Trial Outcomes & Findings for A Study of Setanaxib Co-Administered With Pembrolizumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN) (NCT NCT05323656)
NCT ID: NCT05323656
Last Updated: 2025-09-02
Results Overview
Defined as the best percentage change from Baseline in the sum of diameters of target lesions, as assessed by RECIST v1.1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
Baseline to at least 15 weeks and up to 51 weeks
Results posted on
2025-09-02
Participant Flow
Participant milestones
| Measure |
Setanaxib 1600 mg and Pembrolizumab 200 mg
Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Setanaxib: Oral tablets, 400 mg per tablet
Pembrolizumab: 200 mg IV infusion
|
Placebo and Pembrolizumab 200 mg
Participants will be administered placebo for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Placebo: Oral tablets
Pembrolizumab: 200 mg IV infusion
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
28
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
26
|
27
|
Reasons for withdrawal
| Measure |
Setanaxib 1600 mg and Pembrolizumab 200 mg
Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Setanaxib: Oral tablets, 400 mg per tablet
Pembrolizumab: 200 mg IV infusion
|
Placebo and Pembrolizumab 200 mg
Participants will be administered placebo for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Placebo: Oral tablets
Pembrolizumab: 200 mg IV infusion
|
|---|---|---|
|
Overall Study
Still On-Treatment
|
6
|
6
|
|
Overall Study
Progressive Disease
|
15
|
14
|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Clinical disease progression
|
0
|
1
|
|
Overall Study
Patient and Investigator decision
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
A Study of Setanaxib Co-Administered With Pembrolizumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)
Baseline characteristics by cohort
| Measure |
Setanaxib 1600 mg and Pembrolizumab 200 mg
n=27 Participants
Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Setanaxib: Oral tablets, 400 mg per tablet
Pembrolizumab: 200 mg IV infusion
|
Placebo and Pembrolizumab 200 mg
n=28 Participants
Participants will be administered placebo for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Placebo: Oral tablets
Pembrolizumab: 200 mg IV infusion
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 10 • n=99 Participants
|
65.0 years
STANDARD_DEVIATION 10.54 • n=107 Participants
|
64.8 years
STANDARD_DEVIATION 10.19 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Human papillomavirus (HPV) Status
Positive
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Human papillomavirus (HPV) Status
Negative
|
22 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to at least 15 weeks and up to 51 weeksPopulation: Full Analysis Set
Defined as the best percentage change from Baseline in the sum of diameters of target lesions, as assessed by RECIST v1.1.
Outcome measures
| Measure |
Setanaxib 1600 mg and Pembrolizumab 200 mg
n=26 Participants
Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Setanaxib: Oral tablets, 400 mg per tablet
Pembrolizumab: 200 mg IV infusion
|
Placebo and Pembrolizumab 200 mg
n=28 Participants
Participants will be administered placebo for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Placebo: Oral tablets
Pembrolizumab: 200 mg IV infusion
|
|---|---|---|
|
Best Percentage Change in Tumour Size
|
-7.88 Percentage change from baseline
Standard Error 9.323
|
-12.93 Percentage change from baseline
Standard Error 8.977
|
SECONDARY outcome
Timeframe: Baseline up to approximately 21 monthsPopulation: Full Analysis Set
Defined as time from randomisation to the first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Setanaxib 1600 mg and Pembrolizumab 200 mg
n=27 Participants
Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Setanaxib: Oral tablets, 400 mg per tablet
Pembrolizumab: 200 mg IV infusion
|
Placebo and Pembrolizumab 200 mg
n=28 Participants
Participants will be administered placebo for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Placebo: Oral tablets
Pembrolizumab: 200 mg IV infusion
|
|---|---|---|
|
Progression Free Survival (PFS)
|
151 days
Interval 125.0 to 229.0
|
87 days
Interval 65.0 to 117.0
|
SECONDARY outcome
Timeframe: Baseline up to approximately 9 weeksPopulation: Full Analysis Set
Changes within treatment groups (ie, across paired tissue samples) and between treatment groups summarized both descriptively and as adjusted mean difference between treatment groups.
