Study of Nivolumab in Combination w Radium-223 in Men w Metastatic Castration Resistant Prostate Cancer

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT04109729
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab 480mg IV every 4 weeks for up to 2 years
  • Radium-223 — DRUG
    Radium-223 55 kilobecquerel (kBq)/kg IV q4 weeks for 6 cycles total

Study Details

This is a phase 1, open label, prospective, non-randomized single arm study combining Radium-223 with nivolumab in men with metastatic castration resistant prostate cancer.

Key Dates

Start date
Sep 16, 2020
Status verified
Feb 2026
Primary completion
Apr 28, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
39 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: All patients
    Radium-223 kBq/kg IV every 4 weeks for up to 6 doses. Nivolumab 480 mg IV every 4 weeks for up to 2 years.

Primary Outcome Measure

To assess the frequency of grade 3 or greater non-hematologic treatment-emergent adverse events when combining nivolumab with Radium-223 [ Time Frame: From cycle one day one until cycle 3 day 28 (each cycle is 28 days) - approximately 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Huntsman Cancer Institute at University of UtahSalt Lake CityUtah84112-

Find similar trials in Salt Lake City, UT

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Huntsman Cancer Institute at University of Utah· Salt Lake City, UT

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