Evaluation of the Safety and Tolerability of i.v. Administration of a Cancer Vaccine in Patients With Advanced Melanoma (Lipo-MERIT)
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|ClinicalTrials.gov Identifier: NCT02410733|
Recruitment Status : Recruiting
First Posted : April 8, 2015
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Biological: Lipo-MERIT||Phase 1|
- The Lipo-MERIT vaccine consists of the four naked ribonucleic acid (RNA)-drug products (DPs) RBL001.1, RBL002.2, RBL003.1, and RBL004.1 that are optimised to induce antigen-specific CD8+ and CD4+ T cell responses against four selected malignant melanoma-associated antigens respectively.
- In this study, naked RNA DPs will be formulated with liposomes to form RNA-lipoplexes (RNA(LIP)) that (i) protect RNA from degradation in the serum, (ii) enable in vivo targeting of systemic antigen-presenting cells (APC), and therefore (iii) constitute a novel vaccine formulation that supports intravenous administration.
- The Lipo-MERIT vaccine is expected to lead to several effects contributing to its immunological (therapeutic) effect. First, the RNA-lipoplexes home to APCs in lymphoid organs after intravenous injection, where they are rapidly taken up by professional APCs. Incorporated RNA is translocated to the cytoplasm leading to its translation by the host ribosome complex into four Antigen encoding proteins which are processed and presented on both HLA-class I as well as HLA-class II molecules. Consecutively, antigen-specific CD8+ and CD4+ T cell responses will be triggered by HLA-peptide complexes on the surface of antigen-presenting cells.
- In addition, the Lipo-MERIT vaccine is expected to transiently activate APCs (change of surface marker expression and cytokine secretion) via signalling of TLRs, subsequently leading to the transient induction of inflammatory cytokines (such as IFN-α and IP-10) supporting the induction of tumour-antigen specific T cell responses.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||115 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical First-in-human Dose Escalation Study Evaluating the Safety and Tolerability of Intravenous Administration of a Tetravalent RNA-lipoplex Cancer Vaccine Targeting Four Tumour-associated Antigens in Patients With Advanced Melanoma|
|Actual Study Start Date :||March 2015|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||May 2022|
7 dose escalation cohorts (3 +3 design) and 3 expanded cohorts
- Number of Adverse Events as a Measure of safety and tolerability [ Time Frame: 180 days ]Number of patients with adverse events, total number of adverse events, dose limiting toxicities
- Change of induced T-cell responses for Lipo-MERIT vaccine from visit 2 (day 1) to day 71 (assessed by immunoassays) [ Time Frame: 90 days ]Vaccine induced T-cell responses assessed by immunoassays in peripheral blood and skin
- Clinical Monitoring of tumor lesions (determined by CT or MRI results evaluated by irRECIST 1.1) [ Time Frame: 90 days ]Tumour lesion status as determined by CT or MRI results evaluated by irRECIST 1.1
- Progression Free Survival (PFS) [ Time Frame: every 3 month, From Baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months ]Defined as the time from the first vaccination to confirmed occurence of Progression or death from any course, which ever occurs first,, per irRECIST 1.1
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02410733
|Contact: Marion Kästneremail@example.com|
|Contact: Doreen Schwarck-Kokarakis, Drfirstname.lastname@example.org|
|Johann Wolfgang Goethe Universität Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie||Recruiting|
|Frankfurt, Germany, 60590|
|Universität Heidelberg, Dermatologie und NCT||Recruiting|
|Heidelberg, Germany, 69120|
|Universitätsmedizin Mainz, Hautklinik und Poliklinik||Recruiting|
|Mainz, Germany, 55131|
|Universitätsmedizin Mannheim, Klinik für Dermatologie, Venerologie und Allergologie||Recruiting|
|Mannheim, Germany, 68167|
|Study Director:||Ugur Sahin, Prof. Dr.||Biontech RNA Pharmaceuticals GmbH|