Outcome measures
| Measure |
Setanaxib 1600 mg and Pembrolizumab 200 mg
n=12 Participants
Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Setanaxib: Oral tablets, 400 mg per tablet
Pembrolizumab: 200 mg IV infusion
|
Placebo and Pembrolizumab 200 mg
n=10 Participants
Participants will be administered placebo for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Placebo: Oral tablets
Pembrolizumab: 200 mg IV infusion
|
|---|---|---|
|
Change From Baseline in Cancer-associated Fibroblasts (CAFs) Level in Tumour Tissue
Baseline
|
58.13 % positivity of tumour stromal component
Standard Deviation 37.006
|
52.00 % positivity of tumour stromal component
Standard Deviation 23.357
|
|
Change From Baseline in Cancer-associated Fibroblasts (CAFs) Level in Tumour Tissue
Week 9
|
50.50 % positivity of tumour stromal component
Standard Deviation 31.023
|
36.50 % positivity of tumour stromal component
Standard Deviation 30.373
|
SECONDARY outcome
Timeframe: Baseline up to approximately 9 weeksPopulation: Full Analysis Set)
Changes within treatment groups (ie, across paired tissue samples) and between treatment groups summarized both descriptively and as adjusted mean difference between treatment groups.
Outcome measures
| Measure |
Setanaxib 1600 mg and Pembrolizumab 200 mg
n=11 Participants
Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Setanaxib: Oral tablets, 400 mg per tablet
Pembrolizumab: 200 mg IV infusion
|
Placebo and Pembrolizumab 200 mg
n=8 Participants
Participants will be administered placebo for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Placebo: Oral tablets
Pembrolizumab: 200 mg IV infusion
|
|---|---|---|
|
Change From Baseline in the Number of Cluster of Differentiation 8 (CD8+) Tumour Infiltrating Lymphocytes (TILs) in Tumour Tissue
Baseline
|
18.13 cells/High Power Field (HPF)
Standard Deviation 8.901
|
21.34 cells/High Power Field (HPF)
Standard Deviation 19.789
|
|
Change From Baseline in the Number of Cluster of Differentiation 8 (CD8+) Tumour Infiltrating Lymphocytes (TILs) in Tumour Tissue
Week 9
|
41.14 cells/High Power Field (HPF)
Standard Deviation 34.535
|
38.30 cells/High Power Field (HPF)
Standard Deviation 26.553
|
SECONDARY outcome
Timeframe: Baseline up to approximately 9 weeksChanges within treatment groups (ie, across paired tissue samples) and between treatment groups summarized both descriptively and as adjusted mean difference between treatment groups.
Outcome measures
| Measure |
Setanaxib 1600 mg and Pembrolizumab 200 mg
n=11 Participants
Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Setanaxib: Oral tablets, 400 mg per tablet
Pembrolizumab: 200 mg IV infusion
|
Placebo and Pembrolizumab 200 mg
n=8 Participants
Participants will be administered placebo for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Placebo: Oral tablets
Pembrolizumab: 200 mg IV infusion
|
|---|---|---|
|
Change From Baseline in the Number of Regulatory T-cells in Tumour Tissue
Baseline
|
9.75 cells/High Power Field (HPF)
Standard Deviation 9.955
|
24.36 cells/High Power Field (HPF)
Standard Deviation 27.104
|
|
Change From Baseline in the Number of Regulatory T-cells in Tumour Tissue
Week 9
|
21.14 cells/High Power Field (HPF)
Standard Deviation 22.879
|
30.16 cells/High Power Field (HPF)
Standard Deviation 38.866
|
SECONDARY outcome
Timeframe: Baseline up to approximately 12 monthsPopulation: Full Analysis Set
Proportion of the patients who have a complete response (CR) or partial response (PR) per RECIST v1.1 will be used to access ORR.
