Durvalumab And Radiation Therapy Followed by Adjuvant Durvalumab in Patients With Urothelial Cancer (T2-4 N0-2 M0) of the Bladder

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Monika Joshi, MD
Study ID
NCT02891161
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • durvalumab — DRUG
    1500 mg Q4 weekly
  • Radiation Therapy — RADIATION
    64.8 Gy, 36 daily fractions on weekdays over about 7 weeks

Study Details

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.

Key Dates

Start date
Nov 16, 2016
Status verified
Nov 2024
Primary completion
Aug 6, 2019
Completion
Apr 27, 2022

Study Design

Enrollment
26 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Safety Run In Phase Ib
    Subjects will receive durvalumab 1500mg Q4 weekly with RT to gross disease over 36 fractions. Durvalumab will start on Day 1. RT to start on Day 1 or 2. Subjects will receive adjuvant durvalumab monotherapy Q4 week, up to 12 months. Durvalumab monotherapy to start 4 weeks post completion of durvalumab and RT.
  • Experimental: Arm B: Investigational Treatment Phase II
    Subjects will receive durvalumab 1500mg Q4 weekly with RT to gross disease over 36 fractions. Durvalumab will start on Day 1. RT to start on Day 1 or 2.. Subjects will receive adjuvant durvalumab monotherapy Q4 week, up to 12 months. Adjuvant durvalumab monotherapy to start 4 weeks post completion of durvalumab and RT.

Primary Outcome Measure

Phase Ib: Safety Assessment - Evaluation of DLT (Dose Limiting Toxicity) Rate [ Time Frame: Begin W1 and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 2 years or until unacceptable toxicity. ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of Iowa Hospital and ClinicsIowa CityIowa52242-
Nebraska Methodist HospitalOmahaNebraska68114-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Montefiore Medical CenterThe BronxNew York10641-
Penn State Cancer IntsituteHersheyPennsylvania17033-
University of WisconsinMadisonWisconsin53705-
Froedtert & The Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Iowa City, IA

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
University of Iowa Hospital and Clinics· Iowa City, IANebraska Methodist Hospital· Omaha, NERutgers Cancer Institute of New Jersey· New Brunswick, NJMontefiore Medical Center· The Bronx, NYPenn State Cancer Intsitute· Hershey, PAUniversity of Wisconsin· Madison, WI

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