Phase 2
Completed N=16
CAVATAK in Patients With Stage IIIc or IV Malignant Melanoma to Extend Dosing to 48 Weeks (VLA-008 CALM Ext)
Source: ClinicalTrials.gov NCT01636882 ↗Enrolled (actual)
16
Serious AEs
12.5%
Results posted
Apr 2018
Primary outcomePrimary: Safety — 16 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety |
16 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01636882). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.