Outcome measures
| Measure |
Setanaxib 1600 mg and Pembrolizumab 200 mg
n=27 Participants
Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Setanaxib: Oral tablets, 400 mg per tablet
Pembrolizumab: 200 mg IV infusion
|
Placebo and Pembrolizumab 200 mg
n=28 Participants
Participants will be administered placebo for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Placebo: Oral tablets
Pembrolizumab: 200 mg IV infusion
|
|---|---|---|
|
Overall Response Rate (ORR)
Complete Response
|
1 Participants
|
0 Participants
|
|
Overall Response Rate (ORR)
Partial Response
|
8 Participants
|
9 Participants
|
|
Overall Response Rate (ORR)
Stable Disease
|
10 Participants
|
5 Participants
|
|
Overall Response Rate (ORR)
Progressive Disease
|
7 Participants
|
14 Participants
|
|
Overall Response Rate (ORR)
Not Evaluable
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to approximately 12 monthsPopulation: Full Analysis Set
The minimum time when CR or PR is first observed to the time of progression of disease (PD) or death will be used to access DoR.
Outcome measures
| Measure |
Setanaxib 1600 mg and Pembrolizumab 200 mg
n=27 Participants
Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Setanaxib: Oral tablets, 400 mg per tablet
Pembrolizumab: 200 mg IV infusion
|
Placebo and Pembrolizumab 200 mg
n=28 Participants
Participants will be administered placebo for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Placebo: Oral tablets
Pembrolizumab: 200 mg IV infusion
|
|---|---|---|
|
Duration of Response (DoR)
Duration of Response 25% Percentile
|
170 days
Interval 64.0 to
Insufficient number of participants with events
|
46 days
Interval 43.0 to 79.0
|
|
Duration of Response (DoR)
Duration of Response 50% Percentile
|
NA days
Interval 170.0 to
Insufficient number of participants with events
|
79 days
Interval 49.0 to
Insufficient number of participants with events
|
|
Duration of Response (DoR)
Duration of Response 75% Percentile
|
NA days
Interval 170.0 to
Insufficient number of participants with events
|
300 days
Interval 79.0 to
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Baseline up to approximately 12 monthsPopulation: Full Analysis Set
Proportion of the patients in whom the best overall response is determined as CR, PR, or stable disease (SD) per RECIST v1.1 will be used to access DCR.
Outcome measures
| Measure |
Setanaxib 1600 mg and Pembrolizumab 200 mg
n=27 Participants
Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Setanaxib: Oral tablets, 400 mg per tablet
Pembrolizumab: 200 mg IV infusion
|
Placebo and Pembrolizumab 200 mg
n=28 Participants
Participants will be administered placebo for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Placebo: Oral tablets
Pembrolizumab: 200 mg IV infusion
|
|---|---|---|
|
Disease Control Rate (DCR)
|
70.4 percentage of participants
Interval 54.5 to 82.5
|
50 percentage of participants
Interval 35.2 to 64.8
|
SECONDARY outcome
Timeframe: Baseline up to 12 monthsPopulation: Full Analysis Set
Defined as the time from randomisation to death due to any cause. Patients without documented death at the time of the final analysis will be censored at the date of the last follow-up.
Outcome measures
| Measure |
Setanaxib 1600 mg and Pembrolizumab 200 mg
n=27 Participants
Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Setanaxib: Oral tablets, 400 mg per tablet
Pembrolizumab: 200 mg IV infusion
|
Placebo and Pembrolizumab 200 mg
n=28 Participants
Participants will be administered placebo for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Placebo: Oral tablets
Pembrolizumab: 200 mg IV infusion
|
|---|---|---|
|
Overall Survival (OS)
3 Months
|
96 percentage of participants
Interval 91.3 to 100.0
|
79 percentage of participants
Interval 68.6 to 88.5
|
|
Overall Survival (OS)
6 Months
|
92 percentage of participants
Interval 85.6 to 99.0
|
68 percentage of participants
Interval 56.5 to 79.2
|
|
Overall Survival (OS)
9 Months
|
88 percentage of participants
Interval 79.1 to 96.3
|
58 percentage of participants
Interval 45.9 to 71.0
|
|
Overall Survival (OS)
12 Months
|
46 percentage of participants
Interval 19.4 to 72.5
|
42 percentage of participants
Interval 26.0 to 58.2
|
SECONDARY outcome
Timeframe: Baseline up to approximately 21 monthsPopulation: Safety Analysis Set
Any clinically significant abnormalities in vital signs, physical examination, clinical laboratory tests (including biochemistry, hematology, urinalysis, and thyroid function), or 12- lead electrocardiogram (ECG) results will be recorded as Adverse Events (AEs).
