MedTrace Logo

Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors

NCT02756845 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-02-20

Study results available
· View outcomes & findings →

Summary

This is a phase 1 study to evaluate the safety of intralesional talimogene laherparepvec administration in pediatric subjects with advanced non-CNS tumors that are amenable to direct injection

Conditions

  • Advanced Non CNS Tumors

Interventions

DRUG

Talimogene Laherparepvec

Talimogene laherparepvec will be administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance. The first dose of talimogene laherparepvec will be up to 4.0 mL of 10\^6 PFU/mL administered on day 1. The second injection, up to 4.0 mL of 10\^8 PFU/mL (or up to 4.0 mL of 10\^6 PFU/mL for a dose de-escalated cohort), will be administered 21 (+3) days after the initial injection. All subsequent injections, up to 4.0 mL of 10\^8 PFU/mL (or up to 4.0 mL of 10\^6 PFU/mL for a dose de-escalated cohort), will be administered every 14 (± 3) days. The treatment cycle interval may be increased due to toxicity.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-16
Primary Completion
2022-01-17
Completion
2022-11-29
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Italy
  • Spain
  • Switzerland

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 NCT02756845 on ClinicalTrials.gov