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

NCT05909618 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-07-22

No results posted yet for this study

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.

Conditions

  • Advanced Glioblastoma
  • Metastatic Melanoma in the Central Nervous System
  • MGMT-Unmethylated Glioblastoma

Interventions

DRUG

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

5 mg/kg solution for injection

DRUG

Nivolumab 10 MG/1 ML Intravenous Solution [OPDIVO]

3 mg/mL solution for injection

Sponsors & Collaborators

  • Prof. Ronit Satchi-Fainaro, Director, Cancer Biology Research Center, Tel Aviv University, Tel Aviv, Israel.

    collaborator UNKNOWN

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Ronnie Shapira Frommer, Dr · Ronnie Shapira, MD Study Principal Investigator [email protected]

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-11
Primary Completion
2028-07-30
Completion
2030-07-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05909618 on ClinicalTrials.gov