A Study of SOT101 in Combination With Pembrolizumab to Ev... | NCT05256381

ID	Type	Description
KEYNOTE-D13	Other Identifier	Merck Sharp & Dohme
AURELIO-04	Other Identifier	SOTIO Biotech AG
2021-005774-25	EudraCT Number
MK-3475-D13	Other Identifier	Merck Sharp & Dohme

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Label	Type	Description	Intervention Names
Nanrilkefusp Alfa and Pembrolizumab	Experimental	Participants will be treated with 12 μg/kg of nanrilkefusp alfa on Day 1, Day 2, Day 8, and Day 9 of each 3-week cycle in combination with 200 mg pembrolizumab on Day 1 of each 3-week cycle.	Drug: Nanrilkefusp Alfa Drug: Pembrolizumab

Name	Type	Description	Arm Group Labels	Other Names
Nanrilkefusp Alfa	Drug	Subcutaneous (SC) injection.	Nanrilkefusp Alfa and Pembrolizumab

Measure	Description	Time Frame
Percentage of Patients With Objective Response Rate According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)		Day 1 up to approximately 2 years and 2 months

Measure	Description	Time Frame
Number of Patients With a Treatment-emergent Adverse Event		Day 1 up to approximately 2 years and 2 months
Number of Patients With an Adverse Event of Special Interest		Day 1 up to approximately 2 years and 2 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants with the following histologically or cytologically confirmed solid tumor indications and line of treatment:
1. Non-small cell lung cancer (NSCLC).
2. Colorectal cancer.
3. Cutaneous squamous cell carcinoma (cSCC).
4. Advanced hepatocellular carcinoma (not applicable in France).
5. mCRPC.
6. Ovarian cancer.
Have measurable disease per RECIST 1.1. mCRPC participants with no measurable disease and only widespread bone disease must have a CTC count of ≥5 cells per 7.5 mL of blood.
Availability of tumor tissue from a fresh biopsy at screening unless the biopsy cannot be obtained due to safety reasons or non-accessibility of the tumor site. If it is not possible to obtain a fresh biopsy, every effort should be taken to retrieve an archival biopsy. Archived, fixed tumor tissue may only be collected if taken preferentially after completion of the most recent systemic tumor therapy and within 12 months prior to the first dose of study treatment.
Eastern Cooperative Oncology Group (ECOG) score 0-1.
Have recovered from all AEs (except alopecia) due to previous therapies to grade ≤1 (excluding alopecia) or have stable grade 2 neuropathy.
Have adequate organ function as defined below:
1. Hematology:
  1. Absolute neutrophil count ≥1500/μL.
  2. Platelets ≥100 000/μL.
  3. Hemoglobin ≥9.0 g/dL .
2. Renal function: Creatinine clearance as measured by glomerular filtration rate ≥30 mL/min using Cockcroft-Gault equation.
3. Hepatic function: Alanine transaminase (ALT)/aspartate transaminase (AST) ≤2.5× upper limit of normal (ULN) and total bilirubin ≤1.5×ULN or direct bilirubin ≤ ULN in participants without liver metastasis. In participants with liver metastasis, ALT/AST ≤5×ULN is allowed but total bilirubin must be ≤2×ULN.
4. Prothrombin time and activated partial thromboplastin time ≤1.5×ULN.
Participants must not have active hepatitis B or hepatitis C infection.
Adequate contraception must be applied in all women of childbearing potential (WOCBP) and in male participants.

Exclusion Criteria:

Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and was discontinued from that treatment due to a grade ≥3 AE.
Prior exposure to agonists of interleukin (IL)-2 or IL-15.
Prior systemic anti-cancer therapies, including investigational agents:
1. Less than 4 weeks for systemic chemotherapy and immuno-oncology therapies; and for tyrosine kinase inhibitors 4 weeks or 5 half-lives (whichever is shorter).
2. Less than 4 weeks from major surgeries and not recovered adequately.
Has received prior radiotherapy within 2 weeks of the start of study interventions or have had a history of radiation pneumonitis.
NSCLC indication only: Received radiation therapy to the lung >30 Gy within 6 months.
Has received a live or live-attenuated vaccine within 30 days.
Clinically significant cardiac abnormalities including prior history of any of the following:
1. Cardiomyopathy, with left ventricular ejection fraction ≤ 50%.
2. Congestive heart failure of New York Heart Association grade ≥2.
3. History of clinically significant artery or coronary heart disease.
4. Prolongation of QTcF >450 msec .
5. Clinically significant cardiac arrythmia that cannot be controlled with adequate medication.
Uncontrolled hypertension defined as systolic blood pressure >160 mmHg, diastolic blood pressure >110 mmHg.
Prior allogeneic hematopoietic stem cell transplantation within the last 5 years.
Prior allogeneic tissue/solid organ transplant.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy.
History of or serology positive for human immunodeficiency virus (HIV).
Has a known additional malignancy that is progressing or has required active treatment within the past 5 years, except for basal cell carcinoma of the skin or carcinoma in situ that have undergone potentially curative therapy are not excluded.
Has known active central nervous system metastases and/or carcinomatous meningitis, unless stable.
Had severe hypersensitivity (grade ≥3) to pembrolizumab and/or any of its excipients.
Has an active autoimmune disease that has required systemic treatment in the past 2 years.
History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease.
Has an active infection requiring systemic therapy.
Has any condition that might confound the results of the study or interfere with the participant's participation for the full duration of the study.

Facility	Status	City	State	ZIP	Country	Contacts
Innovative Clinical Research Institute		Whittier	California	90603	United States
University of Pittsburg Medical Center (UPMC) Hillman Cancer Center

ID	Title	Description
FG000	Non-small Cell Lung Cancer	Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 20, 2023	May 16, 2025

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

Percentage of Patients With Objective Response Rate According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)

All patients exposed to the combination therapy for at least one treatment cycle. This is defined as patients with 4 doses of SOT101 and 1 dose of pembrolizumab in Cycle 1, or patients exposed to both SOT101 and pembrolizumab in Cycle 1 who started Cycle 2. Only patients with measurable disease at baseline were included.

Posted

Number

95% Confidence Interval

percentage of participants

Day 1 up to approximately 2 years and 2 months

ID	Title	Description
OG000	Non-small Cell Lung Cancer	Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
OG001	Colorectal Cancer	Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
OG002	Cutaneous Squamous Cell Carcinoma	Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
OG003	Hepatocellular Carcinoma	Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
OG004	Metastatic Castration-resistant Prostate Cancer	Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
OG005	Ovarian Cancer	Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months

Units	Counts
Participants	OG00039 OG0016 OG00211 OG003

Title

Denominators

Categories

Title	Measurements
	OG0005.1(0.6 to 17.3) OG00133.3(4.3 to 77.7) OG00227.3(6.0 to 61.0) OG003

Secondary

Number of Patients With a Treatment-emergent Adverse Event

Posted

Count of Participants

Participants

Day 1 up to approximately 2 years and 2 months

ID	Title	Description
OG000	Non-small Cell Lung Cancer	Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
OG001	Colorectal Cancer	Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
OG002	Cutaneous Squamous Cell Carcinoma	Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
OG003	Hepatocellular Carcinoma	Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)

Secondary

Number of Patients With an Adverse Event of Special Interest

Posted

Count of Participants

Participants

Day 1 up to approximately 2 years and 2 months

ID	Title	Description
OG000	Non-small Cell Lung Cancer	Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
OG001	Colorectal Cancer	Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
OG002	Cutaneous Squamous Cell Carcinoma	Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
OG003	Hepatocellular Carcinoma	Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)

Secondary

Percentage of Patients With Objective Response Rate According to RECIST for Immune-based Therapeutics (iRECIST)

Posted

Number

95% Confidence Interval

percentage of participants

Day 1 up to approximately 2 years and 2 months

ID	Title	Description
OG000	Non-small Cell Lung Cancer	Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
OG001	Colorectal Cancer	Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
OG002	Cutaneous Squamous Cell Carcinoma	Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible

Secondary

Number of Patients With Best Overall Response According to RECIST 1.1: Complete Response

Posted

Count of Participants

Participants

Day 1 up to approximately 2 years and 2 months

ID	Title	Description
OG000	Non-small Cell Lung Cancer	Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
OG001	Colorectal Cancer	Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
OG002	Cutaneous Squamous Cell Carcinoma	Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible

