	Part 1: Arm B	NIVO 3 mg/kg Q3 + IPI 1 mg/kg Q3	2	9	3	9	9	9
EG002	Part 1: Arm C	NIVO 1 mg/kg Q3 + IPI 3 mg/kg Q3	1	9	3	9	9	9
EG003	Part 2: Arm D	NIVO 3 mg/kg Q3 + IPI 1mg/kg Q3	1	9	4	9	9	9