Trial Outcomes & Findings for Non-comparative Study of IFX-1 Alone or IFX-1+Pembrolizumab in Patients With Locally Advanced or Metastatic cSCC. (NCT NCT04812535)
NCT ID: NCT04812535
Last Updated: 2025-02-11
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and immunologic RECIST (iRECIST) for target lesions and assessed by computed tomography (CT) or magnetic resonance imaging (MRI). Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): ≥30% decrease in the sum of the diameters of target lesions; Best Overall Response (OR) = CR + PR, from the start of the treatment until PD/recurrence.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Up to 36 months
Results posted on
2025-02-11
Participant Flow
According to protocol stipulations, a participant is enrolled into the study if informed consent form is completed (signed and dated). This reflects the "Protocol Enrollment: 30" participant number. Five (5) participants failed screening (after ICF signed) and were not assigned to and treated in the different Arms/Groups, constituting the "Total Started in Participant Flow: 25" participant number.
Participant milestones
| Measure |
Arm A:
Vilobelimab monotherapy; Vilobelimab monotherapy was administered as a 30-minute (-5 / +10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT
|
Arm B: Regimen 1:
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 400 mg on Days 1, 4, 8, and 15, followed by 800 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm B: Regimen 2:
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 600 mg on Days 1, 4, 8, and 15, followed by 1200 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm B: Regimen 3:
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
3
|
6
|
6
|
|
Overall Study
COMPLETED
|
1
|
1
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
9
|
2
|
5
|
5
|
Reasons for withdrawal
| Measure |
Arm A:
Vilobelimab monotherapy; Vilobelimab monotherapy was administered as a 30-minute (-5 / +10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT
|
Arm B: Regimen 1:
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 400 mg on Days 1, 4, 8, and 15, followed by 800 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm B: Regimen 2:
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 600 mg on Days 1, 4, 8, and 15, followed by 1200 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm B: Regimen 3:
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Overall Study
Death
|
7
|
2
|
4
|
1
|
|
Overall Study
Due to premature study termination by sponsor
|
2
|
0
|
1
|
3
|
Baseline Characteristics
Non-comparative Study of IFX-1 Alone or IFX-1+Pembrolizumab in Patients With Locally Advanced or Metastatic cSCC.
Baseline characteristics by cohort
| Measure |
Arm A:
n=10 Participants
Vilobelimab monotherapy; Vilobelimab monotherapy was administered as a 30-minute (-5 / +10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT
|
Arm B: Regimen 1:
n=3 Participants
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 400 mg on Days 1, 4, 8, and 15, followed by 800 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm B: Regimen 2:
n=6 Participants
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 600 mg on Days 1, 4, 8, and 15, followed by 1200 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm B: Regimen 3:
n=6 Participants
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
74.0 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
81.3 years
STANDARD_DEVIATION 13.3 • n=7 Participants
|
72.8 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
70.8 years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
73.8 years
STANDARD_DEVIATION 11.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Belgium
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
France
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Weight at screening
|
82.56 kilogram
STANDARD_DEVIATION 45.40 • n=5 Participants
|
73.33 kilogram
STANDARD_DEVIATION 21.57 • n=7 Participants
|
71.12 kilogram
STANDARD_DEVIATION 16.44 • n=5 Participants
|
71.48 kilogram
STANDARD_DEVIATION 9.59 • n=4 Participants
|
76.05 kilogram
STANDARD_DEVIATION 30.29 • n=21 Participants
|
|
Height at screening
|
167.7 centimeter
STANDARD_DEVIATION 12.1 • n=5 Participants
|
167.0 centimeter
STANDARD_DEVIATION 2.6 • n=7 Participants
|
160.3 centimeter
STANDARD_DEVIATION 5.9 • n=5 Participants
|
169.0 centimeter
STANDARD_DEVIATION 9.8 • n=4 Participants
|
166.2 centimeter
STANDARD_DEVIATION 9.7 • n=21 Participants
|
|
BMI at screening
|
29.08 kg/m²
STANDARD_DEVIATION 14.18 • n=5 Participants
|
26.13 kg/m²
STANDARD_DEVIATION 6.79 • n=7 Participants
|
27.90 kg/m²
STANDARD_DEVIATION 7.22 • n=5 Participants
|
25.10 kg/m²
STANDARD_DEVIATION 3.48 • n=4 Participants
|
27.49 kg/m²
STANDARD_DEVIATION 9.76 • n=21 Participants
|
|
Duration of cSCC
|
4.4 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
5.0 years
STANDARD_DEVIATION 1.0 • n=7 Participants
|
3.3 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
4.0 years
STANDARD_DEVIATION 3.5 • n=4 Participants
|
4.1 years
STANDARD_DEVIATION 4.9 • n=21 Participants
|
|
Primary diagnosis
Locally advanced cSCC
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Primary diagnosis
Metastatic cSCC
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Tumor category (TNM staging at initial diagnosis)
TX
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Tumor category (TNM staging at initial diagnosis)
Tis
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Tumor category (TNM staging at initial diagnosis)
T1
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Tumor category (TNM staging at initial diagnosis)
T2
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Tumor category (TNM staging at initial diagnosis)
T3
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Tumor category (TNM staging at initial diagnosis)
T4
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Nodes (TNM staging at initial diagnosis)
NX
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Nodes (TNM staging at initial diagnosis)
N0
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Nodes (TNM staging at initial diagnosis)
N1
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Nodes (TNM staging at initial diagnosis)
N2
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Nodes (TNM staging at initial diagnosis)
N3
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Metastases (TNM staging at initial diagnosis)
M0
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Metastases (TNM staging at initial diagnosis)
M1
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Histologic grade (TNM staging at initial diagnosis)
GX
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Histologic grade (TNM staging at initial diagnosis)
G1
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Histologic grade (TNM staging at initial diagnosis)
G2
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Histologic grade (TNM staging at initial diagnosis)
