An Extended Use Study of Safety and Efficacy of Talimogene Laherparepvec in Melanoma

Browse trials for

• Melanoma 3,006

Keywords

• Melanoma
• Stage IIIb, IIIc and IV Disease
• oncolytic
• OncoVex
• OncoVEX^GM-CSF

Melanoma

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

This study's enrollment of 31 is below 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

• Active comparator
  GM-CSF

  Granulocyte macrophage colony-stimulating factor (GM-CSF) was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.

  Drug: Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF)

• Experimental
  Talimogene Laherparepvec

  Talimogene laherparepvec was administered at a concentration of 10⁸ plaque forming units (PFU)/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.

  Biological: Talimogene Laherparepvec

Interventions

• BiologicalTalimogene Laherparepvec

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

  Also known as: OncoVEX^GM-CSF, IMLYGIC™

• DrugGranulocyte Macrophage Colony-Stimulating Factor (GM-CSF)

  125 µg/m² subcutaneous injection

Primary outcomes

1. Number of Participants With Treatment-emergent Adverse Events (AEs)

   AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 based on the following guideline: Grade 1: Mild AE; Grade 2: Moderate AE; Grade 3: Severe AE; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to AE. Treatment-related AE refers to AEs that have possible or probable relation to study treatment as determined by the investigator. A serious AE is one that meets one or more of the following criteria/outcomes: * Results in death. * Is life-threatening. * Requires inpatient hospitalization or prolongation of existing hospitalization. * Results in persistent or significant disability/incapacity. * Is a congenital anomaly/birth defect. * Is an important medical event.

   Time frame: From first administration of study drug in the extension period until 30 days after last dose. Median duration of treatment was 50 weeks in the GM-CSF group and 36 weeks in the talimogene laherparepvec group.

Secondary outcomes

1. Objective Response Rate

   Objective response rate was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) assessed by the investigator. Best overall response for a patient is the best overall response observed across all time points and is cumulative (ie, includes responses during the parent study 005/05 and during Study 005/05-E). Disease assessments were performed at the beginning of each treatment cycle and assessed in accordance with modified World Health Organization criteria. CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline.

   Time frame: From randomization in study 005/05 until the data-cut-off date for the extension period of 08 August 2014; median treatment duration for 005/05 and 005/05-E studies combined was 88 weeks for talimogene laherparepvec and 100 weeks for GM-CSF.

2. Durable Response Rate

   Durable response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) assessed by the investigator, initiating at any time while receiving talimogene laherparepvec or GM-CSF therapy on the 005/05 or the 005/05-E study and maintained continuously for at least 6 months from response initiation. This reflects all new sites of disease as well as disease sites identified at baseline. Disease assessments were performed at the beginning of each treatment cycle in accordance with modified World Health Organization criteria. CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline.

   Time frame: From randomization in study 005/05 until the data-cut-off date for the extension period of 08 August 2014; median treatment duration for 005/05 and 005/05-E studies combined was 88 weeks for talimogene laherparepvec and 100 weeks for GM-CSF.

Baseline characteristics

Related links

• Sponsor Website ↗