A Study of the Effects of ALKS 4230 (Nemvaleukin Alfa) on... | NCT02799095

Label	Type	Description	Intervention Names
ALKS 4230	Experimental		Drug: ALKS 4230
ALKS 4230 + pembrolizumab	Experimental		Drug: ALKS 4230 + pembrolizumab

Name	Type	Description	Arm Group Labels	Other Names
ALKS 4230	Drug	Intravenous (IV) infusion over 30 minutes given daily for 5 consecutive days followed by an off-treatment period	ALKS 4230

Measure	Description	Time Frame
Part A: Number of Participants With Dose-limiting Toxicities (DLTs) Based on Common Terminology Criteria for Adverse Events (CTCAE)	DLT was defined by any of following events possibly, probably, or definitely related to ALKS 4230: Grade 4 neutrophil count decreased (neutropenia); Febrile neutropenia; CTCAE Grade 4 thrombocytopenia; Thrombocytopenia; Any Grade 3 cardiac or central nervous system toxicity; Liver transaminase elevation higher than 8upper limit of normal (ULN) or total bilirubin higher than 6ULN; Grade 4 hypoalbuminemia; Fever more than (>) 40 degree Celsius (°C) sustained for >24 hours; Hypotension required the use of pressors or prolonged hospitalization (>48 hours) for hypotension requiring medical intervention; Grade 3 or higher electrolyte abnormalities; Increase in amylase or lipase; Grade 3 or higher nausea, vomiting, or diarrhea; Any other Grade 4 nonhematologic toxicity or any other Grade 3 non-hematologic toxicity; Any other toxicity or adverse event (AE) not defined above that resulted in participant removal from the study or discontinuation of dosing by the Investigator.	Cycle 1 Day 1 through Cycle 2 Day 15 (Cycle 1 length = 14 days; Cycle 2 length= 21 days)
Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs)	TEAEs were defined as AEs that were newly occurring or worsening from the time of the first dose of study drug. An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product.	From first dose of study drug until 30 days after last dose (up to 10 months for Part A; up to 41.3 months for Part B; up to 51.5 months for Part C)
Parts A, B, and C: Number of Participants With TEAEs by Severity Grading	TEAEs were defined as AEs that were newly occurring or worsening from the time of the first dose of study drug. Severity was graded according to the National Cancer Institute (NCI) CTCAE (version 4.03) where, Grade 1: Mild- asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate- minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL) Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. As planned, Grades 1 and 2 were combined for reporting.

Measure	Description	Time Frame
Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa	Cycle 1 length = 14 days for Part A and 21 days for Part B and C; Cycle 2 length= 21 days for all parts.	Cycle 1 and 2 Day 1: 0, 0.5, 1, 2, 4, 8, 16, and 24 hours post-dose; Cycle 1 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, and 72 hours post-dose; Cycle 2 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, 72, and 240 hours post-dose

Name	Affiliation	Role
Medical Director	Mural Oncology	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Mural Oncology Investigational Site		Denver	Colorado	80045	United States
Mural Oncology Investigational Site

PubMed Identifier	Type	Citation	Retractions
40759440	Derived	Calvo E, Boni V, Dumas O, Shin SJ, Rosen SD, Chaudhry A, Debruyne PR, He X, Vaishampayan UN, McDermott DF. Nemvaleukin alfa monotherapy in patients with advanced melanoma and renal cell carcinoma: results from the phase 1/2 non-randomized ARTISTRY-1 trial. J Immunother Cancer. 2025 Aug 4;13(8):e010777. doi: 10.1136/jitc-2024-010777.
39567211

ID	Title	Description
FG000	Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.1 microgram per kilogram (mcg/kg) intravenous (IV) infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 8, 2022	Mar 21, 2025

