Back to resultsAn Extension Protocol for the Extended Use of Talimogene Laherparepvec for Eligible Patients Who Participated in Study 002/03 (NCT00289016)
Primary Purpose
Melanoma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Talimogene Laherparepvec
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma
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- Patient requested to be withdrawn from or was unable to comply with the demands of Study 002/03.
- Patient was withdrawn from Study 002/03 at the discretion of the Investigator.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Talimogene Laherparepvec
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Participants With an Objective Response
Objective response is defined as participants with an overall best response of complete response or partial response. The objective response to treatment was assessed by computed tomography (CT) scanning or other clinical measurement using modified Response Evaluation Criteria In Solid Tumors (RECIST).
Responses must have been confirmed two visits not less than 4 weeks apart.
Tumor burden for a visit was calculated as the sum of the longest diameters of all tumors identified and measured up to that visit. Tumor response at each visit was derived from tumor burden, as follows:
Complete response (CR): zero tumor burden
Partial response (PR): a 30% or greater decrease in tumor burden
Progressive disease (PD): a 20% or greater increase in tumor burden
Stable disease (SD): none of the above (a < 30% decrease and < 20% increase in tumor burden)
Number of Participants Alive at the Time of Study Discontinuation or Completion
Full Information
NCT ID
NCT02574260
First Posted
September 18, 2015
Last Updated
November 13, 2015
Sponsor
BioVex Limited
Collaborators
Covance
1. Study Identification
Unique Protocol Identification Number
NCT02574260
Brief Title
An Extension Protocol for the Extended Use of Talimogene Laherparepvec for Eligible Patients Who Participated in Study 002/03 (NCT00289016)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioVex Limited
Collaborators
Covance
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This was an extension study to the multicenter, open-label, phase 2 Study 002/03 (NCT00289016). Participants who had received the maximum 24 treatments under Study 002/03 and met the inclusion and exclusion criteria were eligible to enroll.
Participants continued to receive talimogene laherparepvec until discontinuation criteria were met. The discontinuation criteria were complete response, clinically significant progressive disease that rendered further dosing futile, receipt of 24 treatments or 12 months on treatment (whichever was longer), occurrence of an unacceptable toxicity, death, investigator determination that other treatment was warranted, or another criterion for withdrawal from treatment (participant request, noncompliance with study procedures, or sponsor request).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Talimogene Laherparepvec
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
Talimogene Laherparepvec
Other Intervention Name(s)
OncoVEX^GM-CSF, T-VEC, IMLYGIC
Intervention Description
Administered by intratumoral injection.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
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.
Time Frame
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 Outcome Measure Information:
Title
Number of Participants With an Objective Response
Description
Objective response is defined as participants with an overall best response of complete response or partial response. The objective response to treatment was assessed by computed tomography (CT) scanning or other clinical measurement using modified Response Evaluation Criteria In Solid Tumors (RECIST).
Responses must have been confirmed two visits not less than 4 weeks apart.
Tumor burden for a visit was calculated as the sum of the longest diameters of all tumors identified and measured up to that visit. Tumor response at each visit was derived from tumor burden, as follows:
Complete response (CR): zero tumor burden
Partial response (PR): a 30% or greater decrease in tumor burden
Progressive disease (PD): a 20% or greater increase in tumor burden
Stable disease (SD): none of the above (a < 30% decrease and < 20% increase in tumor burden)
Time Frame
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.
Title
Number of Participants Alive at the Time of Study Discontinuation or Completion
Time Frame
At end of study, median duration of treatment was 267 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director, MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
An Extension Protocol for the Extended Use of Talimogene Laherparepvec for Eligible Patients Who Participated in Study 002/03 (NCT00289016)
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