Melanoma
Conditions
Keywords
Melanoma, CALM
Brief summary
This is an extended use study for patients who have received 10 doses of CAVATAK™ in the VLA 007 trial. There may be patients who have benefitted from the study drug and who might benefit from further treatment. In order to accommodate those patients further treatment to complete 48 weeks of CVA21 intratumoral injections will be made available.
Interventions
BIOLOGICALCVA21
Sponsors
Viralytics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Patients must have reached Week 24 of the core protocol in immune-related complete response (irCR), immune-related partial response (irPR), immune-related stable disease (irSD), or immune-related progressive disease (irPD) (unconfirmed) with evidence of tumor inflammatory reaction. * 2\. If patient is in irPD (unconfirmed) status, they must not have had a decrease in their Karnofsky Performances Scale (KPS) score \> 10 points and to be judged to not have rapid clinical deterioration by the investigator since the subject's last tumor measurement leading to irPD assessment. * 3\. Patients must start treatment in the extension protocol within 8 weeks of their last injection administered in the core protocol. * 4\. Patient is able and willing to provide written informed consent to participate in the study. * 5\. Fertile males and females must agree to the use of an adequate form of contraception, e.g., condoms for males.
Exclusion criteria
* 1\. Tumors to be injected lying in mucosal regions or close to an airway, major blood vessel or spinal cord that, in the opinion of the Investigators, could cause occlusion or compression in the case of tumor swelling or erosion into a major vessel in the case of necrosis. * 2\. If lesions are too small to be visualized or palpable for accurate injection. * 3\. Currently in status of irPD (confirmed) or irPD (unconfirmed) without evidence of tumor inflammatory response, or with rapid clinical deterioration, or with a decrease of 10 points or more on their KPS score since their last assessment before irPD (unconfirmed) assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 12 months | Participants with Grade 3 or Higher Adverse Events |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from medical clinics from 03 July 2012 to 29 July 2015 (last subject enrolled in VLA-008).
Pre-assignment details
Subjects were screened for and excluded from the study if they had pre-existing antibodies to CVA21.
Participants by arm
| Arm | Count |
|---|---|
| CVA21 Dose of CAVATAK up to 3 x 10⁸ TCID50 for an additional 9 treatments at 3-week intervals CVA21 | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | CVA21 |
|---|---|
| Age, Continuous | 68.1 years STANDARD_DEVIATION 12.8 |
| Region of Enrollment United States | 16 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 16 |
| other Total, other adverse events | 13 / 16 |
| serious Total, serious adverse events | 2 / 16 |
Outcome results
Primary
Safety
Participants with Grade 3 or Higher Adverse Events
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CVA21 | Safety | 16 participants |