Outcome measures
| Measure |
Setanaxib 1600 mg and Pembrolizumab 200 mg
n=27 Participants
Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Setanaxib: Oral tablets, 400 mg per tablet
Pembrolizumab: 200 mg IV infusion
|
Placebo and Pembrolizumab 200 mg
n=28 Participants
Participants will be administered placebo for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Placebo: Oral tablets
Pembrolizumab: 200 mg IV infusion
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
27 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Baseline up to approximately 21 monthsPopulation: Safety Analysis Set
AESI include Anaemia and Hypothyroidism.
Outcome measures
| Measure |
Setanaxib 1600 mg and Pembrolizumab 200 mg
n=27 Participants
Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Setanaxib: Oral tablets, 400 mg per tablet
Pembrolizumab: 200 mg IV infusion
|
Placebo and Pembrolizumab 200 mg
n=28 Participants
Participants will be administered placebo for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Placebo: Oral tablets
Pembrolizumab: 200 mg IV infusion
|
|---|---|---|
|
Number of Participants With Adverse Events of Special Interest (AESI)
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline up to approximately 9 weeksPopulation: Full Analysis Set
Combined Positive Score (CPS) is a scoring method that predicts response to pembrolizumab in patients with cancer defined as the number of PD-L1-staining cells (tumor cells, lymphocytes, and macrophages) relative to the total number of viable tumor cells. A higher CPS score indicates an increased likelihood to respond to pembrolizumab treatment. It was hypothesized based on the mode of action of setanaxib that there would be an increased immunological response and therefore an increase in PD-L1 in tumor tissue. Changes within treatment groups (ie, across paired tissue samples) and between treatment groups summarized both descriptively and as adjusted mean difference between treatment groups.
Outcome measures
| Measure |
Setanaxib 1600 mg and Pembrolizumab 200 mg
n=11 Participants
Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Setanaxib: Oral tablets, 400 mg per tablet
Pembrolizumab: 200 mg IV infusion
|
Placebo and Pembrolizumab 200 mg
n=7 Participants
Participants will be administered placebo for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Placebo: Oral tablets
Pembrolizumab: 200 mg IV infusion
|
|---|---|---|
|
Levels of Programmed Death-ligand 1 (PD-L1) Expression in Tumour Tissue
Week 9
|
42.27 ratio
Standard Deviation 37.641
|
18.57 ratio
Standard Deviation 15.999
|
|
Levels of Programmed Death-ligand 1 (PD-L1) Expression in Tumour Tissue
Baseline
|
19.73 ratio
Standard Deviation 29.408
|
13.14 ratio
Standard Deviation 25.149
|
SECONDARY outcome
Timeframe: Baseline up to approximately 9 weeksPopulation: Full Analysis Set with paired observations
Digital cytometry was carried out using CIBERSORTx. This estimates cell type abundance based on gene expression profiles in bulk RNA-Seq data. The abundance of myofibroblastic CAF were enumerated using a custom signature matrix based on gene expression profiles derived from annotated SCCHN scRNA-Seq data. CIBERSORTx Absolute Abundance ratio is calculated by the median expression level of all genes in the signature matrix divided by the median expression level of all genes in the mixture (bulk RNA-Seq data for the sample). This produces a score that quantitatively measures the overall abundance of each cell type using gene expression profiles.
