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Safety and Tolerability of CVGBM in Adults With Newly Diagnosed MGMT-Unmethylated Glioblastoma or Astrocytoma

Primary Purpose

Glioblastoma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CV09050101 mRNA vaccine (CVGBM) 12 μg
CV09050101 mRNA vaccine (CVGBM) 25 μg
CV09050101 mRNA vaccine (CVGBM) 50 μg
CV09050101 mRNA vaccine (CVGBM) 100 μg
CV09050101 mRNA vaccine RDE
CV09050101 mRNA vaccine (CVGBM) 6 μg
Sponsored by
CureVac
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically confirmed, newly diagnosed GBM (CNS WHO Grade 4) and IDH-wildtype astrocytoma with a molecular signature of "unmethylated" GBM. Specific HLA genotype. Gross total or partial resection (i.e., ≥50% of tumor volume resected). Having completed radiotherapy with or without chemotherapy post-surgery at least 2 weeks before study treatment initiation. Patients must have recovered from any radiotherapy or chemotherapy related side effects to ≤ Grade 1 (with the exception of ALC and WBC as per eligibility criteria). Pretreatment (and concomitant treatment) with TTFields therapy for GBM is allowed. Age ≥18 years. Karnofsky Performance Status (KPS) ≥70%. Life expectancy >6 months. Absolute lymphocyte count (ALC) >0.5 x109/L. Each patient must voluntarily sign and date an informed consent form (ICF) approved by an Independent Ethics Committee (IEC), prior to the initiation of any pre-screening, screening or study-specific procedures. Note: Patients will sign a separate ICF to allow pre-screening/HLA genotyping. Female patients who are post-menopausal (no menses for at least 12 months before the Screening Visit), or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy). Females of childbearing potential must: Have a negative serum pregnancy test with a sensitivity of at least 25mIU/mL within 10 to 14 days, and within 24 hours prior to starting the study treatment a negative urine pregnancy test. Agree to ongoing pregnancy testing during the study. Use effective contraception at least 28 days before starting study treatment through to 30 days after the last dose of study treatment. Effective methods of birth control include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral intravaginal transdermal progestogen-only hormonal contraception associated with inhibition of ovulation: oral injectable implantable intrauterine device intrauterine hormone-releasing system bilateral tubal occlusion vasectomised partner + barrier method sexual abstinence: Either agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal (coitus interruptus), spermicides only and lactational amenorrhoea method (LAM) are not acceptable methods of contraception. Male patients, even if surgically sterilized (i.e., status postvasectomy), must: Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal (coitus interruptus), spermicides only and LAM are not acceptable methods of contraception. Agree to practice effective barrier contraception during the entire study treatment period (e.g., condom) and through to 3 months after the last dose of study treatment if their partner is of childbearing potential, even if they have had a successful vasectomy. Exclusion Criteria: Abnormal (≥Grade 2 NCI-CTCAE v5.0) laboratory values for hematology, liver and renal function (serum creatinine). The following values apply as exclusion criteria: Hemoglobin <10 g/dL (6.2 mmol/L) White blood cell (WBC) count decrease (<2.5 x109/L) Absolute neutrophil count (ANC) decrease <1.5 x109/L Platelet count decrease <75 x109/L Bilirubin >1.5 x upper limit of normal (ULN according to the performing lab's reference range), except for patients with Gilbert's syndrome Alanine aminotransferase (ALT) >3 x ULN Aspartate aminotransferase (AST) >3 x ULN Gamma glutamyltransferase (GGT) >2.5 x ULN Serum creatinine increased >1.5 x ULN Tumor biopsy only without gross total or partial resection (i.e., ≥50% of tumor volume resected). Any prior therapy for GBM (except surgery, radiotherapy with or without chemotherapy (e.g., temozolomide [TMZ]), TTFields, and steroids) including immunotherapy. Patient on stable or decreasing steroid levels exceeding 10 mg/day prednisone (or equivalent doses of other steroids) during the last 3 days prior to enrollment. Expectation that the patient will need steroid doses >10 mg/day prednisone or equivalent during the next 3 months. Note: Steroid treatment during the study will be allowed for treatment of cerebral edema or other life-threatening conditions. Active human immunodeficiency virus (HIV) infection (ie, CD4 count below the normal range) or active Hepatitis B or C infection (i.e., detectable levels of Hepatitis B DNA or Hepatitis C RNA), or active infections requiring oral or intravenous antibiotics or that can cause a severe disease. Clinically relevant autoimmune diseases that could impact the assessment of vaccine safety and efficacy (with the exception of clinically stable thyroid diseases under medication and vitiligo). Immunosuppression, not related to prior treatment for malignancy. Any medical condition that requires chronic systemic immunosuppressive therapy including chronic corticosteroids (except physiologic maintenance/replacement doses), methotrexate, tacrolimus or any other immunosuppressive agents within 28 days of treatment start, including, but not limited, to organ transplant-related immunosuppression. Patients with prior hematopoietic stem cell transplantation/prior organ allograft. Any condition that in the judgment of the Investigator is likely to prevent compliance with study procedures. Patients with impaired coagulation or any bleeding disorder in whom an intramuscular injection or blood draw is contraindicated. History of myocarditis or pericarditis within the last 3 months or history of myocarditis or pericarditis following COVID-19 vaccination. Previous mRNA vaccination (e.g., SARS-CoV2) or live attenuated vaccination within 1 month prior to study treatment initiation, other vaccines within 2 weeks prior to study treatment initiation. Serious illness or condition, which according to the Investigator poses an undue risk for the patient when participating in the trial, including, but not limited to, any of the following: Clinically significant cardiovascular disease (myocardial infarction or stroke within last 6 months, uncontrolled angina within last 3 months, diagnosed or suspected clinically significant ventricular arrhythmias, ejection fraction <35%, cerebrovascular event within last 6 months, uncontrolled hypertension [blood pressure ≥180 mm Hg systolic and 110 mmHg diastolic despite medication]) New York Heart Association Class III to IV congestive heart failure Symptomatic peripheral vascular disease Severe pulmonary disease (e.g., severe chronic obstructive pulmonary disease, pneumonitis or interstitial lung disease) Uncontrolled diabetes (repeated episodes of severe hypo- or hyperglycemia requiring hospitalization) Severe mental retardation/impairment, psychiatric conditions or substance abuse resulting in inability to understand informed consent or affecting the patient's cooperation in the study Severe infection/inflammatory conditions History of other malignancies (except for those which have been adequately treated and have had no recurrence). Previous anaphylactic or severe allergic reaction to an LNP formulated drug or vaccine (e.g., Comirnaty or Spikevax) or known allergy to any other component of CVGBM (e.g., PEG). Allergy to aminoglycoside or ß-lactam antibiotics. Pregnant or breastfeeding. Prior (within 30 days prior to study enrollment) or concurrent participation in another interventional clinical trial studying an investigational product, drug or treatment regimen. At least 30 days should have passed prior to the first study treatment with the investigational product (exceptions may be considered on a case-by-case basis after consultation with the CureVac Medical Director).

