Trial Outcomes & Findings for CAVATAK in Patients With Stage IIIc or IV Malignant Melanoma to Extend Dosing to 48 Weeks (VLA-008 CALM Ext) (NCT NCT01636882)
NCT ID: NCT01636882
Last Updated: 2019-07-09
Results Overview
Participants with Grade 3 or Higher Adverse Events
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
12 months
Results posted on
2019-07-09
Participant Flow
Subjects were recruited from medical clinics from 03 July 2012 to 29 July 2015 (last subject enrolled in VLA-008).
Subjects were screened for and excluded from the study if they had pre-existing antibodies to CVA21.
Participant milestones
| Measure |
CVA21
Dose of CVA21 up to 3 x 10⁸ TCID50 for an additional 9 treatments at 3-week intervals
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CAVATAK in Patients With Stage IIIc or IV Malignant Melanoma to Extend Dosing to 48 Weeks (VLA-008 CALM Ext)
Baseline characteristics by cohort
| Measure |
CVA21
n=16 Participants
Dose of CAVATAK up to 3 x 10⁸ TCID50 for an additional 9 treatments at 3-week intervals CVA21
|
|---|---|
|
Age, Continuous
|
68.1 years
STANDARD_DEVIATION 12.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 monthsParticipants with Grade 3 or Higher Adverse Events
Outcome measures
| Measure |
CVA21
n=16 Participants
Dose of CVA21 up to 3 x 10⁸ TCID50 for an additional 9 treatments at 3-week intervals
|
|---|---|
|
Safety
|
16 participants
|
Adverse Events
CVA21
Serious events: 2 serious events
Other events: 13 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
CVA21
n=16 participants at risk
Dose of CVA21 up to 3 x 10⁸ TCID50 for an additional 9 treatments at 3-week intervals
|
|---|---|
|
Cardiac disorders
Cardiac arrest
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Nervous system disorders
Motor Dysfunction
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
Other adverse events
| Measure |
CVA21
n=16 participants at risk
Dose of CVA21 up to 3 x 10⁸ TCID50 for an additional 9 treatments at 3-week intervals
|
|---|---|
|
General disorders
Fatigue
|
18.8%
3/16 • Number of events 3 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
General disorders
Pain
|
18.8%
3/16 • Number of events 3 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
General disorders
Chills
|
12.5%
2/16 • Number of events 4 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
General disorders
Influenza like illness
|
12.5%
2/16 • Number of events 3 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
General disorders
Chest discomfort
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
General disorders
Injection site erythema
|
6.2%
1/16 • Number of events 2 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
General disorders
Injection site inflammation
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
General disorders
Injection site oedema
|
6.2%
1/16 • Number of events 2 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
General disorders
Injection site pain
|
6.2%
1/16 • Number of events 6 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
General disorders
Injection site pruritus
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
General disorders
Injection site vesicles
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
General disorders
Malaise
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
General disorders
Non-cardiac chest pain
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Gastrointestinal disorders
Nausea
|
18.8%
3/16 • Number of events 4 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
2/16 • Number of events 2 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
2/16 • Number of events 2 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Gastrointestinal disorders
Toothache
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Nervous system disorders
Dizziness
|
18.8%
3/16 • Number of events 3 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Nervous system disorders
Motor dysfunction
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Nervous system disorders
Sinus headache
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Infections and infestations
Rhinitis
|
12.5%
2/16 • Number of events 2 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Infections and infestations
Bronchitis
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Infections and infestations
Incision site infection
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.8%
3/16 • Number of events 4 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
18.8%
3/16 • Number of events 3 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
6.2%
1/16 • Number of events 2 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Metabolism and nutrition disorders
Gout
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Cardiac disorders
Cardiac arrest
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Investigations
Occult blood
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • Number of events 1 • 1 year
Listed serious adverse events (SAEs) and adverse events (AEs) are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No serious unexpected adverse events (SUSARs) were reported for the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place