G3
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Histologic grade (TNM staging at initial diagnosis)
G4
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Histologic grade (TNM staging at initial diagnosis)
Missing
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Prognostic stage group
TNM staging at initial diagnosis · Stage 0
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Prognostic stage group
TNM staging at initial diagnosis · Stage I
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Prognostic stage group
TNM staging at initial diagnosis · Stage II
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Prognostic stage group
TNM staging at initial diagnosis · Stage III
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Prognostic stage group
TNM staging at initial diagnosis · Stage IV
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Prognostic stage group
TNM staging at initial diagnosis · Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Prognostic stage group
TNM staging at study entry · Stage 0
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Prognostic stage group
TNM staging at study entry · Stage I
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Prognostic stage group
TNM staging at study entry · Stage II
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Prognostic stage group
TNM staging at study entry · Stage III
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Prognostic stage group
TNM staging at study entry · Stage IV
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Prognostic stage group
TNM staging at study entry · Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Prognostic staging system
TNM staging at initial diagnosis · AJCC 8
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Prognostic staging system
TNM staging at initial diagnosis · AJCC 7
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Prognostic staging system
TNM staging at initial diagnosis · BHW
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Prognostic staging system
TNM staging at initial diagnosis · Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Prognostic staging system
TNM staging at initial diagnosis · Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Prognostic staging system
TNM staging at study entry · AJCC 8
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Prognostic staging system
TNM staging at study entry · AJCC 7
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Prognostic staging system
TNM staging at study entry · BHW
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Prognostic staging system
TNM staging at study entry · Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Prognostic staging system
TNM staging at study entry · Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
H&P Location/size - area L
<20 mm
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
H&P Location/size - area L
>=20 mm
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
H&P Location/size - area L
Missing
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
H&P Location/size - area M
<10 mm
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
H&P Location/size - area M
>=10 mm
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
H&P Location/size - area M
Missing
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
H&P Location/size - area H
No
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
H&P Location/size - area H
Yes
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
H&P Location/size - area H
Missing
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
H&P Borders
Well defined
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
H&P Borders
Poorly defined
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
H&P Borders
Missing
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
H&P Primary vs recurrent
Primary
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
H&P Primary vs recurrent
Recurrent
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
H&P Primary vs recurrent
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
H&P Immunosuppression
-
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
H&P Immunosuppression
+
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
H&P Immunosuppression
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
H&P Site of prior RT or chronic inflammatory process
-
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
H&P Site of prior RT or chronic inflammatory process
+
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
H&P Site of prior RT or chronic inflammatory process
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
H&P Rapidly growing tumour
-
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
H&P Rapidly growing tumour
+
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
H&P Rapidly growing tumour
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
H&P Neurologic symptoms
-
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
H&P Neurologic symptoms
+
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
H&P Neurologic symptoms
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Pathology Degree of differentiation
Well or moderately differentiated
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Pathology Degree of differentiation
Poorly differentiated
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Pathology Degree of differentiation
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Pathology Acantholytic, adenosquamous, desmoplastic, or metaplastic subtypes
-
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Pathology Acantholytic, adenosquamous, desmoplastic, or metaplastic subtypes
+
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Pathology Acantholytic, adenosquamous, desmoplastic, or metaplastic subtypes
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Pathology Depth: thickness or level of invasion
<=6 mm and no invasion beyond subcutaneous fat
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Pathology Depth: thickness or level of invasion
>6 mm or invasion beyond subcutaneous fat
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Pathology Depth: thickness or level of invasion
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Pathology Perineural, lymphatic or vascular involvement
-
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Pathology Perineural, lymphatic or vascular involvement
+
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Pathology Perineural, lymphatic or vascular involvement
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 36 monthsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and immunologic RECIST (iRECIST) for target lesions and assessed by computed tomography (CT) or magnetic resonance imaging (MRI). Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): ≥30% decrease in the sum of the diameters of target lesions; Best Overall Response (OR) = CR + PR, from the start of the treatment until PD/recurrence.