Secondary

Number of Patients With Best Overall Response According to RECIST 1.1: Partial Response

Posted

Count of Participants

Participants

Day 1 up to approximately 2 years and 2 months

ID	Title	Description
OG000	Non-small Cell Lung Cancer	Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
OG001	Colorectal Cancer	Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
OG002	Cutaneous Squamous Cell Carcinoma	Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible

Secondary

Number of Patients With Best Overall Response According to RECIST 1.1: Stable Disease

Posted

Count of Participants

Participants

Day 1 up to approximately 2 years and 2 months

ID	Title	Description
OG000	Non-small Cell Lung Cancer	Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
OG001	Colorectal Cancer	Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
OG002	Cutaneous Squamous Cell Carcinoma	Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible

Secondary

Number of Patients With Best Overall Response According to RECIST 1.1: Progressive Disease

Posted

Count of Participants

Participants

Day 1 up to approximately 2 years and 2 months

ID	Title	Description
OG000	Non-small Cell Lung Cancer	Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
OG001	Colorectal Cancer	Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
OG002	Cutaneous Squamous Cell Carcinoma	Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible

Secondary

Number of Patients With Best Overall Response According to iRECIST: Complete Response

Posted

Count of Participants

Participants

Day 1 up to approximately 2 years and 2 months

ID	Title	Description
OG000	Non-small Cell Lung Cancer	Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
OG001	Colorectal Cancer	Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
OG002	Cutaneous Squamous Cell Carcinoma	Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible

Secondary

Number of Patients With Best Overall Response According to iRECIST: Partial Response

Posted

Count of Participants

Participants

Day 1 up to approximately 2 years and 2 months

ID	Title	Description
OG000	Non-small Cell Lung Cancer	Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
OG001	Colorectal Cancer	Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
OG002	Cutaneous Squamous Cell Carcinoma	Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible

Secondary

Number of Patients With Best Overall Response According to iRECIST: Stable Disease

Posted

Count of Participants

Participants

Day 1 up to approximately 2 years and 2 months

ID	Title	Description
OG000	Non-small Cell Lung Cancer	Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
OG001	Colorectal Cancer	Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
OG002	Cutaneous Squamous Cell Carcinoma	Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible

Secondary

Number of Patients With Best Overall Response According to iRECIST: Unconfirmed Progressive Disease

Posted

Count of Participants

Participants

Day 1 up to approximately 2 years and 2 months

ID	Title	Description
OG000	Non-small Cell Lung Cancer	Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
OG001	Colorectal Cancer	Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
OG002	Cutaneous Squamous Cell Carcinoma	Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible

Secondary

Number of Patients With Best Overall Response According to iRECIST: Confirmed Progressive Disease

Posted

Count of Participants

Participants

Day 1 up to approximately 2 years and 2 months

ID	Title	Description
OG000	Non-small Cell Lung Cancer	Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
OG001	Colorectal Cancer	Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
OG002	Cutaneous Squamous Cell Carcinoma	Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible

Secondary

Duration of Response According to RECIST 1.1

Posted

Median

95% Confidence Interval

months

Day 1 up to approximately 2 years and 2 months

ID	Title	Description
OG000	Non-small Cell Lung Cancer	Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
OG001	Colorectal Cancer	Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
OG002	Cutaneous Squamous Cell Carcinoma	Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
OG003	Hepatocellular Carcinoma	Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)

Secondary

Duration of Response According to iRECIST

Posted

Median

95% Confidence Interval

months

Day 1 up to approximately 2 years and 2 months

ID	Title	Description
OG000	Non-small Cell Lung Cancer	Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
OG001	Colorectal Cancer	Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
OG002	Cutaneous Squamous Cell Carcinoma	Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
OG003	Hepatocellular Carcinoma	Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)

Secondary

Percentage of Patients With Clinical Benefit Rate According to RECIST 1.1

Posted

Number

95% Confidence Interval

percentage of participants

Day 1 up to approximately 2 years and 2 months

ID	Title	Description
OG000	Non-small Cell Lung Cancer	Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
OG001	Colorectal Cancer	Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
OG002	Cutaneous Squamous Cell Carcinoma	Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
OG003	Hepatocellular Carcinoma	Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)

