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

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.

Trial Details

NCT ID
NCT03340129
Phase
PHASE2
Sponsor
Melanoma Institute Australia
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Ipilimumab
  • Nivolumab
  • Stereotactic Radiotherapy
  • Salvage therapy
Locations (sample)
  • Sydney, New South Wales, Australia|-33.86785,151.20732
  • Waratah, New South Wales, Australia|-32.90667,151.72647
  • Wollstonecraft, New South Wales, Australia|-33.8328,151.18981
  • Woolloongabba, Queensland, Australia|-27.48855,153.03655
  • Adelaide, South Australia, Australia|-34.92866,138.59863

Key Eligibility Criteria

  • Female or male patients, ≥18 years of age.
  • Signed, written, informed consent.
  • AJCC Stage IV \[any T, any N, M1d (0) or M1D(1)\] histologically confirmed cutaneous, acral or mucosal unresectable melanoma or unknown primary mel…
  • The BRAF mutation status must be available prior to randomisation.

For full eligibility, visit ClinicalTrials.gov.

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