Etude : WO29636 /

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.

Type d'étude
Présentation de l'étude
Acronyme : WO29636

Nom :

Traitement : Adjuvant

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 26/09/2017
CIM10 - Localisation(s)
Informations principales
Titre : Etude de phase III, multicentrique, randomisée, en ouvert, évaluant MPDL3280A (anticorps anti-PDL1) versus observation en traitement adjuvant chez des patients atteints d'un cancer de la vessie PDL1 positif avec haut risque d’invasion musculaire (MIBC) après cystectomie

Spécialité : Voies urinaires
Localisation : C67 - Tumeur maligne de la vessie
Informations complémentaires
Schéma : A Phase III, Open-Label, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Versus Observation as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Urothelial Carcinoma After Surgical Resection

2 arms:
- Experimental: Atezolizumab
Participants will receive intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
- No Intervention: Observation
Participants will undergo observation starting on Day 1 for 16 cycles (up to 1 year).

Phase : III

Stade : NA

Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Histologically confirmed muscle-invasive UC (also termed transitional cell carcinoma [TCC]) of the bladder or upper urinary tract (i.e., renal pelvis or ureters)
- Participants who have not received prior platinum-based neoadjuvant chemotherapy, have refused or are ineligible ("unfit") for cisplatin-based adjuvant chemotherapy
- Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens from surgical resection (i.e., radical cystectomy, nephroureterectomy, or lymph node dissection) in paraffin blocks (blocks preferred) or at least 15 unstained slides, with an associated pathology report, for central testing and determined to be evaluable for tumor PD-L1 expression prior to study enrollment
- Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan of the pelvis, abdomen, and chest no more than 4 weeks prior to randomization
- Full recovery from cystectomy or nephroureterectomy within 14 weeks following surgery
- Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (=) 2
- Life expectancy greater than or equal to (>/=) 12 weeks
- Adequate hematologic and end-organ function
- For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or use contraceptive methods that result in a failure rate of less than (<) 1 percent (%) per year during the treatment period and for at least 5 months after the last dose of atezolizumab

Critères de non-inclusion : - Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
- Adjuvant chemotherapy or radiation therapy for UC following surgical resection
Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or five half-lives of the drug prior to enrollment
- Malignancies other than UC within 5 years prior to Cycle 1, Day 1
- Pregnancy or breastfeeding
- Significant cardiovascular disease
- Severe infections within 4 weeks prior to Cycle 1, Day 1
- Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day 1
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
- History of autoimmune disease
- Prior allogeneic stem cell or solid organ transplant
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
- Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or hepatitis C or tuberculosis
- Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1
- Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, including anti-CD40, anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), and anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibodies
Informations relatives au promoteur
Promoteur :
Type de sponsor : Industriel

Coordonnateur :
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN
Apicrypt :

Investigateur :
Florence JOLY


Statut de l'essai : CLOS

MAJ : 02/07/2018