Nivolumab and Ipilimumab Treatment in Prostate Cancer With an Immunogenic Signature

Prostate Cancer Clinical Trial

Official title: Nivolumab and Ipilimumab Treatment in Prostate Cancer With an Immunogenic Signature

Status Active, not recruiting

Clinical Trial Summary

The primary objective is to test the following hypothesis: Patients with metastatic castrate resistant prostate cancer that have progressed following at least one line of therapy and have an immunogenic signature will respond to combined PD-1 and CTLA4 inhibition.

Clinical Trial Description

This is a two-arm non-randomised, non-comparative 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 :

Cohort 1:

• 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.

Cohort 2:

• Nivolumab 3 mg/kg + ipilimumab 1 mg/kg every three weeks for a maximum of 4 doses

• 3 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. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT03061539
• Study type: Interventional
• Source: University College, London
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 6, 2018
• Completion date: June 2027