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

Mucosal Melanoma 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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