Trial Outcomes & Findings for Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC (NCT NCT05814666)

NCT ID: NCT05814666

Last Updated: 2026-01-30

Results Overview

Determine the ORR (Partial response \[PR\] + CR defined according to RECIST v1.1) as determined by the Investigator for the combination of danvatirsen and pembrolizumab compared with pembrolizumab alone

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 69 participants
• Primary outcome timeframe: Up to 18 months
• Results posted on: 2026-01-30

Participant Flow

Enrollment was open from May 2023 through May 2025. Patients were recruited from community based practices, research institutions and universities located in the United States, United Kingdom and South Korea. An early assessment of response in patients with CPS ≥1 and <20 was performed and the response rate in this subgroup did not pass the minimum prespecified efficacy level, subsequently eligibility was restricted to patients with CPS ≥20.

From May 2023 through May 2025, 94 patients were screened, 69 met the eligibility criteria and were randomized. Of the 69 patients that started the treatment period (45 danvatirsen combination arm/24 pembrolizumab arm), 3 patients in the pembrolizumab arm discontinued the study before receiving treatment. 66 patients in total received treatment (45 danvatirsen combination/21 pembrolizumab)

Participant milestones

Measure	Danvatirsen Plus Pembrolizumab Danvatirsen dosing: Week 1: Danvatirsen intravenously (IV) on Days 1, 3, and 5 Week 2 and subsequent weeks: Danvatirsen IV weekly Pembrolizumab dosing: Pembrolizumab every 3 weeks after the Danvatirsen dose. Danvatirsen: Danvatirsen is a STAT3 targeting drug. Pembrolizumab: Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2	Pembrolizumab Pembrolizumab IV every 3 weeks Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2
Overall Study STARTED	45	24
Overall Study COMPLETED	34	14
Overall Study NOT COMPLETED	11	10

Reasons for withdrawal

Measure	Danvatirsen Plus Pembrolizumab Danvatirsen dosing: Week 1: Danvatirsen intravenously (IV) on Days 1, 3, and 5 Week 2 and subsequent weeks: Danvatirsen IV weekly Pembrolizumab dosing: Pembrolizumab every 3 weeks after the Danvatirsen dose. Danvatirsen: Danvatirsen is a STAT3 targeting drug. Pembrolizumab: Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2	Pembrolizumab Pembrolizumab IV every 3 weeks Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2
Overall Study Study terminated by Sponsor	11	7
Overall Study Patients withdrew prior to receiving study treatment	0	3

