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Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec

NCT02014441 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2019-11-20

Study results available
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Summary

The primary objective was to estimate the proportion of participants with detectable talimogene laherparepvec deoxyribonucleic acid (DNA) in the blood and urine at any time after administration of talimogene laherparepvec within the first 3 cycles.

Conditions

Interventions

DRUG

Talimogene laherparepvec

Talimogene laherparepvec will be administered by intralesion injection at an initial dose of up to 4.0 mL of 10\^6 PFU/mL. The second and subsequent doses will will be up to 4.0 mL 10\^8 PFU/mL. The second dose should be administered 21 days from the initial dose. All subsequent doses should be given every 14 days.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-07
Primary Completion
2016-01-25
Completion
2018-04-19

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases
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 NCT02014441 on ClinicalTrials.gov