Secondary

Percentage of Patients With Clinical Benefit Rate According to iRECIST

Posted

Number

95% Confidence Interval

percentage of participants

Day 1 up to approximately 2 years and 2 months

ID	Title	Description
OG000	Non-small Cell Lung Cancer	Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
OG001	Colorectal Cancer	Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
OG002	Cutaneous Squamous Cell Carcinoma	Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
OG003	Hepatocellular Carcinoma	Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)

Secondary

Progression-free Survival According to RECIST 1.1

Posted

Median

95% Confidence Interval

months

Day 1 up to approximately 2 years and 2 months

ID	Title	Description
OG000	Non-small Cell Lung Cancer	Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
OG001	Colorectal Cancer	Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
OG002	Cutaneous Squamous Cell Carcinoma	Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
OG003	Hepatocellular Carcinoma	Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)

Secondary

Progression-free Survival According to iRECIST

Posted

Median

95% Confidence Interval

months

Day 1 up to approximately 2 years and 2 months

ID	Title	Description
OG000	Non-small Cell Lung Cancer	Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
OG001	Colorectal Cancer	Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
OG002	Cutaneous Squamous Cell Carcinoma	Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
OG003	Hepatocellular Carcinoma	Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)

Secondary

Time to Response According to RECIST 1.1

Posted

Median

95% Confidence Interval

months

Day 1 up to approximately 2 years and 2 months

ID	Title	Description
OG000	Non-small Cell Lung Cancer	Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
OG001	Colorectal Cancer	Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
OG002	Cutaneous Squamous Cell Carcinoma	Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
OG003	Hepatocellular Carcinoma	Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)

Secondary

Time to Response According to iRECIST

Posted

Median

95% Confidence Interval

months

Day 1 up to approximately 2 years and 2 months

ID	Title	Description
OG000	Non-small Cell Lung Cancer	Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
OG001	Colorectal Cancer	Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
OG002	Cutaneous Squamous Cell Carcinoma	Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
OG003	Hepatocellular Carcinoma	Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)

Secondary

Duration of Response According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1

Posted

Median

95% Confidence Interval

months

Day 1 up to approximately 2 years and 2 months

ID	Title	Description
OG000	Metastatic Castration-resistant Prostate Cancer	Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent

Units	Counts
Participants	OG00040

Secondary

Percentage of Patients With Clinical Benefit Rate According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1

Posted

Number

95% Confidence Interval

percentage of participants

Day 1 up to approximately 2 years and 2 months

ID	Title	Description
OG000	Metastatic Castration-resistant Prostate Cancer	Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent

Units	Counts
Participants	OG00040

Secondary

Progression-free Survival According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1

Posted

Median

95% Confidence Interval

months

Day 1 up to approximately 2 years and 2 months

ID	Title	Description
OG000	Metastatic Castration-resistant Prostate Cancer	Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent

Units	Counts
Participants	OG00040

Secondary

Percentage of Patients With Circulating Tumor Cell Count Conversion as Assessed According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1

Posted

Number

95% Confidence Interval

percentage of participants

Day 1 up to approximately 2 years

ID	Title	Description
OG000	Metastatic Castration-resistant Prostate Cancer	Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent

Units	Counts
Participants	OG00040

Secondary

Percentage of Patients With Confirmed Prostate-specific Antigen Decline of ≥50% as Assessed According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1

Posted

Number

95% Confidence Interval

percentage of participants

Day 1 up to approximately 2 years

ID	Title	Description
OG000	Metastatic Castration-resistant Prostate Cancer	Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent

Units	Counts
Participants	OG00040

Secondary

Time to Confirmed Prostate-specific Antigen Progression as Assessed According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1

Posted

Median

95% Confidence Interval

months

Day 1 up to approximately 2 years

ID	Title	Description
OG000	Metastatic Castration-resistant Prostate Cancer	Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent

Units	Counts
Participants	OG00040

Secondary

Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1, 30 (+/-5) Minutes After Nanrilkefusp Alfa Administration

Posted

Median

Full Range

ng/mL

Cycle 1 Day 1, 30 (+/-5) minutes after nanrilkefusp alfa administration

ID	Title	Description
OG000	Non-small Cell Lung Cancer	Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
OG001	Colorectal Cancer	Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
OG002	Cutaneous Squamous Cell Carcinoma	Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
OG003	Hepatocellular Carcinoma	Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)