Baseline Characteristics

Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC

Baseline characteristics by cohort

Measure	Danvatirsen Plus Pembrolizumab n=45 Participants Danvatirsen dosing: Week 1: Danvatirsen intravenously (IV) on Days 1, 3, and 5 Week 2 and subsequent weeks: Danvatirsen IV weekly Pembrolizumab dosing: Pembrolizumab every 3 weeks after the Danvatirsen dose. Danvatirsen: Danvatirsen is a STAT3 targeting drug. Pembrolizumab: Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2	Pembrolizumab n=21 Participants Pembrolizumab IV every 3 weeks Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2	Total n=66 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=35 Participants	8 Participants n=4328 Participants	27 Participants n=8687 Participants
Age, Categorical >=65 years	26 Participants n=35 Participants	13 Participants n=4328 Participants	39 Participants n=8687 Participants
Age, Continuous	64.3 years STANDARD_DEVIATION 11.68 • n=35 Participants	65.7 years STANDARD_DEVIATION 9.35 • n=4328 Participants	64.7 years STANDARD_DEVIATION 10.94 • n=8687 Participants
Sex: Female, Male Female	11 Participants n=35 Participants	4 Participants n=4328 Participants	15 Participants n=8687 Participants
Sex: Female, Male Male	34 Participants n=35 Participants	17 Participants n=4328 Participants	51 Participants n=8687 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=35 Participants	1 Participants n=4328 Participants	4 Participants n=8687 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=35 Participants	19 Participants n=4328 Participants	60 Participants n=8687 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=35 Participants	1 Participants n=4328 Participants	2 Participants n=8687 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) Asian	13 Participants n=35 Participants	1 Participants n=4328 Participants	14 Participants n=8687 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) Black or African American	3 Participants n=35 Participants	1 Participants n=4328 Participants	4 Participants n=8687 Participants
Race (NIH/OMB) White	24 Participants n=35 Participants	18 Participants n=4328 Participants	42 Participants n=8687 Participants
Race (NIH/OMB) More than one race	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=35 Participants	1 Participants n=4328 Participants	6 Participants n=8687 Participants
Region of Enrollment South Korea	11 Participants n=35 Participants	0 Participants n=4328 Participants	11 Participants n=8687 Participants
Region of Enrollment United States	24 Participants n=35 Participants	18 Participants n=4328 Participants	42 Participants n=8687 Participants
Region of Enrollment United Kingdom	10 Participants n=35 Participants	3 Participants n=4328 Participants	13 Participants n=8687 Participants
PD-L1 Combined Positive Score (CPS) 1-19	12 Participants n=35 Participants	7 Participants n=4328 Participants	19 Participants n=8687 Participants
PD-L1 Combined Positive Score (CPS) >=20	33 Participants n=35 Participants	14 Participants n=4328 Participants	47 Participants n=8687 Participants
PD-L1 Combined Positive Score (CPS) 20-49	12 Participants n=35 Participants	6 Participants n=4328 Participants	18 Participants n=8687 Participants
PD-L1 Combined Positive Score (CPS) >=50	21 Participants n=35 Participants	8 Participants n=4328 Participants	29 Participants n=8687 Participants
Human Papillomavirus (HPV) Positive	11 Participants n=35 Participants	5 Participants n=4328 Participants	16 Participants n=8687 Participants
Human Papillomavirus (HPV) Negative	20 Participants n=35 Participants	6 Participants n=4328 Participants	26 Participants n=8687 Participants
Human Papillomavirus (HPV) Unknown	14 Participants n=35 Participants	10 Participants n=4328 Participants	24 Participants n=8687 Participants
Eastern Cooperative Group Performance Status (ECOG ECOG = 0	15 Participants n=35 Participants	7 Participants n=4328 Participants	22 Participants n=8687 Participants
Eastern Cooperative Group Performance Status (ECOG ECOG = 1	30 Participants n=35 Participants	14 Participants n=4328 Participants	44 Participants n=8687 Participants

PRIMARY outcome

Timeframe: Up to 18 months

Population: Will include all patients who receive at least 1 dose of study treatment based on the treatment assigned at randomization. 45 pts in the danvatirsen arm were randomized and received at least 1 dose of study treatment, 24 patients in the pembrolizumab arm were randomized however only 21 patients received at least one dose of study treatment.

Determine the ORR (Partial response [PR] + CR defined according to RECIST v1.1) as determined by the Investigator for the combination of danvatirsen and pembrolizumab compared with pembrolizumab alone

Outcome measures

Measure	Pembrolizumab n=21 Participants Pembrolizumab IV every 3 weeks Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2	Danvatirsen Plus Pembrolizumab n=45 Participants Danvatirsen dosing: Week 1: Danvatirsen intravenously (IV) on Days 1, 3, and 5 Week 2 and subsequent weeks: Danvatirsen IV weekly Pembrolizumab dosing: Pembrolizumab every 3 weeks after the Danvatirsen dose. Danvatirsen: Danvatirsen is a STAT3 targeting drug. Pembrolizumab: Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2
Confirmed ORR	3 Participants	7 Participants

SECONDARY outcome

Timeframe: Up to 18 months

Population: The Safety Analysis will include all patients who receive at least 1 dose of study treatment based on the actual treatment received. 45 pts in the danvatirsen arm were randomized and received at least 1 dose of study treatment, 24 patients in the pembrolizumab arm were randomized however only 21 patients received at least one dose of study treatment.

Adverse Events are assessed and graded according to Common Toxicity Criteria for Adverse Events (CTCAE) Version 5.0.

