Etude : KEYNOTE-905 / MK-3475-905



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 : KEYNOTE-905

Nom : MK-3475-905

Traitement : Néoadjuvant / Chirurgie

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 12/06/2020
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Etude de phase 3, randomisée évaluant le pembrolizumab en péri opératoire de la cystectomie versus la cystectomie seule chez les patients non éligibles au cisplatine dans le cancer de la vessie infiltrant le muscle

Spécialité : Voies urinaires
Localisation : C67 - Tumeur maligne de la vessie
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : A global, randomized phase III study to evaluate perioperative pembrolizumab with radical cystectomy + pelvic lymph node dissection (RC+PLND) versus RC+PLND alone in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC).

Phase : III

Stade : Localisé

1
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion :
Histologically confirmed diagnosis of muscle invasive bladder cancer (T2-T4aN0M0) with predominant (≥50%) urothelial histology. Participants with mixed histology are eligible provided the urothelial component is ≥50%. Urothelial carcinomas not originating from the bladder are not eligible. Participants whose tumors contain any neuroendocrine component are not eligible.
Clinically non-metastatic bladder cancer determined by imaging
Eligible for radical cystectomy (RC) + pelvic lymph node dissection (PLND ), and agreement to undergo curative intent standard RC + PLND (including prostatectomy if applicable)

Ineligible for treatment with cisplatin, as defined by meeting at least one of the following criteria:
Impaired renal function with measured or calculated CrCl 30 to 59 mL/min
Eastern Cooperative Oncology Group (ECOG) Performance Status 2
Common Terminology Criteria for Adverse Events (CTCAE) v.4 Grade ≥2 audiometric hearing loss
CTCAE v.4 Grade ≥2 peripheral neuropathy
New York Heart Association (NYHA) Class III heart failure
Transurethral resection (TUR) of a bladder tumor that is submitted and adequate for evaluation of histology, muscle invasion and PD-L1 status
ECOG performance status of 0, 1, or 2
Adequate organ function

Critères de non-inclusion :
Known additional non-urothelial malignancy that is progressing or has required active treatment ≤3 years of study randomization, with certain exceptions
Received any prior systemic anti-neoplastic treatment for muscle-invasive bladder cancer (MIBC)
Received prior therapy with a anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-programmed cell death 1 ligand 2 (PD-L2), or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
Received prior systemic anti-cancer therapy including investigational agents within 3 years prior to randomization
Received any prior radiotherapy to the bladder
Received a live vaccine within 30 days prior to the first dose of study drug
Current participation in or participation in a study of an investigational agent or use of an investigational device within 4 weeks prior to the first dose of study intervention
Diagnosis of immunodeficiency or receipt of chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug
Hypersensitivity to monoclonal antibodies (including pembrolizumab) and/or any of their excipients
Active autoimmune disease that has required systemic therapy in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic therapy and is allowed.
History of (non-infectious) pneumonitis that required steroids, or current pneumonitis.
Active infection requiring systemic therapy
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03924895
Promoteur :
MSD (Merck Sharp & Dohme Corp.)
Type de sponsor : Industriel
00000 HORS FRANCE

Coordonnateur :
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 :
Elodie COQUAN

TEC / ARC / IDE :
Astrid LETIEMBRE
a.letiembre@
baclesse.unicancer.fr

Statut de l'essai : SUSPENDU

MAJ : 12/06/2020