Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT04021420
Eligibility Criteria:
Inclusion Criteria:
* Patients with histologically confirmed metastatic melanoma
* Patients must have recovered from all side effects of their most recent systemic or local treatment for metastatic melanoma (grade ≤ 1).
* At least one measurable brain metastasis between 5 mm and 35 mm in diameter, not previously treated with surgery and/or radiosurgery and located less than 5 cm from the skull
* Patients may have received -or not- prior radiosurgery and/or surgery for brain metastases; if they have received prior local treatment, they must have at least 1new RANO and RECIST assessable brain metastases.
* BRAF status wild type or mutated (and in that case previous treatment with BRAF inhibitor and MEK inhibitor allowed)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1.
* Age \>18 year
* Hemoglobin ≥10g/dl
* Platelets ≥ 100000mm3
* Neutrophils ≥1500/mm3
* Creatinine Clearance ≥ 50ml/mn
* AST \<3N
* ALT\<3N
* Total bilirubin \<1.5N
* Alkaline phosphatase \<3N
* INR \< 1.5
* Prothrombin ≥70%
* TCA \<1.2
* No Hepatocellular insufficiency
* No unhealed wound on the head
* No allergy to poly isoprene
* Signed informed consent
* Patient with health insurance coverage
* Life expectancy \> 3 months
Exclusion Criteria:
* Patient previously treated by antiPD1 (except adjuvant antiPD1 therapy)
* Ocular melanoma
* Symptomatic or diffuse leptomeningeal involvement.
* Symptomatic hemorrhagic brain metastases.
* Symptoms of incoercible intracranial pressure; patients receiving corticosteroids and patients presenting intermittent seizures can be enrolled if they have a stable dose of corticosteroids (≤ 30mg/day corticotherapy) and anti-epileptic treatment since at least 2 weeks before enrolment.
* Indication for urgent neurosurgery or radiotherapy
* Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured or stage I untreated Chronic Lymphoid Leukemia.
* Known human immunodeficiency viruses (HIV) infection and any ongoing infectious disease or significant background.
* Concurrent administration of any anticancer therapies other than those administered in this study.
* Treatment with any cytotoxic and/or investigational drug, antiCTLA4 or targeted therapy ≤ 4 weeks or \<5 half lives for targeted therapies or chemotherapy, prior to day 1 of study.
* Prior whole brain radiotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04021420
Study Brief:
Protocol Section:
NCT04021420