Anti-PD 1 Brain Collaboration + Radiotherapy Extension (ABC-X Study)

Sponsor
Melanoma Institute Australia
Study ID
NCT03340129
Phase
PHASE2
Status
Recruiting
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Conditions

  • Melanoma Stage Iv

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — DRUG
    Ipilimumab 3mg per kg every 3 weeks for 4 doses
  • Nivolumab — DRUG
    Nivolumab 1mg/kg every 3 weeks for 4 doses, then 480mg every 4 weeks.
  • Stereotactic Radiotherapy — RADIATION
    The first dose of immunotherapy Must be given prior to the start of radiotherapy. One fraction at between 16 to 22 Gy or 24 to 30 Gy hypofractionated for larger lesions.
  • Salvage therapy — OTHER
    Any form of salvage therapy (surgery or radiotherapy) for intracranial disease progression, further disease control at any site, symptom control or treatment of cerebral haemorrhage or cerebral radionecrosis.

Study Details

This is a phase II, open label, randomised trial of ipilimumab and nivolumab with concurrent intracranial stereotactic radiotherapy versus ipilimumab and nivolumab alone in patients with asymptomatic, untreated melanoma brain metastases.

Key Dates

Start date
Aug 14, 2019
Status verified
Jan 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2029

Study Design

Enrollment
218 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Nivolumab + ipilimumab
    Nivolumab 1mg/kg and ipilimumab 3mg/kg Q3W x 4 doses, then nivolumab 480 mg every 4 weeks. Any form of salvage therapy (surgery or radiotherapy) may be administered to either cohort for the treatment of intracranial disease progression.
  • Active Comparator: Nivolumab + ipilimumab,concurrent SRS
    Nivolumab 1mg/kg and ipilimumab 3mg/kg Q3W x 4 doses, then nivolumab 480 mg every 4 weeks. Stereotactic radiotherapy 16 to 22 Gy in 1 fraction or 24 to 30 Gy, hypofractionated for larger lesions. Stereotactic radiotherapy to commence within 7 days of of the baseline / planning MRI brain. Hypofractionated stereotactic radiotherapy should be completed within 14 day of the first fraction. Any form of salvage therapy (surgery or radiotherapy) may be administered to either cohort for the treatment of intracranial disease progression.

Primary Outcome Measure

Neurological specific cause of death [ Time Frame: One year ]

Central Contacts

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