COMbination of Bipolar Androgen Therapy and Nivolumab
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Castration Resistant Prostate Cancer
- Metastatic Prostate Cancer
- Prostate Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
The trial will enroll up to 44 participants. Eligible participants will continue on androgen ablative therapy with a GnRH analogue (i.e. Zoladex, Trelstar, Eligard, or Lupron) if they have not undergone orchiectomy. Following enrollment, participants will receive an intramuscular injection of testos...
The trial will enroll up to 44 participants. Eligible participants will continue on androgen ablative therapy with a GnRH analogue (i.e. Zoladex, Trelstar, Eligard, or Lupron) if they have not undergone orchiectomy. Following enrollment, participants will receive an intramuscular injection of testosterone cypionate 400mg every 4 weeks for a lead-in period of 12 weeks. After the lead-in period, all participants will be treated with nivolumab 480mg IV every 4 weeks and maintained on testosterone cypionate 400mg IM every 4 weeks. Assessments for response to testosterone + nivolumab will be performed approximately every 3 months. Treatment [with a minimum drug exposure of 12 weeks] will be continued until PSA progression (Prostate Cancer Working Group 3 [PCWG3] criteria) or clinical/radiographic progression (whichever comes first), or until unmanageable toxicity requiring drug cessation.
Tracking Information
- NCT #
- NCT03554317
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Principal Investigator: Mark Markowski, MD, Ph.D Johns Hopkins University
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