Crizanlizumab Alone or in Combination With Nivolumab for Glioblastoma and Melanoma With Brain Metastases
Status:
Not yet recruiting
Trial end date:
2030-07-30
Target enrollment:
Participant gender:
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.