Outcome measures
| Measure |
Arm B Regimen 3:
n=6 Participants
Vilobelimab + pembrolizumab combination therapy Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm A:
n=10 Participants
Vilobelimab monotherapy; Vilobelimab monotherapy was administered as a 30-minute (-5 / +10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT
|
Arm B: Regimen 1:
n=3 Participants
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 400 mg on Days 1, 4, 8, and 15, followed by 800 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm B: Regimen 2:
n=6 Participants
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 600 mg on Days 1, 4, 8, and 15, followed by 1200 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
|---|---|---|---|---|
|
Best Overall Response Rate (Best ORR) - Arm A and Arm B
ORR (Responder)
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Best Overall Response Rate (Best ORR) - Arm A and Arm B
Non-responder
|
4 Participants
|
9 Participants
|
3 Participants
|
4 Participants
|
|
Best Overall Response Rate (Best ORR) - Arm A and Arm B
No post baseline measurement
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 - Cycle 1 Day 36Frequency of dose-limiting toxicities (DLTs) by dose cohort.
Outcome measures
| Measure |
Arm B Regimen 3:
n=6 Participants
Vilobelimab + pembrolizumab combination therapy Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm A:
n=10 Participants
Vilobelimab monotherapy; Vilobelimab monotherapy was administered as a 30-minute (-5 / +10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT
|
Arm B: Regimen 1:
n=3 Participants
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 400 mg on Days 1, 4, 8, and 15, followed by 800 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm B: Regimen 2:
n=6 Participants
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 600 mg on Days 1, 4, 8, and 15, followed by 1200 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
|---|---|---|---|---|
|
Dose-limiting Toxicity (DLT) - Arm B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 36 monthsDisease control rate is defined as the relative number of patients achieving stable disease (SD/iSD), CR/iCR or PR/iPR according to modified RECIST v1.1 (including clinical response)/iRECIST response.
Outcome measures
| Measure |
Arm B Regimen 3:
n=6 Participants
Vilobelimab + pembrolizumab combination therapy Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm A:
n=10 Participants
Vilobelimab monotherapy; Vilobelimab monotherapy was administered as a 30-minute (-5 / +10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT
|
Arm B: Regimen 1:
n=3 Participants
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 400 mg on Days 1, 4, 8, and 15, followed by 800 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm B: Regimen 2:
n=6 Participants
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 600 mg on Days 1, 4, 8, and 15, followed by 1200 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
|---|---|---|---|---|
|
Disease Control Rate - Arm A and Arm B
Cycle 9 Day 1 · No response assessment
|
6 Participants
|
8 Participants
|
3 Participants
|
5 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 10 Day 1 · Controlled disease
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 10 Day 1 · No response assessment
|
6 Participants
|
9 Participants
|
3 Participants
|
5 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 11 Day 1 · Controlled disease
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 11 Day 1 · No controlled disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 12 Day 29 · No controlled disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 2 Day 1 · Controlled disease
|
4 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 2 Day 1 · No controlled disease
|
2 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 2 Day 1 · No response assessment
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 3 Day 1 · Controlled disease
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 3 Day 1 · No controlled disease
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 3 Day 1 · No response assessment
|
2 Participants
|
9 Participants
|
3 Participants
|
4 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 3 Day 29 · Controlled disease
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 3 Day 29 · No controlled disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 3 Day 29 · No response assessment
|
6 Participants
|
9 Participants
|
3 Participants
|
6 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 4 Day 1 · Controlled disease
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 4 Day 1 · No controlled disease
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 4 Day 1 · No response assessment
|
3 Participants
|
9 Participants
|
3 Participants
|
5 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 5 Day 1 · Controlled disease
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 5 Day 1 · No controlled disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 5 Day 1 · No response assessment
|
4 Participants
|
8 Participants
|
3 Participants
|
5 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 6 Day 1 · Controlled disease
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 6 Day 1 · No controlled disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 6 Day 1 · No response assessment
|
4 Participants
|
8 Participants
|
3 Participants
|
5 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 7 Day 1 · Controlled disease
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 7 Day 1 · No controlled disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 7 Day 1 · No response assessment
|
5 Participants
|
8 Participants
|
3 Participants
|
5 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 8 Day 1 · Controlled disease
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 8 Day 1 · No controlled disease
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 8 Day 1 · No response assessment
|
5 Participants
|
9 Participants
|
3 Participants
|
5 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 9 Day 1 · Controlled disease
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 9 Day 1 · No controlled disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 10 Day 1 · No controlled disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 11 Day 1 · No response assessment
