Nivolumab and Ipilimumab Treatment in Prostate Cancer With an Immunogenic Signature
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- 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
This is a single arm phase II trial designed to assess the efficacy of nivolumab + ipilimumab in patients with metastatic castrate resistant prostate cancer that have progressed following at least 1 line of therapy and have an specified immunogenic signature. The immunogenic signature is defined by ...
This is a single arm phase II trial designed to assess the efficacy of nivolumab + ipilimumab in patients with metastatic castrate resistant prostate cancer that have progressed following at least 1 line of therapy and have an specified immunogenic signature. The immunogenic signature is defined by the presence of at least one of the following: Mismatch repair deficiency by IHC Defective DNA repair detected by a targeted sequencing panel High inflammatory infiltrate defined on multiplexed IHC criteria. Treatment consists of : Nivolumab 1 mg/kg + ipilimumab 3 mg/kg every three weeks for a maximum of 4 doses 6 week gap after last combination dose 480 mg flat dose of nivolumab every 4 weeks for up to one year, or until progression, unacceptable toxicity or withdrawal of consent. Patients must have ongoing androgen deprivation to maintain serum testosterone < 1.73 nmol/L.
Tracking Information
- NCT #
- NCT03061539
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Principal Investigator: Dr Mark Linch University College London Hospitals
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