Anti-PD 1 Brain Collaboration for Patients With Melanoma Brain Metastases

Sponsor
Melanoma Institute Australia
Study ID
NCT02374242
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab is a fully human monoclonal antibody directed against the negative immunoregulatory human cell surface receptor PD-1 (programmed death-1 or programmed cell death-1/PCD-1) with immunopotentiation activity.
  • Ipilimumab — DRUG
    Ipilimumab is a recombinant, human monoclonal antibody that binds to the cytotoxic T lymphocyte-associated antigen 4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activation. Ipilimumab binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation. The mechanism of action of ipilimumab's effect in patients with melanoma is indirect, possibly through T-cell mediated anti-tumour immune responses.

Study Details

The purpose of this research project is to test the effectiveness of nivolumab versus nivolumab together with ipilimumab for the treatment of melanoma brain metastases. Patients are eligible to join this study if they are aged 18 years or above and have been diagnosed with melanoma with brain metastases.

Key Dates

Start date
Nov 4, 2014
Status verified
Dec 2025
Primary completion
Sep 4, 2017
Completion
Dec 31, 2028

Study Design

Enrollment
76 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cohort 1 Nivolumab Monotherapy
    Nivolumab 3mg/kg every 2 weeks, until disease progression, withdrawn consent, unacceptable toxicity or death. After 52 weeks, nivolumab dosing can change to 480mg every 4 weeks
  • Active Comparator: Cohort 2 Nivolumab Monotherapy
    Nivolumab 3mg/kg every 2 weeks, until disease progression, withdrawn consent, unacceptable toxicity or death. After 52 weeks, nivolumab dosing can change to 480mg every 4 weeks
  • Active Comparator: Cohort 3 Nivolumab and Ipilimumab
    Nivolumab 1mg/kg every 3 weeks x four doses and ipilimumab 3mg/kg every 3 weeks x four doses. After 12 weeks, nivolumab 3mg/kg alone every 2 weeks until disease progression, withdrawn consent, unacceptable toxicity or death. After 52 weeks, nivolumab dosing can change to 480mg every 4 weeks

Primary Outcome Measure

Intracranial response rate [ Time Frame: Approximately 3 years ]

Related Studies