|
6 Participants
|
8 Participants
|
3 Participants
|
5 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 12 Day 1 · Controlled disease
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 12 Day 1 · No controlled disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 12 Day 1 · No response assessment
|
6 Participants
|
10 Participants
|
3 Participants
|
5 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 12 Day 29 · Controlled disease
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 12 Day 29 · No response assessment
|
6 Participants
|
9 Participants
|
3 Participants
|
6 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 13 Day 1 · Controlled disease
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 13 Day 1 · No controlled disease
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 13 Day 1 · No response assessment
|
6 Participants
|
9 Participants
|
3 Participants
|
5 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 14 Day 1 · Controlled disease
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 14 Day 1 · No controlled disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 14 Day 1 · No response assessment
|
6 Participants
|
10 Participants
|
3 Participants
|
5 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 14 Day 15 · Controlled disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 14 Day 15 · No controlled disease
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 14 Day 15 · No response assessment
|
6 Participants
|
9 Participants
|
3 Participants
|
6 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 15 Day 1 · Controlled disease
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 15 Day 1 · No controlled disease
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 15 Day 1 · No response assessment
|
6 Participants
|
9 Participants
|
3 Participants
|
5 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 16 Day 1 · Controlled disease
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 16 Day 1 · No controlled disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 16 Day 1 · No response assessment
|
6 Participants
|
10 Participants
|
3 Participants
|
5 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 17 Day 1 · Controlled disease
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 17 Day 1 · No controlled disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Disease Control Rate - Arm A and Arm B
Cycle 17 Day 1 · No response assessment
|
6 Participants
|
10 Participants
|
3 Participants
|
5 Participants
|
|
Disease Control Rate - Arm A and Arm B
EOT Visit · Controlled disease
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Disease Control Rate - Arm A and Arm B
EOT Visit · No controlled disease
|
3 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Disease Control Rate - Arm A and Arm B
EOT Visit · No response assessment
|
3 Participants
|
7 Participants
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 36 monthsPFS is defined as the time from first study treatment administration to progression (i.e. PD, iUPD, iCPD) or death. Patients without progression are censored at their last visit/study treatment administration.
Outcome measures
| Measure |
Arm B Regimen 3:
n=6 Participants
Vilobelimab + pembrolizumab combination therapy Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm A:
n=10 Participants
Vilobelimab monotherapy; Vilobelimab monotherapy was administered as a 30-minute (-5 / +10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT
|
Arm B: Regimen 1:
n=3 Participants
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 400 mg on Days 1, 4, 8, and 15, followed by 800 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm B: Regimen 2:
n=6 Participants
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 600 mg on Days 1, 4, 8, and 15, followed by 1200 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
|---|---|---|---|---|
|
Progression-free Survival (PFS)- Arm A and Arm B
|
87.5 days
Interval 49.0 to
The upper confidence limit is not calculable because the number of participants with event is insufficient
|
50.0 days
Interval 40.0 to 51.0
|
106.0 days
Interval 43.0 to 106.0
|
90.0 days
Interval 52.0 to
The upper confidence limit is not calculable because the number of participants with event is insufficient
|
SECONDARY outcome
Timeframe: Up to 36 monthsOverall survival is defined as the time from first study treatment administration to death. Patients alive when they discontinue the study are censored at their last recorded date of being alive.
Outcome measures
| Measure |
Arm B Regimen 3:
n=6 Participants
Vilobelimab + pembrolizumab combination therapy Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm A:
n=10 Participants
Vilobelimab monotherapy; Vilobelimab monotherapy was administered as a 30-minute (-5 / +10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT
|
Arm B: Regimen 1:
n=3 Participants
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 400 mg on Days 1, 4, 8, and 15, followed by 800 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm B: Regimen 2:
n=6 Participants
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 600 mg on Days 1, 4, 8, and 15, followed by 1200 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
|---|---|---|---|---|
|
Overall Survival (OS)- Arm A and Arm B
|
NA days
Interval 77.0 to
The median and upper confidence limit is not calculable because the number of participants with event is insufficient
|
285.0 days
Interval 52.0 to
The upper confidence limit is not calculable because the number of participants with event is insufficient
|
106.0 days
Interval 63.0 to
The upper confidence limit is not calculable because the number of participants with event is insufficient
|
300.5 days
Interval 103.0 to
The upper confidence limit is not calculable because the number of participants with event is insufficient
|
SECONDARY outcome
Timeframe: Up to 27 monthsDevelopment of human antidrug antibodies (ADAs) against Vilobelimab. In contrast to the time frame of the secondary efficacy outcome measures (3.-5., 7.-8), which were reported until EOS (up to 36 months), the time frames of ADAs (6.) and PK (9.) are measured (only) until first FU. Therefore, the time frame is different, i.e. 24 months of treatment until EOT + (approx.) 12 weeks/3 months until first FU up to 27 months.
