A Study of Talimogene Laherparepvec in Stage IIIc and Stage IV Malignant Melanoma
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of the Efficacy, Safety and Immunogenicity of OncoVEX^GM-CSF in Patients With Stage IIIc and Stage IV Malignant Melanoma|
- Objective Tumor Response Rate [ Time Frame: From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days ]
Objective response rate is defined as the percentage of participants with an overall best response of complete response or partial response. The objective response to treatment was assessed by computed tomography (CT) scanning or other clinical measurement using modified Response Evaluation Criteria In Solid Tumors (RECIST). Responses must have been confirmed on two visits not less than 4 weeks apart.
Tumor burden for a visit was calculated as the sum of the longest diameters of all tumors identified and measured up to that visit. Tumor response at each visit was derived from tumor burden, as follows:
- Complete response (CR): zero tumor burden
- Partial response (PR): a 30% or greater decrease in tumor burden
- Progressive disease (PD): a 20% or greater increase in tumor burden
- Stable disease (SD): none of the above (a < 30% decrease and < 20% increase in tumor burden)
- Overall Survival [ Time Frame: From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days ]Overall survival (OS) was calculated from the date of the first talimogene laherparepvec dose to the date of death. Median OS was estimated using the Kaplan-Meier method.
- Time to Progression [ Time Frame: From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days. ]
Time to progression was calculated from the date of the first talimogene laherparepvec dose to the first date of documented progressive disease (via clinical symptom or tumor burden assessment) that was not followed by a later response of CR, PR, or stable disease.
Median time to progression was calculated using the Kaplan-Meier method.
- Time to Longest Continuous Response [ Time Frame: From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days. ]Time to response was calculated from the date of the first talimogene laherparepvec dose to the initial date of the participant's last response interval.
- Duration of Response [ Time Frame: From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days. ]Duration of response was calculated from the initial date of response (CR or PR) until the date of progressive disease (or until last follow up that was CR or PR). Participants could have multiple response periods; in this situation, the last response interval was used for the calculation of duration of response.
- Number of Participants With Adverse Events [ Time Frame: From first dose of talimogene laherparepvec until 30 days after the last dose; the median (minimum, maximum) duration of treatment was 82 (1, 346) days. ]
The severity of an adverse event (AE) was graded according to Common Toxicity Criteria for Adverse Events (CTCAE) Version 3 (1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death).
Serious adverse events include death, life-threatening events, events requiring or prolonging hospitalization, result in persistent or significant disability/incapacity, or a congenital anomaly/birth defect, or otherwise important medical events that may jeopardise the patient or require intervention to prevent one of the above outcomes.
|Study Start Date:||December 2005|
|Study Completion Date:||May 2009|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Experimental: Talimogene Laherparepvec
Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
Drug: Talimogene Laherparepvec
Up to 4 mL of 10⁸ pfu/mL/per intratumoral injection
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289016
|United States, California|
|UCSD Cancer Center, Thornton Hospital|
|La Jolla, California, United States, 92093|
|Los Angeles, California, United States, 90095|
|United States, Colorado|
|University of Colorado, Anschutz Cancer Pavillion|
|Aurora, Colorado, United States, 80010|
|United States, Minnesota|
|Hubert H Humphrey Cancer Center|
|Robbinsdale, Minnesota, United States, 55422|
|United States, New Jersey|
|Montclair, New Jersey, United States, 07042|
|United States, New York|
|Columbia University, Department of Surgery|
|New York, New York, United States, 10032|
|United States, Texas|
|Mary Crowely Medical Research Center|
|Dallas, Texas, United States, 75246|
|Royal Marsden Hospital|
|London, United Kingdom, SW3 6JJ|
|Principal Investigator:||John Nemunaitis, MD||Mary Crowley Medical Research Center|
|Study Director:||Rob Coffin, PhD||BioVex Limited|