A Study of Talimogene Laherparepvec in Stage IIIc and Stage IV Malignant Melanoma

Browse trials for

• Melanoma 3,006

Keywords

• gene transfer
• gene therapy
• oncolytic virus
• GM-CSF
• melanoma

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's enrollment of 50 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.

Lead sponsor

BioVex Limited is the lead sponsor of 6 studies on the registry; none are open to participants now.

Study arms

• 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

Interventions

• DrugTalimogene Laherparepvec

  Up to 4 mL of 10⁸ pfu/mL/per intratumoral injection

  Also known as: OncoVEX^GM-CSF, T-VEC, IMLYGIC

Primary outcomes

1. Objective Tumor Response Rate

   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)

   Time frame: From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days

Secondary outcomes

1. Overall Survival

   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 frame: From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days

2. Time to Progression

   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 frame: From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days.

3. Time to Longest Continuous Response

   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.

   Time frame: From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days.

4. Duration of Response

   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.

   Time frame: From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days.

5. Number of Participants With Adverse Events

   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.

   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.

Baseline characteristics