Status:
UNKNOWN
Safety and Efficacy of Sonocloud Device Combined With Nivolumab in Brain Metastases From Patients With Melanoma
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Melanoma
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Anti PD-1 monoclonal antibodies (nivolumab and pembrolizumab) alone or in association with antiCTLA4 (Ipilimumab) are established as indisputable treatment of metastatic melanoma, with unprecedented o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 5 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04021420
Start Date
October 24 2019
End Date
July 5 2023
Last Update
August 20 2020
Active Locations (1)
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1
Saint-Louis Hospital
Paris, France, 75010