AN OPEN CLINICAL STUDY ASSESSING SAFETY AND TOLERABILITY OF IN PATIENTS WITH

Etude MaxiVax dngn 02.06.2015
AN OPEN PHASE I CLINICAL STUDY ASSESSING SAFETY AND TOLERABILITY OF
MVX-ONCO-1 IN PATIENTS WITH SOLID TUMOR WHO ARE NOT/NOT ANY
LONGER AMENABLE TO STANDARD THERAPY
“Etude MaxiVax”
Sponsor: MaxiVAX S.A.
CONTACTS AUX HUG : Unité de recherche en Onco-Hématologie de la Fondation DFDL
 Coordinatrice de l’étude : Mme Virginie Ancrenaz-Sirot 079 55 32 381
 Investigateur responsable: Dr Denis Migliorini, 079 55 34 417
 Secrétariat: Mme Florence Marti-Klay, 022 372 29 01
DESIGN DE L’ETUDE
15 patients souffrant de tumeurs solides pour lesquels les traitements reconnus et
disponibles ne sont plus efficaces ou pas utilisables seront inclus aux HUG.
Le traitement qui sera administré pendant l’étude est appelé "immunothérapie cellulaire
spécifique MVX-ONCO". Le traitement sera répété toutes les semaines pendant 4 semaines
puis 2 implantations supplémentaires à 15 jours d’intervalle. Le nombre total d’implantations
prévues est donc de 6 sur une durée totale de 8 semaines selon le tableau ci-dessous.
Semaine
1
2
3
4
5
6
7
8
9
Jours
Retrait des capsules
Immunisation
Visites médicales
J-1
I n°1
V-1
J-8
E n°1
I n°2
V-2
J-15
E n°2
I n°3
V-3
J-22
E n°3
I n°4
V-4
J-29
E n°4
V-5
J-36
I n°5
V-6
J-43
E n°5
V-7
J-50
I n°6
V-8
J-57
E n°6
V-9

Etude MaxiVax dngn 02.06.2015
OBJECTF DE L’ETUDE
L'objectif de cet essai clinique est d'évaluer la sécurité, la tolérance ainsi que la réponse
immunitaire et clinique induite par le traitement MVX-ONCO. Durant l’étude diverses
analyses seront effectuées pour évaluer ces paramètres (sécurité, tolérance, faisabilité,
réponse immunitaire, réponse anti-tumorale).
CRITERES D’INCLUSION / EXCLUSION
#
INCLUSION CRITERIA
1
Male or female patients aged 18 years and older with advanced metastatic cancer in progression
of various sites [Carcinoma of lung (either small cell or non-small cell), colon, breast, pancreas
(exocrine or endocrine), stomach, oesophagus, head&neck, thyroid, kidney, bladder, prostate,
ovary, uterus (cervix or corpus); Sarcoma of soft tissue, bone, uterus, melanoma; primary brain
tumor] where all recognized treatment are exhausted or not feasible
2
Life expectancy: estimate of at least 4 months
3
Performance status grade 0-2 (WHO grading)
4
No major impairment of liver function (ALT < 2.5 times the upper limit of normal range, Bilirubin
within the normal range (exception: liver metastases: ALT < 5 times ULN; Bilirubin < 3 times UL)
5
No major impairment of renal function (creatinine ≤ 1.5 times the upper limit of normal range)
6
No major impairment of bone marrow function (hemoglobin > 9.0 g/dl, WBC >2.5 x 109/L,
neutrophils≥1.5 x109L, Thrombocytes≥50 x109/L
7
Primary tumor and/or metastasis amenable for partial/total surgery or tap and subsequent cell
harvesting estimate > 27x106 cells
9
Ability to understand the concept of a clinical trial
10
Able to understand Patient Information Form and Inform Consent Form
11
Has given written informed consent
#
EXCLUSION CRITERIA
1
Have participated in any other investigational study or received an experimental therapeutic
procedure considered to interfere with the study in the 4 preceding weeks
2
Have received any chemotherapy treatment in the 4 preceding weeks
3
Serious concomitant health condition such as organ transplant requiring immunosuppressive
drugs, severe psychiatric disorders.
4
History of second cancer within the last 2 years with the exception of basal cell carcinoma of skin
and localized cervical carcinoma treated with curative intent.
5
Patient with a systemic disease other than cancer, that is not controlled by usual medication
6
Untreated brain metastasis (screening CT or MRI mandatory even for asymptomatic
patients). Patient with history of brain metastasis with no evidence of brain relapse after
surgery/radiotherapy at screening can be enrolled
7
Is there uncontrolled bleeding Chronic immunosuppressive treatment including steroids > 30mg
cortisone or equivalent/day
8
Therapeutic anticoagulation with coumarine or continuous iv heparin. Low- molecular weight
heparin (LMWH) is permitted as long as treatment can be withheld several hours prior to
subcutaneous implantation
9
Positive HIV-1, HIV-2, HTLV-1, HTLV-2, hepatitis B surface antigen, or hepatitis C antibody
10
Females of child-bearing potential who are pregnant or lactating or who are not using adequate
contraception (surgical, hormonal or double barrier, i.e. condom and diaphragm).
11
Known allergy to reagents in the study product (MVX-ONCO-1) such as penicillin, streptomycin.).