[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-glioblastoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-glioblastoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100640717","phase-2-testing-the-addition-of-an-anti-cancer-drug-mycophenolate-mofetil-to-the-usual-treatment-radiation-therapy-and-temozolomide-for-advanced-brain-cancer-100640717",false,"NCT07605364","Testing the Addition of an Anti-Cancer Drug, Mycophenolate Mofetil, to the Usual Treatment (Radiation Therapy and Temozolomide) for Advanced Brain Cancer","Mycophenolate Mofetil to Overcome Glioblastoma Resistance to Radiotherapy and Temozolomide","Inclusion Criteria:\n\n* Newly diagnosed primary glioblastoma by World Health Organization (WHO) 2021 criteria\n* No spinal cord glioblastoma\n* No leptomeningeal disease\n* No extracranial metastatic disease\n* Patient is a candidate for first-line standard of care chemoradiation per treating physician(s)\n* No prior treatment for glioblastoma other than resection (i.e. prior chemotherapy, radiation therapy, or other therapies such as laser ablation are not allowed)\n* Prior biopsy and\u002For resection of glioblastoma must be completed at least 14 days prior to registration with adequate wound healing\n* Age ≥ 18 years\n* Karnofsky performance status (KPS) ≥ 60\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3\n* Platelet count ≥ 100,000 cells\u002Fmm\\^3\n* Hemoglobin (Hg) ≥ 9.0 g\u002FdL\n* Calculated (Calc.) creatinine clearance (CrCl) ≥ 25 mL\u002Fmin\n\n  \\* Calculated using the Cockcroft-Gault equation\n* Bilirubin ≤ 1.5 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 3.0 x ULN\n* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects.\n\nTherefore, for women of childbearing potential only, a negative pregnancy test done ≤ 14 days prior to registration is required.\n\nWomen and men of reproductive potential must agree to use a highly effective method of birth control throughout their participation in this study and for at least 6 weeks (women) or 90 days (men) after last dose of treatment. Reproductive status and discussions about birth control measures should be documented in the patient's record. Appropriate methods of birth control include, but are not limited to: abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom)\n\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* No known history of allergic reaction or hypersensitivity to mycophenolate mofetil (MMF), mycophenolic acid (MPA), or any component of the drug product\n* No known history of hypersensitivity reactions to temozolomide (TMZ) or other ingredients in TMZ\n* No known medical condition causing an inability to swallow oral formulations of agents\n* No active systemic or central nervous system (CNS) infection\n* No grade 4 lymphopenia (if absolute lymphocyte count \\[ALC\\] \\\u003C 0.5, then patient must be on prophylaxis for Pneumocystis jirovecii)\n* No known history of organ transplantation\n* No known hypoxanthine-guanine phosphoribosyl-transferase deficiency\n* No known serious intercurrent illness that limits participation in the trial\n* No known immunosuppressive condition from autoimmune disease, immune deficiency syndrome, or chronic immunosuppressive therapy\n* Patient must be able to undergo MRI brain with and without contrast\n* No known phenylketonuria\n* No known medical contraindication for mycophenolate mofetil (MMF) per treating physician(s)\n* Patients on steroids must be on stable or decreasing dose within 7 days of registration (no more than 8 mg dexamethasone\u002Fday or equivalent)\n\nExclusion Criteria:\n\n\\-","ALL","18 Years",{"count":19,"type":20},422,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","This phase II\u002FIII trial tests how well adding mycophenolate mofetil, to the usual treatment with intensity-modulated radiation therapy and temozolomide works for the treatment of glioblastoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Mycophenolate mofetil blocks enzyme activity which can disrupt tumor activity and may make the tumor more sensitive to radiation and\u002For temozolomide. Intensity modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Temozolomide is a chemotherapy drug and in a class of medications