Outcome measures
| Measure |
Setanaxib 1600 mg and Pembrolizumab 200 mg
n=12 Participants
Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Setanaxib: Oral tablets, 400 mg per tablet
Pembrolizumab: 200 mg IV infusion
|
Placebo and Pembrolizumab 200 mg
n=11 Participants
Participants will be administered placebo for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Placebo: Oral tablets
Pembrolizumab: 200 mg IV infusion
|
|---|---|---|
|
Change From Baseline in CAFs Cell Type Abundance Based on Gene Expression Profiles
Screening
|
0.87 CIBERSORTx Absolute Abundance ratio
Standard Deviation 0.880
|
0.74 CIBERSORTx Absolute Abundance ratio
Standard Deviation 0.787
|
|
Change From Baseline in CAFs Cell Type Abundance Based on Gene Expression Profiles
Week 9
|
0.98 CIBERSORTx Absolute Abundance ratio
Standard Deviation 0.990
|
0.56 CIBERSORTx Absolute Abundance ratio
Standard Deviation 0.581
|
SECONDARY outcome
Timeframe: Baseline up to approximately 9 weeksPopulation: Full Analysis Set with paired observations
Digital cytometry was carried out using CIBERSORTx. This estimates cell type abundance based on gene expression profiles in bulk RNA-Seq data. The abundance of tumor-infiltrating lymphocytes (TILs) were enumerated using a custom signature matrix based on gene expression profiles derived from annotated SCCHN scRNA-Seq data. CIBERSORTx Absolute Abundance ratio is calculated by the median expression level of all genes in the signature matrix divided by the median expression level of all genes in the mixture (bulk RNA-Seq data for the sample). This produces a score that quantitatively measures the overall abundance of each cell type using gene expression profiles.
Outcome measures
| Measure |
Setanaxib 1600 mg and Pembrolizumab 200 mg
n=12 Participants
Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Setanaxib: Oral tablets, 400 mg per tablet
Pembrolizumab: 200 mg IV infusion
|
Placebo and Pembrolizumab 200 mg
n=11 Participants
Participants will be administered placebo for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Placebo: Oral tablets
Pembrolizumab: 200 mg IV infusion
|
|---|---|---|
|
Change From Baseline in CD8+ TILs Cell Type Abundance Based on Gene Expression Profiles
Screening
|
0.03 CIBERSORTx Absolute Abundance ratio
Standard Deviation 0.030
|
0.04 CIBERSORTx Absolute Abundance ratio
Standard Deviation 0.044
|
|
Change From Baseline in CD8+ TILs Cell Type Abundance Based on Gene Expression Profiles
Week 9
|
0.07 CIBERSORTx Absolute Abundance ratio
Standard Deviation 0.063
|
0.02 CIBERSORTx Absolute Abundance ratio
Standard Deviation 0.033
|
SECONDARY outcome
Timeframe: Baseline up to approximately 9 weeksPopulation: Full Analysis Set with paired observations
Digital cytometry was carried out using CIBERSORTx. This estimates cell type abundance based on gene expression profiles in bulk RNA-Seq data. The abundance of regulatory T-cells were enumerated using a custom signature matrix based on gene expression profiles derived from annotated SCCHN scRNA-Seq data. CIBERSORTx Absolute Abundance ratio is calculated by the median expression level of all genes in the signature matrix divided by the median expression level of all genes in the mixture (bulk RNA-Seq data for the sample). This produces a score that quantitatively measures the overall abundance of each cell type using gene expression profiles.
