InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.Learn why

Optimise reading forHealth ProfessionalsPatients

Closed (no longer recruiting)Last updated: 21 December 2023

ABC Trial: This phase II trial is assessing nivolumab alone and in combination with ipilimumab for the treatment of melanoma that has spread to the brainA Phase II Study of Nivolumab and Nivolumab Combined With Ipilimumab in Patients With Melanoma Brain Metastases

Clinical summary

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.

Conditions

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

Cancer

Skin Cancers Skin

Age

People18+

Phase

II

Trial Acronym

ABC Trial

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Australia and New Zealand Melanoma Trials Group (ANZMTG)

Scientific Title

A Phase II Study of Nivolumab and Nivolumab Combined With Ipilimumab in Patients With Melanoma Brain Metastases

Eligibility

Inclusion

Cohort 1 and 3

  1. ≥18 years of age.
  2. Written informed consent
  3. AJCC Stage IV (any T, any N, M1c) histologically confirmed melanoma or unknown primary melanoma. Patients must have at least 1 radiological definitive brain metastasis that is ≥ 5mm and ≤40mm measurable per RECIST version 1.1 guidelines.
  4. In patients with prior BRAF inhibitor treatment, intracranial disease progression must be demonstrated (RECIST >20% or new measurable brain metastases) compared with nadir of intracranial response during BRAF inhibitor treatment, and confirmed with a second MRI brain scan at any time from the beginning of the drug washout period (dabrafenib=5 days, trametinib=14 days).
  5. No prior localised treatment for brain metastases (eg. surgery or radiotherapy).
  6. Neurologically asymptomatic from brain metastases.
  7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2, and life expectancy > 30 days.
  8. Able to undergo MRI with Gadolinium contrast agent.
  9. Adequate haematological, hepatic and renal organ function.
  10. Women of childbearing potential: negative serum pregnancy test and effective contraception from 14 days prior to study treatment until 23 weeks after the last dose.

  11. Men with female partner of childbearing potential to use effective contraception from 14 days prior to study treatment until 31 weeks after the last dose.

Cohort 2 - per Cohorts 1 & 3, except patients must have at least one of the following:

  1. Failed prior local therapy for brain metastases (including surgery, stereotactic radiotherapy or whole brain radiotherapy) where disease has progressed per RECIST (>20% increase in SOD or new measurable brain metastases),

    and/or;

  2. Have current neurological symptoms related to brain metastases. IF they have received prior local therapy for brain metastases, the disease must have progressed per RECIST (>20% increase in SOD or new measurable brain metastases),

    and/or;

  3. Have leptomeningeal disease concurrently with measurable brain metastases. IF they have had failed prior local therapy for brain metastases, this must have progressed per RECIST (>20% increase in SOD or new measurable brain metastases).

Exclusion

Exclusion Criteria:

  1. Any melanoma brain metastasis >40mm.
  2. Ocular melanoma.
  3. Prior treatment with an anti-PD-1 or anti-PD-L1 , anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
  4. Patients with active, known or suspected autoimmune disease. Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  5. Current systemic treatment with corticosteroids, except prednisone at nonimmunosuppressive doses of ≤ 10 mg/day (or equivalent). Past treatment for non-neurological symptoms allowed, if ceased 2 weeks prior to starting study treatment. Inhaled or intranasal corticosteroids (with minimal systemic absorption) may be continued if patient on a stable dose. Non-absorbed intraarticular steroid injections will be permitted.
  6. Any investigational drug or other systemic drug therapy for melanoma within 28 days or 5 half-lives from baseline.
  7. Known to be HIV positive, or a positive test for hepatitis B and C .
  8. Another malignancy or concurrent malignancy unless disease-free for 3 years.
  9. Serious or unstable pre-existing medical conditions or other conditions that could interfere with the patient's safety, consent, or compliance.
  10. Pregnant or breastfeeding females.
  11. Administration of any form of live vaccination (such as influenza vaccine) within 30 days of starting trial and anticipated use during the trial. Administration of any other vaccine is cautionary within 30 days of starting the trial and during the trial.

Inclusion

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

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

+ Show non-recruiting hospitals

Closed hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Example

Cancer Connect

Speak with someone who has cancer clinical trial experience.

Learn more

Example

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more

Example

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

CloseReport inaccuracy

Thank you for helping us to increase accuracy of the trial. Our team will validate the information and update the information as soon as possible.

Submitting ... Please wait

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.