Durvalumab And Radiation Therapy Followed by Adjuvant Durvalumab in Patients With Urothelial Cancer (T2-4 N0-2 M0) of the Bladder
NCT02891161 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2024-11-27
Summary
This is an open label, multi-institutional, single arm study of a phase Ib study, followed by a phase II study of durvalumab with radiation therapy (RT) in patients with urothelial cancer (UC). No randomization or blinding is involved.
Conditions
Interventions
- DRUG
-
1500 mg Q4 weekly
- RADIATION
-
Radiation Therapy
64.8 Gy, 36 daily fractions on weekdays over about 7 weeks
Sponsors & Collaborators
- collaborator INDUSTRY
-
Monika Joshi, MD
lead OTHER
Principal Investigators
-
Monika Joshi, MD, MRCP · Penn State Cancer Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-11-16
- Primary Completion
- 2019-08-06
- Completion
- 2022-04-27
Countries
- United States
Study Locations
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