Outcome measures
| Measure |
Setanaxib 1600 mg and Pembrolizumab 200 mg
n=12 Participants
Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Setanaxib: Oral tablets, 400 mg per tablet
Pembrolizumab: 200 mg IV infusion
|
Placebo and Pembrolizumab 200 mg
n=11 Participants
Participants will be administered placebo for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Placebo: Oral tablets
Pembrolizumab: 200 mg IV infusion
|
|---|---|---|
|
Change From Baseline in Regulatory T-cell Abundance Based on Gene Expression Profiles
Screening
|
0.01 CIBERSORTx Absolute Abundance ratio
Standard Deviation 0.012
|
0.02 CIBERSORTx Absolute Abundance ratio
Standard Deviation 0.033
|
|
Change From Baseline in Regulatory T-cell Abundance Based on Gene Expression Profiles
Week 9
|
0.01 CIBERSORTx Absolute Abundance ratio
Standard Deviation 0.016
|
0.03 CIBERSORTx Absolute Abundance ratio
Standard Deviation 0.054
|
SECONDARY outcome
Timeframe: Baseline, Week 3, week 9, week 24, week 51Population: PK analysis set
Outcome measures
| Measure |
Setanaxib 1600 mg and Pembrolizumab 200 mg
n=27 Participants
Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Setanaxib: Oral tablets, 400 mg per tablet
Pembrolizumab: 200 mg IV infusion
|
Placebo and Pembrolizumab 200 mg
Participants will be administered placebo for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Placebo: Oral tablets
Pembrolizumab: 200 mg IV infusion
|
|---|---|---|
|
Area Under The Concentration-time Curve Over a 24-hour Period at Steady State (AUC[0-24]-ss) of Setanaxib
|
240.41 ug*h*mL-¹
Geometric Coefficient of Variation 28.86
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 3, week 9, week 24, week 51Population: PK analysis set
Outcome measures
| Measure |
Setanaxib 1600 mg and Pembrolizumab 200 mg
n=27 Participants
Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Setanaxib: Oral tablets, 400 mg per tablet
Pembrolizumab: 200 mg IV infusion
|
Placebo and Pembrolizumab 200 mg
Participants will be administered placebo for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Placebo: Oral tablets
Pembrolizumab: 200 mg IV infusion
|
|---|---|---|
|
Area Under The Concentration-time Curve Over a 24-hour Period at Steady State (AUC24-ss) of GKT138184
|
50.2 ug*h*mL-¹
Geometric Coefficient of Variation 41.49
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 3, week 9, week 24, week 51Population: PK analysis set
Outcome measures
| Measure |
Setanaxib 1600 mg and Pembrolizumab 200 mg
n=27 Participants
Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Setanaxib: Oral tablets, 400 mg per tablet
Pembrolizumab: 200 mg IV infusion
|
Placebo and Pembrolizumab 200 mg
Participants will be administered placebo for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Placebo: Oral tablets
Pembrolizumab: 200 mg IV infusion
|
|---|---|---|
|
Minimum Plasma Concentration at Steady State (Cmax-ss) of Setanaxib
|
2.14 ug*mL-¹
Geometric Coefficient of Variation 85.71
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 3, week 9, week 24, week 51Population: PK analysis set
Outcome measures
| Measure |
Setanaxib 1600 mg and Pembrolizumab 200 mg
n=27 Participants
Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Setanaxib: Oral tablets, 400 mg per tablet
Pembrolizumab: 200 mg IV infusion
|
Placebo and Pembrolizumab 200 mg
Participants will be administered placebo for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Placebo: Oral tablets
Pembrolizumab: 200 mg IV infusion
|
|---|---|---|
|
Minimum Plasma Concentration at Steady State (Cmin-ss) of GKT138184
|
0.76 ug*mL-¹
Geometric Coefficient of Variation 68.98
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 3, week 9, week 24, week 51Population: PK analysis set
Outcome measures
| Measure |
Setanaxib 1600 mg and Pembrolizumab 200 mg
n=27 Participants
Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Setanaxib: Oral tablets, 400 mg per tablet
Pembrolizumab: 200 mg IV infusion
|
Placebo and Pembrolizumab 200 mg
Participants will be administered placebo for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Placebo: Oral tablets
Pembrolizumab: 200 mg IV infusion
|
|---|---|---|
|
Maximum Plasma Concentration at Steady State (Cmax-ss) of Setanaxib
|
26.24 ug*mL-¹
Geometric Coefficient of Variation 24.84
|
—
|
SECONDARY outcome
Timeframe: Baseline up to approximately 26 monthsPopulation: PK analysis set
Outcome measures
| Measure |
Setanaxib 1600 mg and Pembrolizumab 200 mg
n=27 Participants
Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Setanaxib: Oral tablets, 400 mg per tablet
Pembrolizumab: 200 mg IV infusion
|
Placebo and Pembrolizumab 200 mg
Participants will be administered placebo for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Placebo: Oral tablets
