Etude : JAVELIN REIN B9991003 / JAVELIN Renal 101

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Acronyme / Nom
Situation thérapeutique
Cadre réglementaire
Présentation de l'étude
Acronyme / Nom : JAVELIN REIN B9991003 / JAVELIN Renal 101

Situation thérapeutique : Adjuvant / Métastatique ou localement avancé

Traitement :

Cadre réglementaire : RIPH1

Dernière MÀJ : 04/02/2022
CIM10 - Localisation(s)
Informations principales
Titre : Etude de phase III, multinationale, randomisée, en ouvert, en groupes parallèles, de l'avélumab (MSB010718C) en association avec l'axitinib (Inlyta®) comparé à une monothérapie par sunitinib (Sutent®) en traitement de première intention chez des patients atteints d'un carcinome à cellules rénales avancé

Spécialité : Voies urinaires
Localisation : C64 - Tumeur maligne du rein, à l'exception du bassinet
Informations complémentaires
Schéma : This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma

2 arms:
- Experimental: Avelumab in combination with axitinib
Avelumab administered at 10 mg/kg IV every two weeks in combination with axitinib, 5 mg PO BID.
- Active Comparator: Sunitinib
Sunitinib given at 50 mg PO QD on schedule 4/2

Phase : III

Stade : NA

Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Histologically or cytologically confirmed advanced or metastatic RCC with clear cell component
- Availability of a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block from a de novo tumor biopsy during screening (biopsied tumor lesion should not be a RECIST target lesion). Alternatively, a recently obtained archival FFPE tumor tissue block (not cut slides) from a primary or metastatic tumor resection or biopsy can be provided if the following criteria are met:
1) the biopsy or resection was performed within 1 year of randomization AND
2) the patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained and randomization onto the current study. If an FFPE tissue block cannot be provided as per documented regulations then, 15 unstained slides (10 minimum) will be acceptable
- Availability of an archival FFPE tumor tissue from primary tumor resection specimen (if not provided per above). If an FFPE tissue block cannot be providedas per documented regulations 15 unstained slides (10 minimum) will be acceptable
- At least one measureable lesion as defined by RECIST version 1.1 that has not been previously irradiated
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate bone marrow function, renal and liver functions

Critères de non-inclusion : - Prior systemic therapy directed at advanced or metastatic RCC
- Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occurred during or within 12 months after the last dose of treatment.
- Prior immunotherapy with IL-2, IFN-α, or anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways
- Prior therapy with axitinib and/or sunitinib as well as any prior therapies with other VEGF pathway inhibitors
- Newly diagnosed or active brain metastasis
- Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥3), any history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partially controlled asthma Global Initiative for Asthma 2011)
- Any of the following in the previous 12 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, LVEF less than LLN, clinically significant pericardial effusion, cerebrovascular accident, transient ischemic attack
- Any of the following in the previous 6 months: deep vein thrombosis or symptomatic pulmonary embolism
- Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines (for example, inactivated influenza vaccines)
Informations relatives au promoteur
Promoteur :
Type de sponsor : Industriel

Coordonnateur :
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
CHU de Rouen - 1 Rue de Germont - 76000 ROUEN

Investigateur :
Christian PFISTER


Statut de l'essai : CLOS

MAJ : 04/02/2022