Phase 2
Completed N=3
An Extension Protocol for the Extended Use of Talimogene Laherparepvec for Eligible Patients Who Participated in Study 002/03 (NCT00289016)
Source: ClinicalTrials.gov NCT02574260 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcomePrimary: Number of Participants With Adverse Events — 3; 3; 0; 0 participants
Summary
The primary objective of this extension study was to further assess the safety and tolerability of talimogene laherparepvec. Secondary objectives were to assess objective tumor response rate and survival.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
3; 3; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With an Objective Response |
2 | — |
| SECONDARY Number of Participants Alive at the Time of Study Discontinuation or Completion |
3 | — |
Eligibility Criteria
Inclusion Criteria
- Previously participated in Study 002/03 and met 1 of the following:
- Received the maximum 24 treatment injections in Study 002/03 and had not yet achieved a complete response (CR) and whose response to OncoVEX^GM-CSF indicated that treatment beyond 12 months was warranted, or
- Did achieve a CR in Study 002/03 and developed disease progression within 12 months of achieving a CR, or
- Terminated treatment in Study 002/03 to allow for treatment of brain metastases. Treatment for brain metastases was no longer ongoing and the patient was able to return to OncoVEX^GM-CSF injections within 3 months of completing treatment for brain metastases.
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
Exclusion Criteria
- Prior Common Toxicity Criteria for Adverse Events (CTCAE) Grade 3 or 4 toxicity related to OncoVEX^GM-CSF of any organ system (with the exception of injection site reactions, fever and vomiting);
- History of Grade 3 fatigue lasting > 1 week while on OncoVEX^GM-CSF treatment;
- History of Grade 3 arthralgia/myalgias while on OncoVEX^GM-CSF treatment;
- History of ≥ Grade 2 autoimmune reactions, allergic reactions or urticaria or other OncoVEX^GM-CSF-related non-hematological toxicities while on OncoVEX^GM-CSF treatment that required a dose delay or discontinuation of OncoVEX^GM-CSF therapy;
- Symptomatic malignant disease progression that required alternative melanoma treatment;
- Primary malignancy disease progression despite treatment with OncoVEX^GM-CSF;
- Patient requested to be withdrawn from or was unable to comply with the demands of Study 002/03.
- Patient was withdrawn from Study 002/03 at the discretion of the Investigator.
Data sourced from ClinicalTrials.gov (NCT02574260). 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.