Clinical trial · Interventional

An Extension Protocol for the Extended Use of Talimogene Laherparepvec for Eligible Patients Who Participated in Study 002/03 (NCT00289016)

Phase 2 Extension Protocol for Extended Use of OncoVEX^GM-CSF for Eligible Patients Participating in Study 002/03: Study of the Efficacy, Safety and Immunogenicity of OncoVEX^GM-CSF in Patients With Stage IIIc and Stage IV Malignant Melanoma

NCT02574260CI-TRIAL-00020231completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Melanoma	Melanoma	ONTOLOGY_EXACT	0.98

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Talimogene Laherparepvec	Biological	Talimogene Laherparepvec	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Talimogene Laherparepvec
description
Participants received talimogene laherparepvec 10⁸ plaque forming units (PFU)/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
interventionNames
1. Biological: Talimogene Laherparepvec

Primary outcomes (1)

measure
Number of Participants With Adverse Events
timeFrame
From the first dose of talimogene laherparepvec in Study 002-03-E and within 30 days of the last dose; median duration of treatment was 267 days.
description
The severity of an adverse event (AE) was graded according to Common Toxicity Criteria for Adverse Events (CTCAE) Version 3 (1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death). Serious adverse events include death, life-threatening events, events requiring or prolonging hospitalization, result in persistent or significant disability/incapacity, or a congenital anomaly/birth defect, or otherwise important medical events that may jeopardise the patient or require intervention to prevent one of the above outcomes.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

1. Previously participated in Study 002/03 and met 1 of the following:

1. 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
2. Did achieve a CR in Study 002/03 and developed disease progression within 12 months of achieving a CR, or
3. 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.
2. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.

Exclusion Criteria:

1. 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);
2. History of Grade 3 fatigue lasting \> 1 week while on OncoVEX\^GM-CSF treatment;
3. History of Grade 3 arthralgia/myalgias while on OncoVEX\^GM-CSF treatment;
4. 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;
5. Symptomatic malignant disease progression that required alternative melanoma treatment;
6. Primary malignancy disease progression despite treatment with OncoVEX\^GM-CSF;
7. Patient requested to be withdrawn from or was unable to comply with the demands of Study 002/03.
8. Patient was withdrawn from Study 002/03 at the discretion of the Investigator.

References

Publications (0)

Data not yet available

No reference posted for this study.