Arm/Group Information

ID	Title	Description
BG000	Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.1 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
BG001	Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.3 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
BG002	Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 1 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
BG003	Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 3 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
BG004	Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
BG005	Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 8 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
BG006	Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 10 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
BG007	Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg	Participants with melanoma received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
BG008	Part B, Dose Expansion, RCC: Nemvaleukin 6 Alfa mcg/kg	Participants with RCC received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
BG009	Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg	Participants with any tumor type received nemvaleukin alfa 1 mcg/kg IV infusion administration daily from Days 1 to 5 in combination with pembrolizumab 200 mg IV infusion on Day 1 in each Cycle (cycle length = 21 days) for a maximum of 2 years for as long as the Participant appeared to be deriving clinical benefit (i.e., objective response or SD) and had tolerated therapy well. Participants could continue nemvaleukin alfa as monotherapy beyond the maximum of 2 years of treatment by switching to monotherapy at the joint discretion of the Investigator and Sponsor and if they did not meet any other criteria for discontinuation.
BG010	Part C, Combination Therapy, Cohort 1 + Safety Run-in: Nemvaleukin Alfa 3mcg/kg +Pembrolizumab 200mg	Participants with PD-1/L1 unapproved tumor types (PD-1/L1 treatment naive) received nemvaleukin alfa 3 mcg/kg IV infusion administration daily from Days 1 to 5 in combination with pembrolizumab 200 mg IV infusion on Day 1 in each Cycle (cycle length = 21 days) for a maximum of 2 years for as long as the participant appeared to be deriving clinical benefit (i.e., objective response or SD) and had tolerated therapy well. Participants could continue nemvaleukin alfa as monotherapy beyond the maximum of 2 years of treatment by switching to monotherapy at the joint discretion of the Investigator and Sponsor and if they did not meet any other criteria for discontinuation. The Safety Run-in for nemvaleukin alfa 3 mcg/kg was combined with Cohort 1 of Part C due to same dosing level and regimen.
BG011	Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg	Participants with PD-1/L1 approved tumor types (PD-1/L1 treatment pretreated) received nemvaleukin alfa 3 mcg/kg IV infusion administration daily from Days 1 to 5 in combination with pembrolizumab 200 mg IV infusion on Day 1 in each Cycle (cycle length = 21 days) for a maximum of 2 years for as long as the participant appeared to be deriving clinical benefit (i.e., objective response or SD) and had tolerated therapy well. Participants could continue nemvaleukin alfa as monotherapy beyond the maximum of 2 years of treatment by switching to monotherapy at the joint discretion of the Investigator and Sponsor and if they did not meet any other criteria for discontinuation.
BG012	Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg	Participants with PD-1/L1 approved tumor types (PD-1/L1 treatment naive) received nemvaleukin alfa 3 mcg/kg IV infusion administration daily from Days 1 to 5 in combination with pembrolizumab 200 mg IV infusion on Day 1 in each Cycle (cycle length = 21 days) for a maximum of 2 years for as long as the participant appeared to be deriving clinical benefit (i.e., objective response or SD) and had tolerated therapy well. Participants could continue nemvaleukin alfa as monotherapy beyond the maximum of 2 years of treatment by switching to monotherapy at the joint discretion of the Investigator and Sponsor and if they did not meet any other criteria for discontinuation.
BG013	Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg	Participants rollover from Parts A or B received nemvaleukin alfa 3 mcg/kg IV infusion administration daily from Days 1 to 5 in combination with pembrolizumab 200 mg IV infusion on Day 1 in each Cycle (cycle length = 21 days) for a maximum of 2 years for as long as the participant appeared to be deriving clinical benefit (i.e., objective response or SD) and had tolerated therapy well. Participants could continue nemvaleukin alfa as monotherapy beyond the maximum of 2 years of treatment by switching to monotherapy at the joint discretion of the Investigator and Sponsor and if they did not meet any other criteria for discontinuation.
BG014	Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg	Participants with melanoma received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in combination with pembrolizumab 200 mg IV infusion on Day 1 in each Cycle (cycle length = 21 days) for a maximum of 2 years for as long as the participant appeared to be deriving clinical benefit (i.e., objective response or SD) and had tolerated therapy well. Participants could continue nemvaleukin alfa as monotherapy beyond the maximum of 2 years of treatment by switching to monotherapy at the joint discretion of the Investigator and Sponsor and if they did not meet any other criteria for discontinuation.
BG015	Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg	Participants with NSCLC received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in combination with pembrolizumab 200 mg IV infusion on Day 1 in each Cycle (cycle length = 21 days) for a maximum of 2 years for as long as the participant appeared to be deriving clinical benefit (i.e., objective response or SD) and had tolerated therapy well. Participants could continue nemvaleukin alfa as monotherapy beyond the maximum of 2 years of treatment by switching to monotherapy at the joint discretion of the Investigator and Sponsor and if they did not meet any other criteria for discontinuation.
BG016	Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg	Participants with SCCHN received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in combination with pembrolizumab 200 mg IV infusion on Day 1 in each Cycle (cycle length = 21 days) for a maximum of 2 years for as long as the participant appeared to be deriving clinical benefit (i.e., objective response or SD) and had tolerated therapy well. Participants could continue nemvaleukin alfa as monotherapy beyond the maximum of 2 years of treatment by switching to monotherapy at the joint discretion of the Investigator and Sponsor and if they did not meet any other criteria for discontinuation.
BG017	Total	Total of all reporting groups