Outcome measures

Measure	Pembrolizumab n=21 Participants Pembrolizumab IV every 3 weeks Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2	Danvatirsen Plus Pembrolizumab n=45 Participants Danvatirsen dosing: Week 1: Danvatirsen intravenously (IV) on Days 1, 3, and 5 Week 2 and subsequent weeks: Danvatirsen IV weekly Pembrolizumab dosing: Pembrolizumab every 3 weeks after the Danvatirsen dose. Danvatirsen: Danvatirsen is a STAT3 targeting drug. Pembrolizumab: Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2
Number of Participants With Adverse Events as Assessed by CTCAE v5.0	10 Participants	37 Participants

SECONDARY outcome

Timeframe: Up to 18months

Population: Will include all patients who receive at least 1 dose of study treatment and whose best overall response was a CR or PR.

Duration of Response by RECIST v1.1

Outcome measures

Measure	Pembrolizumab n=3 Participants Pembrolizumab IV every 3 weeks Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2	Danvatirsen Plus Pembrolizumab n=7 Participants Danvatirsen dosing: Week 1: Danvatirsen intravenously (IV) on Days 1, 3, and 5 Week 2 and subsequent weeks: Danvatirsen IV weekly Pembrolizumab dosing: Pembrolizumab every 3 weeks after the Danvatirsen dose. Danvatirsen: Danvatirsen is a STAT3 targeting drug. Pembrolizumab: Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2
DOR	NA Months There were insufficient events to estimate the specific parameter	6.36 Months Interval 5.68 to There were insufficient events to estimate the specific parameter

SECONDARY outcome

Timeframe: Up to 18months

Population: Will include all patients that received at least 1 dose of study treatment. 45 pts in the danvatirsen arm were randomized and received at least 1 dose of study treatment, 24 patients in the pembrolizumab arm were randomized however only 21 patients received at least one dose of study treatment. DCR and CR rates will be determined in all patients and within patients with a CPS \>=20

Disease control rate and complete response rate by RECIST v1.1

Outcome measures

Measure	Pembrolizumab n=21 Participants Pembrolizumab IV every 3 weeks Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2	Danvatirsen Plus Pembrolizumab n=45 Participants Danvatirsen dosing: Week 1: Danvatirsen intravenously (IV) on Days 1, 3, and 5 Week 2 and subsequent weeks: Danvatirsen IV weekly Pembrolizumab dosing: Pembrolizumab every 3 weeks after the Danvatirsen dose. Danvatirsen: Danvatirsen is a STAT3 targeting drug. Pembrolizumab: Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2
DCR & CR Rate Disease Control Rate (DCR) in patients with a CPS>=20	9 Participants	15 Participants
DCR & CR Rate Complete Response (CR) Rate in all patients	0 Participants	1 Participants
DCR & CR Rate Complete Response (CR) Rate in patients with a CPS>=20	0 Participants	1 Participants
DCR & CR Rate Disease Control Rate (DCR) In all patients	12 Participants	21 Participants

SECONDARY outcome

Timeframe: Up to 18months

Population: Will include all patients who receive at least 1 dose of study treatment based on the treatment assigned at randomization. 45 pts in the danvatirsen arm were randomized and received at least 1 dose of study treatment, 24 patients in the pembrolizumab arm were randomized however only 21 patients received at least one dose of study treatment. ORR will be determined in patients with a CPS\< 20, CPS \>=20 and CPS\>=50.

Overall response rate per RECIST v1.1 in tumors with CPS< 20, CPS ≥ 20 and CPS ≥ 50

Outcome measures

Measure	Pembrolizumab n=21 Participants Pembrolizumab IV every 3 weeks Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2	Danvatirsen Plus Pembrolizumab n=45 Participants Danvatirsen dosing: Week 1: Danvatirsen intravenously (IV) on Days 1, 3, and 5 Week 2 and subsequent weeks: Danvatirsen IV weekly Pembrolizumab dosing: Pembrolizumab every 3 weeks after the Danvatirsen dose. Danvatirsen: Danvatirsen is a STAT3 targeting drug. Pembrolizumab: Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2
ORR in Tumors With CPS ≥20 and ≥ 50 In patients with a CPS>=50	3 Participants	4 Participants
ORR in Tumors With CPS ≥20 and ≥ 50 In patients with CPS<20	0 Participants	1 Participants
ORR in Tumors With CPS ≥20 and ≥ 50 In patients with a CPS>=20	3 Participants	6 Participants

SECONDARY outcome

Timeframe: Up to 18months

Population: Includes only patients that achieved a CR or PR. DOR is defined as the date of the patient's first best overall response of CR or PR to the earliest date of documented progression or to death if no prior evidence of disease progression.

