Etude : MK3475-866 / KEYNOTE-866

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
Situation thérapeutique
Cadre réglementaire
Présentation de l'étude
Acronyme / Nom : MK3475-866 / KEYNOTE-866

Situation thérapeutique : Néoadjuvant / Adjuvant

Traitement : Chimiothérapie / Immunothérapie / Chirurgie

Cadre réglementaire : RIPH1

Dernière MÀJ : 01/12/2021
CIM10 - Localisation(s)
Informations principales
Titre : Etude de phase III, randomisée, en double-aveugle évaluant l'administration périopératoire du pembrolizumab (Mk-3475) + chimiothérapie néoadjuvante versus placebo périopératoire + chimiothérapie néoadjuvante chez des patients éligible au cisplatine atteins de cancer de la vessie envahissant le muscle

Spécialité : Voies urinaires
Localisation : C67 - Tumeur maligne de la vessie
Informations complémentaires
Schéma : A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.

Phase : II/III

Stade : Localisé à Localement avancé

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 : - Have a histologically confirmed diagnosis of muscle invasive bladder cancer (T2-T4aN0M0) with predominant (≥50%) urothelial histology (histology and presence of muscle invasion to be confirmed by BICR): Participants with mixed histology are eligible provided the urothelial component is ≥50%.

Participants whose tumors contain any neuroendocrine component are not eligible.

Urothelial carcinomas not originating from the bladder (e.g., upper tract [ureters, renal pelvis], urethra) are not eligible.

Have clinically non-metastatic bladder cancer (N0M0) determined by imaging (computed tomography (CT) chest or magnetic resonance imaging (MRI) of the abdomen/pelvis.
Be deemed eligible for RC + PLND by his/her urologist and/or oncologist and agree to undergo curative intent standard RC + PLND (including prostatectomy if applicable).
Have a transurethral resection (TUR) of a bladder tumor that is submitted and adequate to determine histology, muscle invasion, and PD-L1 status by central pathology vendor.
Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Have demonstrated adequate organ function.

Critères de non-inclusion :
Has a known additional malignancy that is progressing or has required active anti-cancer treatment ≤3 years of study randomization with certain exceptions.
Has received any prior systemic anti-neoplastic treatment for MIBC.
Is cisplatin-ineligible, as defined by meeting any one of the study criteria.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).
Has received therapy with hematopoietic growth factor such as granulocyte-colony stimulating factor (G-CSF) or granulocyte-monocyte-colony stimulating factor(GM-CSF) in 14 days prior to randomization.
Has received prior systemic anti-cancer therapy including investigational agents within 3 years of randomization.
Has received any prior radiotherapy to the bladder.
Has received a live vaccine within 30 days prior to the first dose of study drug.
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.
Has hypersensitivity to monoclonal antibodies (mAbs, including pembrolizumab) and/or any of their excipients.
Has severe hypersensitivity (≥Grade 3) to cisplatin and/or gemcitabine and any of their excipients.
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
Has an active infection requiring systemic therapy.
Informations relatives au promoteur
Promoteur :
MSD (Merck Sharp & Dohme Corp.)
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 : OUVERT

MAJ : 30/03/2021