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

Part A: Number of Participants With Dose-limiting Toxicities (DLTs) Based on Common Terminology Criteria for Adverse Events (CTCAE)

DLT was defined by any of following events possibly, probably, or definitely related to ALKS 4230: Grade 4 neutrophil count decreased (neutropenia); Febrile neutropenia; CTCAE Grade 4 thrombocytopenia; Thrombocytopenia; Any Grade 3 cardiac or central nervous system toxicity; Liver transaminase elevation higher than 8*upper limit of normal (ULN) or total bilirubin higher than 6*ULN; Grade 4 hypoalbuminemia; Fever more than (>) 40 degree Celsius (°C) sustained for >24 hours; Hypotension required the use of pressors or prolonged hospitalization (>48 hours) for hypotension requiring medical intervention; Grade 3 or higher electrolyte abnormalities; Increase in amylase or lipase; Grade 3 or higher nausea, vomiting, or diarrhea; Any other Grade 4 nonhematologic toxicity or any other Grade 3 non-hematologic toxicity; Any other toxicity or adverse event (AE) not defined above that resulted in participant removal from the study or discontinuation of dosing by the Investigator.

Safety population included all participants who received at least 1 dose of nemvaleukin alfa or pembrolizumab.

Posted

Count of Participants

Participants

Cycle 1 Day 1 through Cycle 2 Day 15 (Cycle 1 length = 14 days; Cycle 2 length= 21 days)

ID	Title	Description
OG000	Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.1 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
OG001	Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.3 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
OG002	Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 1 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
OG003	Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 3 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
OG004	Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.

Units	Counts
Participants	OG0005 OG0014 OG0027 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Primary

Parts A, B, and C: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

TEAEs were defined as AEs that were newly occurring or worsening from the time of the first dose of study drug. An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product.

Safety population included all participants who received at least 1 dose of nemvaleukin alfa or pembrolizumab.

Posted

Count of Participants

Participants

From first dose of study drug until 30 days after last dose (up to 10 months for Part A; up to 41.3 months for Part B; up to 51.5 months for Part C)

ID	Title	Description
OG000	Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.1 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
OG001	Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.3 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.

Primary

Parts A, B, and C: Number of Participants With TEAEs by Severity Grading

TEAEs were defined as AEs that were newly occurring or worsening from the time of the first dose of study drug. Severity was graded according to the National Cancer Institute (NCI) CTCAE (version 4.03) where, Grade 1: Mild- asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate- minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL) Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. As planned, Grades 1 and 2 were combined for reporting.

Safety population included all participants who received at least 1 dose of nemvaleukin alfa or pembrolizumab.

Posted

Count of Participants

Participants

From first dose of study drug until 30 days after last dose (up to 10 months for Part A; up to 41.3 months for Part B; up to 51.5 months for Part C)

ID	Title	Description
OG000	Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.1 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
OG001

Primary

Parts B and C: Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1

ORR rate was defined as the percentage of participants with objective evidence of CR or PR based on RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). Partial Response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

The antitumor evaluable population consisted of participants who complete 2 cycles of therapy and had at least one follow-up scan.

Posted

Number

95% Confidence Interval

percentage of participants

From first dose of study drug up to 40.3 months for Part B and up to 50.5 months for Part C

ID	Title	Description
OG000	Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg	Participants with melanoma received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
OG001	Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg	Participants with RCC received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.

Secondary

Parts A, B, and C: Serum Concentrations of Nemvaleukin Alfa

Cycle 1 length = 14 days for Part A and 21 days for Part B and C; Cycle 2 length= 21 days for all parts.

The pharmacokinetic (PK) population consisted of all participants who received at least 1 dose of nemvaleukin alfa and had at least 1 measurable serum concentration of nemvaleukin alfa at any scheduled PK time point. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.

Posted

Mean

Standard Deviation

nanograms per milliliter (ng/mL)

Cycle 1 and 2 Day 1: 0, 0.5, 1, 2, 4, 8, 16, and 24 hours post-dose; Cycle 1 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, and 72 hours post-dose; Cycle 2 Day 5: 0, 0.5, 1, 2, 4, 8, 16, 24, 72, and 240 hours post-dose

ID	Title	Description
OG000	Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.1 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
OG001	Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.3 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.