Outcome measures
| Measure |
Arm B Regimen 3:
n=6 Participants
Vilobelimab + pembrolizumab combination therapy Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm A:
n=10 Participants
Vilobelimab monotherapy; Vilobelimab monotherapy was administered as a 30-minute (-5 / +10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT
|
Arm B: Regimen 1:
n=3 Participants
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 400 mg on Days 1, 4, 8, and 15, followed by 800 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm B: Regimen 2:
n=6 Participants
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 600 mg on Days 1, 4, 8, and 15, followed by 1200 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
|---|---|---|---|---|
|
Antidrug Antibodies (ADAs) - Arm A and Arm B
Patients with at least one positive result
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Antidrug Antibodies (ADAs) - Arm A and Arm B
Patients without positive result
|
6 Participants
|
8 Participants
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Not all patients are analyzed at each visit as the values for these patients are missing. This reason for this is either that the values for these patients are missing in the data or that these patients have already discontinued the study.
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 version 3.0 measures the different aspects that define the quality of life of cancer patients or survivors. The reported total score ranges from 0 to 100 whereas a higher score represents a higher response level. The total score was calculated as mean of all 15 single scores. It was only calculated if all 15 single scores were non-missing (for more information see Fayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A, on behalf of the EORTC Quality of Life Group. The EORTC QLQ-C30 Scoring Manual (3rd Edition). Published by: European Organisation for Research and Treatment of Cancer, Brussels 2001.). The absolute changes from baseline are presented.
Outcome measures
| Measure |
Arm B Regimen 3:
n=6 Participants
Vilobelimab + pembrolizumab combination therapy Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm A:
n=10 Participants
Vilobelimab monotherapy; Vilobelimab monotherapy was administered as a 30-minute (-5 / +10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT
|
Arm B: Regimen 1:
n=3 Participants
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 400 mg on Days 1, 4, 8, and 15, followed by 800 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm B: Regimen 2:
n=6 Participants
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 600 mg on Days 1, 4, 8, and 15, followed by 1200 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
|---|---|---|---|---|
|
Quality of Life (QoL) - Arm A and Arm B
Cycle 2 Day 1
|
-3.04 units on a scale
Standard Deviation 6.21
|
0.31 units on a scale
Standard Deviation 4.38
|
-0.80 units on a scale
Standard Deviation NA
The standard deviation is not calculable, because the number of participants with available values at this visit and treatment group is one.
|
-2.68 units on a scale
Standard Deviation 3.58
|
|
Quality of Life (QoL) - Arm A and Arm B
Cycle 3 Day 1
|
-3.27 units on a scale
Standard Deviation 1.62
|
-0.35 units on a scale
Standard Deviation 5.73
|
—
|
3.00 units on a scale
Standard Deviation 5.66
|
|
Quality of Life (QoL) - Arm A and Arm B
Cycle 4 Day 1
|
-6.35 units on a scale
Standard Deviation 0.78
|
1.95 units on a scale
Standard Deviation 0.21
|
—
|
-2.40 units on a scale
Standard Deviation NA
The standard deviation is not calculable, because the number of participants with available values at this visit and treatment group is one.
|
|
Quality of Life (QoL) - Arm A and Arm B
Cycle 5 Day 1
|
-3.20 units on a scale
Standard Deviation 2.83
|
-1.15 units on a scale
Standard Deviation 2.19
|
—
|
-3.80 units on a scale
Standard Deviation NA
The standard deviation is not calculable, because the number of participants with available values at this visit and treatment group is one.
|
|
Quality of Life (QoL) - Arm A and Arm B
Cycle 6 Day 1
|
-1.85 units on a scale
Standard Deviation 2.33
|
0.75 units on a scale
Standard Deviation 0.49
|
—
|
-1.40 units on a scale
Standard Deviation NA
The standard deviation is not calculable, because the number of participants with available values at this visit and treatment group is one.
|
|
Quality of Life (QoL) - Arm A and Arm B
Cycle 7 Day 1
|
-3.50 units on a scale
Standard Deviation NA
The standard deviation is not calculable, because the number of participants with available values at this visit and treatment group is one.
|
2.55 units on a scale
Standard Deviation 1.63
|
—
|
1.20 units on a scale
Standard Deviation NA
The standard deviation is not calculable, because the number of participants with available values at this visit and treatment group is one.
|
|
Quality of Life (QoL) - Arm A and Arm B
Cycle 8 Day 1
|
-3.40 units on a scale
Standard Deviation NA
The standard deviation is not calculable, because the number of participants with available values at this visit and treatment group is one.