Secondary

Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1, 2 Hours (+/-15 Minutes) After Nanrilkefusp Alfa Administration

Posted

Median

Full Range

ng/mL

Cycle 1 Day 1, 2 hours (+/-15 minutes) after nanrilkefusp alfa administration

ID	Title	Description
OG000	Non-small Cell Lung Cancer	Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
OG001	Colorectal Cancer	Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
OG002	Cutaneous Squamous Cell Carcinoma	Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
OG003	Hepatocellular Carcinoma

Secondary

Number of Patients With Anti-drug Antibodies, Cycle 4 Day 1

Posted

Count of Participants

Participants

Cycle 4 Day 1, approximately 9 weeks

ID	Title	Description
OG000	Non-small Cell Lung Cancer	Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
OG001	Colorectal Cancer	Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
OG002	Cutaneous Squamous Cell Carcinoma	Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
OG003	Hepatocellular Carcinoma	Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment		EG0005 events5 affected40 at risk EG0010 events0 affected8 at risk EG0021 events1 affected12 at risk EG0030 events0 affected12 at risk EG004
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0021 events1 affected12 at risk EG003
Hypotension	Vascular disorders	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Jugular vein thrombosis	Vascular disorders	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Pyrexia	General disorders	MedDRA 25.0	Systematic Assessment		EG0002 events2 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
General physical health deterioration	General disorders	MedDRA 25.0	Systematic Assessment		EG0004 events4 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Fatigue	General disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Death	General disorders	MedDRA 25.0	Systematic Assessment	2 SAEs were classified by the investigator as Unknown cause of death. Both were coded per MedDRA as General disorders and administration site conditions/Death.	EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Discomfort	General disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0021 events1 affected12 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Oedema peripheral	General disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Systemic inflammatory response syndrome	General disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Cytokine release syndrome	Immune system disorders	MedDRA 25.0	Systematic Assessment		EG0006 events2 affected40 at risk EG0011 events1 affected8 at risk EG0024 events3 affected12 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment		EG0002 events2 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Blood creatinine increased	Investigations	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Cardiopulmonary failure	Cardiac disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0011 events1 affected8 at risk EG0020 events0 affected12 at risk EG003
Myocarditis	Cardiac disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Right ventricular failure	Cardiac disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Biliary dilatation	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Pneumonia	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Sepsis	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0011 events1 affected8 at risk EG0020 events0 affected12 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
COVID-19	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Urosepsis	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Cachexia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected8 at risk EG0021 events1 affected12 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment		EG0001 events1 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphocyte count decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG00026 events17 affected40 at risk EG00110 events5 affected8 at risk EG00210 events4 affected12 at risk EG00314 events8 affected12 at risk EG00442 events21 affected54 at risk EG0059 events7 affected39 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG00023 events15 affected40 at risk EG0014 events3 affected8 at risk EG0021 events1 affected12 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG00022 events14 affected40 at risk EG0013 events2 affected8 at risk EG0021 events1 affected12 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0006 events5 affected40 at risk EG0013 events1 affected8 at risk EG0020 events0 affected12 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0003 events1 affected40 at risk EG0017 events2 affected8 at risk EG0025 events2 affected12 at risk EG003
Platelet count decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0004 events3 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Blood creatinine increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0005 events4 affected40 at risk EG0012 events1 affected8 at risk EG0022 events2 affected12 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG00011 events8 affected40 at risk EG0011 events1 affected8 at risk EG0021 events1 affected12 at risk EG003
Amylase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Weight decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0005 events5 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Lipase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0005 events4 affected40 at risk EG0011 events1 affected8 at risk EG0020 events0 affected12 at risk EG003
Hypotension	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG00011 events9 affected40 at risk EG0014 events2 affected8 at risk EG0027 events2 affected12 at risk EG003
