a study of the safety and efficacy of various combinations of avelumab as therapy in locally advanced or metastatic urothelial carcinoma (javelin bladder medley)

Conditions: Locally Advanced or Metastatic Urothelial Carcinoma

Summary: 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.


Eligibility criteria:
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

Keywords: avelumab avelumab in combination bladder cancer m6223 (anti-tigit antibody) pd-l1 sacituzumab govitecan (trop-2 antibody drug conjugate) nktr-255 (il-15 agonist)