|
-2.10 units on a scale
Standard Deviation 8.20
|
—
|
-0.70 units on a scale
Standard Deviation NA
The standard deviation is not calculable, because the number of participants with available values at this visit and treatment group is one.
|
|
Quality of Life (QoL) - Arm A and Arm B
Cycle 9 Day 1
|
—
|
-2.10 units on a scale
Standard Deviation 12.02
|
—
|
-3.40 units on a scale
Standard Deviation NA
The standard deviation is not calculable, because the number of participants with available values at this visit and treatment group is one.
|
|
Quality of Life (QoL) - Arm A and Arm B
Cycle 10 Day 1
|
—
|
0.20 units on a scale
Standard Deviation 7.78
|
—
|
-1.10 units on a scale
Standard Deviation NA
The standard deviation is not calculable, because the number of participants with available values at this visit and treatment group is one.
|
|
Quality of Life (QoL) - Arm A and Arm B
Cycle 11 Day 1
|
—
|
-0.75 units on a scale
Standard Deviation 8.27
|
—
|
—
|
|
Quality of Life (QoL) - Arm A and Arm B
Cycle 12 Day 1
|
—
|
0.60 units on a scale
Standard Deviation 7.21
|
—
|
-2.30 units on a scale
Standard Deviation NA
The standard deviation is not calculable, because the number of participants with available values at this visit and treatment group is one.
|
|
Quality of Life (QoL) - Arm A and Arm B
Cycle 13 Day 1
|
—
|
1.00 units on a scale
Standard Deviation 5.09
|
—
|
-3.50 units on a scale
Standard Deviation NA
The standard deviation is not calculable, because the number of participants with available values at this visit and treatment group is one.
|
|
Quality of Life (QoL) - Arm A and Arm B
Cycle 14 Day 1
|
—
|
4.60 units on a scale
Standard Deviation NA
The standard deviation is not calculable, because the number of participants with available values at this visit and treatment group is one.
|
—
|
-4.00 units on a scale
Standard Deviation NA
The standard deviation is not calculable, because the number of participants with available values at this visit and treatment group is one.
|
|
Quality of Life (QoL) - Arm A and Arm B
Cycle 15 Day 1
|
—
|
4.60 units on a scale
Standard Deviation NA
The standard deviation is not calculable, because the number of participants with available values at this visit and treatment group is one.
|
—
|
0.20 units on a scale
Standard Deviation NA
The standard deviation is not calculable, because the number of participants with available values at this visit and treatment group is one.
|
|
Quality of Life (QoL) - Arm A and Arm B
Cycle 16 Day 1
|
—
|
—
|
—
|
-5.10 units on a scale
Standard Deviation NA
The standard deviation is not calculable, because the number of participants with available values at this visit and treatment group is one.
|
|
Quality of Life (QoL) - Arm A and Arm B
Cycle 17 Day 1
|
—
|
—
|
—
|
-2.30 units on a scale
Standard Deviation NA
The standard deviation is not calculable, because the number of participants with available values at this visit and treatment group is one.
|
|
Quality of Life (QoL) - Arm A and Arm B
EOT Visit
|
-4.67 units on a scale
Standard Deviation 6.53
|
-1.67 units on a scale
Standard Deviation 3.91
|
0.80 units on a scale
Standard Deviation NA
The standard deviation is not calculable, because the number of participants with available values at this visit and treatment group is one.
|
1.13 units on a scale
Standard Deviation 4.14
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Only patients with response were analyzed. As in Arm B: Regimen 1: there was no patient with a response, the overall number of participants analyzed is 0.
Duration of stable disease is defined as the time from first diagnosis of response or stable disease (i.e., CR/iCR/PR/iPR/SD/iSD) to progression (i.e. progressive disease (PD), unconfirmed progressive disease according to iRECIST (iUPD), confirmed progressive disease (iCPD)) or death. Responding and stable patients without progression are censored at their last visit/study treatment administration. Patients who never respond or have a stable disease are excluded from this analysis.
Outcome measures
| Measure |
Arm B Regimen 3:
n=4 Participants
Vilobelimab + pembrolizumab combination therapy Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm A:
n=2 Participants
Vilobelimab monotherapy; Vilobelimab monotherapy was administered as a 30-minute (-5 / +10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT
|
Arm B: Regimen 1:
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 400 mg on Days 1, 4, 8, and 15, followed by 800 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm B: Regimen 2:
n=3 Participants
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 600 mg on Days 1, 4, 8, and 15, followed by 1200 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
|---|---|---|---|---|
|
Response (Complete Response (CR) / CR According to iRECIST (iCR) / Partial Response (PR) / PR According to iRECIST (iPR)) and Stable Disease (SD) Duration - Arm A and Arm B
|
128.0 days
Interval 43.0 to
The upper confidence limit is not calculable because the number of participants with event is insufficient
|
490.0 days
Interval 462.0 to 518.0
|
—
|
NA days
Interval 43.0 to
The median and upper confidence limit is not calculable because the number of participants with event is insufficient
|
SECONDARY outcome
Timeframe: Up to 27 monthsPopulation: Not all patients are analyzed at each visit as the values for these patients are missing. This reason for this is either that the values for these patients are missing in the data or that these patients have already discontinued the study.
