Study of a Multi-Antigen Therapeutic Vaccine in Patients With Metastatic Melanoma

Phase 2

Terminated

• Conditions: Cancer; Melanoma
• Interventions: Biological: Intron A, Interferon alpha -2b; Biological: ALVAC(2) Melanoma multi-antigen therapeutic vaccine

• Registration Number: NCT00613509
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Study Timeline

• Study First Submitted: 2008-01-16
• Study First Submitted QC: 2008-01-30
• Study First Posted: 2008-02-13
• Study Start: 2008-06
• Primary Completion: 2010-04
• Study Completion: 2010-06
• Results First Submitted: 2010-09-14
• Results First Submitted QC: 2010-11-22
• Results First Posted: 2010-12-17
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group 2: Interferon alpha-2b	Intron A, Interferon alpha -2b	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.
Study Group 1: ALVAC melanoma vaccine	ALVAC(2) Melanoma multi-antigen therapeutic vaccine	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.

Primary Outcome Measures

Name	Time	Method
Summary of Disease Progression in Study Participants, Intent-to-treat Population	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	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 Outcome Measures

Name	Time	Method
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	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.
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	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.
Best Overall Objective Response in the Intent-to-treat Population	Day 0 to 32 weeks post 1st vaccination or treatment	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.
Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term	Day 0 to 12 months post last vaccination	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.