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

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 w

Trial Details

NCT ID
NCT05909618
Phase
PHASE2
Sponsor
Sheba Medical Center
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Crizanlizumab-Tmca 10 MG/1 ML Intravenous Solution [ADAKVEO]
  • Nivolumab 10 MG/1 ML Intravenous Solution [OPDIVO]
Locations (sample)
  • Ramat Gan, Israel, Israel|32.08227,34.81065

Key Eligibility Criteria

  • Age ≥ 18 years.
  • Estimated life expectancy at least 3 months
  • Have metastatic melanoma with primarily diagnosed or newly progressing brain metastases.
  • Was treated with 1 prior systemic line of immunotherapy - either PD-1 inhibitor monotherapy or combined CTLA4 and PD-1 antibodies or another invest…

For full eligibility, visit ClinicalTrials.gov.

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