Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Infections

Rare Diseases

Melanoma

Virus Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Talimogene laherparepvec

Antineoplastic Agents, Immunological

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.

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

Talimogene Laherparepvec

John Nemunaitis, MD

Rob Coffin, PhD

The primary objective of the study was to assess the clinical efficacy of talimogene laherparepvec in terms of tumor response rates.

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

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 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 (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 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 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 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.

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.

Symbion Research International

BioVex Limited

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Age, Continuous

Sex: Female, Male

White

Asian

Hispanic

Race/Ethnicity, Customized

0 (Fully active)

1 (Restrictive but ambulatory)

Scale used to assess how a patient's disease is progressing, how the disease affects the daily living abilities of the patient: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about \> 50% of waking hours; 3 = Capable of only limited self care, confined to a bed or chair \> 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.

Eastern Cooperative Oncology Group (ECOG) Performance

Stage IIIC

Stage IVM1a

Stage IVM1b

Stage IVM1c

Stage IIIC: Ulcerated lesion and 1 lymph node with macrometastasis; 2-3 nodes with macrometastasis or ≥ 4 metastatic lymph nodes, matted lymph nodes, or in-transit met(s)/satellite(s); Stage IV: M1a: Spread to skin, subcutaneous tissue, or lymph nodes; normal lactate dehydrogenase (LDH) level; M1b: Spread to lungs; normal LDH level; M1c: Spread to all other visceral organs, normal LDH level or any distant disease with elevated LDH level.

Tumor, Node, Metastasis (TNM) Disease Stage

Study Director

Intent-to-treat (ITT) population (all participants who received at least 1 dose of talimogene laherparepvec)

Spots Global Cancer Trial Database for A Study of Talimogene Laherparepvec in Stage IIIc and Stage IV Malignant Melanoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial