MelanomaPhase 2NCT00613509
Study of a Multi-Antigen Therapeutic Vaccine in Patients With Metastatic Melanoma
A Phase 2 study testing ALVAC(2) Melanoma multi-antigen therapeutic vaccine and Intron A, Interferon alpha -2b in people with Melanoma and Cancer, run by Sanofi Pasteur, a Sanofi Company at 19 sites in 2 countries.
Trial summary
Primary objective: To evaluate the clinical activity of the vaccine regimen, as indicated by progression-free survival versus the clinical activity of the reference treatment. Secondary objectives: Safety: To describe the safety profile in both treatment groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- ALVAC(2) Melanoma multi-antigen therapeutic vaccine and Intron A, Interferon alpha -2b
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Jun 2008to Jun 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
- A pathologically confirmed diagnosis of malignant melanoma with at least one measurable metastatic lesion with a minimum lesion size of 20 mm, based on radiological assessment (or 10 mm if assessed by spiral computed tomography [CT] scan ) as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Stages IIIc, IVa, or IVb only, according to the American Joint Committee on Cancer (AJCC) staging system for melanoma). Cutaneous metastasis (assessed by physical examination) must be at least 10 mm. CT scan or magnetic resonance imaging (MRI) is required to rule out brain metastases.
- Patients who received prior treatment for their metastatic disease must have objective evidence of disease progression.
- Aged ≥ 18 years on the day of inclusion
- IRB-approved informed consent form signed
- Able to attend all scheduled visits and to comply with all trial procedures
- For a woman, inability to bear a child or negative serum pregnancy test
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- For a woman of child-bearing potential, using an effective method of contraception or abstinence during the study and at least 4 weeks after the last study treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life expectancy of at least 6 months.
- Adequate hematologic, hepatic, and renal function (at pre-defined laboratory values).
- Fully recovered from surgery, if applicable.
Who cannot join
- Receipt of two or more previous therapies for metastatic melanoma.
- Receipt of chemotherapy or another therapy for metastatic melanoma within the last four weeks
- Receipt of adjuvant interferon therapy within the last six months
- Concurrent receipt of radiotherapy for the metastatic disease, unless for palliative purposes
- Participation in another clinical trial within the four weeks preceding the first trial treatment
- Planned participation in another clinical trial during the present trial period
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- Known Human Immunodeficiency Virus (HIV) infection or hepatitis B (Ag HBs) or hepatitis C seropositivity
- Presence of active autoimmune disease (excluding vitiligo)
- Systemic hypersensitivity to bovine products or to any of the vaccine components, including egg products or Neomycin (used to prepare the vaccine), or history of a life-threatening reaction to granulocyte-macrophage colony stimulating factor (GM-CSF) or interferon (IFN)-α2b
- Current alcohol or drug addiction that may interfere with the ability to comply with trial procedures
- Significant co-morbid medical conditions, including pre-existing renal disease, cirrhosis, or major depression, which in the estimation of the investigator would preclude safe participation in the study or the accurate interpretation of data.
- A calculated glomerular filtration rate (GFR) <60 mL/min (based on the Cockroft-Gault formula).
- Previous receipt of a modified canarypox virus (ALVAC)-based vaccine.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States15 sites
Study site
Atlanta, Georgia, 30322
Study site
Aurora, Colorado, 80045
Study site
Bethlehem, Pennsylvania, 18015
Study site
Chicago, Illinois, 60611
Study site
Dallas, Texas, 75246
Study site
Greenville, South Carolina, 29605
Study site
Lebanon, New Hampshire, 03756
Study site
Los Angeles, California, 90024
Study site
Madison, Wisconsin, 53792
Study site
Omaha, Nebraska, 68198
Study site
Pittsburgh, Pennsylvania, 15232
Study site
Portland, Oregon, 97213
Study site
San Antonio, Texas, 78229
Study site
St Louis, Missouri, 63110
Study site
Tucson, Arizona, 85724
Canada4 sites
Study site
Hamilton, Ontario, L8V 5C2
Study site
London, Ontario
Study site
Montreal, Quebec, H3A 1A1
Study site
Toronto, Ontario, M4N 3M5
About this study
Official title: Phase II Study of a Multi-Antigen Therapeutic Vaccine in Patients With Metastatic Melanoma
Primary objective:
To evaluate the clinical activity of the vaccine regimen, as indicated by progression-free survival versus the clinical activity of the reference treatment.