called alkylating agents. It damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. Giving mycophenolate mofetil with intensity-modulated radiation therapy and temozolomide may be more effective than intensity-modulated radiation therapy and temozolomide alone for the treatment of advanced glioblastoma.",[27],"Advanced Glioblastoma","NOT_YET_RECRUITING","2026-05-19",{"date":31,"type":32},"2026-05-26","ACTUAL",{"date":34,"type":20},"2026-06-10",{"date":36,"type":20},"2031-01-05",{"name":38,"class":39},"Alliance for Clinical Trials in Oncology","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100513775","phase-2-at-home-cancer-directed-therapy-versus-in-clinic-for-the-treatment-of-patients-with-advanced-cancer-100513775","NCT05969860","At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer","Cancer CARE Beyond Walls - A Pilot of a Randomized, Pragmatic Trial of Cancer Directed Therapy Administration in the Patients' Homes Versus in Clinic","Inclusion Criteria:\n\n* Female or male patients with histologically confirmed malignancy. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis along; histologic confirmation is not required.\n* Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) FDA-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. NCCN, ASCO, ASH, etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines.\n\n  * Note, patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Patients may receive any combination of any above listed medications or regimens:\n  * Eligible disease cancer types:\n\n    * Anal cancer\n    * Appendiceal carcinoma\n    * Basal cell carcinoma\n    * Bladder cancer\n    * Biliary cancer\n    * Breast cancer\n    * Central Nervous System malignancy including glioblastoma\n    * Cervical cancer\n    * Cholangiocarcinoma\n    * Colorectal carcinoma\n    * Endometrial cancer\n    * Fallopian tube cancer\n    * Gastroesophageal cancer \\[including gastric, esophageal, and gastroesophageal junction (GEJ) cancers\\]\n    * Germ cell carcinoma\n    * Head and Neck cancer\n    * Hepatocellular Carcinoma\n    * Liver\n    * Lung\n    * Lymphoma\n    * Melanoma\n    * Merkel Cell\n    * Multiple Myeloma\n    * Myelodysplastic syndrome\n    * Myeloid Disorders\n    * Neuroendocrine carcinoma\n    * Ovarian cancer\n    * Pancreatic adenocarcinoma\n    * Penile carcinoma\n    * Peritoneal carcinoma\n    * Prostate cancer\n    * Renal cell cancer\n    * Sarcoma\n    * Squamous cell Carcinoma of the Skin\n    * Testicular cancer\n    * Urethral carcinoma\n    * Vaginal carcinoma\n    * Vulvar carcinoma\n  * Eligible Regimens\n\n    * Fluorouracil (5-FU) +\u002F- leucovorin +\u002F- bevacizumab +\u002F- trastuzumab\n    * 5FU +\u002F- leucovorin +\u002F- bevacizumab +\u002F- nivolumab\n    * Atezolizumab +\u002F- bevacizumab\n    * Atezolizumab +\u002F- bevacizumab + cobimetinib, atezolizumab +\u002F- bevacizumab + vemurafenib, atezolizumab +\u002F- bevacizumab + cobimetinib + vemurafenib\n    * Avelumab\n    * Avelumab + axitinib\n    * Bevacizumab\n    * Bevacizumab + capecitabine\n    * Bevacizumab + irinotecan (+\u002F- capecitabine)\n    * Bevacizumab + olaparib, bevacizumab + lenvatinib, bevacizumab + niraparib, bevacizumab + rucaparib\n    * Bevacizumab + Temozolomide, Bevacizumab + Lomustine, or Bevacizumab + everolimus\n    * Bevacizumab + trifluridine\u002Ftipiracil\n    * Bortezomib\n    * Bortezomib + cyclophosphamide, bortezomib + lenalidomide, bortezomib + pomalidomide, bortezomib + selinexor\n    * Bortezomib + venetoclax\n    * Carfilzomib\n    * Carfilzomib + cyclophosphamide, carfilzomib + lenalidomide, carfilzomib + pomalidomide, carfilzomib + selinexor\n    * Carfilzomib + venetoclax\n    * Cemiplimab\n    * Cisplatin\n    * Cisplatin\u002F5-FU\n    * Cisplatin\u002Fetoposide\n    * Cisplatin + durvalumab\n    * Cisplatin + gemcitabine\n    * Cisplatin + gemcitabine + durvalumab\n    * Daratumumab (+ oral \\[PO\\] cyclophosphamide, lenalidomide, pomalidomide, or selinexor)\n    * Daratumumab + bortezomib (+ PO cyclophosphamide, lenalidomide, pomalidomide, or selinexor)\n    * Daratumumab + carfilzomib (+ PO cyclophosphamide, lenalidomide, pomalidomide, or selinexor)\n    * Degarelix\n    * Durvalumab\n    * Durvalumab + tremelimumab\n    * Eribulin\n    * FOLFIRI +\u002F- bevacizumab (5FU +\u002F- leucovorin + irinotecan)\n    * Fam-trastuzumab deruxtecan\n    * Fulvestrant\n    * Fulvestrant + ribociclib, fulvestrant + abemaciclib, fulvestrant + palbociclib, fulvestrant + alpelisib, or fulvestrant + capivasertib\n    * Gemcitabine\n    * Gemcitabine + durvalumab\n    * Gemcitabine + paclitaxel protein-bound\n    * Goserelin acetate\n    * Irinotecan\n    * Irinotecan + capecitabine\n    * Lanreotide\n    * Leuprolide\n    * Nivolumab\n    * Nivolumab + cabozantinib\n    * Nivolumab-relatlimab\n    * Octreotide\n    * Paclitaxel\n    * Pembrolizumab\n    * Pembrolizumab + axitinib, pembrolizumab + lenvatinib, pembrolizumab + capecitabine, pembrolizumab + dabrafenib +\u002F- trametinib, pembrolizumab + trametinib)\n    * Pemetrexed\n    * Pertuzumab\n    * Pemetrexed + pembrolizumab\n    * Rituximab\n    * Trastuzumab + paclitaxel\n    * Trastuzumab with or without pertuzumab maintenance (SQ or IV) (+\u002F- tucatinib +\u002F- capecitabine)\n    * Decitabine\n    * These regimens can be used only if patients are receiving one of the regimens above:\n\n      * Darbepoetin-alfa\n      * Epoetin\n      * Filgrastim\n* Note: Female or male patients with histologically confirmed malignancy who are currently receiving treatment with one of the above eligible regimens may receive supportive care medications for treatment or prevention of bone metastases, including agents such as:\n\n  * Zoledronic acid\n  * Denosumab\n* Patient has had adequate tolerability of their clinical standard of care cancer treatment in the opinion of their treating physician and no drug-related infusion reactions prior to consent\n* Patients who according to documentation from their treating provider plan to continue the treatment regimen they are currently prescribed for at least 24 weeks from the start of cycle following randomization.\n* Residing within the area serviced by supplier and paramedic network\n* Residence has wireless fidelity (wifi) to enable a reliable connection with the remote Command Center or it is suitable for connection through a wireless network solution\n* Age \\>= 18 years at time of registration\n* Signed informed consent form by patient\n* Willing and able to comply with the study protocol in the investigator's judgement\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2\n* Ability to complete questionnaire(s) by themselves or with assistance\n* RANDOMIZATION ELIGIBILITY CRITERIA: In addition to the criteria above, confirmation by the CCBW Command Center that the patient has adequate tolerability to the standard of care cancer therapy and no drug-related infusion reactions since pre-registration and prior to registration\n\nExclusion Criteria:\n\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm. Note: Patients are permitted concomitant standard of care oral drugs such as ribociclib, abemaciclib, or palbociclib in combination with endocrine therapy (e.g., Leuprolide, fulvestrant intramuscular \\[IM\\], etc.); tucatinib and capecitabine in combination with trastuzumab and pertuzumab for HER2 positive breast cancer; dexamethasone, cyclophosphamide, lenalidomide or pomalidomide for multiple myeloma; temozolomide, lomustine, or afinitor in combination with avastin for glioblastoma. In addition, all oral anti-hormonal agents for breast and prostate cancer are permitted (e.g., tamoxifen, arimidex, abiraterone, etc.) if used in combination with any of the drugs\n* Requiring 24\u002F7 assistance with activities of daily living (ADLs)\n* Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Myocardial infarction =\\\u003C 6 months\n  * Wound healing disorder\n  * Or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements",{"count":48,"type":20},220,[23],"This clinical trial studies the effect of cancer directed therapy given at-home versus in the clinic for patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Currently most drug-related cancer care is conducted in infusion centers or specialty hospitals, where patients spend many hours a day isolated from family, friends, and familiar surroundings. This separation adds to the physical, emotional, social, and financial burden for patients and their