Secondary

Parts A, B and C: Area Under Concentration From Time Zero to the Last Quantifiable Concentration (AUClast) of Nemvaleukin Alfa

Cycle 1 length = 14 days for Part A and 21 days for Part B and C; Cycle 2 length= 21 days for all parts.

The PK population consisted of all participants who received at least 1 dose of nemvaleukin alfa and had at least 1 measurable serum concentration of nemvaleukin alfa at any scheduled PK time point. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.

Posted

Geometric Mean

Geometric Coefficient of Variation

hour*nanogram per milliliter (h*ng/mL)

ID	Title	Description
OG000	Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.1 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
OG001	Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.3 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.

Secondary

Parts A, B and C: Maximum Observed Serum Concentration (Cmax) of Nemvaleukin Alfa

Cycle 1 length = 14 days for Part A and 21 days for Part B and C; Cycle 2 length= 21 days for all parts.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanograms per milliliters (ng/mL)

ID	Title	Description
OG000	Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.1 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
OG001	Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.3 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.

Secondary

Parts A, B and C: Time to Reach Cmax (Tmax) of Nemvaleukin Alfa

Cycle 1 length = 14 days for Part A and 21 days for Part B and C; Cycle 2 length= 21 days for all parts.

Posted

Median

Full Range

hours

ID	Title	Description
OG000	Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.1 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
OG001	Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.3 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.

Secondary

Parts A, B, and C: Proportion of Positive Anti-Nemvaleukin Alfa Antibodies (ADA)

Overall proportion was calculated as: Number of participants (overall positive)/total number of participants in the cohort. Overall positive: Participants with at least 1 treatment-emergent ADA positive sample at any time during the treatment period.

Immunogenicity analysis set included all participants who received at least one dose of active study drug and had at least one post baseline blood sample collected to assess immunogenicity.

Posted

Number

proportion of participants

From first dose of study drug up to 9 months (for Part A); up to 40.3 months (for Part B); up to 50.5 months (for Part C)

ID	Title	Description
OG000	Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.1 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
OG001	Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.3 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.

Secondary

Parts A, B, and C: Immune ORR (iORR) Based on Immune RECIST (iRECIST)

iORR was defined as the percentage of participants with objective evidence of immune CR (iCR) or immune PR (iPR) based on iRECIST guidelines.

No data collection or analysis based on immune-related response criteria (irRC) and iRECIST was performed as iRECIST was implemented during the middle of the study conduct to replace irRC. However, no data was collected and analyzed for iRECIST either. Therefore, no data is available to report for this outcome measure.

Posted

From first dose of study drug up to 9 months for Part A; up to 40.3 months for Part B; up to 50.5 months for Part C

ID	Title	Description
OG000	Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.1 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
OG001	Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.3 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.

Secondary

Parts A, B, and C: Disease Control Rate (DCR) Based on RECIST v.1.1

Disease control rate was defined as the percentage of participants with objective evidence of CR, PR, or SD based on RECIST v.1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

The antitumor evaluable population consisted of participants who complete 2 cycles of therapy and had at least one follow-up scan.

Posted

Number

95% Confidence Interval

percentage of participants

From first dose of study drug up to 9 months for Part A; up to 40.3 months for Part B; up to 50.5 months for Part C

ID	Title	Description
OG000	Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.1 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
OG001	Part A, Dose Escalation: Nemvaleukin 0.3 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.3 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.

Secondary

Parts A, B, and C: Immune DCR (iDCR) Based on iRECIST v1.1

iDCR was defined as the percentage of participants with objective evidence of iCR, iPR (where iCR or iPR required confirmation), or immune stable disease (iSD) (where the iSD requires to occur at Cycle 4 or later).

No data collection or analysis based on irRC and iRECIST was performed as iRECIST was implemented during the middle of the study conduct to replace irRC. However, no data was collected and analyzed for iRECIST either. Therefore, no data is available to report for this outcome measure.

Posted

From first dose of study drug up to 9 months for Part A; up to 40.3 months for Part B; up to 50.5 months for Part C

ID	Title	Description
OG000	Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.1 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
OG001	Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.3 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.

Secondary

Parts B, and C: Duration of Response (DOR) Based on RECIST v1.1

Duration of response was defined as the time from the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

The antitumor evaluable population consisted of participants who complete 2 cycles of therapy and had at least one follow-up scan. Here, "overall number of participants analyzed" signified participants who had CR or PR.

