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

NCT03340129 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2026-02-02

No results posted yet for this study

Summary

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.

Conditions

  • Melanoma Stage Iv

Interventions

DRUG

Ipilimumab

Ipilimumab 3mg per kg every 3 weeks for 4 doses

DRUG

Nivolumab

Nivolumab 1mg/kg every 3 weeks for 4 doses, then 480mg every 4 weeks.

RADIATION

Stereotactic Radiotherapy

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.

OTHER

Salvage therapy

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.

Sponsors & Collaborators

Principal Investigators

  • Georgina V Long, MBBS PhD · Melanoma Institute Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-14
Primary Completion
2026-08-31
Completion
2029-08-31

Countries

  • Australia
  • Norway

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03340129 on ClinicalTrials.gov