Sites / Locations

  • Cliniques Universitaires Saint-LucRecruiting
  • Universitair Ziekenhuis Brussel - PPDSRecruiting
  • CHU de LiègeRecruiting
  • Universitätsklinikum Freiburg
  • University Clinic Heidelberg
  • Universitätsmedizin Mannheim
  • Universitätsklinikum TübingenRecruiting
  • University Clinic RegensburgRecruiting
  • Universitätsklinikum FrankfurtRecruiting
  • Universitätsklinikum BonnRecruiting
  • University Hospital EssenRecruiting
  • Universitatsklinikum LeipzigRecruiting
  • Neurosurgical Clinic at the LMU Munich
  • Erasmusmc Cancer instituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Dose escalation: CVGBM Dose Level -1

Dose escalation: CVGBM Dose Level 1

Dose escalation: CVGBM Dose Level 2

Dose escalation: CVGBM Dose Level 3

Dose escalation: CVGBM Dose Level 4

Dose expansion

Arm Description

Dose Level -1 represents a dose that may be evaluated if dose level 1 is poorly tolerated. No dose de-escalation below this level is planned for this study. If the dose level -1 is poorly tolerated, the study will be terminated.

After completion of the dose-escalation part and safety data review by the DSMB, approximately 20 patients will be enrolled at the selected Recommended Dose for Expansion (RDE) to generate more data on safety, tolerability and immunogenicity.

