NCT03061539

Nivolumab and Ipilimumab Treatment in Prostate Cancer With an Immunogenic Signature

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 380 (actual)
• Sponsor: University College, London · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab & Ipilimumab	Combination Therapy: Cohort 1: Nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks for a maximum of 4 cycles . Cohort 2 : Nivolumab 3mg/kg + ipilimumab 1mg/kg every 3 weeks for a maximum of 4 cycles. Treatment free gap after last combination dose : Cohort 1: 6 weeks; Cohort 2: 3 weeks Monotherapy: 480 mg flat dose of nivolumab every 4 weeks for up to 10 cycles, or until progression, unacceptable toxicity or withdrawal of consent

Timeline

• Start date: 2018-02-06
• Primary completion: 2022-06-20
• Completion: 2027-06-01
• First posted: 2017-02-23
• Last updated: 2022-09-28

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study