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Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma

NCT02366195 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2021-11-30

Study results available
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Summary

The study is a phase 2, multi centered, single arm study designed to evaluate the correlation between cluster of differentiation 8-positive (CD8+) cell density and objective response rate in adults with unresected stage IIIB to IVM1c melanoma. This study will also evaluate the safety and tolerability profile of talimogene laherparepvec.

Conditions

  • Unresected Stage IIIb to IVM1c Melanoma

Interventions

DRUG

Talimogene Laherparepvec

The initial dose of talimogene laherparepvec is up to 4.0 mL of 10\^6 PFU/mL. Subsequent doses of talimogene laherparepvec are up to 4.0 mL of 10\^8 PFU/mL.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-07
Primary Completion
2017-06-26
Completion
2020-12-25

Countries

  • United States
  • Austria
  • Belgium
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Russia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02366195 on ClinicalTrials.gov