families. The logistics and costs of navigating cancer treatments have become a principal contributor to patients' reduced quality of life. It is therefore important to reduce the burden of cancer in the lives of patients and their caregivers, and a vital aspect of this involves moving beyond traditional hospital and clinic-based care and evaluate innovative care delivery models with virtual capabilities. Providing cancer treatment at-home, versus in the clinic, may help reduce psychological and financial distress and increase treatment compliance, especially for marginalized patients and communities.",[52,53,54,55,56,57,58,59,27,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94],"Advanced Anal Carcinoma","Advanced Biliary Tract Carcinoma","Advanced Bladder Carcinoma","Advanced Breast Carcinoma","Advanced Carcinoid Tumor","Advanced Cervical Carcinoma","Advanced Colorectal Carcinoma","Advanced Gastric Carcinoma","Advanced Head and Neck Carcinoma","Advanced HER2 Positive Breast Carcinoma","Advanced Lung Carcinoma","Advanced Lung Small Cell Carcinoma","Advanced Malignant Germ Cell Tumor","Advanced Malignant Solid Neoplasm","Advanced Neuroendocrine Carcinoma","Advanced Ovarian Carcinoma","Advanced Pancreatic Carcinoma","Advanced Prostate Small Cell Neuroendocrine Carcinoma","Advanced Prostate Carcinoma","Hematopoietic and Lymphoid System Neoplasm","Multiple Myeloma","Myelodysplastic Syndrome","Advanced Basal Cell Carcinoma","Advanced Cholangiocarcinoma","Advanced Endometrial Carcinoma","Advanced Esophageal Carcinoma","Advanced Fallopian Tube Carcinoma","Advanced Hepatocellular Carcinoma","Advanced Liver Carcinoma","Advanced Lymphoma","Advanced Malignant Testicular Neoplasm","Advanced Melanoma","Advanced Merkel Cell Carcinoma","Advanced Penile Carcinoma","Advanced Primary Malignant Central Nervous System Neoplasm","Advanced Renal Cell Carcinoma","Advanced Sarcoma","Advanced Skin Squamous Cell Carcinoma","Advanced Urethral Carcinoma","Advanced Vaginal Carcinoma","Advanced Vulvar Carcinoma","Advanced Appendix Carcinoma","Advanced Gastroesophageal Junction Adenocarcinoma","RECRUITING","2026-04-15",{"date":98,"type":32},"2026-04-20",{"date":100,"type":32},"2023-08-23",{"date":102,"type":20},"2027-01-01",{"name":104,"class":39},"Mayo Clinic",2,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":131},"100509145","phase-2-crizanlizumab-alone-or-in-combination-with-nivolumab-for-glioblastoma-and-melanoma-with-brain-metastases-100509145","NCT05909618","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","14","Cohort 1 (MBM) Inclusion Criteria\n\n1. Age ≥ 18 years.\n2. Estimated life expectancy at least 3 months\n3. Have metastatic melanoma with primarily diagnosed or newly progressing brain metastases.\n4. 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.\n5. Have failed prior immunotherapy line, either due to primary resistance or acquired resistance.\n6. 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.\n7. Is clinically stable with no neurological deficits. Patients may receive steroid supportive therapy up to 10 mg of prednisone or the equivalent.\n8. Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n9. Adequate organ function defined by blood tests for blood count and chemistry.\n10. Women of childbearing potential practicing an acceptable method of birth control.\n11. Understand study procedures and willingness to comply for the entire duration of the study and to give written informed consent.\n\n    Exclusion Criteria\n12. Systemic steroid therapy for symptomatic brain disease. Note: a dose equivalent to 10 mg prednisone will be allowed\n13. Have leptomeningeal spread.\n14. Previous life-threatening toxicity to anti-PD-1 antibody monotherapy.\n15. Auto-immune disease in the last 2 years requiring systemic immune-suppressive therapy.\n16. Previous exposure to Crizanlizumab or any other P-selectin inhibitor.\n17. Previous or current brain hemorrhage.\n18. The patient had, or is expected to undergo, allogeneic hematopoietic stem cell transplantation (HSCT).\n19. The patient had a contraindication for undergoing brain MRI.\n20. Any other severe concurrent disease which, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n21. Pregnant or lactating\n22. Treatment with other investigational drugs within \\\u003C21 days of start of day 1 of the study treatment.