Trial Outcomes & Findings for A Study of Intratumoral CAVATAK™ in Patients With Stage IIIc and Stage IV Malignant Melanoma (VLA-007 CALM ) (NCT NCT01227551)

Last Updated: 2019-07-05

Results Overview

To assess the clinical efficacy of Intratumoral (IT) CVA21 in terms of immune-related Progression-Free Survival (irPFS) at 6 months.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

57 participants

Primary outcome timeframe

6 months

Results posted on

2019-07-05

Participant Flow

Subjects were recruited from medical clinics from 27-Dec-2011 to 29-Jul-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

Participant milestones
Measure	CVA21 CVA21 monotherapy
Overall Study STARTED	57
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	34

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Intratumoral CAVATAK™ in Patients With Stage IIIc and Stage IV Malignant Melanoma (VLA-007 CALM )

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CVA21 n=57 Participants CVA21 monotherapy
Age, Continuous	64.7 years STANDARD_DEVIATION 14.91 • n=93 Participants
Sex: Female, Male Female	21 Participants n=93 Participants
Sex: Female, Male Male	36 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	56 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	56 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Height	172.7 centimeters STANDARD_DEVIATION 11.84 • n=93 Participants
Weight	86.16 kilograms STANDARD_DEVIATION 21.869 • n=93 Participants

PRIMARY outcome

Timeframe: 6 months

Population: ITT Population

To assess the clinical efficacy of Intratumoral (IT) CVA21 in terms of immune-related Progression-Free Survival (irPFS) at 6 months.

Outcome measures

Outcome measures
Measure	CVA21 n=57 Participants CVA21 monotherapy
Percentage of Participants With Immune-related Progression-Free Survival (irPFS) at 6 Months	38.6 percentage of participants Interval 26.0 to 52.4

SECONDARY outcome

Timeframe: 6 months or more

Population: ITT Population

Per Immune-Related Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI or calipers: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Durable Response Rate (DRR) = CR + PR.

Outcome measures

Outcome measures
Measure	CVA21 n=57 Participants CVA21 monotherapy
Durable Response Rate	21.1 percentage of participants

Adverse Events

CVA21

Serious events: 11 serious events

Other events: 54 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CVA21 n=57 participants at risk CVA21 monotherapy
Neoplasms benign, malignant and unspecified (incl cysts and polyps) squamous cell carcinoma	3.5% 2/57 • Number of events 2 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Cardiac disorders cardiac arrest	1.8% 1/57 • Number of events 1 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Cardiac disorders cardiogenic shock	1.8% 1/57 • Number of events 1 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Gastrointestinal disorders abdominal pain	1.8% 1/57 • Number of events 1 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Gastrointestinal disorders nausea	1.8% 1/57 • Number of events 1 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Gastrointestinal disorders vomiting	1.8% 1/57 • Number of events 1 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
General disorders fatigue	1.8% 1/57 • Number of events 1 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Infections and infestations bacteremia	1.8% 1/57 • Number of events 1 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Infections and infestations cellulitis	1.8% 1/57 • Number of events 1 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Infections and infestations sepsis	1.8% 1/57 • Number of events 1 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) metastatic malignant melanoma	1.8% 1/57 • Number of events 1 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) renal cell carcinoma	1.8% 1/57 • Number of events 1 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Nervous system disorders haemorrhage intracranial	1.8% 1/57 • Number of events 1 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Nervous system disorders motor dysfunction	1.8% 1/57 • Number of events 1 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Respiratory, thoracic and mediastinal disorders pulmonary embolism	1.8% 1/57 • Number of events 1 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.

Other adverse events

Other adverse events
Measure	CVA21 n=57 participants at risk CVA21 monotherapy
Blood and lymphatic system disorders anaemia	8.8% 5/57 • Number of events 7 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Blood and lymphatic system disorders iron deficiency	7.0% 4/57 • Number of events 4 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Gastrointestinal disorders constipation	12.3% 7/57 • Number of events 7 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Gastrointestinal disorders diarrhoea	14.0% 8/57 • Number of events 8 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Gastrointestinal disorders nausea	14.0% 8/57 • Number of events 11 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Gastrointestinal disorders vomiting	12.3% 7/57 • Number of events 8 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
General disorders chills	28.1% 16/57 • Number of events 27 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Gastrointestinal disorders fatigue	40.4% 23/57 • Number of events 33 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
General disorders influenza like illness	8.8% 5/57 • Number of events 7 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
General disorders injection site discharge	5.3% 3/57 • Number of events 4 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
General disorders injection site erythema	14.0% 8/57 • Number of events 11 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
General disorders injection site oedema	5.3% 3/57 • Number of events 4 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
General disorders injection site pain	31.6% 18/57 • Number of events 49 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
General disorders injection site pruritus	5.3% 3/57 • Number of events 7 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
General disorders injection site reaction	5.3% 3/57 • Number of events 3 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
General disorders malaise	7.0% 4/57 • Number of events 4 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
General disorders oedema peripheral	5.3% 3/57 • Number of events 3 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
General disorders pain	19.3% 11/57 • Number of events 13 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
General disorders pyrexia	12.3% 7/57 • Number of events 7 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Infections and infestations rhinitis	5.3% 3/57 • Number of events 3 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Infections and infestations upper respiratory tract infection	8.8% 5/57 • Number of events 6 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Metabolism and nutrition disorders decreased appetite	10.5% 6/57 • Number of events 8 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Musculoskeletal and connective tissue disorders arthralgia	10.5% 6/57 • Number of events 7 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Musculoskeletal and connective tissue disorders back pain	5.3% 3/57 • Number of events 3 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Musculoskeletal and connective tissue disorders myalgia	15.8% 9/57 • Number of events 11 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Musculoskeletal and connective tissue disorders neck pain	5.3% 3/57 • Number of events 4 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Musculoskeletal and connective tissue disorders pain in extremity	8.8% 5/57 • Number of events 5 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Nervous system disorders dizziness	15.8% 9/57 • Number of events 10 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Nervous system disorders headache	21.1% 12/57 • Number of events 16 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Psychiatric disorders anxiety	7.0% 4/57 • Number of events 4 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Respiratory, thoracic and mediastinal disorders cough	10.5% 6/57 • Number of events 8 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Respiratory, thoracic and mediastinal disorders dyspnoea	5.3% 3/57 • Number of events 3 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Respiratory, thoracic and mediastinal disorders oropharyngeal pain	12.3% 7/57 • Number of events 8 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Respiratory, thoracic and mediastinal disorders sinus congestion	7.0% 4/57 • Number of events 4 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Skin and subcutaneous tissue disorders hyperhidrosis	8.8% 5/57 • Number of events 8 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Skin and subcutaneous tissue disorders pruritus	10.5% 6/57 • Number of events 7 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.
Skin and subcutaneous tissue disorders rash	5.3% 3/57 • Number of events 4 • 1 year Listed SAEs and AEs are irrespective of treatment relationship. No SAEs reported were attributable to CVA21. No SUSARs were reported for the VLA-007/008 study.

Additional Information

Mark Grose

Viralytics

Phone: 1 647 821 7673

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER