The purpose of this study is to assess the efficacy and safety of adding the immunotherapy Avelumab as a fourth component, alongside tumor removal, chemotherapy, and radiation, to increase the chance of preserving the bladder in the treatment of muscle-invasive bladder cancer.
Provision of signed and dated informed consent form (ICF) before any trial related procedures.
Male or female participant with ≥ 18 years of age at time of consenting.
Participant is able and willing to comply with the requirements of trial protocol.
Pathologically (histologically or cytologically) and radiologically confirmed newly diagnosed MIBC (T2-T4 N0 M0) or recurrent previously NMIBC.
Participant with non-muscle invasive bladder cancer or Metastatic disease (M1) and/or lymph node positive.
Participant who underwent radical cystectomy or is planned for radical cystectomy.
Histologically confirmed squamous cell carcinoma, micropapillary carcinoma, neuroendocrine carcinoma, adenocarcinoma, or mixed histology.
Participant had received treatment for urothelial carcinoma, with any of the following anti-cancer therapies prior the first dose of trial treatment: systemic chemotherapy, targeted small molecule therapy, or radiation therapy.
American University of Beirut Medical Center
Lead sponsor
Merck KGaA, Darmstadt, Germany
Collaborator