ABC Trial : A phase II study assessing the intracranial response to nivolumab and nivolumab combined with ipilimumab in patients with melanoma brain metastases

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

Over 18Age Over 18

Skin<br/>CancersCancer LocationSkin
Cancers

Systemic therapy | SkinMelanoma (Skin),

Trial Overview Read MoreRead more

This phase II trial is assessing nivolumab alone and in combination with ipilimumab for the treatment of melanoma that has spread to the brain.
 

This trial is treating patients with Melanoma that has spread to the brain.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

A phase II study assessing the intracranial response to nivolumab and nivolumab combined with ipilimumab in patients with melanoma brain metastases

Cooperative Group

Australia and New Zealand Melanoma Trials Group (ANZMTG)

Summary

Initially, this study will recruit patients with melanoma brain metastases who have received no prior local treatment for their intracranial metastatic disease and who are asymptomatic (Cohort 1) and in parallel, patients who have been previously treated for their brain metastases, have symptoms, or have concurrent leptomeningeal disease (Cohort 2) will be enrolled to receive nivolumab monotherapy (3mg/kg). A third group of patients with brain metastases who have received no prior treatment for their metastatic disease and who are asymptomatic to receive combined nivolumab 1 mg/kg and ipilimumab 3mg/kg (Cohort 3) every 3 weeks for 4 doses, then continuing on nivolumab monotherapy per cohorts 1 and 2. Recruitment to cohort 3 will commence once the first 6 patients from cohort 1 have received at least 6 doses of study treatment (equivalent to 12 weeks) and have a satisfactory adverse event record. After this safety assessment, patients will continue to be recruited to this cohort. To minimise bias, treatment allocation to cohort 3 and the remainder of cohort 1 will be assigned by unequal randomisation ratio to achieve an overall balance of 30 patients receiving nivolumab 3 mg/kg (including the 6 patients from cohort 1) and 30 patients receiving the combination treatment. Allocation concealment for Cohort 1 and 3 will be performed through central randomisation.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville cancer clinical trials unit) *
Parkville
Ms Marian Lieschke
marian.lieschke@petermac.org
03 8559 7140