CAVATAK in Patients With Stage IIIc or IV Malignant Melanoma to Extend Dosing to 48 Weeks (VLA-008 CALM Ext)

Phase 2

Completed

• Conditions: Melanoma
• Interventions: Biological: CVA21

• Registration Number: NCT01636882
• Lead Sponsor: Viralytics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-03
• Study First Submitted: 2012-07-05
• Study First Submitted QC: 2012-07-05
• Study First Posted: 2012-07-10
• Primary Completion: 2016-04-06
• Study Completion: 2016-04-06
• Results First Submitted: 2018-02-15
• Results First Submitted QC: 2018-04-19
• Results First Posted: 2018-04-23
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-26
• Last Update Posted: 2019-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CVA21	CVA21	Dose of CAVATAK up to 3 x 10⁸ TCID50 for an additional 9 treatments at 3-week intervals

Primary Outcome Measures

Name	Time	Method
Safety	12 months	Participants with Grade 3 or Higher Adverse Events

Trial Locations

Locations (4)

Oncology Specialists; 🇺🇸 Park Ridge, Illinois, United States

Mary Crowley Medical Center; 🇺🇸 Dallas, Texas, United States

Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States

Providence Medical Centre; 🇺🇸 Portland, Oregon, United States