Trial Outcomes & Findings for A Pilot Study of Sequential ONCOS-102, an Engineered Oncolytic Adenovirus Expressing GMCSF, and Pembrolizumab in Patients With Advanced or Unresectable Melanoma Progressing After Programmed Cell Death Protein 1 (PD1) Blockade (NCT NCT03003676)
NCT ID: NCT03003676
Last Updated: 2021-11-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
21 participants
Primary outcome timeframe
6 months
Results posted on
2021-11-08
Participant Flow
Participant milestones
| Measure |
Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab - Part 1
Part I: Patients will receive 3 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, and 8) at 3x10\^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. They will receive pembrolizumab i.v., 2mg/kg or 200 mg flat dose on day 22 (Week 3) and every three weeks thereafter until Day 169/Week 24.
ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF)
Cyclophosphamide: Pre-treatment
Pembrolizumab: PD1 blockade
|
Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab - Part 2
Part II: Patients will receive 4 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, 8 and 15) at 3x10\^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. ONCOS-102 will be given in combination with Pembrolizumab starting on Day 22/Week 3 and every three weeks thereafter until Day 169/Week 24 or until unacceptable toxicity or clinically relevant disease progression, whichever occurs first. Pembrolizumab will be given according to institutional practice (2mg/kg or 200mg flat dose).
ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF) Cyclophosphamide: Pre-treatment Pembrolizumab: PD1 blockade
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
12
|
|
Overall Study
COMPLETED
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
| Measure |
Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab - Part 1
Part I: Patients will receive 3 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, and 8) at 3x10\^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. They will receive pembrolizumab i.v., 2mg/kg or 200 mg flat dose on day 22 (Week 3) and every three weeks thereafter until Day 169/Week 24.
ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF)
Cyclophosphamide: Pre-treatment
Pembrolizumab: PD1 blockade
|
Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab - Part 2
Part II: Patients will receive 4 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, 8 and 15) at 3x10\^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. ONCOS-102 will be given in combination with Pembrolizumab starting on Day 22/Week 3 and every three weeks thereafter until Day 169/Week 24 or until unacceptable toxicity or clinically relevant disease progression, whichever occurs first. Pembrolizumab will be given according to institutional practice (2mg/kg or 200mg flat dose).
ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF) Cyclophosphamide: Pre-treatment Pembrolizumab: PD1 blockade
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
5
|
7
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Hepatitis B infection
|
1
|
0
|
Baseline Characteristics
A Pilot Study of Sequential ONCOS-102, an Engineered Oncolytic Adenovirus Expressing GMCSF, and Pembrolizumab in Patients With Advanced or Unresectable Melanoma Progressing After Programmed Cell Death Protein 1 (PD1) Blockade
Baseline characteristics by cohort
| Measure |
Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab Part 1
n=9 Participants
Part I: Patients will receive 3 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, and 8) at 3x10\^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. They will then receive pembrolizumab i.v., 2mg/kg or 200mg flat dose, on day 22 (Week 3) and every 3 weeks thereafter until the end of treatment visit on day 169 (Week 24).
ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF)
Cyclophosphamide: Pre-treatment
Pembrolizumab: PD1 blockade
|
Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab Part 2
n=12 Participants
Part II: Patients will receive 4 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, 8 and 15) at 3x10\^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. ONCOS-102 will be given in combination with Pembrolizumab starting on Day 22/Week 3 and every three weeks thereafter until Day 169/Week 24 or until unacceptable toxicity or clinically relevant disease progression, whichever occurs first. Pembrolizumab will be given according to institutional practice (2mg/kg or 200mg flat dose).
ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF)
Cyclophosphamide: Pre-treatment
Pembrolizumab: PD1 blockade
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Continuous
|
69.1 years
STANDARD_DEVIATION 13.68 • n=5 Participants
|
67.3 years
STANDARD_DEVIATION 13.50 • n=7 Participants
|
68.1 years
STANDARD_DEVIATION 13.26 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab Part 1
n=9 Participants
Part I1 Patients will receive 3 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, and 8) at 3x10\^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. They will then receive pembrolizumab i.v., 2mg/kg or 200mg flat dose, on day 22 (Week 3) and every 3 weeks thereafter until the end of treatment visit on day 169 (Week 24).
ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF)
Cyclophosphamide: Pre-treatment
Pembrolizumab: PD1 blockade
|
Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab Part 2
n=12 Participants
Part 2: Patients will receive 4 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, 8 and 15) at 3x10\^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. ONCOS-102 will be given in combination with Pembrolizumab starting on Day 22/Week 3 and every three weeks thereafter until Day 169/Week 24 or until unacceptable toxicity or clinically relevant disease progression, whichever occurs first. Pembrolizumab will be given according to institutional practice (2mg/kg or 200mg flat dose).
ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF)
Cyclophosphamide: Pre-treatment
Pembrolizumab: PD1 blockade
|
|---|---|---|
|
Incidence of Treatment-emergent Adverse Events Including Treatment-emergent Serious Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE).
