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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

Crizanlizumab Alone or in Combination With Nivolumab for Glioblastoma and Melanoma With Brain Metastases (NCT05909618) is a Phase 2 interventional studying Advanced Glioblastoma and Metastatic Melanoma in the Central Nervous System, sponsored by Sheba Medical Center. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Advanced Glioblastoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 33 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Cohort 1 (MBM) Inclusion Criteria 1. Age ≥ 18 years. 2. Estimated expected to live at least 3 months 3. Have metastatic melanoma with primarily diagnosed or newly progressing brain metastases. 4. Was treated with 1 prior systemic line of immunotherapy - either PD-1 inhibitor monotherapy or combined CTLA4 and PD-1 antibodies or another investigational combination of immunotherapy. Patients with BRAF-mutant melanoma who have also received BRAF mutation targeted therapy are also eligible. 5. Have failed prior immunotherapy line, either due to primary resistance or acquired resistance. 6. Have measurable disease defined by RECIST criteria and have at least one, non-previously irradiated brain metastasis of at least 1-cm short diameter. Otherwise, previously irradiated lesions should present with enlargement following radiation therapy. 7. Is clinically stable with no neurological deficits. Patients may receive steroid supportive therapy up to 10 mg of prednisone or the equivalent. 8. Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 9. your organs (liver, kidneys, etc.) are working well enough based on blood tests defined by blood tests for blood count and chemistry. 10. Women of childbearing potential practicing an acceptable method of birth control. 11. Understand study procedures and willingness to comply for the entire duration of the study and to give written willing to sign a consent form. Exclusion Criteria 12. Systemic steroid therapy for symptomatic brain disease. Note: a dose equivalent to 10 mg prednisone will be allowed 13. Have leptomeningeal spread. 14. Previous life-threatening toxicity to anti-PD-1 antibody monotherapy. 15. Auto-immune disease in the last 2 years requiring systemic immune-suppressive therapy. 16. Previous exposure to Crizanlizumab or any other P-selectin inhibitor. 17. Previous or current brain hemorrhage. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Cohort 1 (MBM) Inclusion Criteria 1. Age ≥ 18 years. 2. Estimated life expectancy at least 3 months 3. Have metastatic melanoma with primarily diagnosed or newly progressing brain metastases. 4. Was treated with 1 prior systemic line of immunotherapy - either PD-1 inhibitor monotherapy or combined CTLA4 and PD-1 antibodies or another investigational combination of immunotherapy. Patients with BRAF-mutant melanoma who have also received BRAF mutation targeted therapy are also eligible. 5. Have failed prior immunotherapy line, either due to primary resistance or acquired resistance. 6. Have measurable disease defined by RECIST criteria and have at least one, non-previously irradiated brain metastasis of at least 1-cm short diameter. Otherwise, previously irradiated lesions should present with enlargement following radiation therapy. 7. Is clinically stable with no neurological deficits. Patients may receive steroid supportive therapy up to 10 mg of prednisone or the equivalent. 8. Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 9. Adequate organ function defined by blood tests for blood count and chemistry. 10. Women of childbearing potential practicing an acceptable method of birth control. 11. Understand study procedures and willingness to comply for the entire duration of the study and to give written informed consent. Exclusion Criteria 12. Systemic steroid therapy for symptomatic brain disease. Note: a dose equivalent to 10 mg prednisone will be allowed 13. Have leptomeningeal spread. 14. Previous life-threatening toxicity to anti-PD-1 antibody monotherapy. 15. Auto-immune disease in the last 2 years requiring systemic immune-suppressive therapy. 16. Previous exposure to Crizanlizumab or any other P-selectin inhibitor. 17. Previous or current brain hemorrhage. 18. The patient had, or is expected to undergo, allogeneic hematopoietic stem cell transplantation (HSCT). 19. The patient had a contraindication for undergoing brain MRI. 20. Any other severe concurrent disease which, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 21. Pregnant or lactating 22. Treatment with other investigational drugs within \<21 days of start of day 1 of the study treatment. 23. Any contraindication for treatment with nivolumab according to the product's labels. Cohort 2 (Recurrent or Progressive GB) Inclusion Criteria 1. Age ≥ 18 years. 2. Estimated life expectancy at least 3 months 3. Have with recurrent or persistent GB 4. Received first line therapy with brain irradiation and maintenance temozolamide. 5. Measurable disease per RANO criteria on brain MRI. 6. Have Eastern Cooperative Oncology Group (ECOG) performance status \<2. 7. Adequate organ function defined by blood tests for blood count and chemistry. 8. Women of childbearing potential practicing an acceptable method of birth control. 9. Understand study procedures and willingness to comply for the entire duration of the study and to give written informed consent. Exclusion Criteria 1. Systemic steroid therapy for symptomatic brain disease. Note: a dose equivalent to 20 mg prednisone will be allowed 2. Have leptomeningeal spread. 3. Previous life-threatening toxicity to anti-PD-1 antibody monotherapy. 4. Auto-immune disease in the last 2 years requiring systemic immune-suppressive therapy. 5. Previous exposure to Crizanlizumab or any other P-selectin inhibitor. 6. Previous or current brain hemorrhage. 7. The patient had, or is expected to undergo, allogeneic HSCT. 8. The patient had a contraindication for undergoing brain MRI. 9. Any other severe concurrent disease which, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 10. Pregnant or lactating 11. Treatment with other investigational drugs within \<21 days of start of day 1 of the study treatment. 12. Any contraindication for treatment with nivolumab according to the product's labels. Cohort 3 (Newly Diagnosed Unmethylated GB) Inclusion Criteria 1. Age ≥ 18 years. 2. Estimated life expectancy at least 3 months. 3. Histologically confirmed newly diagnosed GB. 4. Tumor test result shows MGMT unmethylated type. 5. Received definitive brain irradiation. 6. Patients may be treated with novo TTF (optune) per local standard. 7. Have Eastern Cooperative Oncology Group (ECOG) performance status ≤2. 8. Adequate organ function defined by blood tests for blood count and chemistry. 9. Women of childbearing potential practicing an acceptable method of birth control. 10. Understand study procedures and willingness to comply for the entire duration of the study and to give written informed consent. Exclusion Criteria 1. Systemic steroid therapy for symptomatic brain disease. Note: a dose equivalent to 20 mg prednisone will be allowed 2. Have leptomeningeal spread. 3. Previous life-threatening toxicity to anti-PD-1 antibody monotherapy. 4. Auto-immune disease in the last 2 years requiring systemic immune-suppressive therapy. 5. Previous exposure to Crizanlizumab or any other P-selectin inhibitor. 6. Previous or current brain hemorrhage. 7. The patient had, or is expected to undergo, allogeneic HSCT. 8. The patient had a contraindication for undergoing brain MRI. 9. Any other severe concurrent disease which, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 10. Be pregnant or lactating 11. Treatment with other investigational drugs within \<21 days of start of day 1 of the study treatment. Any contraindication for treatment with nivolumab according to the product's labels

Treatments Being Tested

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Sheba medical center
Ramat Gan, Israel, Israel

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05909618), the sponsor (Sheba Medical Center), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05909618 clinical trial studying?

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… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05909618?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05909618?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05909618. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05909618. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.