Outcomes

Primary Outcome Measures

Incidence of treatment-related adverse events (TRAEs)
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of serious adverse events (SAEs)
Incidence of immune related adverse events (irAEs)
Incidence of injection site reactions (ISRs)
Incidence of clinically significant laboratory abnormalities per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.5.0
Incidence dose-limiting toxicities (DLTs)
Severity of DLTs (Unit: Grading via NCI-CTCAE v5.0)

Secondary Outcome Measures

Time to relapse from the day of surgery until the last scheduled visit of the study
Progression-Free Survival (PFS) rate from the day of surgery until the last scheduled visit of the study
Overall survival (OS) rate from the day of surgery until the last scheduled visit of the study
Change in the patients' quality of life measured using a patient-reported-outcome questionnaire

Full Information

First Posted
June 6, 2023
Last Updated
September 14, 2023
Sponsor
CureVac
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1. Study Identification

Unique Protocol Identification Number
NCT05938387
Brief Title
Safety and Tolerability of CVGBM in Adults With Newly Diagnosed MGMT-Unmethylated Glioblastoma or Astrocytoma
Official Title
A Phase 1 Dose-Finding Study to Evaluate Safety and Tolerability of CVGBM in Patients With Surgically Resected Glioblastoma (GBM) or Astrocytoma With a Molecular Signature of Unmethylated Glioblastoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2023 (Actual)
Primary Completion Date
March 30, 2026 (Anticipated)
Study Completion Date
March 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CureVac

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is an open-label, first-in-human, dose-escalation study of CV09050101 mRNA vaccine (CVGBM) in patients with newly diagnosed "MGMT-unmethylated" Glioblastoma (GBM). Patients with isocitrate dehydrogenase (IDH)-wildtype astrocytoma with a molecular signature of "unmethylated" GBM are also eligible. After surgical resection and completion of radiotherapy for GBM with or without chemotherapy, patients will receive CVGBM i.e. as monotherapy after radiotherapy with or without chemotherapy. The study will consist of a dose-escalation part (Part A) and a dose-expansion part (Part B). Patients will receive a total of 7 administrations of CVGBM on Days 1, 8, 15, 29, 43, 57, and 71. At the discretion of the Investigator in alignment with the Sponsor's medical monitor the vaccinations may continue beyond Day 71 every 6 weeks until one year after the first CVGBM vaccination or upon disease progression or undue toxicity