Secondary objectives:
Safety: To describe the safety profile in both treatment groups.
Efficacy: To determine the objective clinical responses of patients in both treatment groups: complete response and partial response.
Read the detailed description
Eligible participants will be randomized to receive either a vaccine treatment consisting of a series of multi-antigen melanoma vaccine and GM-CSF injections, followed by high-dose IFN-α2b or only the high-dose IFN-α2b.
- Being tested
- ALVAC(2) Melanoma multi-antigen therapeutic vaccine, Intron A, Interferon alpha -2b
- Keywords
- Melanoma, Cancer
- Medical subject headings
- Melanoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALVAC(2) Melanoma multi-antigen therapeutic vaccineBiological
0.5 mL, 2 cycles
Intron A, Interferon alpha -2bBiological
Also called Intron-A®: IFN-α2b
0.5 mL, 5 times per week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Study Group 1: ALVAC melanoma vaccine | Experimental | Participants will receive a multi-antigen of modified canarypox virus (ALVAC[2]) melanoma vaccine and granulocyte macrophage colony stimulating factor (GM-CSF) every 3 weeks, followed by 4 weeks of high-dose interferon alpha-2b 5 times per week. Receives: Biological: ALVAC(2) Melanoma multi-antigen therapeutic vaccine |
| Study Group 2: Interferon alpha-2b | Active comparator | Participants on 4 weeks of high-dose interferon alpha-2b 5 times per week. Participants who showed disease progression after Cycle 1 will be permitted to cross over to Group 1 treatment. Receives: Biological: Intron A, Interferon alpha -2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary of Disease Progression in Study Participants, Intent-to-treat Population
Number of evaluable study participants who had died or experienced objective disease progression (no clinical objective response to treatment as evaluated by computed tomography [CT] scans or physical examination).
Measured: Day 0 up to 35 weeks post 1st vaccination or treatment
Progression-Free Survival Time by Response Evaluation Criteria in Solid Tumor (RECIST) Criteria in the Intent-to-treat Population
Progression-Free Survival was assessed by the Response Evaluation Criteria in Solid Tumor criteria from the computed tomography (CT) scans, as per-protocol
Measured: Day 0 - up to 35 weeks post 1st vaccination or treatment
Secondary outcomes (4)
Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population
Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter.
Measured: Day 0 to 32 weeks post 1st vaccination or treatment
Best Overall Objective Response in the Intent-to-treat Population
Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter.
Measured: Day 0 to 32 weeks post 1st vaccination or treatment
Best Overall Objective Response as Mean Duration of Response (Weeks) in the Intent-to-treat Population
Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter.
Measured: Day 0 to 32 weeks post 1st vaccination or treatment
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Common Terminology Criteria for Adverse Events (CTCAE) definitions:
Grade 3 is a severe adverse event; Grade 4 is a life-threatening or disabling adverse event.
Measured: Day 0 to 12 months post last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startJun 2008
- Primary completionApr 2010
- Study completionJun 2010
Why it stopped: No safety concerns, the study was terminated due to slow enrollment. All enrolled patients were followed per protocol.
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.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613509
- Sponsor's protocol ID
- MEL11
- Status last verified
- Apr 2016
- First submitted
- 16 Jan 2008
- Last updated
- 14 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of a Multi-Antigen Therapeutic Vaccine in Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00613509
- Acronym / sponsor ID
- MEL11
- Keywords
- Melanoma, Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No safety concerns, the study was terminated due to slow enrollment. All enrolled patients were followed per protocol.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 13 Feb 2008 (estimated)
- Results
- Posted 17 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective:
To evaluate the clinical activity of the vaccine regimen, as indicated by progression-free survival versus the clinical activity of the reference treatment.
Secondary objectives:
Safety: To describe the safety profile in both treatment groups.
Efficacy: To determine the objective clinical responses of patients in both treatment groups: complete response and partial response.