Number of patients with Treatment Emergent Adverse Event (TEAE)
|
9 participants
|
12 participants
|
|
Incidence of Treatment-emergent Adverse Events Including Treatment-emergent Serious Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE).
Number of patients with Treatment Emergent Adverse Serious Event (TESAE)
|
4 participants
|
2 participants
|
|
Incidence of Treatment-emergent Adverse Events Including Treatment-emergent Serious Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE).
Number of patients with Grade 3 or 4 Treatment Emergent Adverse Event (TEAE)
|
5 participants
|
4 participants
|
|
Incidence of Treatment-emergent Adverse Events Including Treatment-emergent Serious Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE).
Number of patients with Treatment Emergent Adverse Event related to any of the study treatments
|
8 participants
|
11 participants
|
|
Incidence of Treatment-emergent Adverse Events Including Treatment-emergent Serious Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE).
Number of patients with fatal events
|
0 participants
|
0 participants
|
|
Incidence of Treatment-emergent Adverse Events Including Treatment-emergent Serious Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE).
Number of patients discontinuing for Adverse Events
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab Part 1
n=8 Participants
Part I1 Patients will receive 3 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, and 8) at 3x10\^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. They will then receive pembrolizumab i.v., 2mg/kg or 200mg flat dose, on day 22 (Week 3) and every 3 weeks thereafter until the end of treatment visit on day 169 (Week 24).
ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF)
Cyclophosphamide: Pre-treatment
Pembrolizumab: PD1 blockade
|
Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab Part 2
n=12 Participants
Part 2: Patients will receive 4 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, 8 and 15) at 3x10\^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. ONCOS-102 will be given in combination with Pembrolizumab starting on Day 22/Week 3 and every three weeks thereafter until Day 169/Week 24 or until unacceptable toxicity or clinically relevant disease progression, whichever occurs first. Pembrolizumab will be given according to institutional practice (2mg/kg or 200mg flat dose).
ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF)
Cyclophosphamide: Pre-treatment
Pembrolizumab: PD1 blockade
|
|---|---|---|
|
Objective Response Rates by RECIST 1.1 and irRECIST.
Number of patient with Complete Response or Partial Response
|
3 Participants
|
4 Participants
|
|
Objective Response Rates by RECIST 1.1 and irRECIST.
Number of patients with Stable Disease or Progressive Disease
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
Adverse Events
Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab Part 1
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab Part 2
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab Part 1
n=9 participants at risk
Part 1: Patients will receive 3 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, and 8) at 3x10\^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. They will then receive pembrolizumab i.v., 2mg/kg or 200mg flat dose, on day 22 (Week 3) and every 3 weeks thereafter until the end of treatment visit on day 169 (Week 24).
ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF)
Cyclophosphamide: Pre-treatment
Pembrolizumab: PD1 blockade
|
Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab Part 2
n=12 participants at risk
Part 2: Patients will receive 4 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, 8 and 15) at 3x10\^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. ONCOS-102 will be given in combination with Pembrolizumab starting on Day 22/Week 3 and every three weeks thereafter until Day 169/Week 24 or until unacceptable toxicity or clinically relevant disease progression, whichever occurs first. Pembrolizumab will be given according to institutional practice (2mg/kg or 200mg flat dose).
ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF)
Cyclophosphamide: Pre-treatment
Pembrolizumab: PD1 blockade
|
|---|---|---|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
11.1%
1/9 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
0.00%
0/12 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
8.3%
1/12 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
0.00%
0/12 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/9 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
8.3%
1/12 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/9 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
8.3%
1/12 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
General disorders
Pyrexia
|
0.00%
0/9 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
16.7%
2/12 • Number of events 4 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Infections and infestations
Large intestine infection
|
11.1%
1/9 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
0.00%
0/12 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Infections and infestations
Pneumonia
|
11.1%
1/9 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
0.00%
0/12 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Infections and infestations
Staphylococcal infection
|
11.1%
1/9 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
0.00%
0/12 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Investigations
Blood bilirubin increased
|
11.1%
1/9 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
0.00%
0/12 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
11.1%
1/9 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
0.00%
0/12 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.1%
1/9 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
0.00%
0/12 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
11.1%
1/9 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
0.00%
0/12 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
11.1%
1/9 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
0.00%
0/12 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Nervous system disorders
Syncope
|
0.00%
0/9 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
8.3%
1/12 • Number of events 2 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
8.3%
1/12 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/9 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
8.3%
1/12 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
11.1%
1/9 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
0.00%
0/12 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
Other adverse events
| Measure |
Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab Part 1
n=9 participants at risk
Part 1: Patients will receive 3 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, and 8) at 3x10\^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. They will then receive pembrolizumab i.v., 2mg/kg or 200mg flat dose, on day 22 (Week 3) and every 3 weeks thereafter until the end of treatment visit on day 169 (Week 24).
ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF)
Cyclophosphamide: Pre-treatment
Pembrolizumab: PD1 blockade
|
Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab Part 2
n=12 participants at risk
Part 2: Patients will receive 4 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, 8 and 15) at 3x10\^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. ONCOS-102 will be given in combination with Pembrolizumab starting on Day 22/Week 3 and every three weeks thereafter until Day 169/Week 24 or until unacceptable toxicity or clinically relevant disease progression, whichever occurs first. Pembrolizumab will be given according to institutional practice (2mg/kg or 200mg flat dose).
ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF)
Cyclophosphamide: Pre-treatment
Pembrolizumab: PD1 blockade
|
|---|---|---|
|
Vascular disorders
Embolism
|
11.1%
1/9 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
8.3%
1/12 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Vascular disorders
Hypertension
|
55.6%
5/9 • Number of events 7 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
33.3%
4/12 • Number of events 5 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Blood and lymphatic system disorders
Anaemia
|
22.2%
2/9 • Number of events 2 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
25.0%
3/12 • Number of events 4 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Gastrointestinal disorders
Abdominal distension
|
11.1%
1/9 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
8.3%
1/12 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
16.7%
2/12 • Number of events 2 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 2 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
25.0%
3/12 • Number of events 3 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Gastrointestinal disorders
Diarrhoea
|
44.4%
4/9 • Number of events 8 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
8.3%
1/12 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Gastrointestinal disorders
Nausea
|
33.3%
3/9 • Number of events 3 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
33.3%
4/12 • Number of events 9 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
2/9 • Number of events 2 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
25.0%
3/12 • Number of events 3 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
General disorders
Chills
|
55.6%
5/9 • Number of events 8 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
33.3%
4/12 • Number of events 15 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
General disorders
Fatigue
|
33.3%
3/9 • Number of events 3 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
25.0%
3/12 • Number of events 3 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
General disorders
Injection site pain
|
11.1%
1/9 • Number of events 2 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
25.0%
3/12 • Number of events 4 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
General disorders
Injection site reaction
|
0.00%
0/9 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
25.0%
3/12 • Number of events 3 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
General disorders
Malaise
|
22.2%
2/9 • Number of events 2 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
0.00%
0/12 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
General disorders
Oedema peripheral
|
22.2%
2/9 • Number of events 3 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
8.3%
1/12 • Number of events 2 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
General disorders
Pain
|
0.00%
0/9 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
16.7%
2/12 • Number of events 2 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
General disorders
Pyrexia
|
33.3%
3/9 • Number of events 7 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
58.3%
7/12 • Number of events 23 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Infections and infestations
Urinary tract infection
|
22.2%
2/9 • Number of events 3 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
8.3%
1/12 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Investigations
Alanine aminotransferase increased
|
44.4%
4/9 • Number of events 5 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
25.0%
3/12 • Number of events 5 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Investigations
Aspartate aminotransferase increased
|
22.2%
2/9 • Number of events 8 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
25.0%
3/12 • Number of events 6 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/9 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
25.0%
3/12 • Number of events 4 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Investigations
Weight decreased
|
11.1%
1/9 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
8.3%
1/12 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Investigations
White blood cell count decreased
|
11.1%
1/9 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
8.3%
1/12 • Number of events 4 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
22.2%
2/9 • Number of events 3 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
16.7%
2/12 • Number of events 3 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.1%
1/9 • Number of events 2 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
16.7%
2/12 • Number of events 2 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.2%
2/9 • Number of events 2 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
8.3%
1/12 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
3/9 • Number of events 6 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
0.00%
0/12 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
16.7%
2/12 • Number of events 2 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Nervous system disorders
Headache
|
33.3%
3/9 • Number of events 6 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
0.00%
0/12 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Renal and urinary disorders
Pollakisuria
|
11.1%
1/9 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
8.3%
1/12 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
16.7%
2/12 • Number of events 2 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
1/9 • Number of events 2 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
25.0%
3/12 • Number of events 3 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
11.1%
1/9 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
8.3%
1/12 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
3/9 • Number of events 3 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
0.00%
0/12 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.1%
1/9 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
8.3%
1/12 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/9 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
16.7%
2/12 • Number of events 2 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/9 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
16.7%
2/12 • Number of events 2 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
3/9 • Number of events 4 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
33.3%
4/12 • Number of events 4 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Skin and subcutaneous tissue disorders
Rash
|
22.2%
2/9 • Number of events 3 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
8.3%
1/12 • Number of events 1 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
22.2%
2/9 • Number of events 2 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
25.0%
3/12 • Number of events 4 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Vascular disorders
Hypotension
|
0.00%
0/9 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
16.7%
2/12 • Number of events 2 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Investigations
Blood bilirubin increased
|
22.2%
2/9 • Number of events 2 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
0.00%
0/12 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
22.2%
2/9 • Number of events 2 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
0.00%
0/12 • 27 weeks
Adverse events were reported according to NCI CTCAE vs 5.0
|
Additional Information
Dr. Lone H. Ottesen, Chief Development Officer
Targovax
Phone: +44 7920567911
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place