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

PHASE2RecruitingINTERVENTIONAL
Enrollment

218

Participants

Timeline

Start Date

August 14, 2019

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2029

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.

Trial Locations (10)

2065

RECRUITING

Melanoma Institute Australia, Wollstonecraft

2145

RECRUITING

Westmead Hospital, Sydney

2298

RECRUITING

Calvary Mater NewcastleHospital, Waratah

3002

RECRUITING

Peter MacCallum Cancer Centre, East Melbourne

3004

RECRUITING

Alfred Hospital, Melbourne

4102

RECRUITING

Princess Alexandra Hospital, Woolloongabba

5000

RECRUITING

Royal Adelaide Hospital, Adelaide

6009

RECRUITING

Sir Charles Gairdner Hosptial, Perth

0379

RECRUITING

Oslo Univesity Hospital Radiumhospitalet, Oslo

Unknown

NOT_YET_RECRUITING

Skåne University Hospital, Lund

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Melanoma Institute Australia

OTHER