RecruitingPhase 2NCT03340129

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

A Phase II, Open Label, Randomised, Controlled Trial of Ipilimumab and Nivolumab With Concurrent Intracranial Stereotactic Radiotherapy Versus Ipilimumab and Nivolumab Alone in Patients With Melanoma Brain Metastases.

Sponsor

Melanoma Institute Australia

Enrollment

218 participants

Start Date

Aug 14, 2019

Study Type

INTERVENTIONAL

Conditions

Melanoma Stage IV

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.

Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This trial (ABC-X) is testing a combination of immunotherapy drug nivolumab (anti-PD-1) and radiotherapy (targeted radiation) to treat advanced melanoma — a serious form of skin cancer — that has spread to the brain, for patients who have not previously received immunotherapy. **You may be eligible if...** - You are 18 or older - You have stage IV melanoma (cutaneous, acral, mucosal, or unknown primary) confirmed by tissue biopsy - You have at least one measurable brain metastasis between 5mm and 40mm - You have not previously received anti-PD-1 or anti-CTLA-4 immunotherapy - You have signed informed consent **You may NOT be eligible if...** - You have already received immunotherapy for melanoma - Your brain metastases are too large or too numerous - You have leptomeningeal disease (cancer spread along the brain's lining) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGIpilimumab

Ipilimumab 3mg per kg every 3 weeks for 4 doses

DRUGNivolumab

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

RADIATIONStereotactic 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.

OTHERSalvage 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.