Ipilimumab With Nivolumab for Molecular-selected Patients With Castration-resistant Prostate Cancer

Sponsor
Radboud University Medical Center
Study ID
NCT04717154
Phase
PHASE2
Status
Completed

Conditions

  • Prostatic Neoplasms, Castration-Resistant

Eligibility Criteria

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

Interventions

  • Ipilimumab — BIOLOGICAL
    4 courses of 1mg/kg q3w
  • Nivolumab — BIOLOGICAL
    4 courses of 3mg/kg q3w, followed by maintenance flat dose (480mg, q4w, for 10 doses)

Study Details

The purpose of this study is to evaluate the effects of 4 cycles of combinatory immunotherapy (ipilimumab and nivolumab), followed by monotherapy nivolumab in participants with immunogenic metastatic castration-resistant prostate cancer.

Key Dates

Start date
Jan 19, 2021
Status verified
Apr 2024
Primary completion
Aug 15, 2024
Completion
Dec 18, 2025

Study Design

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

Arms

  • Experimental: Treatment arm
    Combinatory regimen of nivolumab 3mg/kg and ipilimumab 1mg/kg, followed by nivolumab 480mg flat dose (Q4w) to up to one year. This regimen will be given to participants in both cohort 1 and 2.

Primary Outcome Measure

Efficacy endpoint: DCR [ Time Frame: At inclusion, Weeks 7, 17, 29, and 41, and 30 days after last dose given at week 49 ]

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