Radium-223 and Atezolizumab in Patients With Urothelial Carcinoma With Bone Metastases Who Have Had Disease Progression After Platinum-Based Chemotherapy

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT03208712
Phase
EARLY_PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab 1200 mg IV once every 3 weeks
  • Radium-223 — DRUG
    Radium- 223 IV (55 kBq/kg) every 3 weeks for up to 6 doses

Study Details

This is a single-arm, single-site pilot of Radium-223 (55 kBq/kg) IV q3 weeks for up to 6 doses in combination with Atezolizumab 1200mg IV once every 3 weeks until investigator determined lack of benefit, unacceptable toxicity, or 17 doses in patients with urothelial carcinoma with bone metastases who have disease progression after platinum-containing chemotherapy.

Key Dates

Start date
Nov 1, 2017
Status verified
Oct 2018
Primary completion
Aug 2, 2018
Completion
Aug 2, 2018

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Radium-223 and Atezolizumab
    Radium- 223 IV (55 kBq/kg) every 3 weeks for up to 6 doses Atezolizumab 1200 mg IV once every 3 weeks until investigator determined lack of benefit, unacceptable toxicity, or 17 doses

Primary Outcome Measure

Percent of Patients that respond to Treatment [ Time Frame: Up to 52 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-

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