A Phase 3, Multicenter, Multinational, Randomized, Open-Label, Parallel-Arm Study of Avelumab (MSB0010718C) Plus Best Supportive Care Versus Best Supportive Care Alone as a Maintenance Treatment in Patients with Locally Advanced or Metastatic Urothelial Cancer Whose Disease Did Not Progress After Completion of First-Line Platinum-Containing Chemotherapy

Pfizer Inc0 个研究点目标入组 6 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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:
•1. Prior adjuvant or neoadjuvan therapy within 12 months of randomization
•2. Prior immunotherapy with IL-2, IFN-Î±, 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.

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