Etude : BIONIKK /



ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.


Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : BIONIKK

Nom :

Traitement : Métastasique ou localement avancé

Type d'étude : Ciblage moléculaire / Innovation thérapeutique

Dernière MÀJ : 01/07/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : A phase II, biomarker driven trial with Nivolumab and Ipilimumab or VEGFR TKI in naïve metastatic kidney cancer

Spécialité : Voies urinaires
Localisation : C64 - Tumeur maligne du rein, à l'exception du bassinet
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : Etude randomisée, en double aveugle, groupe parallèles

Phase : II

Stade : IV

1
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Histological confirmation of RCC with a clear-cell component
- Metastatic (American Joint Committee on Cancer [AJCC] Stage IV) RCC
- No prior systemic therapy for mRCC
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2
- Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Frozen tumor samples (primary tumor and/or metastasis biopsies) must be available and received by the central laboratory (Cordelier Research Center) to determine molecular groups. (Note: fine needle aspiration [FNA] and bone metastases samples are not acceptable for submission).
- Molecular group has to be determined prior to randomization.
- Formalin-fixed, paraffin-embedded (FFPE) tumor tissue available for biomarker (gene expression and immunohistochemistry (IHC)) analysis.

Critères de non-inclusion : - Any untreated CNS metastases. Patients with CNS metastases will be eligible if they are: asymptomatic, without significant oedema, not on corticosteroids, not eligible for radiation therapy/surgery or have already received radiation therapy.
- Prior systemic treatment with vascular endothelial growth factor (VEGF) or VEGF receptor-targeted therapy (including, but not limited to, sunitinib, pazopanib, axitinib, tivozanib, and bevacizumab) except in an adjuvant setting with a free interval of more than 1 year.
- Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (>10 mg daily prednisone equivalent) or immunosuppressive medications except for syndromes which would not be expected to recur in the absence of an external trigger. Subjects with vitiligo or type 1 diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll.
- Any condition requiring systemic treatment with corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses >10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- Uncontrolled adrenal insufficiency.
- Ongoing symptomatic cardiac dysrhythmias, uncontrolled atrial fibrillation, or prolongation of the Fridericia corrected QT (QTcF) interval defined as >450 msec for males and >470 msec for females, where QTcF = QT / 3√RR.
- Poorly controlled hypertension (defined as systolic blood pressure (SBP) of >150 mmHg or diastolic blood pressure (DBP) of >90 mmHg), despite antihypertensive therapy.
- History of any of the following cardiovascular conditions within 12 months of enrollment: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery by-pass graft surgery, symptomatic peripheral vascular disease, class III or IV congestive heart failure, as defined by the New York Heart Association.
- History of cerebrovascular accident including transient ischemic attack within the past 12 months.
- History of deep vein thrombosis (DVT) unless adequately treated with low molecular weight heparin.
- History of pulmonary embolism within the past 6 months unless stable, asymptomatic, and treated with low molecular weight heparin for at least 6 weeks.
- Known history of COPD (of any stage).
- Known history of uveitis or complaint of double vision.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months.
- Serious, non-healing wound or ulcer.
- Evidence of active bleeding or bleeding susceptibility; or medically significant hemorrhage within prior 30 days.
- Any requirement for anti-coagulation, except for low molecular weight heparin.
- Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection.
- Known medical condition (e.g., a condition associated with diarrhea or acute diverticulitis) that, in the Investigator's opinion, would increase the risk associated with study participation or study drug administration, or interfere with the interpretation of safety results.
- Known history of hyperesthesia, hypoesthesia, paresthesia, dysesthesia, peripheral motor neuropathy, peripheral sensory, neuropathy, and polyneuropathy.
Major surgery (e.g., nephrectomy) less than 28 days prior to the first dose of study drug.
- Focal radiation therapy less than 14 days prior to the first dose of study drug.
- Receiving concomitant CYP3A4 inducers or strong CYP3A4 inhibitors
Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of cabozantinib (e.g., malabsorptive disorder, ulcerative disease, uncontrolled nausea, vomiting, diarrhea, or small bowel resection).
- Any of the following laboratory test findings:
1) WBC <2,000/mm3
2) Neutrophils <1,500/mm3
3) Platelets <100,000/mm3
4) AST or ALT >3 x ULN (>5 x ULN if liver metastases are present)
5) Lipase and amylase > 1.5 ULN
6) Total Bilirubin >1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin <3.0 mg/dL)
7) Serum creatinine >1.5 x ULN or creatinine clearance <40 mL/min (measured or calculated by Cockroft-Gault formula)
8) Proteinuria: patients with ≥2+ protein on urine dipstick at baseline must undergo a 24-hour urine collection for protein then if > 1.0 g of protein patient will not be included.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
Promoteur :
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
Type de sponsor : Institutionnel
ARTIC Service d'oncologie médicale Hôpital Européen Georges Pompidou 20-30, rue Leblanc 75908 Paris cedex 15
75015 PARIS 15

Coordonnateur :
Reza ELAIDI
reza-thierry.elaidi-ext@aphp.fr
0156092340
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN

Investigateur :
Florence JOLY

TEC / ARC / IDE :
Jérémy BOUTROIS
j.boutrois@
baclesse.unicancer.fr

Ouverture de l'essai : CLOS

MAJ : 01/07/2019