Phase II Study of a Multi-Antigen Therapeutic Vaccine in Patients With Metastatic Melanoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Melanoma
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Enrollment
- 23
- Primary Endpoint
- Summary of Disease Progression in Study Participants, Intent-to-treat Population
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
Brief 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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population(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(Day 0 to 32 weeks post 1st vaccination or treatment)
- Best Overall Objective Response in the Intent-to-treat Population(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(Day 0 to 12 months post last vaccination)