\ Clinical Trials – Phase 2 CALM
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“CAVATAK continues to demonstrate very promising anti-cancer activity whilst being well tolerated in these late stage melanoma patients. Based on the robust interim results, further clinical evaluation of CAVATAK in a randomised study as either a monotherapy prior to surgery or in combination with other new immunotherapies is warranted.” -- Dr. Robert Andtbacka, Huntsman Cancer Institute, Utah


Clinical Trials – Phase 2 CALM

CALM Trial

Status: Study Complete

A Phase 2 study entitled the CALM Study (CAVATAK in Late stage Melanoma) is a 57 evaluable patient trial. The dosing schedule provides for injections of CAVATAK® into multiple tumours over an 18-week treatment phase, and monitoring for immune-related progression-free survival at 6 months after the first dose.

Final results from this trial have demonstrated a highly encouraging overall irPFS (immune related Progression Free Survival) rate of 39% at 6 months (22 of 57 evaluable patients) and a one-year survival rate of 75.4% (43 of 57 patients alive at one year). irPFS is the length of time during and after the first injection of CAVATAK that the patient lives without the cancer progressing.

The primary endpoint of the study required 10 patients from a total of 54 evaluable patients reporting irPFS at 6 months after the first dose of CAVATAK. This endpoint was achieved in September 2013 after only 30 evaluable patients.

A recruitment extension to the CALM study to enable a deeper interrogation of the immunotherapeutic activity of CAVATAK has completed enrolment. It consists of an additional cohort of 12 patients from three sites in the US. Biopsies taken from both injected and non-injected melanoma lesions are being examined in order to better understand the role of CAVATAK in triggering an immune response against cancer cells.

For further information about this trial, please visit the Clinical Trial website at ClinicalTrials.gov Identifier: NCT01227551

CALM results chart Nov 2015

Click here for the latest news on the CALM study

CALM Extension Trial

Status: Study Complete

A phase 2 extension trial investigating additional intratumoural injections of CAVATAK for treatment of Late Stage Melanoma has completed enrolment. Eligibility for the extension trial was met when patients demonstrated response to CAVATAK treatment in the initial CALM trial. For further information about this trial please visit the Clinical Trial website at:
ClinicalTrials.gov Identifier: NCT01636882

Click here for the latest news on the CALM Extension Trial

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