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ACTIVE NOT RECRUITING
NCT03061539
PHASE2

Nivolumab and Ipilimumab Treatment in Prostate Cancer With an Immunogenic Signature

Sponsor: University College, London

View on ClinicalTrials.gov

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.

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

380

Start Date

2018-02-06

Completion Date

2027-06

Last Updated

2022-09-28

Healthy Volunteers

No

Conditions

Interventions

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

Locations (1)

University College London Hospital

London, United Kingdom