Investigator Initiated Studies
Independent investigators wishing to use CAVATAKTM for clinical trials are encouraged to contact Viralytics: clinicaltrials@viralytics.com
Phase II Melanoma Trial: The CALM Study (CAVATAKTM in Late Stage Melanoma)
Viralytics is now recruiting patients for this trial in the US, following approval from the FDA to carry out the CALM Study in the USA – a phase II clinical trial aimed at investigating the efficacy of CAVATAK™ as a therapeutic for Late Stage Melanoma. CAVATAK™ is an investigational drug, which means that it is only available to registered clinical trial participants. It has not been approved by regulatory authorities to be sold for general use.
Trial Status:
Patient recruitment has commenced and is ongoing at multiple sites. Additional site selection is ongoing. The trial will be open to patients with stage IIIc/IV melanoma patients.
Trial Design:
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Trial Details:
1) THE PRODUCT: CAVATAK™
- CAVATAK™ (Coxsackievirus A21) is a common cold virus, an enterovirus, which is capable of infecting cells expressing ICAM-1 (intercellular adhesion molecule 1) and/or DAF (decay accelerating factor).
- CAVATAK™ is a naturally occurring cold virus for which infection is associated with a self-limiting common cold and ultimately leads to long-lasting immunity.
- Melanoma tumor cells (and many other tumors) commonly express high levels of ICAM-1 and/or DAF and are especially susceptible to lysis by CAVATAK™.
- Most normal human cells express low levels ICAM-1 or DAF and are therefore, less susceptible to infection by CAVATAK™.
- CAVATAK™ can therefore, be regarded as a “targeted oncolytic virus”.
- CAVATAK™’s proposed method of action is to kill tumor cells both locally and systemically by direct cytolysis and by inducing a systemic cytotoxic T-cell response to tumor cells by the exposure of tumor specific antigens during infection.
- CAVATAK™ is being studied both by IT (intratumoral) and by IV injection. The upcoming Phase II CALM trial will be only for IT injection.
- It is proposed that direct IT injection of CAVATAKTM will not only lead to direct oncolysis of tumor cells, but the lysis of the tumor cells will allow the proliferating viruses to disseminate systemically.
- Injury and lysis of melanoma cells will allow their tumor specific antigens to be exposed and will then activate dendritic cells and other antigen presenting cells to initiate a systemic response to melanoma cells by activated cytotoxic T lymphocytes. Such a cytotoxic T-cell response may lead to systemic tumor control.
2) INCLUSION/EXCLUSION CRITERIA (SUMMARY)
- Unresectable melanoma requiring first or second-line treatment
- Performance status PS-0 or PS-1
- Absence of circulating serum neutralizing antibodies to CVA21
- At least one accessible lesion for IT injection
- Adequate hematologic, renal and liver function
- No ocular or mucosal melanomas
- No unstable brain metastases
3) HUMAN EXPERIENCE
- A Phase I trial of IT CAVATAKTM in unresectable melanoma patients has been completed.
- Intratumoral CAVATAKTM administration was well-tolerated with 5 of 9 patients experiencing reductions or stabilization of injected lesions. A Phase I intravenous trial is currently in progress in patients with late stage melanoma, prostate and breast cancer.
ClinicalTrials.gov Identifier: NCT01227551
If you would like more information about this trial please contact Viralytics: clinicaltrials@viralytics.com
Phase I Stage IV Solid Tumour Trial
Stage IV solid tumour cancer patients bearing ICAM-1 are needed for the completion of our intravenous CAVATAK™ trial. Patients with stage IV solid tumor disease who are over 18 years of age and who have failed or refused standard treatment may be suitable for inclusion in the trial.
ClinicalTrials.gov Identifier: NCT00636558
Status: recruiting patients
Sites: Redcliff Hospital, Qld and St George Hospital, Kogarah, NSW