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

NCT02574260 | Completed Phase 2 Results

• 1 other identifier: 002/03-E
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  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.

  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.

Secondary Outcomes (2)

• Number of Participants With an Objective Response

  Every 12 weeks from the start of therapy in this extension protocol, or 12 weeks from the last assessment in the 002/03 protocol (whichever date is later) through 30 days after administration of the last dose; median duration of treatment was 267 days.

• Number of Participants Alive at the Time of Study Discontinuation or Completion

  At end of study, median duration of treatment was 267 days

Study Arms (1)

Talimogene Laherparepvec

EXPERIMENTAL

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.

Biological: Talimogene Laherparepvec

Interventions

Talimogene Laherparepvec BIOLOGICAL

Administered by intratumoral injection.

Also known as: OncoVEX^GM-CSF, T-VEC, IMLYGIC

Talimogene Laherparepvec

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioVex Limited: lead
• Covance: collaborator

MeSH Terms

Conditions

Melanoma

Interventions

talimogene laherparepvec

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen, Inc.

866-572-6436

Study Officials

• Study Director, MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: October 12, 2015
• Study Start: August 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: December 17, 2015
• Results First Posted: December 17, 2015

Record last verified: 2015-11