Phase 3
Completed N=31
An Extended Use Study of Safety and Efficacy of Talimogene Laherparepvec in Melanoma
Source: ClinicalTrials.gov NCT01368276 ↗Enrolled (actual)
31
Serious AEs
29.0%
Results posted
Dec 2015
Primary outcomePrimary: Number of Participants With Treatment-emergent Adverse Events (AEs) — 3; 26; 0; 5 participants
Summary
The purpose of this study is to learn about the safety and the risks of using talimogene laherparepvec in patients who already received treatment with talimogene laherparepvec in study 005/05 (NCT00769704), and to see if extended treatment with talimogene laherparepvec can destroy melanoma tumors.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (AEs) |
3; 26; 0; 5; 0; 1 | — |
| SECONDARY Objective Response Rate |
100.0; 57.1 | 0.2645 |
| SECONDARY Durable Response Rate |
33.3; 32.1 | 1.0000 |
Eligibility Criteria
Inclusion Criteria
- Previously participated in protocol 005/05 (NCT00769704) and:
- received the maximum number of talimogene laherparepvec treatment injections or cycles of GM-CSF allowable for that patient on study 005/05, or
- new injectable lesion(s) appeared after previous resolution of all injectable disease while on study 005/05. New injectable lesions must have appeared within ≤ 12 months from the End of Treatment visit on the 005/05 study.
- In the opinion of the investigator and the sponsor's medical monitor further treatment is warranted [e.g., those patients who do not have clinically relevant progressive disease (PDr)].
- Performance status (Eastern Cooperative Oncology Group, ECOG) 0 or 1.
- For patients randomized to talimogene laherparepvec only: Injectable disease (i.e. suitable for direct injection or through the use of ultrasound guidance) defined as at least 1 injectable cutaneous, subcutaneous or nodal melanoma lesion. There is no minimum size for injection.
Exclusion Criteria
- Prior Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or 4 toxicity related to talimogene laherparepvec of any organ system (with the exception of injection site reactions, fever and vomiting).
- History of Grade 3 fatigue lasting > 1 week while on talimogene laherparepvec treatment.
- History of Grade 3 arthralgia/myalgias while on talimogene laherparepvec treatment.
- History of ≥ Grade 2 autoimmune reactions, allergic reactions or urticaria or other talimogene laherparepvec related non-hematological toxicities while on talimogene laherparepvec treatment that required a dose delay or discontinuation of talimogene laherparepvec therapy.
- PDr while participating in study 005/05
- Patient requested to be withdrawn from study 005/05 or was unable to comply with the demands of the 005/05 trial.
- At the discretion of the investigator, patient was withdrawn from the 005/05 trial.
Data sourced from ClinicalTrials.gov (NCT01368276). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.