Trial Outcomes & Findings for Study of Intratumoral (IT) Ulevostinag (MK-1454) in Combination With Intravenous (IV) Pembrolizumab (MK-3475) Compared to IV Pembrolizumab Alone as the First Line Treatment of Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) (MK-1454-002) (NCT NCT04220866)

NCT ID: NCT04220866

Last Updated: 2025-10-29

Results Overview

ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR was assessed by blinded independent central review (BICR), and the 95% confidence interval (CI) was based on the exact method for binomial data.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

Up to 913.0 days

Results posted on

2025-10-29

Participant Flow

Adults with a confirmed diagnosis of metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) with a tumor programmed cell death-1 ligand 1 (PD-L1) immunohistochemistry (IHC) combined positive scoring (CPS) ≥1 and had at least 1 measurable lesion that was amenable to intratumor (IT) injection were enrolled in this study.

Participant milestones

Participant milestones
Measure	Ulevostinag + Pembrolizumab Participants received ulevostinag 540 ug via intratumoral (IT) injection on Day 1 of every week for two 3-week cycles (Cycles 1-2), then on Day 1 of each 3-week cycle for up 33 cycles (Cycles 3-35), for a total of 35 cycles PLUS pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles. The total duration of treatment was up to approximately 2 years.	Pembrolizumab Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles. The total duration of treatment is up to approximately 2 years.
Overall Study STARTED	8	10
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	8	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Ulevostinag + Pembrolizumab Participants received ulevostinag 540 ug via intratumoral (IT) injection on Day 1 of every week for two 3-week cycles (Cycles 1-2), then on Day 1 of each 3-week cycle for up 33 cycles (Cycles 3-35), for a total of 35 cycles PLUS pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles. The total duration of treatment was up to approximately 2 years.	Pembrolizumab Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles. The total duration of treatment is up to approximately 2 years.
Overall Study Death	4	5
Overall Study Participation at the site terminated By Sponsor	2	0
Overall Study Participation in the study terminated By Sponsor	2	4
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Study of Intratumoral (IT) Ulevostinag (MK-1454) in Combination With Intravenous (IV) Pembrolizumab (MK-3475) Compared to IV Pembrolizumab Alone as the First Line Treatment of Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) (MK-1454-002)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ulevostinag + Pembrolizumab n=8 Participants Participants received ulevostinag 540 ug via IT injection on Day 1 of every week for two 3-week cycles (Cycles 1-2), then on Day 1 of each 3-week cycle for up 33 cycles (Cycles 3-35), for a total of 35 cycles PLUS pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles. The total duration of treatment was up to approximately 2 years.	Pembrolizumab n=10 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles. The total duration of treatment is up to approximately 2 years.	Total n=18 Participants Total of all reporting groups
Age, Continuous	65.3 Years STANDARD_DEVIATION 9.8 • n=5 Participants	59.8 Years STANDARD_DEVIATION 9.8 • n=7 Participants	62.2 Years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 913.0 days

Population: All randomized participants based on the treatment arm to which they were randomized.

Outcome measures

Outcome measures
Measure	Ulevostinag + Pembrolizumab n=8 Participants Participants received ulevostinag 540 ug via IT injection on Day 1 of every week for two 3-week cycles (Cycles 1-2), then on Day 1 of each 3-week cycle for up 33 cycles (Cycles 3-35), for a total of 35 cycles PLUS pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles. The total duration of treatment was up to approximately 2 years.	Pembrolizumab n=10 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles. The total duration of treatment is up to approximately 2 years.
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	50.0 Percentage of participants Interval 15.7 to 84.3	10.0 Percentage of participants Interval 0.3 to 44.5

SECONDARY outcome

Timeframe: Up to 913.0 days

Population: All randomized participants based on the treatment arm to which they were randomized.

PFS was defined as the time from randomization to the first documented progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. PFS was assessed by BICR and was based on the product-limit (Kaplan-Meier) method for censored data.

Outcome measures

Outcome measures
Measure	Ulevostinag + Pembrolizumab n=8 Participants Participants received ulevostinag 540 ug via IT injection on Day 1 of every week for two 3-week cycles (Cycles 1-2), then on Day 1 of each 3-week cycle for up 33 cycles (Cycles 3-35), for a total of 35 cycles PLUS pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles. The total duration of treatment was up to approximately 2 years.	Pembrolizumab n=10 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles. The total duration of treatment is up to approximately 2 years.
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	6.4 Months Interval 1.0 to NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	1.5 Months Interval 0.5 to NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.

SECONDARY outcome

Timeframe: Up to 913.0 days

Population: All randomized participants based on the treatment arm to which they were randomized.

DOR was defined as the time from the first documented evidence of a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 until Progressive Disease (PD) or death due to any cause, whichever occurs first, in participants demonstrating a CR or PR. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR was based on the product-limit (Kaplan-Meier) method for censored data.