Posted

Median

95% Confidence Interval

weeks

From the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause (up to 40.3 months for Part B and up to 50.5 months for Part C)

ID	Title	Description
OG000	Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg	Participants with melanoma received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.

Secondary

Parts B, and C: Immune DOR (iDOR) Based on iRECIST

iDOR was defined as the time from the first documentation of response (iCR or iPR) to the first documentation of objective tumor progression (immune confirmed progressive disease [iCPD]) or death due to any cause based on iRECIST.

Posted

From first dose of study drug up to 40.3 months for Part B; up to 50.5 months for Part C

ID	Title	Description
OG000	Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg	Participants with melanoma received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
OG001	Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg	Participants with RCC received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.

Secondary

Part B and Part C Cohorts C5, C6, C7: Durable Response Rate (DRR) Based on RECIST v.1.1

DRR was defined as the percentage of participants with an objective response (complete or partial response per RECIST 1.1) lasting continuously for 6 months and starting any time within 12 months of initiating the study drug.

As pre-specified in statistical analysis plan, this outcome measure of DRR was not summarized and hence, no data was reported in this outcome measure.

Posted

From first dose of study drug up to 40.3 months for Part B; up to 50.5 months for Part C

ID	Title	Description
OG000	Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg	Participants with melanoma received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
OG001	Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg	Participants with RCC received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
OG002	Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg

Secondary

Part B and Part C Cohorts C5, C6, C7: Immune DRR (iDRR) Based on iRECIST

iDRR was defined as the percentage of participants with an objective response (complete or partial response per iRECIST) lasting continuously for 6 months and starting any time within 12 months of initiating the study drug.

Posted

From first dose of study drug up to 40.3 months for Part B; up to 50.5 months for Part C

ID	Title	Description
OG000	Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg	Participants with melanoma received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
OG001	Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg	Participants with RCC received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.

Secondary

Part B and Part C Cohorts C5, C6, C7: Progression-free Survival (PFS) Based on RECIST v.1.1

Progression-free survival was defined as the time from the first dose of nemvaleukin to the first documentation of objective tumor progression or death due to any cause. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

The antitumor evaluable population consisted of participants who complete 2 cycles of therapy and had at least one follow-up scan.

Posted

Median

95% Confidence Interval

weeks

From first dose of study drug up to the first documentation of objective tumor progression or death due to any cause (up to 40.3 months for Part B and up to 50.5 months for Part C)

ID	Title	Description
OG000	Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg	Participants with melanoma received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
OG001	Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg	Participants with RCC received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.

Secondary

Part B and Part C Cohorts C5, C6, C7: Immune PFS (iPFS)

iPFS was defined as the time from the first dose of study medication to the first documentation of objective tumor progression based on iRECIST (immune confirmed progressive disease [iCPD]) or death due to any cause.

Posted

From first dose of study drug up to 40.3 months for Part B; up to 50.5 months for Part C

ID	Title	Description
OG000	Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg	Participants with melanoma received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
OG001	Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg	Participants with RCC received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.

Secondary

Parts A, B and C: Maximum Cell Count of Whole Blood FoxP3+ T Cells (Tregs), Total Cluster of Differentiation (CD)8+ T Cells and Natural Killer (NK) Cells

The pharmacodynamic (PD) population consisted of all participants who received at least 1 dose of nemvaleukin alfa and had at least one available postbaseline PD measurement. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.

Posted

Mean

Standard Deviation

cells per microliters (cells/mcL)

Cycle 1 Day 1 (Cycle 1 length = 14 days for Part A and 21 days for Part B and C)

ID	Title	Description
OG000	Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.1 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
OG001	Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.3 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.

Secondary

Parts A, B and C: Maximum Cell Count of Interferon-gamma (INF-γ) and Interleukin 6 (IL-6)

The PD population consisted of all participants who received at least 1 dose of nemvaleukin alfa and had at least one available postbaseline PD measurement. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.

Posted

Mean

Standard Deviation

nanogram per liter (ng/L)

Cycle 1 Days 1 and 5; Cycle 2 Days 1 and 5 (Cycle 1 length = 14 days for Part A and 21 days for Part B and C; Cycle 2 length= 21 days for all parts)

ID	Title	Description
OG000	Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.1 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.
OG001	Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.3 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.