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose escalation: CVGBM Dose Level -1
Arm Type
Experimental
Arm Description
Dose Level -1 represents a dose that may be evaluated if dose level 1 is poorly tolerated. No dose de-escalation below this level is planned for this study. If the dose level -1 is poorly tolerated, the study will be terminated.
Arm Title
Dose escalation: CVGBM Dose Level 1
Arm Type
Experimental
Arm Title
Dose escalation: CVGBM Dose Level 2
Arm Type
Experimental
Arm Title
Dose escalation: CVGBM Dose Level 3
Arm Type
Experimental
Arm Title
Dose escalation: CVGBM Dose Level 4
Arm Type
Experimental
Arm Title
Dose expansion
Arm Type
Experimental
Arm Description
After completion of the dose-escalation part and safety data review by the DSMB, approximately 20 patients will be enrolled at the selected Recommended Dose for Expansion (RDE) to generate more data on safety, tolerability and immunogenicity.
Intervention Type
Biological
Intervention Name(s)
CV09050101 mRNA vaccine (CVGBM) 12 μg
Intervention Description
CVGBM will be administered as an IM injection.
Intervention Type
Biological
Intervention Name(s)
CV09050101 mRNA vaccine (CVGBM) 25 μg
Intervention Description
CVGBM will be administered as an IM injection.
Intervention Type
Biological
Intervention Name(s)
CV09050101 mRNA vaccine (CVGBM) 50 μg
Intervention Description
CVGBM will be administered as an IM injection.
Intervention Type
Biological
Intervention Name(s)
CV09050101 mRNA vaccine (CVGBM) 100 μg
Intervention Description
CVGBM will be administered as an IM injection.
Intervention Type
Biological
Intervention Name(s)
CV09050101 mRNA vaccine RDE
Intervention Description
CVGBM will be administered as an IM injection.
Intervention Type
Biological
Intervention Name(s)
CV09050101 mRNA vaccine (CVGBM) 6 μg
Intervention Description
CVGBM will be administered as an IM injection.
Primary Outcome Measure Information:
Title
Incidence of treatment-related adverse events (TRAEs)
Time Frame
1 year
Title
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame
1 year
Title
Incidence of serious adverse events (SAEs)
Time Frame
1 year
Title
Incidence of immune related adverse events (irAEs)
Time Frame
1 year
Title
Incidence of injection site reactions (ISRs)
Time Frame
1 year
Title
Incidence of clinically significant laboratory abnormalities per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.5.0
Time Frame
1 year
Title
Incidence dose-limiting toxicities (DLTs)
Time Frame
Through the first 2 weeks of treatment
Title
Severity of DLTs (Unit: Grading via NCI-CTCAE v5.0)
Time Frame
Through the first 2 weeks of treatment
Secondary Outcome Measure Information:
Title
Time to relapse from the day of surgery until the last scheduled visit of the study
Time Frame
1 year
Title
Progression-Free Survival (PFS) rate from the day of surgery until the last scheduled visit of the study
Time Frame
1 year
Title
Overall survival (OS) rate from the day of surgery until the last scheduled visit of the study
Time Frame
1 year
Title
Change in the patients' quality of life measured using a patient-reported-outcome questionnaire
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed, newly diagnosed GBM (CNS WHO Grade 4) and IDH-wildtype astrocytoma with a molecular signature of "unmethylated" GBM. Specific HLA genotype. Gross total or partial resection (i.e., ≥50% of tumor volume resected). Having completed radiotherapy with or without chemotherapy post-surgery at least 2 weeks before study treatment initiation. Patients must have recovered from any radiotherapy or chemotherapy related side effects to ≤ Grade 1 (with the exception of ALC and WBC as per eligibility criteria). Pretreatment (and concomitant treatment) with TTFields therapy for GBM is allowed. Age ≥18 years. Karnofsky Performance Status (KPS) ≥70%. Life expectancy >6 months. Absolute lymphocyte count (ALC) >0.5 x109/L. Each patient must voluntarily sign and date an informed consent form (ICF) approved by an Independent Ethics Committee (IEC), prior to the initiation of any pre-screening, screening or study-specific procedures. Note: Patients will sign a separate ICF to allow pre-screening/HLA genotyping. Female patients who are post-menopausal (no menses for at least 12 months before the Screening Visit), or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy). Females of childbearing potential must: Have a negative serum pregnancy test with a sensitivity of at least 25mIU/mL within 10 to 14 days, and within 24 hours prior to starting the study treatment a negative urine pregnancy test. Agree to ongoing pregnancy testing during the study. Use effective contraception at least 28 days before starting study treatment through to 30 days after the last dose of study treatment. Effective methods of birth control include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral intravaginal transdermal progestogen-only hormonal contraception associated with inhibition of ovulation: oral injectable implantable intrauterine device intrauterine hormone-releasing system bilateral tubal occlusion vasectomised partner + barrier method sexual abstinence: Either agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal (coitus interruptus), spermicides only and lactational amenorrhoea method (LAM) are not acceptable methods of contraception. Male patients, even if surgically sterilized (i.e., status postvasectomy), must: Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal (coitus interruptus), spermicides only and LAM are not acceptable methods of contraception. Agree to practice effective barrier contraception during the entire study treatment period (e.g., condom) and through to 3 months after the last dose of study treatment if their partner is of childbearing potential, even if they have had a successful vasectomy. Exclusion Criteria: Abnormal (≥Grade 2 NCI-CTCAE v5.0) laboratory values for hematology, liver and renal function (serum creatinine). The following values apply as exclusion criteria: Hemoglobin <10 g/dL (6.2 mmol/L) White blood cell (WBC) count decrease (<2.5 x109/L) Absolute neutrophil count (ANC) decrease <1.5 x109/L Platelet count decrease <75 x109/L Bilirubin >1.5 x upper limit of normal (ULN according to the performing lab's reference range), except