Adults 2 to 21, any sex, with Advanced Non CNS Tumors. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Who Experienced a Dose-limiting Toxicity (DLT)Primary· Day 1 to Day 35
All toxicities were graded using the Common Terminology Criteria for Adverse Events version 4.0:
* Grade 1: Mild
* Grade 2: Moderate
* Grade 3: Severe/medically significant but not immediately life-threatening
* Grade 4: Life-threatening
* Grade 5: Death related to adverse event
The occurrence of any of the below was considered a DLT, if judged to be related to talimogene laherparepvec:
* Grade 4 non-hematologic toxicity
* Grade 3 non-hematologic toxicity that lasted \> 3 days despite optimal supportive care
* Any ≥ grade 3 non-hematologic laboratory value if medical intervention was requir
Experienced a DLT
Group
Value
95% CI
Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years
0.0
0.0 – 28.5
Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years
0.0
0.0 – 84.2
Did Not Experience a DLT
Group
Value
95% CI
Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years
100.0
71.5 – 100.0
Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years
100.0
15.8 – 100.0
Overall Response Rate (ORR)Secondary· Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months
ORR was defined as the percentage of participants who experienced either complete response (CR) or partial response (PR) per modified immune-related response criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST) response criteria.
CR was defined as the disappearance of all lesions (whether measurable or not and whether baseline or new) and confirmation by a repeat, consecutive assessment no less than 4 weeks (28 days) from the date first documented. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
PR was defin
Group
Value
95% CI
Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years
0.0
0.00 – 24.71
Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years
0.0
0.00 – 84.19
Duration of Response (DOR)Secondary· Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months
DOR was defined as the time from the date of an initial response of CR or PR to the earlier of PD/death.
Group
Value
95% CI
Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years
NA
NA – NA
Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years
NA
NA – NA
Time to Response (TTR)Secondary· Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months
TTR was defined as the number of days from the first dose of talimogene laherparepvec to the first objective assessment of response as per modified irRC-RECIST.
Group
Value
95% CI
Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years
NA
NA – NA
Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years
NA
NA – NA
Time to Progression (TTP)Secondary· Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months
TTP was defined as the time from the first dose of talimogene laherparepvec until objective tumor progression per irRC-RECIST.
TTP was estimated using the Kaplan-Meier method.
Group
Value
95% CI
Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years
2.50
0.00 – 9.0
Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years
NA
1.6 – 3.5
Progression Free Survival (PFS)Secondary· Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months
PFS was defined as the time from the first dose to the earlier of disease progression per modified irRC-RECIST or death from any cause.
PFS was estimated using the Kaplan-Meier method.
Group
Value
95% CI
Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years
3.32
1.1 – 11.6
Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years
6.42
1.6 – 11.2
Overall Survival (OS)Secondary· Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months
OS was defined as as the time from first dose to the event of death from any cause.
OS was estimated using the Kaplan-Meier method.
Group
Value
95% CI
Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years
9.40
1.1 – 54.5
Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years
8.02
4.8 – 11.2
Adverse events — posted to ClinicalTrials.gov
Time frame: Mortality: Day 1 until end of follow-up; The median [min, max] duration of follow-up was 9.396 [1.12, 54.51] months Adverse events: From first dose of study drug until 30 days after last dose. The median [min, max] duration of treatment was 1.18 [0.0, 9.1] months in T-VEC Cohort A1 and 2.81 [2.0, 3.6] months in T-VEC Cohort B1.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years
Serious: 5/13 (38%)
Deaths: 12/13
Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years
Serious: 1/2 (50%)
Deaths: 2/2
Serious adverse events (11 terms)
Reaction
System
Cohort A1: Talimogene Lahe…
Cohort B1: Talimogene Lahe…
Nausea
Gastrointestinal disorders
—
—
Vascular device infection
Infections and infestations
—
—
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
—
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
—
Skin ulcer
Skin and subcutaneous tissue disorders
—
—
Metastatic malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Osteosarcoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06660810 — Neoadjuvant Intralesional Injection of Talimogene Laherparepvec
· Phase 2
· active not recruiting
NCT04599062 — TVEC and Preop Radiation for Sarcoma (8 ml Dose)
· Phase 1, PHASE2
· active not recruiting
NCT03554044 — T-VEC With Chemotherapy or Endocrine Therapy in Treating Participants With HER2- Negative Breast Cancer
· Phase 1
· completed
NCT04163952 — Talimogene Laherparepvec and Panitumumab for the Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of
· Phase 1
· terminated
NCT02923778 — Talimogene Laherparepvec and Radiation Therapy in Treating Patients With Newly Diagnosed Soft Tissue Sarcoma That Can Be
· Phase 2
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 20 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02756845.