\n23. Any contraindication for treatment with nivolumab according to the product's labels.\n\nCohort 2 (Recurrent or Progressive GB) Inclusion Criteria\n\n1. Age ≥ 18 years.\n2. Estimated life expectancy at least 3 months\n3. Have with recurrent or persistent GB\n4. Received first line therapy with brain irradiation and maintenance temozolamide.\n5. Measurable disease per RANO criteria on brain MRI.\n6. Have Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C2.\n7. Adequate organ function defined by blood tests for blood count and chemistry.\n8. Women of childbearing potential practicing an acceptable method of birth control.\n9. Understand study procedures and willingness to comply for the entire duration of the study and to give written informed consent.\n\nExclusion Criteria\n\n1. Systemic steroid therapy for symptomatic brain disease. Note: a dose equivalent to 20 mg prednisone will be allowed\n2. Have leptomeningeal spread.\n3. Previous life-threatening toxicity to anti-PD-1 antibody monotherapy.\n4. Auto-immune disease in the last 2 years requiring systemic immune-suppressive therapy.\n5. Previous exposure to Crizanlizumab or any other P-selectin inhibitor.\n6. Previous or current brain hemorrhage.\n7. The patient had, or is expected to undergo, allogeneic HSCT.\n8. The patient had a contraindication for undergoing brain MRI.\n9. Any other severe concurrent disease which, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n10. Pregnant or lactating\n11. Treatment with other investigational drugs within \\\u003C21 days of start of day 1 of the study treatment.\n12. Any contraindication for treatment with nivolumab according to the product's labels.\n\nCohort 3 (Newly Diagnosed Unmethylated GB) Inclusion Criteria\n\n1. Age ≥ 18 years.\n2. Estimated life expectancy at least 3 months.\n3. Histologically confirmed newly diagnosed GB.\n4. Tumor test result shows MGMT unmethylated type.\n5. Received definitive brain irradiation.\n6. Patients may be treated with novo TTF (optune) per local standard.\n7. Have Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n8. Adequate organ function defined by blood tests for blood count and chemistry.\n9. Women of childbearing potential practicing an acceptable method of birth control.\n10. Understand study procedures and willingness to comply for the entire duration of the study and to give written informed consent.\n\nExclusion Criteria\n\n1. Systemic steroid therapy for symptomatic brain disease. Note: a dose equivalent to 20 mg prednisone will be allowed\n2. Have leptomeningeal spread.\n3. Previous life-threatening toxicity to anti-PD-1 antibody monotherapy.\n4. Auto-immune disease in the last 2 years requiring systemic immune-suppressive therapy.\n5. Previous exposure to Crizanlizumab or any other P-selectin inhibitor.\n6. Previous or current brain hemorrhage.\n7. The patient had, or is expected to undergo, allogeneic HSCT.\n8. The patient had a contraindication for undergoing brain MRI.\n9. Any other severe concurrent disease which, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n10. Be pregnant or lactating\n11. Treatment with other investigational drugs within \\\u003C21 days of start of day 1 of the study treatment.\n\nAny contraindication for treatment with nivolumab according to the product's labels",{"count":115,"type":20},33,[23],"A single-center, open-label, non-randomized phase I\u002FII 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.\n\nSubjects will be screened for up to 28 days prior to treatment initiation. Eligible subjects will be allocated to one of 3 cohorts:\n\nCohort 1: Patients with metastatic melanoma with primarily diagnosed or newly progressing brain metastases who failed immunotherapy.\n\nCohort 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.\n\nCohort 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.",[27,119,120],"Metastatic Melanoma in the Central Nervous System","MGMT-Unmethylated Glioblastoma","2025-07-17",{"date":123,"type":32},"2025-07-22",{"date":125,"type":32},"2023-07-11",{"date":127,"type":20},"2030-07-30",{"name":129,"class":130},"Sheba Medical Center","OTHER_GOV",1]