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	Part A, Dose Escalation: Nemvaleukin Alfa 0.1 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.1 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.	0	5	2	5	5	5
EG001	Part A, Dose Escalation: Nemvaleukin Alfa 0.3 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 0.3 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.	0	4	0	4	4	4
EG002	Part A, Dose Escalation: Nemvaleukin Alfa 1 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 1 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.	0	7	2	7	7	7
EG003	Part A, Dose Escalation: Nemvaleukin Alfa 3 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 3 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.	0	8	3	8	8	8
EG004	Part A, Dose Escalation: Nemvaleukin Alfa 6 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.	1	12	5	12	12	12
EG005	Part A, Dose Escalation: Nemvaleukin Alfa 8 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 8 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.	0	3	0	3	3	3
EG006	Part A, Dose Escalation: Nemvaleukin Alfa 10 mcg/kg	Participants with advanced solid tumors received nemvaleukin alfa 10 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.	3	7	5	7	7	7
EG007	Part B, Dose Expansion, Melanoma: Nemvaleukin Alfa 6 mcg/kg	Participants with melanoma received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.	7	47	11	47	46	47
EG008	Part B, Dose Expansion, RCC: Nemvaleukin Alfa 6 mcg/kg	Participants with RCC received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in Cycle 1 (Cycle length = 14 days) and then in Cycle 2 and subsequent cycles (each Cycle length = 21 days) until disease progression or the participant met any discontinuation criteria.	7	27	12	27	27	27
EG009	Part C, Combination Therapy, Safety Run-in: Nemvaleukin Alfa 1 mcg/kg	Participants with any tumor type received nemvaleukin alfa 1 mcg/kg IV infusion administration daily from Days 1 to 5 in combination with pembrolizumab 200 mg IV infusion on Day 1 in each Cycle (cycle length = 21 days) for a maximum of 2 years for as long as the Participant appeared to be deriving clinical benefit (i.e., objective response or SD) and had tolerated therapy well. Participants could continue nemvaleukin alfa as monotherapy beyond the maximum of 2 years of treatment by switching to monotherapy at the joint discretion of the Investigator and Sponsor and if they did not meet any other criteria for discontinuation.	0	3	0	3	3	3
EG010	Part C, Combination Therapy, Cohort 1 +Safety Run-in: Nemvaleukin Alfa 3 mcg/kg +Pembrolizumab 200mg	Participants with PD-1/L1 unapproved tumor types (PD-1/L1 treatment naive) received nemvaleukin alfa 3 mcg/kg IV infusion administration daily from Days 1 to 5 in combination with pembrolizumab 200 mg IV infusion on Day 1 in each Cycle (cycle length = 21 days) for a maximum of 2 years for as long as the participant appeared to be deriving clinical benefit (i.e., objective response or SD) and had tolerated therapy well. Participants could continue nemvaleukin alfa as monotherapy beyond the maximum of 2 years of treatment by switching to monotherapy at the joint discretion of the Investigator and Sponsor and if they did not meet any other criteria for discontinuation. The Safety Run-in for nemvaleukin alfa 3 mcg/kg was combined with Cohort 1 of Part C due to same dosing level and regimen.	7	42	19	42	42	42
EG011	Part C, Combination Therapy, Cohort 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg	Participants with PD-1/L1 approved tumor types (PD-1/L1 treatment pretreated) received nemvaleukin alfa 3 mcg/kg IV infusion administration daily from Days 1 to 5 in combination with pembrolizumab 200 mg IV infusion on Day 1 in each Cycle (cycle length = 21 days) for a maximum of 2 years for as long as the participant appeared to be deriving clinical benefit (i.e., objective response or SD) and had tolerated therapy well. Participants could continue nemvaleukin alfa as monotherapy beyond the maximum of 2 years of treatment by switching to monotherapy at the joint discretion of the Investigator and Sponsor and if they did not meet any other criteria for discontinuation.	7	26	10	26	26	26
