Nivolumab and Ipilimumab Treatment in Prostate Cancer With an Immunogenic Signature

Sponsor
University College, London
Study ID
NCT03061539
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab & Ipilimumab — DRUG
    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

Study Details

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 Dates

Start date
Feb 6, 2018
Status verified
Jun 2022
Primary completion
Jun 20, 2022
Completion
Jun 30, 2027

Study Design

Enrollment
380 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab & Ipilimumab - Cohort 1
    Patients will receive Nivolumab 1 mg/kg + ipilimumab 3 mg/kg every three weeks for a maximum of 4 doses followed by a 6 week gap after last combination dose. The patients will then receive 480 mg flat dose of nivolumab every 4 weeks for up to one year, or until progression, unacceptable toxicity or withdrawal of consent.
  • Experimental: Nivolumab & Ipilimumab - Cohort 2
    Patients will receive Nivolumab 3 mg/kg + ipilimumab 1 mg/kg every three weeks for a maximum of 4 doses followed by a 3 week gap after last combination dose. The patients will then receive 480 mg flat dose of nivolumab every 4 weeks for up to one year, or until progression, unacceptable toxicity or withdrawal of consent.

Primary Outcome Measure

Composite response rate [ Time Frame: Up to 5 years following the start of treatment ]

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