EMOTIV Trial - Enhancing Melanoma Outcomes using a Timed Immunotherapy Vaccine
Phase 2
- Conditions
- Advanced Stage IIIb/c and IV MelanomaCancer - Malignant melanoma
- Registration Number
- ACTRN12612001069842
- Lead Sponsor
- Australian Melanoma Research Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
18 - 80 years of age. ECOG 0-2. Evaluable metastases. Primary cutaneous melanoma. Advanced surgically non-resectable AJCC Stage IIIB/IIIC or IV. Able to give informed consent. Tumour volume < 20cm diameter or <70% of organ replacement.
Exclusion Criteria
Presence of another primary invasive cancer (not BCC, SCC or resected in-situ malignancy)
Untreated brain mets
Extremely extensive disease
Bone mets only
High dose oral steroid therapy
Pregnancy or lactation
Severe atopia
Severe cachexia
Immunodeficiency
HIV
Hep B or C +ve
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete response rate as defined by WHO criteria, utilising laboratory markers and CT scans[Assessments at 3, 6, 9 and 12 months for each patient and collectively 1, 2 and 5 years.];Overall survival[Assessments at 3, 6, 9 and 12 months for each patient and collectively 1, 2 and 5 years.]
- Secondary Outcome Measures
Name Time Method Toxicity as assessed by any reported SAE's.[Ongoing assessment for up to 18mo from enrollment and recorded at time of treatment or SAE.];Overall response rate as assessed by CT scans[Assessments at 3, 6, 9 and 12 months for each patient and collectively 1, 2 and 5 years.];Disease progression as assessed by CT scans[Assessments at 3, 6, 9 and 12 months for each patient and collectively 1, 2 and 5 years.];Immunologic parameters as assessed by laboratory markers[Assessments at 3, 6, 9 and 12 months for each patient and collectively 1, 2 and 5 years.]