Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Clinical Trial NCT05909618 – Eligibility in Plain Language

This trial has three groups (cohorts). Please read the section that may apply to the patient's situation.

COHORT 1 – Melanoma that has spread to the brain (MBM)

Who might be able to join this trial:

• People aged 18 or older
• People with a life expectancy of at least 3 months
• People with melanoma that has spread to the brain, either newly diagnosed or with brain tumours that are growing again
• People who have previously received one course of immunotherapy (such as a PD-1 inhibitor alone, or a combination of CTLA-4 and PD-1 treatments, or another investigational immunotherapy combination)
• People with a BRAF gene mutation in their melanoma who have also received a targeted therapy for that mutation, in addition to immunotherapy
• People whose melanoma stopped responding to immunotherapy, whether it never responded or stopped working over time
• People with measurable tumours (as defined by standard RECIST measurement guidelines) and at least one brain tumour that has not previously been treated with radiation and measures at least 1 cm — or, if previously irradiated, shows signs of growth after that radiation
• People who are medically stable with no ongoing neurological symptoms; steroid use of up to 10 mg of prednisone (or an equivalent dose) is permitted
• People with a general health status rated 0 or 1 on the ECOG scale, meaning fully active or able to carry out light activity (confirm with trial site)
• People with acceptable blood test results showing the liver, kidneys, and blood cells are functioning adequately
• Women who could become pregnant and are using an acceptable form of contraception
• People who understand and are willing to follow the study procedures for the full duration and are able to provide written consent

Who may not be able to join:

• People requiring high-dose steroid treatment (above the equivalent of 10 mg prednisone) specifically to manage brain tumour symptoms
• People whose cancer has spread to the fluid and membranes surrounding the brain and spinal cord (called leptomeningeal spread)
• People who previously had a severe, life-threatening reaction to a type of immunotherapy drug called an anti-PD-1 antibody
• People who have had an autoimmune disease in the past 2 years that required immune-suppressing medication
• People who have previously been treated with Crizanlizumab or any other drug that blocks a protein called P-selectin
• People who have a history of bleeding in the brain, or who currently have brain bleeding
• People who have undergone, or are expected to undergo, a bone marrow/stem cell transplant from a donor (allogeneic HSCT)
• People for whom having a brain MRI scan is not medically safe
• People with another serious illness that, in the treating doctor's judgement, would make participation inappropriate
• People who are pregnant or breastfeeding
• People who have received another experimental drug within 21 days before the trial treatment starts
• People for whom the drug nivolumab is medically contraindicated based on the manufacturer's guidelines

COHORT 2 – Glioblastoma (GB) that has come back or continued to grow

Who might be able to join this trial:

• People aged 18 or older
• People with a life expectancy of at least 3 months
• People with glioblastoma (a type of brain tumour) that has returned or continued to grow despite treatment
• People who have already received standard first-line treatment, which includes brain radiation and a chemotherapy drug called temozolomide
• People with tumours that are measurable on a brain MRI scan according to standard RANO criteria (confirm with trial site)
• People with a general health status rated below 2 on the ECOG scale, meaning fully active or able to carry out light activity (confirm with trial site)
• People with acceptable blood test results showing the liver, kidneys, and blood cells are functioning adequately
• Women who could become pregnant and are using an acceptable form of contraception
• People who understand and are willing to follow the study procedures for the full duration and are able to provide written consent

Who may not be able to join:

• People requiring high-dose steroid treatment (above the equivalent of 20 mg prednisone) specifically to manage brain tumour symptoms
• People whose cancer has spread to the fluid and membranes surrounding the brain and spinal cord (leptomeningeal spread)
• People who previously had a severe, life-threatening reaction to an anti-PD-1 antibody immunotherapy drug
• People who have had an autoimmune disease in the past 2 years that required immune-suppressing medication
• People who have previously been treated with Crizanlizumab or any other P-selectin inhibitor drug
• People who have a history of bleeding in the brain, or who currently have brain bleeding
• People who have undergone, or are expected to undergo, a bone marrow/stem cell transplant from a donor (allogeneic HSCT)
• People for whom having a brain MRI scan is not medically safe
• People with another serious illness that, in the treating doctor's judgement, would make participation inappropriate
• People who are pregnant or breastfeeding
• People who have received another experimental drug within 21 days before the trial treatment starts
• People for whom the drug nivolumab is medically contraindicated based on the manufacturer's guidelines

COHORT 3 – Newly diagnosed Glioblastoma (GB) with unmethylated MGMT

Who might be able to join this trial:

• People aged 18 or older
• People with a life expectancy of at least 3 months
• People with a newly diagnosed glioblastoma confirmed by tissue testing (biopsy or surgery)
• People whose tumour has been tested and shown to have an "unmethylated MGMT" result — a specific tumour characteristic identified through laboratory testing
• People who have already completed definitive (full-course) brain radiation treatment
• People who are receiving or have received a device-based treatment called TTFields (Optune) as part of their local standard care — this is permitted but not required
• People with a general health status rated 2 or below on the ECOG scale (confirm with trial site)
• People with acceptable blood test results showing the liver, kidneys, and blood cells are functioning adequately
• Women who could become pregnant and are using an acceptable form of contraception
• People who understand and are willing to follow the study procedures for the full duration and are able to provide written consent

Who may not be able to join:

• People requiring high-dose steroid treatment (above the equivalent of 20 mg prednisone) specifically to manage brain tumour symptoms
• People whose cancer has spread to the fluid and membranes surrounding the brain and spinal cord (leptomeningeal spread)
• People who previously had a severe, life-threatening reaction to an anti-PD-1 antibody immunotherapy drug
• People who have had an autoimmune disease in the past 2 years that required immune-suppressing medication
• People who have previously been treated with Crizanlizumab or any other P-selectin inhibitor drug
• People who have a history of bleeding in the brain, or who currently have brain bleeding
• People who have undergone, or are expected to undergo, a bone marrow/stem cell transplant from a donor (allogeneic HSCT)
• People for whom having a brain MRI scan is not medically safe
• People with another serious illness that, in the treating doctor's judgement, would make participation inappropriate
• People who are pregnant or breastfeeding
• People who have received another experimental drug within 21 days before the trial treatment starts
• People for whom the drug nivolumab is medically contraindicated based on the manufacturer's guidelines

Important: Always verify eligibility with the trial site directly before applying.