EG012	Part C, Combination Therapy, Cohort 3: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg	Participants with PD-1/L1 approved tumor types (PD-1/L1 treatment naive) received nemvaleukin alfa 3 mcg/kg IV infusion administration daily from Days 1 to 5 in combination with pembrolizumab 200 mg IV infusion on Day 1 in each Cycle (cycle length = 21 days) for a maximum of 2 years for as long as the participant appeared to be deriving clinical benefit (i.e., objective response or SD) and had tolerated therapy well. Participants could continue nemvaleukin alfa as monotherapy beyond the maximum of 2 years of treatment by switching to monotherapy at the joint discretion of the Investigator and Sponsor and if they did not meet any other criteria for discontinuation.	8	26	11	26	25	26
EG013	Part C, Combination Therapy, Rollover, Cohort 4: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg	Participants rollover from Parts A or B received nemvaleukin alfa 3 mcg/kg IV infusion administration daily from Days 1 to 5 in combination with pembrolizumab 200 mg IV infusion on Day 1 in each Cycle (cycle length = 21 days) for a maximum of 2 years for as long as the participant appeared to be deriving clinical benefit (i.e., objective response or SD) and had tolerated therapy well. Participants could continue nemvaleukin alfa as monotherapy beyond the maximum of 2 years of treatment by switching to monotherapy at the joint discretion of the Investigator and Sponsor and if they did not meet any other criteria for discontinuation.	8	43	14	43	38	43
EG014	Part C, Combination Therapy, Cohort 5: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg	Participants with melanoma received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in combination with pembrolizumab 200 mg IV infusion on Day 1 in each Cycle (cycle length = 21 days) for a maximum of 2 years for as long as the participant appeared to be deriving clinical benefit (i.e., objective response or SD) and had tolerated therapy well. Participants could continue nemvaleukin alfa as monotherapy beyond the maximum of 2 years of treatment by switching to monotherapy at the joint discretion of the Investigator and Sponsor and if they did not meet any other criteria for discontinuation.	1	3	2	3	3	3
EG015	Part C, Combination Therapy, Cohort 6: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg	Participants with NSCLC received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in combination with pembrolizumab 200 mg IV infusion on Day 1 in each Cycle (cycle length = 21 days) for a maximum of 2 years for as long as the participant appeared to be deriving clinical benefit (i.e., objective response or SD) and had tolerated therapy well. Participants could continue nemvaleukin alfa as monotherapy beyond the maximum of 2 years of treatment by switching to monotherapy at the joint discretion of the Investigator and Sponsor and if they did not meet any other criteria for discontinuation.	8	21	12	21	21	21
EG016	Part C, Combination Therapy, Cohort 7: Nemvaleukin Alfa 6 mcg/kg + Pembrolizumab 200 mg	Participants with SCCHN received nemvaleukin alfa 6 mcg/kg IV infusion administration daily from Days 1 to 5 in combination with pembrolizumab 200 mg IV infusion on Day 1 in each Cycle (cycle length = 21 days) for a maximum of 2 years for as long as the participant appeared to be deriving clinical benefit (i.e., objective response or SD) and had tolerated therapy well. Participants could continue nemvaleukin alfa as monotherapy beyond the maximum of 2 years of treatment by switching to monotherapy at the joint discretion of the Investigator and Sponsor and if they did not meet any other criteria for discontinuation.	1	2	2	2	2	2