Duration of response by RECIST v1.1 in tumors with CPS ≥ 20 and ≥50

Outcome measures

Measure	Pembrolizumab n=3 Participants Pembrolizumab IV every 3 weeks Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2	Danvatirsen Plus Pembrolizumab n=6 Participants Danvatirsen dosing: Week 1: Danvatirsen intravenously (IV) on Days 1, 3, and 5 Week 2 and subsequent weeks: Danvatirsen IV weekly Pembrolizumab dosing: Pembrolizumab every 3 weeks after the Danvatirsen dose. Danvatirsen: Danvatirsen is a STAT3 targeting drug. Pembrolizumab: Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2
DOR in Tumors With CPS ≥20 and ≥50 In patients with a CPS>=20	NA Months There were insufficient events to estimate the specific parameter	6.36 Months Interval 5.68 to There were insufficient events to estimate the specific parameter.
DOR in Tumors With CPS ≥20 and ≥50 In patients with a CPS>=50	NA Months There were insufficient events to estimate the specific parameter	7.03 Months There were insufficient events to estimate the specific parameter. Note that only 4 participants were analyzed, those with a response. Of the 4 responders only 1 had a non-censored value, while the other 3 remained as responders at the time of the analysis cut-off date. With only 1 non-censored value, there is no estimate of variability, and as a result, both confidence interval limits appear as NA.

SECONDARY outcome

Timeframe: Up to 18months

Population: PFS will be determined in all patients and in patients with a CPS\>=20 who receive at least 1 dose of study treatment.45 pts in the danvatirsen arm were randomized and received at least 1 dose of study treatment, 24 patients in the pembrolizumab arm were randomized however only 21 patients received at least one dose of study treatment.

Progression-free survival by RECIST v1.1, defined as the time from randomization to the first documentation of progressive disease (PD) or death from any cause, whichever comes first

Outcome measures

Measure	Pembrolizumab n=21 Participants Pembrolizumab IV every 3 weeks Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2	Danvatirsen Plus Pembrolizumab n=45 Participants Danvatirsen dosing: Week 1: Danvatirsen intravenously (IV) on Days 1, 3, and 5 Week 2 and subsequent weeks: Danvatirsen IV weekly Pembrolizumab dosing: Pembrolizumab every 3 weeks after the Danvatirsen dose. Danvatirsen: Danvatirsen is a STAT3 targeting drug. Pembrolizumab: Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2
PFS In all patients	2.92 Months Interval 1.41 to There were insufficient events to estimate the specific parameter	3.52 Months Interval 1.48 to 6.83
PFS In patients with a CPS>20	NA Months There were insufficient events to estimate the specific parameter	3.52 Months Interval 1.35 to 6.83

SECONDARY outcome

Timeframe: Up to 30months

Population: Data were not collected due to study termination prior to participants' assessment at the pre-specified time points

Overall survival, defined as time from randomization to death from any cause

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 18 months

Population: An interim analysis of the Overall Response Rate failed to demonstrate a clinical benefit of danvatirsen. As a result the study was terminated early, all development activities of danvatirsen were discontinued and the PK analysis was not performed. Samples were not analyzed for this pre-specified Outcome Measurement and have since been destroyed therefore no future analysis will occur.

Maximum concentration recorded [Cmax]of danvatirsen at defined timepoints in the combination regimen

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 18 months

Population: An interim analysis of the Overall Response Rate failed to demonstrate a clinical benefit of danvatirsen. As a result the study was terminated early, all development activities of danvatirsen were discontinued and the PK analysis was not performed. Samples were not analyzed for this pre-specified Outcome Measurement and have since been destroyed therefore no future analysis will occur.

