CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
Talimogene Laherparepvecdrug
Likely dose
Up to 4 mL of 10⁸ pfu/mL per intratumoral injectionAI-extracted
Key inclusion· 7
  • ✓Histologically proven stage IIIc or IV melanoma not eligible for curative surgery with one or more tumors accessible for intratumoral injection
  • ✓Injected tumors must be 0.5 to 10 cm in longest diameter and suitable for injection (not bleeding or weeping)
  • ✓Serum LDH ≤2.0 times upper limit of normal
  • ✓Age 18 years or older
Key exclusion· 13
  • ✕Prior melanoma immunotherapy trial within 1 month or other investigational agent within last month
  • ✕Tumors in mucosal regions or close to airway, major blood vessel, or spinal cord that could cause occlusion or compression
  • ✕Major surgery within 14 days prior to entry
  • ✕Serious infections within 28 days prior to entry

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00289016
NCT00289016Phase 2Completed
CompareCT.gov

A Phase II Study of the Efficacy, Safety and Immunogenicity of OncoVEX^GM-CSF in Patients With Stage IIIc and Stage IV Malignant Melanoma

BioVex Limited·interventional·Posted Feb 9, 2006·Updated Dec 18, 2015

In Brief

A Phase 2 clinical trial evaluating Talimogene Laherparepvec for Melanoma. Completed, enrolled 50 participants across 8 sites in 2 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesUnited Kingdom, United States
CollaboratorsSymbion Research International

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 9, 2006
Enrollment StartDec 1, 2005
Primary CompletionDec 1, 2008
Study CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 20.4 years ago

Interventions

Talimogene Laherparepvecdrug

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