KURZPROTOKOLL Lipo-MERIT

KURZPROTOKOLL
Lipo-MERIT
Öffentlicher Titel
Phase I Studie zum Impfstoff Lipo-MERIT bei Patienten mit fortgeschrittenem Melanom
Wissenschaftl. Titel
Clinical first-in-human dose escalation study evaluating the safety and tolerability of
intravenous administration of a tetravalent RNA-lipoplex cancer vaccine targeting the
tumor-associated antigens NY-ESO-1, tyrosinase, MAGE-A3, and TPTE in patients with
advanced melanoma
Kurztitel
Lipo-MERIT
Studienart
multizentrisch, prospektiv, Therapiestudie, randomisiert, offen/unverblindet, einarmig
Studienphase
Phase I
Erkrankung
DERMA: Melanom: Zweitlinie oder höher
Ziele
-
Number of Adverse Events as a Measure of safety and tolerability [ Time Frame: 90
days ] [ Designated as safety issue: Yes ] Number of patients with adverse events,
total number of adverse events, dose limiting toxicities
-
Maximum Tolerated Dose (MTD) [ Time Frame: dose escalation phase, an average
of 15 days per patient ] [ Designated as safety issue: Yes ] MTD for multiple dosing of
Lipo-MERIT vaccine by assessment of patient data, adverse events and/or dose
limiting toxicities (DLT) by the independent data safety monitoring board (DSMB)
-
Change of induced T-cell responses for Lipo-MERIT vaccine from visit 2 to 8
(assessed by immunoassays) [ Time Frame: 43 days ] [ Designated as safety issue:
No ] vaccine induced T-cell responses assessed by immunoassays in peripheral
blood and skin
-
Clinical Monitoring of tumour lesions (determined by CT or MRI results evaluated by
irRC) [ Time Frame: 90days ] [ Designated as safety issue: No ] Tumour lesion status
as determined by CT or MRI results evaluated by irRC
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Cohort I: stage IV malignant melanoma (AJCC 2009 melanoma classification)
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Cohorts II-VI (after DSMB release): stage IIC, IIIA-C, or stage IV of malignant
melanoma (AJCC 2009 melanoma classification)
-
Therapy only for subjects not eligible or declining any other available approved
therapy after all available treatment options have been transparently disclosed (to be
documented!) Expression of either one of the selected TAA confirmed by RT-PCR
analysis from FFPE
-
18 years of age
-
Written informed consent
-
ECOG performance status (PS) 0-1
-
Life expectancy > 6 months
-
WBC 3x109/L
-
Haemoglobin 10 g/dL
-
Platelet count 100,000/mm³
-
LDH level < 2.0 x ULN
-
ALT/AST < 3 x ULN (except patients with liver metastasis)
-
Negative pregnancy test (measured by -HCG) for females with childbearing age
-
Pregnancy or breastfeeding
-
Primary ocular melanoma
-
Concurrence of a second malignancy other than squamous or basal cell carcinoma,
non-active prostate cancer or cervical carcinoma in situ or non-active treated
urothelial carcinoma
-
Brain metastases
-
Post-splenectomy patients
-
Known or symptomatic pleural effusions and/or ascites
Einschlusskriterien
Ausschlusskriterien
© Universitäres Centrum für Tumorerkrankungen (UCT) am Universitätsklinikum Frankfurt
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KURZPROTOKOLL
Lipo-MERIT
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Known hypersensitivity to the active substance or to any of the excipients
-
A serious local infection (e. g. cellulitis, abscess) or systemic infection (e. g.
pneumonia, septicemia) which requires systemic antibiotic treatment within 2 weeks
prior to the first dose of study medication
-
Positive test for acute or chronic active hepatitis B or C infection, acute EBV, or acute
CMV
-
Clinically relevant autoimmune disease
-
Systemic immune suppression: HIV disease; Use of chronic oral or systemic steroid
medication (topical or inhalational steroids are permitted); Other clinical relevant
systemic immune suppression
-
Symptomatic congestive heart failure (NYHA 3 or 4)
-
Unstable angina pectoris
-
Radiotherapy and minor surgery within 14 days prior to the first administration of
study treatment
-
Myelosuppressive chemotherapy within 14 days and after reconstitution of blood
values prior to the first administration of study treatment
-
Ipilimumab within 28 days prior to the first administration of study treatment
-
Interferon, major surgery,vaccination, and other investigational agents within 28 days
or 5 half-life's depending on what gives the longer range before the first treatment
-
Approved BRAF inhibitors Vemurafenib or Dabrafenib as well as the approved MEK
inhibitor Trametinib in patients of the dose escalation cohorts. Concomitant treatment
with approved BRAF inhibitors or MEK inhibitor is allowed for patients included in one
of the two expanded dose cohorts, after analysis of safety data collected for the dose
escalation cohorts and DSMB approval.Local radiation will be allowed as concurrent
treatment.
-
Fertile males and females who are unwilling to use a highly effective method of birth
control (less than 1% per year, e.g. condom with spermicide, diaphragm with
spermicide, birth control pills, injections, patches or intrauterine device) during study
treatment and 28 days after the last dose of study treatment
-
Presence of a serious concurrent illness or other condition (e. g. psychological,
family, sociological, or geographical circumstances) that does not permit adequate
follow-up and compliance with the protocol
Alter
18 Jahre und älter
Status
Aktiv
Beginn der Rekrutierung
01.04.2016
Fallzahl
42
Prüfzentren
Universitätsklinikum Frankfurt
Klinik für Dermatologie, Venerologie und Allergologie
Theodor-Stern-Kai 7
60590 Frankfurt am Main
Dr. Vesselina Laubach
Tel: 069 6301 6162
Fax: 069 6301 83175
[email protected]
Sponsoren
BioNTech AG
Registrierung in anderen
Studienregistern
ClinicalTrials NCT02410733
EUDRACT 2013-001646-33
© Universitäres Centrum für Tumorerkrankungen (UCT) am Universitätsklinikum Frankfurt
Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.uct-frankfurt.de
Stand: 20.01.2017; Seite 2 von 2