Trough concentration [Ctrough] of danvatirsen at defined timepoints in the combination regimen

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 18 months

Population: An interim analysis of the Overall Response Rate failed to demonstrate a clinical benefit of danvatirsen. As a result the study was terminated early, all development activities of danvatirsen were discontinued and the PK analysis was not performed. Samples were not analyzed for this pre-specified Outcome Measurement and have since been destroyed therefore no future analysis will occur.

Area under the plasma concentration-time curve over the dosing interval [AUCtau] of danvatirsen at defined timepoints in the combination regimen

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 18 months

Population: An interim analysis of the Overall Response Rate failed to demonstrate a clinical benefit of danvatirsen. As a result the study was terminated early, all development activities of danvatirsen were discontinued and the PK analysis was not performed. Samples were not analyzed for this pre-specified Outcome Measurement and have since been destroyed therefore no future analysis will occur.

Time to maximum plasma concentration [Tmax]) after single and multiple doses at defined timepoints in the combination regimen

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 18 months

Population: An interim analysis of the Overall Response Rate failed to demonstrate a clinical benefit of danvatirsen. As a result the study was terminated early, all development activities of danvatirsen were discontinued and the ADA analysis was not performed. Samples were not analyzed for this pre-specified Outcome Measurement and have since been destroyed therefore no future analysis will occur.

Anti-danvatirsen antibody titers at defined timepoints in the combination regimen

Outcome measures

Outcome data not reported

Adverse Events

Danvatirsen Plus Pembrolizumab

Serious events: 25 serious events

Other events: 44 other events

Deaths: 8 deaths

Pembrolizumab

Serious events: 6 serious events

Other events: 18 other events

Deaths: 4 deaths

Serious adverse events

Measure	Danvatirsen Plus Pembrolizumab n=45 participants at risk Danvatirsen dosing: Week 1: Danvatirsen intravenously (IV) on Days 1, 3, and 5 Week 2 and subsequent weeks: Danvatirsen IV weekly Pembrolizumab dosing: Pembrolizumab every 3 weeks after the Danvatirsen dose. Danvatirsen: Danvatirsen is a STAT3 targeting drug. Pembrolizumab: Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2	Pembrolizumab n=21 participants at risk Pembrolizumab IV every 3 weeks after the Danvatirsen dose. Pembrolizumab: Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2
Blood and lymphatic system disorders Leukaemoid reaction	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Cardiac disorders Angina pectoris	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Cardiac disorders Atrial flutter	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Gastrointestinal disorders Colitis	2.2% 1/45 • Number of events 2 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Gastrointestinal disorders Dysphagia	4.4% 2/45 • Number of events 2 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Gastrointestinal disorders Abdominal pain	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Gastrointestinal disorders Abdominal wall haematoma	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Gastrointestinal disorders Gastric haemorrhage	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Gastrointestinal disorders Small intestinal perforation	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
General disorders Disease progression	6.7% 3/45 • Number of events 3 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	9.5% 2/21 • Number of events 2 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
General disorders Death	0.00% 0/45 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	4.8% 1/21 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
General disorders Multiple organ dysfunction syndrome	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
General disorders Swelling face	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Hepatobiliary disorders Hepatitis	4.4% 2/45 • Number of events 2 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Infections and infestations Pneumonia aspiration	6.7% 3/45 • Number of events 3 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	4.8% 1/21 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Infections and infestations Pneumonia	4.4% 2/45 • Number of events 3 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Infections and infestations Pneumonia klebsiella	2.2% 1/45 • Number of events 2 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Infections and infestations Sepsis	4.4% 2/45 • Number of events 2 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Infections and infestations Cellulitis	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Infections and infestations Escherichia bacteraemia	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Infections and infestations Escherichia pyelonephritis	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Injury, poisoning and procedural complications Tracheal haemorrhage	2.2% 1/45 • Number of events 2 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Injury, poisoning and procedural complications Fall	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Injury, poisoning and procedural complications Jaw fracture	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Injury, poisoning and procedural complications Toxicity to various agents	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Injury, poisoning and procedural complications Wrong product administered	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Investigations Alanine aminotransferase increased	6.7% 3/45 • Number of events 3 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Investigations Aspartate aminotransferase increased	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/45 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	4.8% 1/21 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/45 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	4.8% 1/21 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Musculoskeletal and connective tissue disorders Back pain	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	11.1% 5/45 • Number of events 5 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Nervous system disorders Embolic stroke	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Nervous system disorders Hemiparesis	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Nervous system disorders Lethargy	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Nervous system disorders Spinal cord compression	0.00% 0/45 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	4.8% 1/21 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Nervous system disorders Vasogenic cerebral oedema	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Psychiatric disorders Confusional state	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Psychiatric disorders Mental status changes	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Respiratory, thoracic and mediastinal disorders Pleural effusion	4.4% 2/45 • Number of events 2 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/45 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	4.8% 1/21 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/45 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	4.8% 1/21 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Respiratory, thoracic and mediastinal disorders Laryngeal obstruction	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Respiratory, thoracic and mediastinal disorders Tracheal inflammation	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Vascular disorders Deep vein thrombosis	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.