Outcome measures

Outcome measures
Measure	Ulevostinag + Pembrolizumab n=8 Participants Participants received ulevostinag 540 ug via IT injection on Day 1 of every week for two 3-week cycles (Cycles 1-2), then on Day 1 of each 3-week cycle for up 33 cycles (Cycles 3-35), for a total of 35 cycles PLUS pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles. The total duration of treatment was up to approximately 2 years.	Pembrolizumab n=10 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles. The total duration of treatment is up to approximately 2 years.
Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	NA Months Interval 4.2 to 30.4 NA = Median not reached at time of data cut-off due to insufficient number of responding participants with relapse.	NA Months Interval 1.4 to 1.4 NA = Median, not reached at time of data cut-off due to insufficient number of responding participants with relapse.

SECONDARY outcome

Timeframe: Up to 913.0 days

Population: All randomized participants based on the treatment arm to which they were randomized.

OS is defined as the time from randomization to the date of death from any cause, and is based on the product-limit (Kaplan-Meier) method for censored data.

Outcome measures

Outcome measures
Measure	Ulevostinag + Pembrolizumab n=8 Participants Participants received ulevostinag 540 ug via IT injection on Day 1 of every week for two 3-week cycles (Cycles 1-2), then on Day 1 of each 3-week cycle for up 33 cycles (Cycles 3-35), for a total of 35 cycles PLUS pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles. The total duration of treatment was up to approximately 2 years.	Pembrolizumab n=10 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles. The total duration of treatment is up to approximately 2 years.
Overall Survival (OS)	NA Months Interval 1.0 to NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	11.1 Months Interval 0.8 to NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.

SECONDARY outcome

Timeframe: Up to 913.0 days

Population: All randomized participants who received at least 1 dose of study treatment.

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Outcome measures

Outcome measures
Measure	Ulevostinag + Pembrolizumab n=8 Participants Participants received ulevostinag 540 ug via IT injection on Day 1 of every week for two 3-week cycles (Cycles 1-2), then on Day 1 of each 3-week cycle for up 33 cycles (Cycles 3-35), for a total of 35 cycles PLUS pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles. The total duration of treatment was up to approximately 2 years.	Pembrolizumab n=10 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles. The total duration of treatment is up to approximately 2 years.
Number of Participants Who Experienced an Adverse Event (AE)	8 Participants	10 Participants

SECONDARY outcome

Timeframe: Up to approximately 715.0 days

Population: All randomized participants who received at least 1 dose of study treatment.

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Outcome measures

Outcome measures
Measure	Ulevostinag + Pembrolizumab n=8 Participants Participants received ulevostinag 540 ug via IT injection on Day 1 of every week for two 3-week cycles (Cycles 1-2), then on Day 1 of each 3-week cycle for up 33 cycles (Cycles 3-35), for a total of 35 cycles PLUS pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles. The total duration of treatment was up to approximately 2 years.	Pembrolizumab n=10 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles. The total duration of treatment is up to approximately 2 years.
Number of Participants Discontinuing Study Treatment Due to an AE	3 Participants	2 Participants

Adverse Events

Ulevostinag + Pembrolizumab

Serious events: 5 serious events

Other events: 8 other events

Deaths: 4 deaths

Pembrolizumab

Serious events: 4 serious events

Other events: 9 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Publication restrictions are in place

Restriction type: OTHER

Measure	Ulevostinag + Pembrolizumab n=8 participants at risk Participants received ulevostinag 540 ug via IT injection on Day 1 of every week for two 3-week cycles (Cycles 1-2), then on Day 1 of each 3-week cycle for up 33 cycles (Cycles 3-35), for a total of 35 cycles PLUS pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles. The total duration of treatment was up to approximately 2 years.	Pembrolizumab n=10 participants at risk Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles. The total duration of treatment is up to approximately 2 years.
Cardiac disorders Pericarditis	12.5% 1/8 • Number of events 1 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Constipation	12.5% 1/8 • Number of events 1 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Injection site ulcer	12.5% 1/8 • Number of events 1 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Pyrexia	12.5% 1/8 • Number of events 1 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations COVID-19 pneumonia	0.00% 0/8 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Pneumonia aspiration	12.5% 1/8 • Number of events 1 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Sepsis	12.5% 1/8 • Number of events 1 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Injury, poisoning and procedural complications Injection related reaction	12.5% 1/8 • Number of events 1 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Injury, poisoning and procedural complications Wound haemorrhage	12.5% 1/8 • Number of events 1 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/8 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Carotid artery aneurysm	12.5% 1/8 • Number of events 1 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	12.5% 1/8 • Number of events 1 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/8 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/8 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 1/10 • Number of events 1 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Pneumonitis aspiration	12.5% 1/8 • Number of events 1 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/10 • Adverse Events (AEs): from first treatment up to 913.0 days. All Cause Mortality (ACM): from randomization up to 913.0 days.: The population analyzed for ACM consisted of all randomized participants. The population for AEs consisted of all randomized participants who received at least1 dose of study treatment. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.