MelanomaPhase 2NCT02574260
An Extension Protocol for the Extended Use of Talimogene Laherparepvec for Eligible Patients Who Participated in Study 002/03 (NCT00289016)
A Phase 2 study testing Talimogene Laherparepvec in people with Melanoma, run by BioVex Limited.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Talimogene Laherparepvec
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Jan 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
Read the 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).
- Conditions
- Melanoma
- Being tested
- Talimogene Laherparepvec
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talimogene LaherparepvecBiological
Also called OncoVEX^GM-CSF, T-VEC, IMLYGIC
Administered by intratumoral injection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Talimogene Laherparepvec |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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)
Measured: 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
Measured: At end of study, median duration of treatment was 267 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startAug 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioVex Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
- Investigators
- Study Director, MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574260
- Sponsor's protocol ID
- 002/03-E
- Status last verified
- Nov 2015
- First submitted
- 18 Sep 2015
- Last updated
- 17 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02574260
- Acronym / sponsor ID
- 002/03-E
- Conditions
- Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- BioVex LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- Aug 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 12 Oct 2015 (estimated)
- Results
- Posted 17 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Talimogene Laherparepvec | Experimental | Biological: Talimogene LaherparepvecParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Previously participated in Study 002/03 and met 1 of the following:
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Talimogene LaherparepvecAlso: OncoVEX^GM-CSF, T-VEC, IMLYGICAdministered by intratumoral injection. | Biological | Talimogene Laherparepvec |
Primary outcome
Number of Participants With Adverse Events
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.
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.
2 secondary outcomes
Number of Participants With an Objective Response
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.
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director, MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Talimogene Laherparepvec in people with Melanoma, run by BioVex Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2015.