Other adverse events

Measure	Danvatirsen Plus Pembrolizumab n=45 participants at risk Danvatirsen dosing: Week 1: Danvatirsen intravenously (IV) on Days 1, 3, and 5 Week 2 and subsequent weeks: Danvatirsen IV weekly Pembrolizumab dosing: Pembrolizumab every 3 weeks after the Danvatirsen dose. Danvatirsen: Danvatirsen is a STAT3 targeting drug. Pembrolizumab: Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2	Pembrolizumab n=21 participants at risk Pembrolizumab IV every 3 weeks after the Danvatirsen dose. Pembrolizumab: Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2
Blood and lymphatic system disorders Anaemia	31.1% 14/45 • Number of events 40 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	19.0% 4/21 • Number of events 9 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Blood and lymphatic system disorders Thrombocytopenia	13.3% 6/45 • Number of events 12 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Blood and lymphatic system disorders Neutropenia	6.7% 3/45 • Number of events 11 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Endocrine disorders Hypothyroidism	11.1% 5/45 • Number of events 5 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	9.5% 2/21 • Number of events 2 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Gastrointestinal disorders Diarrhoea	20.0% 9/45 • Number of events 12 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	19.0% 4/21 • Number of events 4 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Gastrointestinal disorders Nausea	22.2% 10/45 • Number of events 12 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	4.8% 1/21 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Gastrointestinal disorders Constipation	22.2% 10/45 • Number of events 10 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	9.5% 2/21 • Number of events 2 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Gastrointestinal disorders Vomiting	15.6% 7/45 • Number of events 10 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	9.5% 2/21 • Number of events 2 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Gastrointestinal disorders Dysphagia	11.1% 5/45 • Number of events 6 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	9.5% 2/21 • Number of events 2 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Gastrointestinal disorders Dry mouth	11.1% 5/45 • Number of events 5 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	4.8% 1/21 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Gastrointestinal disorders Abdominal pain	11.1% 5/45 • Number of events 5 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
General disorders Fatigue	37.8% 17/45 • Number of events 25 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	38.1% 8/21 • Number of events 10 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
General disorders Pyrexia	6.7% 3/45 • Number of events 4 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
General disorders Secretion discharge	6.7% 3/45 • Number of events 3 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	4.8% 1/21 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
General disorders Asthenia	6.7% 3/45 • Number of events 3 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
General disorders Chills	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	9.5% 2/21 • Number of events 2 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
General disorders Disease Progression	6.7% 3/45 • Number of events 3 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	9.5% 2/21 • Number of events 2 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Hepatobiliary disorders Hepatitis	13.3% 6/45 • Number of events 10 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Infections and infestations Pneumonia	13.3% 6/45 • Number of events 8 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	4.8% 1/21 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Infections and infestations Urinary tract infection	6.7% 3/45 • Number of events 4 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Infections and infestations Pneumonia Aspiration	8.9% 4/45 • Number of events 6 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	4.8% 1/21 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Injury, poisoning and procedural complications Fall	4.4% 2/45 • Number of events 2 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	9.5% 2/21 • Number of events 2 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Investigations Alanine aminotransferase increased	42.2% 19/45 • Number of events 50 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Investigations Platelet count decreased	17.8% 8/45 • Number of events 32 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Investigations Aspartate aminotransferase increased	35.6% 16/45 • Number of events 30 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Investigations Weight decreased	6.7% 3/45 • Number of events 11 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	14.3% 3/21 • Number of events 3 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Investigations White blood cell count decreased	13.3% 6/45 • Number of events 10 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Investigations Neutrophil count decreased	11.1% 5/45 • Number of events 7 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Investigations Blood bilirubin increased	6.7% 3/45 • Number of events 4 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Metabolism and nutrition disorders Decreased appetite	8.9% 4/45 • Number of events 5 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	4.8% 1/21 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Metabolism and nutrition disorders Hypercalcaemia	6.7% 3/45 • Number of events 5 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Metabolism and nutrition disorders Hyponatraemia	8.9% 4/45 • Number of events 5 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Metabolism and nutrition disorders Hypokalaemia	6.7% 3/45 • Number of events 3 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Metabolism and nutrition disorders Dehydration	2.2% 1/45 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	9.5% 2/21 • Number of events 3 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Musculoskeletal and connective tissue disorders Arthralgia	17.8% 8/45 • Number of events 11 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Musculoskeletal and connective tissue disorders Back pain	13.3% 6/45 • Number of events 7 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	19.0% 4/21 • Number of events 4 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	13.3% 6/45 • Number of events 6 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	6.7% 3/45 • Number of events 3 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Nervous system disorders Headache	11.1% 5/45 • Number of events 5 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	4.8% 1/21 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Nervous system disorders Dizziness	6.7% 3/45 • Number of events 4 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	4.8% 1/21 • Number of events 1 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Nervous system disorders Dysgeusia	6.7% 3/45 • Number of events 4 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Psychiatric disorders Insomnia	8.9% 4/45 • Number of events 4 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	9.5% 2/21 • Number of events 2 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Respiratory, thoracic and mediastinal disorders Dyspnoea	13.3% 6/45 • Number of events 8 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	9.5% 2/21 • Number of events 2 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Respiratory, thoracic and mediastinal disorders Cough	8.9% 4/45 • Number of events 6 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	9.5% 2/21 • Number of events 2 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Respiratory, thoracic and mediastinal disorders Laryngeal pain	0.00% 0/45 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	9.5% 2/21 • Number of events 2 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.7% 3/45 • Number of events 3 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.7% 3/45 • Number of events 3 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Skin and subcutaneous tissue disorders Pruritus	11.1% 5/45 • Number of events 5 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/45 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	14.3% 3/21 • Number of events 3 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.00% 0/45 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	9.5% 2/21 • Number of events 2 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Skin and subcutaneous tissue disorders Rash maculo-papular	6.7% 3/45 • Number of events 3 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.
Vascular disorders Hypotension	6.7% 3/45 • Number of events 3 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.	0.00% 0/21 • Approximately 25 months AEs from first dose through 30 days after the last dose and 90 days after the last dose of pembrolizumab or until the patient began a new anticancer treatment were reported in the CRF. All AEs and SAEs that occur from the signing of the ICF until the first dose of study treatment were recorded in the CRF only if the event was related to a study procedure.

Additional Information

Chief Medical Officer

Flamingo Therapeutics

Phone: 484 482 0007

Email: clinical@flamingotx.com

Results disclosure agreements

• Principal investigator is a sponsor employee All data is owned by the Sponsor. Sponsor shall have right to first publication of the results of the Study. PI may publish after 18 months of study termination if no publication by the sponsor. Sponsor may have up to 120 days to review the publication and has the right for confidential information to be removed.
• Publication restrictions are in place

Restriction type: OTHER