Pembrolizumab: 200 mg IV infusion
|
|---|---|---|
|
Maximum Plasma Concentration at Steady State (Cmax-ss) of GKT138184
|
3.74 ug*mL-¹
Geometric Coefficient of Variation 34.33
|
—
|
Adverse Events
Setanaxib 1600 mg and Pembrolizumab 200 mg
Serious events: 8 serious events
Other events: 27 other events
Deaths: 6 deaths
Placebo and Pembrolizumab 200 mg
Serious events: 10 serious events
Other events: 23 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Setanaxib 1600 mg and Pembrolizumab 200 mg
n=27 participants at risk
Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Setanaxib: Oral tablets, 400 mg per tablet
Pembrolizumab: 200 mg IV infusion
|
Placebo and Pembrolizumab 200 mg
n=28 participants at risk
Participants will be administered placebo for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Placebo: Oral tablets
Pembrolizumab: 200 mg IV infusion
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/27 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
7.1%
2/28 • Number of events 2 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/27 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
3.6%
1/28 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.7%
1/27 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/27 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
3.6%
1/28 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/27 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
3.6%
1/28 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Gastrointestinal disorders
Colitis
|
7.4%
2/27 • Number of events 2 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
1/27 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/27 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
3.6%
1/28 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
3.7%
1/27 • Number of events 2 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
3.6%
1/28 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/27 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
10.7%
3/28 • Number of events 3 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Infections and infestations
Herpes simplex
|
3.7%
1/27 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Infections and infestations
Pneumonia
|
3.7%
1/27 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Infections and infestations
Septic shock
|
3.7%
1/27 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/27 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
3.6%
1/28 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Investigations
Blood creatinine increased
|
3.7%
1/27 • Number of events 2 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Investigations
Lipase increased
|
3.7%
1/27 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Investigations
Troponin I increased
|
3.7%
1/27 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/27 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
3.6%
1/28 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/27 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
3.6%
1/28 • Number of events 3 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Cardiac disorders
Cardiogenic shock
|
3.7%
1/27 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Gastrointestinal disorders
Asthenia
|
0.00%
0/27 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
3.6%
1/28 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
3.7%
1/27 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.4%
2/27 • Number of events 3 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/27 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
3.6%
1/28 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.7%
1/27 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Vascular disorders
Hypotension
|
3.7%
1/27 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Injury, poisoning and procedural complications
Fall
|
3.7%
1/27 • Number of events 2 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Cardiac disorders
Atrial fibrillation
|
3.7%
1/27 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Infections and infestations
COVID-19
|
3.7%
1/27 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Nervous system disorders
Dizziness
|
3.7%
1/27 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
Other adverse events
| Measure |
Setanaxib 1600 mg and Pembrolizumab 200 mg
n=27 participants at risk
Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Setanaxib: Oral tablets, 400 mg per tablet
Pembrolizumab: 200 mg IV infusion
|
Placebo and Pembrolizumab 200 mg
n=28 participants at risk
Participants will be administered placebo for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.
