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Virus Therapy

Talimogene Laherparepvec for Non-Central Nervous System Tumors

Phase 1
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug in children with advanced tumors. The goal is to see if it is safe.

Eligible Conditions
  • Non-Central Nervous System Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Who Experienced a Dose-limiting Toxicity (DLT)
Secondary outcome measures
Duration of Response (DOR)
Overall Response Rate (ORR)
Overall Survival (OS)
+3 more

Side effects data

From 2014 Phase 3 trial • 31 Patients • NCT01368276
67%
Cough
67%
Fatigue
33%
Influenza like illness
33%
Dyspnoea
33%
Injection site mass
33%
Flushing
33%
Chills
33%
Ecchymosis
33%
Urticaria
33%
Diarrhoea
33%
Nausea
33%
Vomiting
33%
Oedema peripheral
33%
Pyrexia
33%
Folliculitis
33%
Oral herpes
33%
Pneumonia
33%
Upper respiratory tract infection
33%
Lipoma
33%
Haemoptysis
33%
Hypopnoea
33%
Oropharyngeal pain
33%
Blood blister
33%
Hyperhidrosis
33%
Night sweats
33%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
GM-CSF
Talimogene Laherparepvec

Trial Design

1Treatment groups
Experimental Treatment
Group I: Talimogene Laherparepvec (TVEC)Experimental Treatment1 Intervention
The first dose of talimogene laherparepvec will be administered at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (+3 days) later. Subsequent doses of up to 4.0 mL of 10ᶺ8 PFU/mL will be administered every 14 days (± 3 days) thereafter. Cohorts will be assigned as follows: Cohort A1 (age 12 to ≤ 21 years). Cohort B1 (age 2 to < 12 years). The DLRT will review the safety data of the first 3 subjects in the older age cohort A1 to decide if the younger age cohort B1 can be opened for enrollment. If dose de-escalation is needed and if permissible based on the incidence of DLTs, additional DLT-evaluable subjects will be enrolled and treated at a lower dose level of talimogene laherparepvec. Dose de-escalation cohorts will be assigned as follows and the same DLT rules will be applied: Cohort A2 (age 12 to ≤ 21 years), Cohort B2 (age 2 to < 12 years).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talimogene Laherparepvec
2008
Completed Phase 3
~640

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,367 Previous Clinical Trials
1,386,238 Total Patients Enrolled
MDStudy DirectorAmgen
910 Previous Clinical Trials
923,771 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Talimogene Laherparepvec received authorization from the FDA?

"Given the limited data on efficacy and safety, Talimogene Laherparepvec receives a score of 1."

Answered by AI

How many medical institutions are overseeing the implementation of this experiment?

"As of now, 8 medical centres are actively recruiting patients for this trial. These sites can be found in cities like Detroit, Columbus and Philadelphia amongst other locations. It is advisable to opt for the clinic closest to you, as it would reduce your travelling commitments if enrolled."

Answered by AI

Are there any prior investigations concerning Talimogene Laherparepvec?

"Talimogene Laherparepvec was first studied in 2015 at University of Iowa Hospitals and Clinics, with 13 trials to date. At present, 22 additional clinical studies are underway; the majority of them taking place near Detroit, Michigan."

Answered by AI

Does this medical experiment accept individuals aged 65 and above?

"To be considered for this trial, participants must fall between the ages of 2 to 21. Of the trials currently active on clinicaltrials.gov pertaining to pediatric patients, 301 are recruiting individuals younger than 18 and 2215 are enlisting those older than 65 years old."

Answered by AI

What is the current threshold for enrolment in this research trial?

"Patient recruitment for this particular trial has been suspended; the original posting was on August 16th 2017 and the last update being January 19th 2022. If you are searching for alternate medical studies, there are currently 2379 trials actively enrolling patients suffering from neoplasms and 22 concerning Talimogene Laherparepvec that require participants."

Answered by AI

Is this experimental protocol the inaugural one of its kind?

"As of now, 22 ongoing clinical trials for Talimogene Laherparepvec are being conducted in 93 cities and 16 countries. This drug first underwent testing back in 2015 when Amgen sponsored a trial with 30 participants to complete Phase 1 & 2 approval stages. Since then, 13 more studies have been done on this medicine."

Answered by AI

Is it still possible to enroll in this clinical research?

"According to clinicaltrials.gov this medical trial, which was first made available on August 16th 2017 and last updated on January 19th 2022, is no longer actively recruiting patients. Nevertheless, 2401 other trials are currently seeking volunteers right now."

Answered by AI

What eligibility criteria must be met to join this research endeavor?

"This clinical trial seeks 15 individuals, between the ages of two and 21, with neoplasms. To meet the requirements for enrollment, these patients must have a life expectancy exceeding four months from registration date as well as measurable or non-measurable lesions per International Response Criteria RECIST criteria."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors
2017. "Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02756845.
~2 spots leftby Apr 2025
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