Hypertension	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0004 events4 affected40 at risk EG0010 events0 affected8 at risk EG0022 events2 affected12 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected40 at risk EG0011 events1 affected8 at risk EG0020 events0 affected12 at risk EG003
Headache	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0006 events6 affected40 at risk EG0013 events1 affected8 at risk EG0025 events1 affected12 at risk EG003
Tremor	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0005 events4 affected40 at risk EG0011 events1 affected8 at risk EG0020 events0 affected12 at risk EG003
Pyrexia	General disorders	MedDRA 25.0	Systematic Assessment	EG000114 events26 affected40 at risk EG00140 events4 affected8 at risk EG00230 events10 affected12 at risk EG003
Chills	General disorders	MedDRA 25.0	Systematic Assessment	EG00020 events15 affected40 at risk EG00112 events3 affected8 at risk EG00211 events3 affected12 at risk EG003
Fatigue	General disorders	MedDRA 25.0	Systematic Assessment	EG00016 events15 affected40 at risk EG0011 events1 affected8 at risk EG0024 events3 affected12 at risk EG003
Injection site reaction	General disorders	MedDRA 25.0	Systematic Assessment	EG00048 events11 affected40 at risk EG0019 events3 affected8 at risk EG0023 events2 affected12 at risk EG003
Asthenia	General disorders	MedDRA 25.0	Systematic Assessment	EG00012 events12 affected40 at risk EG0011 events1 affected8 at risk EG0026 events4 affected12 at risk EG003
Oedema peripheral	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Chest pain	General disorders	MedDRA 25.0	Systematic Assessment	EG0005 events5 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG00023 events17 affected40 at risk EG0011 events1 affected8 at risk EG0023 events1 affected12 at risk EG003
Cytokine release syndrome	Immune system disorders	MedDRA 25.0	Systematic Assessment	EG00023 events6 affected40 at risk EG00110 events2 affected8 at risk EG0024 events2 affected12 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG00014 events11 affected40 at risk EG0010 events0 affected8 at risk EG0021 events1 affected12 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG00018 events10 affected40 at risk EG00119 events1 affected8 at risk EG0022 events2 affected12 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0008 events5 affected40 at risk EG0018 events1 affected8 at risk EG0021 events1 affected12 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected40 at risk EG0010 events0 affected8 at risk EG0022 events2 affected12 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0003 events2 affected40 at risk EG0011 events1 affected8 at risk EG0021 events1 affected12 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0007 events7 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0008 events6 affected40 at risk EG0010 events0 affected8 at risk EG0022 events1 affected12 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 25.0	Systematic Assessment	EG0004 events3 affected40 at risk EG0011 events1 affected8 at risk EG0021 events1 affected12 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0005 events5 affected40 at risk EG0013 events1 affected8 at risk EG0023 events1 affected12 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0004 events3 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected40 at risk EG0016 events1 affected8 at risk EG0021 events1 affected12 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG00012 events11 affected40 at risk EG0010 events0 affected8 at risk EG0021 events1 affected12 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0005 events5 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0002 events1 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0007 events7 affected40 at risk EG0010 events0 affected8 at risk EG0021 events1 affected12 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG00011 events6 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0005 events3 affected40 at risk EG0010 events0 affected8 at risk EG0020 events0 affected12 at risk EG003

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D015179	Colorectal Neoplasms
D006528	Carcinoma, Hepatocellular
D010051	Ovarian Neoplasms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D008113	Liver Neoplasms
D008107	Liver Diseases
D004701	Endocrine Gland Neoplasms
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D000091662	Genital Diseases
D004700	Endocrine System Diseases
D006058	Gonadal Disorders

ID	Title	Description
BG000	Non-small Cell Lung Cancer	Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
BG001	Colorectal Cancer	Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
BG002	Cutaneous Squamous Cell Carcinoma	Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
BG003	Hepatocellular Carcinoma	Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
BG004	Metastatic Castration-resistant Prostate Cancer	Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
BG005	Ovarian Cancer	Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
BG006	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Non-small Cell Lung Cancer	Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment	17	40	23	40	40	40
EG001	Colorectal Cancer	Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic	3	8	3	8	8	8
EG002	Cutaneous Squamous Cell Carcinoma	Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible	4	12	3	12	12	12
EG003	Hepatocellular Carcinoma	Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)	5	12	3	12	12	12
EG004	Metastatic Castration-resistant Prostate Cancer	Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent	24	55	28	54	54	54
EG005	Ovarian Cancer	Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months	21	39	28	39	39	39