Placebo: Oral tablets
Pembrolizumab: 200 mg IV infusion
|
|---|---|---|
|
General disorders
Asthenia
|
40.7%
11/27 • Number of events 15 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
32.1%
9/28 • Number of events 14 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
General disorders
Fatigue
|
18.5%
5/27 • Number of events 6 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
7.1%
2/28 • Number of events 2 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
General disorders
Oedema peripheral
|
7.4%
2/27 • Number of events 2 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
7.1%
2/28 • Number of events 2 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
General disorders
Pyrexia
|
14.8%
4/27 • Number of events 4 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
3.6%
1/28 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
General disorders
Implant site extravasation
|
7.4%
2/27 • Number of events 4 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/27 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
7.1%
2/28 • Number of events 2 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
General disorders
Xerosis
|
7.4%
2/27 • Number of events 2 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.9%
7/27 • Number of events 10 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
17.9%
5/28 • Number of events 13 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Gastrointestinal disorders
Nausea
|
25.9%
7/27 • Number of events 9 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
17.9%
5/28 • Number of events 6 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Gastrointestinal disorders
Constipation
|
14.8%
4/27 • Number of events 5 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
21.4%
6/28 • Number of events 8 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Gastrointestinal disorders
Vomiting
|
14.8%
4/27 • Number of events 6 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
10.7%
3/28 • Number of events 3 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Gastrointestinal disorders
Dry mouth
|
11.1%
3/27 • Number of events 3 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
14.3%
4/28 • Number of events 4 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Gastrointestinal disorders
Stomatitis
|
7.4%
2/27 • Number of events 2 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
10.7%
3/28 • Number of events 3 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
3/27 • Number of events 3 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
3.6%
1/28 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.1%
3/27 • Number of events 3 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.9%
7/27 • Number of events 9 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
17.9%
5/28 • Number of events 6 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
11.1%
3/27 • Number of events 3 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
10.7%
3/28 • Number of events 4 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
11.1%
3/27 • Number of events 3 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
3.6%
1/28 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/27 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
10.7%
3/28 • Number of events 5 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.4%
2/27 • Number of events 2 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
3.6%
1/28 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/27 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
7.1%
2/28 • Number of events 4 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.9%
7/27 • Number of events 7 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
21.4%
6/28 • Number of events 8 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
3/27 • Number of events 3 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
7.1%
2/28 • Number of events 3 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.7%
1/27 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
7.1%
2/28 • Number of events 2 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.8%
4/27 • Number of events 4 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
21.4%
6/28 • Number of events 11 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.1%
3/27 • Number of events 6 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
10.7%
3/28 • Number of events 3 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.7%
1/27 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
10.7%
3/28 • Number of events 4 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
11.1%
3/27 • Number of events 3 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/27 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
7.1%
2/28 • Number of events 2 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/27 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
7.1%
2/28 • Number of events 2 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.4%
2/27 • Number of events 2 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Investigations
Blood creatinine increased
|
14.8%
4/27 • Number of events 13 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
3.6%
1/28 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Investigations
Lymphocyte count decreased
|
18.5%
5/27 • Number of events 9 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
7.1%
2/28 • Number of events 7 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Investigations
Weight decreased
|
11.1%
3/27 • Number of events 3 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
7.1%
2/28 • Number of events 2 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/27 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
7.1%
2/28 • Number of events 2 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
3/27 • Number of events 3 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
14.3%
4/28 • Number of events 9 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
14.8%
4/27 • Number of events 4 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
10.7%
3/28 • Number of events 4 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.4%
2/27 • Number of events 2 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.4%
2/27 • Number of events 2 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/27 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
10.7%
3/28 • Number of events 3 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Infections and infestations
Pneumonia
|
14.8%
4/27 • Number of events 4 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Infections and infestations
Lower respiratory tract infection
|
7.4%
2/27 • Number of events 4 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
14.8%
4/27 • Number of events 5 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
10.7%
3/28 • Number of events 4 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.4%
2/27 • Number of events 2 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Endocrine disorders
Hypothyroidism
|
33.3%
9/27 • Number of events 11 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
17.9%
5/28 • Number of events 6 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Endocrine disorders
Hyperthyroidism
|
11.1%
3/27 • Number of events 3 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
0.00%
0/28 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Nervous system disorders
Headache
|
7.4%
2/27 • Number of events 3 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
7.1%
2/28 • Number of events 2 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/27 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
10.7%
3/28 • Number of events 3 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/27 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
7.1%
2/28 • Number of events 2 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/27 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
7.1%
2/28 • Number of events 2 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/27 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
7.1%
2/28 • Number of events 2 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.4%
2/27 • Number of events 3 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
3.6%
1/28 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Psychiatric disorders
Insomnia
|
3.7%
1/27 • Number of events 1 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
7.1%
2/28 • Number of events 2 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/27 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
7.1%
2/28 • Number of events 2 • Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Patients were monitored for death also after the adverse event collection period, until approximately 38 progression events as defined by RECIST v1.1 had occurred in the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place