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New treatment option for Advanced Glioblastoma
Official title Crizanlizumab Alone or in Combination With Nivolumab for Glioblastoma and Melanoma With Brain Metastases
ClinicalTrials.gov ID: NCT05909618
What this study is testing
What is Crizanlizumab-Tmca 10 MG/1 ML Intravenous Solution [ADAKVEO]?
Crizanlizumab-Tmca 10 MG/1 ML Intravenous Solution [ADAKVEO] is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for advanced glioblastoma.
Also referred to as crizanlizumab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Cohort 1 (MBM) 1. 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...
- Have failed prior immunotherapy line, either due to primary resistance or acquired resistance.
You likely can't join if
- Systemic steroid therapy for symptomatic brain disease. Note: a dose equivalent to 10 mg prednisone will be allowed
- Have leptomeningeal spread.
- Previous life-threatening toxicity to anti-PD-1 antibody monotherapy.
- Auto-immune disease in the last 2 years requiring systemic immune-suppressive therapy.
- Previous exposure to Crizanlizumab or any other P-selectin inhibitor.
- Previous or current brain hemorrhage.
See the full eligibility criteria
Who can join
- Cohort 1 (MBM) 1. 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 investigational combination of immunotherapy. Patients with BRAF-mutant...
- Have failed prior immunotherapy line, either due to primary resistance or acquired resistance.
- 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...
- Is clinically stable with no neurological deficits. Patients may receive steroid supportive therapy up to 10 mg of prednisone or the equivalent.
- Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Adequate organ function defined by blood tests for blood count and chemistry.
- Women of childbearing potential practicing an acceptable method of birth control.
- Understand study procedures and willingness to comply for the entire duration of the study and to give written informed consent.
What rules you out
- Systemic steroid therapy for symptomatic brain disease. Note: a dose equivalent to 10 mg prednisone will be allowed
- Have leptomeningeal spread.
- Previous life-threatening toxicity to anti-PD-1 antibody monotherapy.
- Auto-immune disease in the last 2 years requiring systemic immune-suppressive therapy.
- Previous exposure to Crizanlizumab or any other P-selectin inhibitor.
- Previous or current brain hemorrhage.
- The patient had, or is expected to undergo, allogeneic hematopoietic stem cell transplantation (HSCT).
- The patient had a contraindication for undergoing brain MRI.
- Any other severe concurrent disease which, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- Pregnant or lactating
- 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. Cohort 2 (Recurrent or Progressive GB) Inclusion Criteria
- Age ≥ 18 years.
- Estimated life expectancy at least 3 months
- Have with recurrent or persistent GB
- Received first line therapy with brain irradiation and maintenance temozolamide.
- Measurable disease per RANO criteria on brain MRI.
- Have Eastern Cooperative Oncology Group (ECOG) performance status \<2.
- Adequate organ function defined by blood tests for blood count and chemistry.
- Women of childbearing potential practicing an acceptable method of birth control.
- Understand study procedures and willingness to comply for the entire duration of the study and to give written informed consent. Exclusion Criteria
- Systemic steroid therapy for symptomatic brain disease. Note: a dose equivalent to 20 mg prednisone will be allowed
- Have leptomeningeal spread.
- Previous life-threatening toxicity to anti-PD-1 antibody monotherapy.
- Auto-immune disease in the last 2 years requiring systemic immune-suppressive therapy.
- Previous exposure to Crizanlizumab or any other P-selectin inhibitor.
- Previous or current brain hemorrhage.
- The patient had, or is expected to undergo, allogeneic HSCT.
- The patient had a contraindication for undergoing brain MRI.
- Any other severe concurrent disease which, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- Pregnant or lactating
- 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. Cohort 3 (Newly Diagnosed Unmethylated GB) Inclusion Criteria
- Age ≥ 18 years.
- Estimated life expectancy at least 3 months.
- Histologically confirmed newly diagnosed GB.
- Tumor test result shows MGMT unmethylated type.
- Received definitive brain irradiation.
- Patients may be treated with novo TTF (optune) per local standard.
- Have Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Adequate organ function defined by blood tests for blood count and chemistry.
- Women of childbearing potential practicing an acceptable method of birth control.
- Understand study procedures and willingness to comply for the entire duration of the study and to give written informed consent. Exclusion Criteria
- Systemic steroid therapy for symptomatic brain disease. Note: a dose equivalent to 20 mg prednisone will be allowed
- Have leptomeningeal spread.
- Previous life-threatening toxicity to anti-PD-1 antibody monotherapy.
- Auto-immune disease in the last 2 years requiring systemic immune-suppressive therapy.
- Previous exposure to Crizanlizumab or any other P-selectin inhibitor.
- Previous or current brain hemorrhage.
- The patient had, or is expected to undergo, allogeneic HSCT.
- The patient had a contraindication for undergoing brain MRI.
- Any other severe concurrent disease which, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- Be pregnant or lactating
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ramat Gan, Israel, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ramat Gan, Israel, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.