A Combination of Avelumab and Taxane (AVETAX) for Urothelial Cancer
NCT03575013 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2025-12-03
Summary
This study evaluates the safety and efficacy of the combination of Avelumab, (a fully human anti-programmed death ligand 1 (PD-L1) IgG1 antibody) in combination with a taxane chemotherapy (docetaxel) in patients with metastatic urothelial cancer who are either ineligible to receive cisplatin based chemotherapy, refractory to cisplatin in first line setting or have disease relapse after receiving cisplatin based chemotherapy within a year in the neoadjuvant or adjuvant setting.
Conditions
Interventions
- DRUG
-
Avelumab
Avelumab is a fully human anti-programmed death ligand 1 (PD-L1) IgG1 antibody
- DRUG
-
Docetaxel is a antineoplastic agent belonging to the taxoid family
Sponsors & Collaborators
- collaborator INDUSTRY
-
University of Iowa
collaborator OTHER -
Yousef Zakharia
lead OTHER
Principal Investigators
-
Yousef Zakharia, MD · University of Iowa
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-10-29
- Primary Completion
- 2021-12-15
- Completion
- 2024-02-09
- FDA Drug
- Yes
Countries
- United States
Study Locations
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