Detailed description
Eligible participants will be randomized to receive either a vaccine treatment consisting of a series of multi-antigen melanoma vaccine and GM-CSF injections, followed by high-dose IFN-α2b or only the high-dose IFN-α2b.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group 1: ALVAC melanoma vaccine | Experimental | Biological: ALVAC(2) Melanoma multi-antigen therapeutic vaccineParticipants will receive a multi-antigen of modified canarypox virus (ALVAC[2]) melanoma vaccine and granulocyte macrophage colony stimulating factor (GM-CSF) every 3 weeks, followed by 4 weeks of high-dose interferon alpha-2b 5 times per week. |
| Study Group 2: Interferon alpha-2b | Active comparator | Biological: Intron A, Interferon alpha -2bParticipants on 4 weeks of high-dose interferon alpha-2b 5 times per week. Participants who showed disease progression after Cycle 1 will be permitted to cross over to Group 1 treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- A pathologically confirmed diagnosis of malignant melanoma with at least one measurable metastatic lesion with a minimum lesion size of 20 mm, based on radiological assessment (or 10 mm if assessed by spiral computed tomography [CT] scan ) as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Stages IIIc, IVa, or IVb only, according to the American Joint Committee on Cancer (AJCC) staging system for melanoma). Cutaneous metastasis (assessed by physical examination) must be at least 10 mm. CT scan or magnetic resonance imaging (MRI) is required to rule out brain metastases.
- Patients who received prior treatment for their metastatic disease must have objective evidence of disease progression.
- Aged ≥ 18 years on the day of inclusion
- IRB-approved informed consent form signed
- Able to attend all scheduled visits and to comply with all trial procedures
Key exclusion criteria (13 listed)
- Receipt of two or more previous therapies for metastatic melanoma.
- Receipt of chemotherapy or another therapy for metastatic melanoma within the last four weeks
- Receipt of adjuvant interferon therapy within the last six months
- Concurrent receipt of radiotherapy for the metastatic disease, unless for palliative purposes
- Participation in another clinical trial within the four weeks preceding the first trial 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 |
|---|---|---|
| ALVAC(2) Melanoma multi-antigen therapeutic vaccine0.5 mL, 2 cycles | Biological | Study Group 1: ALVAC melanoma vaccine |
| Intron A, Interferon alpha -2bAlso: Intron-A®: IFN-α2b0.5 mL, 5 times per week for 4 weeks | Biological | Study Group 2: Interferon alpha-2b |
Primary outcome
Summary of Disease Progression in Study Participants, Intent-to-treat Population
Time frame: Day 0 up to 35 weeks post 1st vaccination or treatment
Number of evaluable study participants who had died or experienced objective disease progression (no clinical objective response to treatment as evaluated by computed tomography [CT] scans or physical examination).
Progression-Free Survival Time by Response Evaluation Criteria in Solid Tumor (RECIST) Criteria in the Intent-to-treat Population
Time frame: Day 0 - up to 35 weeks post 1st vaccination or treatment
Progression-Free Survival was assessed by the Response Evaluation Criteria in Solid Tumor criteria from the computed tomography (CT) scans, as per-protocol
4 secondary outcomes
Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population
Time frame: Day 0 to 32 weeks post 1st vaccination or treatment
Best Overall Objective Response in the Intent-to-treat Population
Time frame: Day 0 to 32 weeks post 1st vaccination or treatment
Best Overall Objective Response as Mean Duration of Response (Weeks) in the Intent-to-treat Population
Time frame: Day 0 to 32 weeks post 1st vaccination or treatment
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term
Time frame: Day 0 to 12 months post last vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
Medical Director study director
Sanofi Pasteur Inc.
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALVAC(2) Melanoma multi-antigen therapeutic vaccine and Intron A, Interferon alpha -2b in people with Melanoma and Cancer, run by Sanofi Pasteur, a Sanofi Company at 19 sites in 2 countries.
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 10 inclusion and 13 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: stopped early, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2010). 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?
Summary of Disease Progression in Study Participants, Intent-to-treat Population (time frame: Day 0 up to 35 weeks post 1st vaccination or treatment). The study lists 2 primary outcomes in all. 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 14 Apr 2016.