NCT01636882

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2012

Typical duration for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2016

Completed
2 years until next milestone

Results Posted

Study results publicly available

April 23, 2018

Completed
Last Updated

July 9, 2019

Status Verified

June 1, 2019

Enrollment Period

3.8 years

First QC Date

July 5, 2012

Results QC Date

February 15, 2018

Last Update Submit

June 26, 2019

Conditions

Melanoma

Keywords

MelanomaCALM

Outcome Measures

Primary Outcomes (1)

  • Safety

    Participants with Grade 3 or Higher Adverse Events

    12 months

Study Arms (1)

CVA21

EXPERIMENTAL

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

Biological: CVA21

Interventions

CVA21BIOLOGICAL
CVA21

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.
  • \. 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.
  • \. Patients must start treatment in the extension protocol within 8 weeks of their last injection administered in the core protocol.
  • \. Patient is able and willing to provide written informed consent to participate in the study.
  • \. Fertile males and females must agree to the use of an adequate form of contraception, e.g., condoms for males.

You may not qualify if:

  • \. 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.
  • \. If lesions are too small to be visualized or palpable for accurate injection.
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Oncology Specialists

Park Ridge, Illinois, 60714, United States

Location

Providence Medical Centre

Portland, Oregon, 97213, United States

Location

Mary Crowley Medical Center

Dallas, Texas, 75230, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

  • Andtbacka RHI, Curti B, Daniels GA, Hallmeyer S, Whitman ED, Lutzky J, Spitler LE, Zhou K, Bommareddy PK, Grose M, Wang M, Wu C, Kaufman HL. Clinical Responses of Oncolytic Coxsackievirus A21 (V937) in Patients With Unresectable Melanoma. J Clin Oncol. 2021 Dec 1;39(34):3829-3838. doi: 10.1200/JCO.20.03246. Epub 2021 Aug 31.

    PMID: 34464163DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Mark Grose
Organization
Viralytics Ltd
mark.grose@viralytics.com
1 647 821 7673

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2012

First Posted

July 10, 2012

Study Start

July 3, 2012

Primary Completion

April 6, 2016

Study Completion

April 6, 2016

Last Updated

July 9, 2019

Results First Posted

April 23, 2018

Record last verified: 2019-06

Locations

US(4)