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG0030 events0 affected8 at risk EG0040 events0 affected12 at risk EG0050 events0 affected3 at risk EG0062 events2 affected7 at risk EG0070 events0 affected47 at risk EG0080 events0 affected27 at risk EG0090 events0 affected3 at risk EG0100 events0 affected42 at risk EG0110 events0 affected26 at risk EG0120 events0 affected26 at risk EG0131 events1 affected43 at risk EG0140 events0 affected3 at risk EG0155 events3 affected21 at risk EG0160 events0 affected2 at risk
Urinary tract infection	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Pneumonia aspiration	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Sepsis	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Pain	General disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Pyrexia	General disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0021 events1 affected7 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Blood creatinine increased	Investigations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0021 events1 affected7 at risk EG003
Immune thrombocytopenia	Blood and lymphatic system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
COVID-19	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Bacteraemia	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Cellulitis	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Extravasation	General disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Blood bilirubin increased	Investigations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Electrocardiogram T wave abnormal	Investigations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Troponin I increased	Investigations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Iritis	Eye disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Vitritis	Eye disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Hypotension	Vascular disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Urosepsis	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Abscess neck	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Arthritis infective	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Catheter site infection	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Peritoneal abscess	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Vascular device infection	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Immune-mediated enterocolitis	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Supraventricular extrasystoles	Cardiac disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Cardiac tamponade	Cardiac disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Tachycardia	Cardiac disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Brain oedema	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Depressed level of consciousness	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Lethargy	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Metabolic encephalopathy	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Myelopathy	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Syncope	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Hypovolaemia	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Starvation	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Fatigue	General disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Asthenia	General disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Stomal hernia	Injury, poisoning and procedural complications	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Vaccination complication	Injury, poisoning and procedural complications	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Biliary obstruction	Hepatobiliary disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Immune-mediated hepatitis	Hepatobiliary disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Confusional state	Psychiatric disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Hallucination	Psychiatric disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Cytokine release syndrome	Immune system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Myositis	Musculoskeletal and connective tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Embolism arterial	Vascular disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Urinary tract infection enterococcal	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pyrexia	General disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0012 events2 affected4 at risk EG0028 events5 affected7 at risk EG00324 events8 affected8 at risk EG00459 events12 affected12 at risk EG00510 events2 affected3 at risk EG0067 events3 affected7 at risk EG007104 events33 affected47 at risk EG00827 events17 affected27 at risk EG0091 events1 affected3 at risk EG010148 events30 affected42 at risk EG01180 events17 affected26 at risk EG01245 events16 affected26 at risk EG01333 events7 affected43 at risk EG0147 events2 affected3 at risk EG01537 events10 affected21 at risk EG01629 events2 affected2 at risk
Chills	General disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0018 events2 affected4 at risk EG00216 events5 affected7 at risk EG003
Fatigue	General disorders	MedDRA version 25.0	Systematic Assessment	EG0006 events4 affected5 at risk EG0011 events1 affected4 at risk EG0022 events2 affected7 at risk EG003
Oedema peripheral	General disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events1 affected5 at risk EG0011 events1 affected4 at risk EG0020 events0 affected7 at risk EG003
Asthenia	General disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Malaise	General disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0022 events2 affected7 at risk EG003
Pain	General disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected4 at risk EG0021 events1 affected7 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0004 events2 affected5 at risk EG0012 events2 affected4 at risk EG0022 events2 affected7 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0003 events2 affected5 at risk EG0011 events1 affected4 at risk EG0024 events1 affected7 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected5 at risk EG0011 events1 affected4 at risk EG0025 events2 affected7 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0022 events2 affected7 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected4 at risk EG0022 events1 affected7 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected4 at risk EG0021 events1 affected7 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0003 events1 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0021 events1 affected7 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected5 at risk EG0010 events0 affected4 at risk EG0021 events1 affected7 at risk EG003
Hypotension	Vascular disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0012 events1 affected4 at risk EG0020 events0 affected7 at risk EG003
Hypertension	Vascular disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0011 events1 affected4 at risk EG0021 events1 affected7 at risk EG003
Embolism	Vascular disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0012 events2 affected4 at risk EG0020 events0 affected7 at risk EG003
Blood creatinine increased	Investigations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0024 events3 affected7 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Weight decreased	Investigations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Blood bilirubin increased	Investigations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Weight increased	Investigations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected4 at risk EG0020 events0 affected7 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0011 events1 affected4 at risk EG0021 events1 affected7 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected4 at risk EG0020 events0 affected7 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected4 at risk EG0021 events1 affected7 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected5 at risk EG0011 events1 affected4 at risk EG0021 events1 affected7 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0012 events1 affected4 at risk EG0020 events0 affected7 at risk EG003
Headache	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected4 at risk EG0021 events1 affected7 at risk EG003
Dizziness	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0012 events1 affected4 at risk EG0023 events2 affected7 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events1 affected5 at risk EG0010 events0 affected4 at risk EG0021 events1 affected7 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected4 at risk EG0021 events1 affected7 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected4 at risk EG0021 events1 affected7 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0022 events1 affected7 at risk EG003
Tachycardia	Cardiac disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected4 at risk EG0024 events3 affected7 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Confusional state	Psychiatric disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Insomnia	Psychiatric disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0023 events3 affected7 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0013 events1 affected4 at risk EG0024 events3 affected7 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0021 events1 affected7 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Peripheral swelling	General disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected4 at risk EG0023 events3 affected7 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Palpitations	Cardiac disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
COVID-19	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Anxiety	Psychiatric disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Blood pressure	Investigations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
White blood cell count decreased	Investigations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003
Pneumonia	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected4 at risk EG0020 events0 affected7 at risk EG003

ID	Term
D008545	Melanoma
D002292	Carcinoma, Renal Cell
D002289	Carcinoma, Non-Small-Cell Lung
D000077195	Squamous Cell Carcinoma of Head and Neck

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
D012878	Skin Neoplasms
D009371	Neoplasms by Site
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D007680	Kidney Neoplasms
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D007674	Kidney Diseases
D014570	Urologic Diseases
D052801	Male Urogenital Diseases
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002294	Carcinoma, Squamous Cell
D006258	Head and Neck Neoplasms