The plasma concentration of vilobelimab was assessed at different time points pre- and post-dose. The post-dose Cycle 1 Day 22 values correspond to Cmax and the pre-dose Cycle 1 Day 8, pre-dose Cycle 1 Day 22, pre-dose Cycle 2 Day 1 and per-dose Cycle 5 Day 1 values to Ctrough. In contrast to the time frame of the secondary efficacy outcome measures (3.-5., 7.-8), which were reported until EOS (up to 36 months), the time frames of ADAs (6.) and PK (9.) are measured (only) until first FU. Therefore, the time frame is different, i.e. 24 months of treatment until EOT + (approx.) 12 weeks/3 months until first FU up to 27 months.
Outcome measures
| Measure |
Arm B Regimen 3:
n=6 Participants
Vilobelimab + pembrolizumab combination therapy Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm A:
n=10 Participants
Vilobelimab monotherapy; Vilobelimab monotherapy was administered as a 30-minute (-5 / +10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT
|
Arm B: Regimen 1:
n=3 Participants
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 400 mg on Days 1, 4, 8, and 15, followed by 800 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm B: Regimen 2:
n=6 Participants
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 600 mg on Days 1, 4, 8, and 15, followed by 1200 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
|---|---|---|---|---|
|
Plasma Concentration of Vilobelimab - Arm A and Arm B
Pre-dose Cycle 1 Day 8
|
88749.9 ng/mL
Geometric Coefficient of Variation 52.4
|
128404.2 ng/mL
Geometric Coefficient of Variation 86.8
|
32488.5 ng/mL
Geometric Coefficient of Variation 51.9
|
80525.0 ng/mL
Geometric Coefficient of Variation 41.5
|
|
Plasma Concentration of Vilobelimab - Arm A and Arm B
Pre-dose Cycle 1 Day 22
|
78248.6 ng/mL
Geometric Coefficient of Variation 48.6
|
85088.6 ng/mL
Geometric Coefficient of Variation 135.8
|
25312.8 ng/mL
Geometric Coefficient of Variation 94.1
|
72792.5 ng/mL
Geometric Coefficient of Variation 57.5
|
|
Plasma Concentration of Vilobelimab - Arm A and Arm B
Post-dose Cycle 1 Day 22
|
210169.5 ng/mL
Geometric Coefficient of Variation 66.1
|
514953.9 ng/mL
Geometric Coefficient of Variation 43.5
|
208865.8 ng/mL
Geometric Coefficient of Variation 27.6
|
261068.1 ng/mL
Geometric Coefficient of Variation 96.7
|
|
Plasma Concentration of Vilobelimab - Arm A and Arm B
Pre-dose Cycle 2 Day 1
|
80697.1 ng/mL
Geometric Coefficient of Variation 104.1
|
81260.1 ng/mL
Geometric Coefficient of Variation 281.2
|
11124.0 ng/mL
Geometric Coefficient of Variation NA
The geometric coefficient of variation is not calculable, because the number of participants with available values at this visit and treatment group is one
|
48722.9 ng/mL
Geometric Coefficient of Variation 106.9
|
|
Plasma Concentration of Vilobelimab - Arm A and Arm B
Pre-dose Cycle 5 Day 1
|
41506.4 ng/mL
Geometric Coefficient of Variation 65.9
|
107989.9 ng/mL
Geometric Coefficient of Variation 43.6
|
—
|
132497.0 ng/mL
Geometric Coefficient of Variation NA
The geometric coefficient of variation is not calculable, because the number of participants with available values at this visit and treatment group is one
|
Adverse Events
Arm A:
Serious events: 7 serious events
Other events: 9 other events
Deaths: 7 deaths
Arm B Regimen 1:
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Arm B Regimen 2:
Serious events: 2 serious events
Other events: 5 other events
Deaths: 4 deaths
Arm B Regimen 3:
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm A:
n=10 participants at risk
Vilobelimab monotherapy Vilobelimab monotherapy was administered as a 30-minute (-5 / +10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT
|
Arm B Regimen 1:
n=3 participants at risk
Vilobelimab + pembrolizumab combination therapy Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 400 mg on Days 1, 4, 8, and 15, followed by 800 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm B Regimen 2:
n=6 participants at risk
Vilobelimab + pembrolizumab combination therapy Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 600 mg on Days 1, 4, 8, and 15, followed by 1200 mg Q2W starting on Day 22 of Cycle 1 until EOT.
Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm B Regimen 3:
n=6 participants at risk
Vilobelimab + pembrolizumab combination therapy Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
|---|---|---|---|---|
|
General disorders
General physical health deterioration
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
66.7%
2/3 • Number of events 2 • Up to 36 months
|
33.3%
2/6 • Number of events 2 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
|
Nervous system disorders
Metabolic encephalopathy
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Nervous system disorders
Presyncope
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Cardiac disorders
Cardiac Failure
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Cardiac disorders
Cardio-respiratory arrest
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Infections and infestations
COVID-19
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Infections and infestations
Clostridium difficile infection
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
16.7%
1/6 • Number of events 2 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/10 • Up to 36 months
|
33.3%
1/3 • Number of events 1 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Immune system disorders
Amyloidosis
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
Other adverse events
| Measure |
Arm A:
n=10 participants at risk
Vilobelimab monotherapy Vilobelimab monotherapy was administered as a 30-minute (-5 / +10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT
|
Arm B Regimen 1:
n=3 participants at risk
Vilobelimab + pembrolizumab combination therapy Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 400 mg on Days 1, 4, 8, and 15, followed by 800 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm B Regimen 2:
n=6 participants at risk
Vilobelimab + pembrolizumab combination therapy Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 600 mg on Days 1, 4, 8, and 15, followed by 1200 mg Q2W starting on Day 22 of Cycle 1 until EOT.
Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
Arm B Regimen 3:
n=6 participants at risk
Vilobelimab + pembrolizumab combination therapy Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
33.3%
1/3 • Number of events 1 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
33.3%
2/6 • Number of events 2 • Up to 36 months
|
|
General disorders
Asthenia
|
20.0%
2/10 • Number of events 2 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
16.7%
1/6 • Number of events 2 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
General disorders
Pain
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
33.3%
2/6 • Number of events 2 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
General disorders
Chest pain
|
0.00%
0/10 • Up to 36 months
|
33.3%
1/3 • Number of events 1 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
General disorders
Extravasation
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
General disorders
General physical health deterioration
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
General disorders
Influenza like illness
|
10.0%
1/10 • Number of events 2 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
General disorders
Infusion site paraesthesia
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
General disorders
Oedema peripheral
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • Up to 36 months
|
33.3%
1/3 • Number of events 1 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Gastrointestinal disorders
Dental discomfort
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
|
Gastrointestinal disorders
Oral hyperkeratosis
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
|
Gastrointestinal disorders
Oral pain
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
33.3%
1/3 • Number of events 1 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
33.3%
1/3 • Number of events 1 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Infections and infestations
COVID-19
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
|
Infections and infestations
Gingivitis
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Infections and infestations
Tooth abscess
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Infections and infestations
Wound infection pseudomonas
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
16.7%
1/6 • Number of events 2 • Up to 36 months
|
|
Nervous system disorders
Dizziness
|
20.0%
2/10 • Number of events 2 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
|
Nervous system disorders
Dementia
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Investigations
Weight decreased
|
20.0%
2/10 • Number of events 2 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Investigations
Blood creatinine increased
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
|
Investigations
Lipase increased
|
0.00%
0/10 • Up to 36 months
|
33.3%
1/3 • Number of events 1 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
16.7%
1/6 • Number of events 3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/10 • Up to 36 months
|
33.3%
1/3 • Number of events 1 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Investigations
Thyroxine free increased
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo papular
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
|
Skin and subcutaneous tissue disorders
Skin discharge
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
2/10 • Number of events 3 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Injury, poisoning and procedural complications
Contusion
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Injury, poisoning and procedural complications
Osteoradionecrosis
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
|
Injury, poisoning and procedural complications
Traumatic haematome
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Injury, poisoning and procedural complications
Wound complication
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
20.0%
2/10 • Number of events 2 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin neoplasm bleeding
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/10 • Up to 36 months
|
33.3%
1/3 • Number of events 1 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour ulceration
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Blood and lymphatic system disorders
Eosinophilia
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • Up to 36 months
|
33.3%
1/3 • Number of events 1 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/10 • Up to 36 months
|
33.3%
1/3 • Number of events 1 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • Up to 36 months
|
33.3%
1/3 • Number of events 1 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Vascular disorders
Lymphoedema
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Vascular disorders
Lymphorrhoea
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Vascular disorders
Scalp haematoma
|
10.0%
1/10 • Number of events 1 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
10.0%
1/10 • Number of events 2 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/10 • Up to 36 months
|
0.00%
0/3 • Up to 36 months
|
0.00%
0/6 • Up to 36 months
|
16.7%
1/6 • Number of events 1 • Up to 36 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place