Pilot Study of Intradermal Vaccination of Melanoma Patients With a Fixed Combination of mRNAs Compared to an Individualized Selection After Analysis of Antigen Expression in Tumor Tissue
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Tolerability
Study Overview
Brief Summary
The purpose of the vaccination protocol is to induce specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigen.
Detailed Description
vaccination protocol to induce clinically specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigens. Half of patients is treated with mRNA coding for Melan-A, Mage-A1, Mage-A3, Survivin, GP100 and Tyrosinase. The other half of patients is treated with an individualized selection of mRNAs after analysis of overexpressed melanoma antigens in autologous tumor tissue. GM-CSF is used as an adjuvants. Phase I/II clinical trial to analyse safety and immune responses in stage III/IV melanoma patients.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •malignant melanoma stage III/IV
- •fresh frozen tumor tissue available
- •informed consent given
- •Karnofsky >= 70%
Exclusion Criteria
- •brain metastasis
- •parallel chemotherapy
- •systemic treatment with glucocorticoids
- •other malignancies
Arms & Interventions
mRNA Vacc
Intervention: mRNA coding for melanoma associated antigens (Biological)
mRNA Vacc
Intervention: GM-CSF (Drug)
Outcomes
Primary Outcomes
Tolerability
Time Frame: every 4 weeks
Side effects will be monitored using CTCAE criteria. Tolerability and toxicity profiles will be calculated.
Secondary Outcomes
No secondary outcomes reported
Investigators
Thomas Eigentler
Study Coordinator
University Hospital Tuebingen