RecruitingPhase 2NCT05909618

Crizanlizumab Alone or in Combination With Nivolumab for Glioblastoma and Melanoma With Brain Metastases

An Open Label Phase 2 Study of Intravenously Administered Crizanlizumab Alone or in Combination With Nivolumab for Glioblastoma and Melanoma With Brain Metastases


Sponsor

Sheba Medical Center

Enrollment

33 participants

Start Date

Jul 11, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

A single-center, open-label, non-randomized phase I/II study to evaluate the efficacy, safety and tolerance of crizanlizumab monotherapy and in combination with nivolumab in patients with advanced glioblastoma (GB) who exhausted standard of care (SOC) therapy, patients with metastatic brain melanoma (MBM) and patients with newly diagnosed unmethylated GB. Subjects will be screened for up to 28 days prior to treatment initiation. Eligible subjects will be allocated to one of 3 cohorts: Cohort 1: Patients with metastatic melanoma with primarily diagnosed or newly progressing brain metastases who failed immunotherapy. Cohort 2: Patients with recurrent or progressing GB following primary radiation therapy and temozolomide. Patients may have failed up to 2 prior systemic treatment lines (including temozolomide as adjuvant therapy) and are candidates for further treatment. Cohort 3: Patients with newly diagnosed GB who were evaluated for methylguanine-DNA methyltransferase(MGMT) methylation status and have un-methylated MGMT promotor-therefore, they are not candidates for maintenance temozolomide therapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug combination — crizanlizumab (alone or with nivolumab) — in three groups of patients: melanoma with brain metastases that has failed immunotherapy, glioblastoma (a brain tumor) that has come back after treatment, and newly diagnosed glioblastoma of a specific genetic type. Crizanlizumab targets a protein called P-selectin that tumors may use to evade the immune system. **You may be eligible if...** - You are 18 or older in good general health (ECOG 0–1 for melanoma cohort; ECOG 0–2 for glioblastoma cohorts) - Melanoma cohort: You have melanoma that has spread to the brain, have had at least one prior immunotherapy regimen, and the disease has stopped responding - Glioblastoma cohort 1: You have recurrent or persistent glioblastoma after standard treatment (radiation + temozolomide) - Glioblastoma cohort 2: You have newly diagnosed glioblastoma of the MGMT-unmethylated type and have completed radiation therapy **You may NOT be eligible if...** - You are on high-dose steroids for brain symptoms - You have cancer spread to the lining around the brain (leptomeningeal disease) - You had a life-threatening reaction to prior anti-PD-1 therapy - You have had a recent brain bleed - You are pregnant or breastfeeding - You have an active autoimmune disease requiring systemic treatment - You have been exposed to crizanlizumab before Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCrizanlizumab-Tmca 10 MG/1 ML Intravenous Solution [ADAKVEO]

5 mg/kg solution for injection

DRUGNivolumab 10 MG/1 ML Intravenous Solution [OPDIVO]

3 mg/mL solution for injection


Locations(1)

Sheba medical center

Ramat Gan, Israel, Israel

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NCT05909618


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