A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)
Phase 2 – studying effectiveness and dosage
Conditions:
Locally Advanced or Metastatic Urothelial Carcinoma
Sponsor: EMD Serono Research & Development Institute, Inc.
trial.available_in:
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Overview
The purpose of this study is to assess the safety and efficacy of avelumab in combination with other anti-tumor agents as a maintenance treatment in participants with bladder cancer.
Who can participate
Inclusion Criteria:
* Participants with histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma. Both transitional cell and mixed transitional/non- transitional cell histologies are allowed, but transitional cell carcinoma must be the predominant histology
* Participants has documented Stage IIIA/IIIB with N1-N3, or Stage IV disease (per American Joint Committee on Cancer/International Union for Cancer Control Tumor Node Metastasis system, 8th edition) at the start of first line chemotherapy.
* The last dose of first line chemotherapy must have been received no less than 4 weeks, and no more than 10 weeks, prior to randomization in the present study
* Estimated life expectancy of at least 3 months
* Participants without progressive disease as per RECIST v1.1 guidelines following completion of 4 to 6 cycles of 1L chemotherapy. Eligibility based on this criterion will be determined by Investigator review of pre chemotherapy and post chemotherapy radiological assessments (CT/MRI scans).
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
* Adequate hematological, hepatic, and renal function as defined in the protocol
* Other protocol defined inclusion criteria could apply
Exclusion Criteria:
* Participants with prior immunotherapy with Interleukin-2 (IL-2), IL-15, interferon alfa (IFN-α), or an anti programmed death receptor-1 (PD-1), anti programmed death-ligand 1 (PD-L1), anti PD-L2, anti CD137, or cytotoxic T cell lymphocyte-4 (CTLA-4) antibody (including ipilimumab), anti TROP2, anti-T-cell-immuno-receptor with Ig and ITM domains (anti-TIGIT) any other antibody or drug specifically targeting T cell costimulation or immune checkpoint pathways, agents targeting Nectin-4, or any of the investigational drugs used in combination with avelumab.
* Participants with active infection 48 hours before randomization requiring systemic therapy
* Participants with known prior or suspected hypersensitivity to study drugs or any component in their formulations
* Participants with prior adjuvant or neoadjuvant systemic therapy within 12 months of randomization
* Participants with vaccination within 4 weeks of the first dose of study treatment and while on trial is prohibited except for administration of inactivated vaccines (for example, inactivated influenza vaccines) administered \>= 2 weeks prior first dose of study treatment. All severe acute respiratory syndrome coronavirus (SARS-CoV-2) vaccines approved or authorized by local Health Authorities are allowed
* Other protocol defined exclusion criteria could apply
Interventions
Avelumab
DRUG
Sacituzumab Govitecan
DRUG
M6223
DRUG
NKTR-255
DRUG
Locations
97
Australia (8)
Flinders Medical Centre
Bedford Park
Sunshine Hospital - PARENT
Footscray
Ashford Cancer Centre Research
Kurralta Park
Liverpool Hospital - PARENT
Liverpool
Calvary Mater Newcastle - PARENT
Newcastle
Tasman Oncology Research Ltd - Oncology
Southport
Macquarie University Hospital - PARENT
Sydney
The Kinghorn Can Cen
Westmead
Belgium (8)
ZNA Middelheim - Middelheim - account 2
Antwerp
AZ Klina - PARENT
Brasschaat
Institut Jules Bordet - Medical Oncology
Brussels
Universitair Ziekenhuis Gent - Medical Oncology
Ghent
AZ Groeninge - Campus Kennedylaan - account 2
Kortrijk
Centre Hospitalier de l'Ardenne - PARENT
Libramont
CHU de Liège - PARENT
Liège
Universitaetsklinikum Wuerzburg - Klinik u. Poliklinik f. Urologie u. Kinderurologie
Wuerzburg
Canada (4)
William Osler Health System - Brampton Civic Hospital
Brampton
CISSS de la Monteregie-Centre - Hospital Charles Le Moyne
Greenfield Park
CHUM Centre de Recherche
Montreal
The Ottawa Hospital Cancer Centre
Ottawa
France (15)
ICO - Site Paul Papin - service d'oncologie medicale
Angers
Institut Bergonié - Service d'Oncologie Médicale
Bordeaux
Centre François Baclesse - Pathologies Gynecologiques
Caen
Hôpital Henri Mondor - Service d'Oncologie Médicale
Créteil
Clinique Victor Hugo - Centre Jean Bernard - Service d'Oncologie Médical
Le Mans
Centre Leon Berard - Service d'Oncologie Medicale
Lyon
Hôpital de la Timone - service d'urologie
Marseille
Hopital Caremeau - Service Hématologie Clinique/Oncologie Médicale
Nîmes
Hôpital Cochin - Hematologie et Oncologie Médicale
Paris
CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale
Poitiers
CRLCC Eugene Marquis - Service d'Oncologie médicale
Rennes
ICO - Site René Gauducheau - Service d'Oncologie medicale
Saint-Herblain
Clinique Sainte-Anne - Service d'Oncologie Médicale
Strasbourg
Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale