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. (ABC-X)

NCT03340129 Phase 2 RECRUITING

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.

Details

Lead sponsor	Melanoma Institute Australia
Phase	Phase 2
Status	RECRUITING
Enrolment	218
Start date	2019-08-14
Completion	2029-08

Conditions

• Melanoma Stage Iv

Interventions

• Ipilimumab
• Nivolumab
• Stereotactic Radiotherapy
• Salvage therapy

Primary outcomes

• Neurological specific cause of death — One year
  Proportion of patients dead at one year from randomisation and whose immediate cause of death is neurological.

Countries

Australia, Norway