Health Condition 1: null- locally advanced or metastatic urothelial cancer Health Condition 2: C679- Malignant neoplasm of bladder, unspecified Health Condition 3: C659- Malignant neoplasm of unspecifiedrenal pelvis Health Condition 4: C669- Malignant neoplasm of unspecifiedureter
Conditions
Interventions
Intervention1: The investigational product in the present clinical trial is avelumab (MSB0010718C): 1 hour intravenous infusion every 2 weeks (Q2W) in 4 week cycles
Other: Best Supportive Care
Control
Sponsors
Pfizer Inc
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1.Histologically confirmed, unresectable locally advanced or metastatic transitional cell carcinoma of the urothelium 2. Stage IV disease at the start of first-line chemotherapy 3. Measurable disease (per RECIST v1.1) prior to the start of first-line chemotherapy 4. Prior first-line chemotherapy must have consisted of at least 4 cycles and no more than 6 cycles of gemcitabine + cisplatin and/or gemcitabine + carboplatin 5. No evidence of progressive disease following completion of first-line chemotherapy (i.e., ongoing CR, PR, or SD per RECIST v1.1 guidelines )
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Prior adjuvant or neoadjuvan therapy within 12 months of randomization 2. Prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA 4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways 3. Persisting toxicity related to prior therapy (Grade >1 NCI CTCAE v4.0); however, sensory neuropathy (Grade 2 or less) is allowed 4.Diagnosis of any other malignancy within 5 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the breast or of the cervix, low grade prostate cancer on surveillance without any plans for treatment intervention 5. patients with known symptomatic central nervous system metastases requiring steroids.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives 1. Compare progression free survival 2. Anti-tumor activity by RECIST v1.1 3. Overall safety profile of avelumab plus BSC and BSC alone 4. Pharmacokinetics (PK) and immunogenicity of avelumab 5. Evaluate candidate predictive biomarkers of sensitivity or resistance to avelumab 6. Evaluate the effect of treatment on patient-reported outcomes (PROs)Timepoint: Up to approximately 40 months for each specified outcomes. | — |
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the benefit of maintenance treatment with avelumab plus BSC vs. BSC alone in prolonging overall survival (OS) in patients with unresectable locally advanced or metastatic UC whose disease did not progress on or following completion of first-line platinum-containing chemotherapy in each co-primary UC patient population: 1) patients determined to have PD-L1-positive tumors (including infiltrating immune cells) by a verified GMP PD-L1 IHC test, and 2) all randomized patients.Timepoint: Up to approximately 40 months | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Hong Kong, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Portugal, Republic of Korea, Spain, Sweden, Taiwan, United Kingdom, United States of America
Contacts
Public ContactDr Seema Pai
Pfizer India
Outcome results
None listed