Adults 18 to 99, any sex, with Unresectable Stage IIIB-IV Malignant Melanoma. 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.
Number of Participants Who Experienced One or More Dose Limiting Toxicities (DLTs)Primary· Day 1 to Day 35
DLTs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4
Events were considered DLTs, if judged by the investigator to be related to study treatment:
Grade 4 non-hematologic toxicity Grade 3 non-hematologic toxicity lasting \> 3 days despite optimal supportive care (grade 3 fatigue not a DLT)
Grade 3 or higher non-hematologic laboratory value reported as an adverse event if:
medical intervention is required, or abnormality leads to hospitalization, or abnormality persists for \> 1 week (Laboratory values that persist for \> 1 week but are deemed not clini
Group
Value
95% CI
Talimogene Laherparepvec
0
Durable Response Rate (DRR) Using Modified World Health Organization (WHO) Response CriteriaPrimary· Day 1 up to the maximum time on treatment or follow-up at primary data cutoff date (03 August 2020): 89.1 weeks of treatment and 37 months of follow-up
DRR using WHO response criteria was defined as the percentage of participants who experienced objective response (complete response \[CR\] or partial response \[PR\]) lasting continuously for ≥ 6 months that starting any time within 12 months of initiating treatment.
CR: Complete disappearance of all index lesions, including any new tumors which might have appeared.
PR: Achieving a 50% or greater reduction in the SPD of the perpendicular diameters of all index lesions at the time of assessment as compared to the sum of the products of the perpendicular diameters of all index lesions at basel
Group
Value
95% CI
Talimogene Laherparepvec
11.1
1.4 – 34.7
Overall Response Rate (ORR) Using Modified World Health Organization (WHO) Response CriteriaSecondary· Day 1 to end of study, maximum time to end of study was 212.6 weeks
ORR was defined as the percentage of participants who experienced an objective response of CR or PR per modified WHO response criteria among the set of participants analyzed.
Group
Value
95% CI
Talimogene Laherparepvec
11.1
1.4 – 34.7
Time to Response (TTR) Using Modified World Health Organization (WHO) Response CriteriaSecondary· Day 1 to end of study, maximum time to end of study was 212.6 weeks
TTR was defined as the time from the first treatment administration to the first incidence of a confirmed CR or PR according to modified WHO response criteria among the set of participants analyzed.
TTR was estimated using Kaplan-Meier (KM) method.
Group
Value
95% CI
Talimogene Laherparepvec
NA
8.08 – NA
Duration of Response (DOR) Using Using Modified World Health Organization (WHO) Response CriteriaSecondary· Day 1 to end of study, maximum time to end of study was 212.6 weeks
DOR was defined as the time from the date of an initial response (CR or PR) to the earlier of progressive disease (PD) or death. Participants who had not ended their response at the time of analysis were censored at their last evaluable tumor assessment.
PD: A \> 25% increase in the sum of the products of the perpendicular diameters of all index tumors since baseline, or the unequivocal appearance of a new tumor since the last response assessment time point.
DOR was estimated using Kaplan-Meier (KM) method.
Group
Value
95% CI
Talimogene Laherparepvec
NA
11.07 – NA
Progression Free Survival (PFS) Using Using Modified World Health Organization (WHO) Response CriteriaSecondary· Day 1 to end of study, maximum time to end of study was 212.6 weeks
PFS was defined as the interval from the first dose to the earlier of PD per modified WHO response criteria or death from any cause; otherwise, PFS was censored at the last evaluable tumor assessment.
PFS was estimated using Kaplan-Meier (KM) method.
Group
Value
95% CI
Talimogene Laherparepvec
3.07
2.56 – 5.78
Overall Survival (OS)Secondary· Day 1 to end of study, maximum time to end of study was 212.6 weeks
OS was defined as the interval from first dose to the event of death from any cause; otherwise, OS was censored at the date the participant was last known to be alive.
OS was estimated using Kaplan-Meier (KM) method.
Group
Value
95% CI
Talimogene Laherparepvec
NA
17.51 – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Deaths: From enrollment to end of study, up to maximum of 212.6 weeks; SAE and non-serious AEs: Day 1 (post 1st dose) to 30 days after last dose. Median (min, max) duration of treatment overall was 23.14 (3.1, 201.6) weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Talimogene Laherparepvec
Serious: 6/18 (33%)
Deaths: 8/18
Serious adverse events (9 terms)
Reaction
System
Talimogene Laherparepvec
Malaise
General disorders
—
Jaundice cholestatic
Hepatobiliary disorders
—
Enteritis infectious
Infections and infestations
—
Epiglottitis
Infections and infestations
—
Pneumonia
Infections and infestations
—
Forearm fracture
Injury, poisoning and procedural complications
—
Decreased appetite
Metabolism and nutrition disorders
—
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
There are 2 fold of purposes for this study. 1 is to evaluate safety and tolerability and the other is to study the anti-tumor effects of talimogene laherparepvec in Japanese participants with unresectable stage IIIB-IV malignant melanoma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04065152 — Phase II Multicenter Study of Talimogene Laherparepvec in Classic or Endemic Kaposi Sarcoma
· Phase 2
· unknown
NCT04068181 — Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKE
· Phase 2
· completed
NCT03802604 — Combination of Talimogene Laherparepvec With Atezolizumab in Early Breast Cancer
· EARLY_PHASE1
· completed
NCT03086642 — Study of Talimogene Laherparepvec (T-VEC) in Pancreatic Cancer
· Phase 1
· completed
NCT02779855 — Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer
· Phase 1, PHASE2
· completed
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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: 9 August 2023
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/NCT03064763.