for patients with Gilbert's syndrome Alanine aminotransferase (ALT) >3 x ULN Aspartate aminotransferase (AST) >3 x ULN Gamma glutamyltransferase (GGT) >2.5 x ULN Serum creatinine increased >1.5 x ULN Tumor biopsy only without gross total or partial resection (i.e., ≥50% of tumor volume resected). Any prior therapy for GBM (except surgery, radiotherapy with or without chemotherapy (e.g., temozolomide [TMZ]), TTFields, and steroids) including immunotherapy. Patient on stable or decreasing steroid levels exceeding 10 mg/day prednisone (or equivalent doses of other steroids) during the last 3 days prior to enrollment. Expectation that the patient will need steroid doses >10 mg/day prednisone or equivalent during the next 3 months. Note: Steroid treatment during the study will be allowed for treatment of cerebral edema or other life-threatening conditions. Active human immunodeficiency virus (HIV) infection (ie, CD4 count below the normal range) or active Hepatitis B or C infection (i.e., detectable levels of Hepatitis B DNA or Hepatitis C RNA), or active infections requiring oral or intravenous antibiotics or that can cause a severe disease. Clinically relevant autoimmune diseases that could impact the assessment of vaccine safety and efficacy (with the exception of clinically stable thyroid diseases under medication and vitiligo). Immunosuppression, not related to prior treatment for malignancy. Any medical condition that requires chronic systemic immunosuppressive therapy including chronic corticosteroids (except physiologic maintenance/replacement doses), methotrexate, tacrolimus or any other immunosuppressive agents within 28 days of treatment start, including, but not limited, to organ transplant-related immunosuppression. Patients with prior hematopoietic stem cell transplantation/prior organ allograft. Any condition that in the judgment of the Investigator is likely to prevent compliance with study procedures. Patients with impaired coagulation or any bleeding disorder in whom an intramuscular injection or blood draw is contraindicated. History of myocarditis or pericarditis within the last 3 months or history of myocarditis or pericarditis following COVID-19 vaccination. Previous mRNA vaccination (e.g., SARS-CoV2) or live attenuated vaccination within 1 month prior to study treatment initiation, other vaccines within 2 weeks prior to study treatment initiation. Serious illness or condition, which according to the Investigator poses an undue risk for the patient when participating in the trial, including, but not limited to, any of the following: Clinically significant cardiovascular disease (myocardial infarction or stroke within last 6 months, uncontrolled angina within last 3 months, diagnosed or suspected clinically significant ventricular arrhythmias, ejection fraction <35%, cerebrovascular event within last 6 months, uncontrolled hypertension [blood pressure ≥180 mm Hg systolic and 110 mmHg diastolic despite medication]) New York Heart Association Class III to IV congestive heart failure Symptomatic peripheral vascular disease Severe pulmonary disease (e.g., severe chronic obstructive pulmonary disease, pneumonitis or interstitial lung disease) Uncontrolled diabetes (repeated episodes of severe hypo- or hyperglycemia requiring hospitalization) Severe mental retardation/impairment, psychiatric conditions or substance abuse resulting in inability to understand informed consent or affecting the patient's cooperation in the study Severe infection/inflammatory conditions History of other malignancies (except for those which have been adequately treated and have had no recurrence). Previous anaphylactic or severe allergic reaction to an LNP formulated drug or vaccine (e.g., Comirnaty or Spikevax) or known allergy to any other component of CVGBM (e.g., PEG). Allergy to aminoglycoside or ß-lactam antibiotics. Pregnant or breastfeeding. Prior (within 30 days prior to study enrollment) or concurrent participation in another interventional clinical trial studying an investigational product, drug or treatment regimen. At least 30 days should have passed prior to the first study treatment with the investigational product (exceptions may be considered on a case-by-case basis after consultation with the CureVac Medical Director).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Information, CureVac SE
Phone
Please email:
Email
glioblastoma.trial@curevac.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Information
Organizational Affiliation
CureVac SE
Official's Role
Study Director
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc
City
Woluwe-Saint-Lambert
State/Province
Brussels
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Brussel - PPDS
City
Brussel
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU de Liège
City
Liège
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Freiburg
City
Freiburg im Breisgau
State/Province
Baden-Württemberg
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
University Clinic Heidelberg
City
Heidelberg
State/Province
Baden-Württemberg
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitätsmedizin Mannheim
City
Mannheim
State/Province
Baden-Württemberg
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
State/Province
Baden-Württemberg
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Clinic Regensburg
City
Regensburg
State/Province
Bayern
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt am Main
State/Province
Hessen
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Bonn
City
Bonn
State/Province
Nordrhein-Westfalen
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Hospital Essen
City
Essen
State/Province
Nordrhein-Westfalen
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitatsklinikum Leipzig
City
Leipzig
State/Province
Sachsen
Country
Germany
Individual Site Status
Recruiting
Facility Name
Neurosurgical Clinic at the LMU Munich
City
München
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Erasmusmc Cancer institute
City
Rotterdam
State/Province
Zuid-Holland
Country
Netherlands
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety and Tolerability of CVGBM in Adults With Newly Diagnosed MGMT-Unmethylated Glioblastoma or Astrocytoma

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