Neoadjuvant and Adjuvant Durvalumab in Combination With Neoadjuvant Chemotherapy in Patients With Operable Urothelial Cancer.
NCT03406650 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61
Last updated 2025-05-04
Summary
The main objective is to demonstrate that the addition of neoadjuvant and adjuvant immunotherapy with durvalumab, to standard neoadjuvant chemotherapy (with cisplatin/gemcitabine) and surgery in urothelial carcinoma could improve event-free survival.
Conditions
Interventions
- DRUG
-
Neoadjuvant and adjuvant durvalumab
Neoadjuvant durvalumab 1500 mg q3w for 4 cycles Adjuvant durvalumab 1500 mg q4w for 10 cycles
Sponsors & Collaborators
-
Swiss Cancer Institute
lead OTHER
Principal Investigators
-
Richard Cathomas, MD · Kantonsspital Graubünden, Chur
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-15
- Primary Completion
- 2022-02-25
- Completion
- 2025-01-31
Countries
- Germany
- Switzerland
Study Locations
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