Clinical trial • Phase III • Oncology
PEMBROLIZUMAB for Glioblastoma
Phase III trial of PEMBROLIZUMAB for Glioblastoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Glioblastoma
- Trial Stage
- Phase III
- Drug Modality
- Small molecule|Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 26-07-2024
- First CTIS Authorization Date
- 27-01-2025
Trial design
Randomised, optune concomitant with maintenance temozolomide (150-200 mg/m^2 daily x 5, q28 days) plus pembrolizumab versus optune concomitant with maintenance temozolomide (150-200 mg/m^2 daily x 5, q28 days) plus placebo (saline solution for infusion). pembrolizumab product: keytruda 25 mg/ml concentrate for solution for infusion. placebo: saline solution for infusion.-controlled Phase III trial in Poland, France, Spain and others.
- Randomised
- Yes
- Comparator
- Optune concomitant with maintenance temozolomide (150-200 mg/m^2 daily x 5, Q28 days) plus pembrolizumab versus Optune concomitant with maintenance temozolomide (150-200 mg/m^2 daily x 5, Q28 days) plus placebo (saline solution for infusion). Pembrolizumab product: KEYTRUDA 25 mg/mL concentrate for solution for infusion. Placebo: saline solution for infusion.
- Target Sample Size
- 461
- Trial Duration For Participant
- 730
Eligibility
Recruits 461 Vulnerable population selected; consent must be documented and may be provided by the participant or a legally acceptable representative ("The participant (or legally acceptable representative) has provided documented informed consent for the study."). No assent for minors is applicable since participants must be ≥ 18 years of age..
- Vulnerable Population
- Vulnerable population selected; consent must be documented and may be provided by the participant or a legally acceptable representative ("The participant (or legally acceptable representative) has provided documented informed consent for the study."). No assent for minors is applicable since participants must be ≥ 18 years of age.
Inclusion criteria
- {"criterion_text":"- 1. The participant (or legally acceptable representative) has provided documented informed consent for the study.\n- 10. Life expectancy ≥ 3 months.\n- 11. Stable or decreasing dose of corticosteroids (dexamethasone ≤ 2mg or equivalent) for the last 7 days prior to randomization, if applicable.\n- 12. For the full list of inclusion criteria, please refer to the protocol.\n- 2. Be ≥ 18 years of age on day of providing informed consent.\n- 3. Participant with new diagnosis of GBM according to WHO 2021 Classification.\n- 4. Recovered from maximal debulking surgery (gross total resection, partial resection and biopsy-only patients are all acceptable), Gliadel wafers placement at the time of surgical resection is not allowed.\n- 5. Have completed standard adjuvant chemoradiotherapy of RT according to local practice (56-64 Gy), and concomitant TMZ chemotherapy.\n- 6. Able to start treatment between 4 to 7 weeks from the later of last dose of concomitant temozolomide or radiotherapy.\n- 7. Amenable to treatment with Optune concomitant with maintenance temozolomide (150-200 mg/m^2 daily x 5, Q28 days).\n- 8. All patients must have had tissue submitted for MGMT Promoter Methylation determination prior to randomization.\n- 9. Have an ECOG Performance Status of 0 to 1 assessed within 7 days before randomization."}
Exclusion criteria
- {"criterion_text":"- 1. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).\n- 10. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.\n- 11. Has an active infection requiring systemic therapy.\n- 12. Has a known history of human immunodeficiency virus (HIV), Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection Note: Hepatitis B and C screening tests are not required unless: \t- Known history of HBV and HCV infection \t- As mandated by local health authority\n- 13. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n- 14. Has a known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the study.\n- 15. Has had an allogenic tissue/solid organ transplant.\n- 16. Early progressive disease after the end of TMZ/RT. If pseudoprogression is suspected, additional imaging studies should be performed to rule out true progression.\n- 17. Infratentorial or leptomeningeal disease.\n- 18. Implanted pacemaker, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.\n- 19. A skull defect (such as, missing bone with no replacement) or bullet fragments.\n- 2. Ongoing requirement for >2 mg dexamethasone (or equivalent), due to intracranial mass effect.\n- 20. Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness).\n- 21. Known allergies to medical adhesives or hydrogel and/or compounds of similar chemical or biologic composition to Temozolomide.\n- 22. Admitted to an institution by administrative or court order.\n- 3. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to randomization. Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible. Note: If the participant had a major operation, the participant must have recovered adequately from the procedure and/or any complications from the operation before starting study intervention.\n- 4. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed. Refer to Section 6.5.1 for information on COVID-19 vaccines\n- 5. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first study treatment. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.\n- 6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication.\n- 7. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n- 8. Has severe hypersensitivity (≥Grade 3) to the experimental drug and/or any of its excipients.\n- 9. Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed."}
Endpoints
Primary endpoints
- {"endpoint_text":"- OS","definition_or_measurement_approach":"To compare overall survival (OS) for subjects treated with Optune concomitant with maintenance temozolomide (TMZ) plus pembrolizumab versus those treated with Optune concomitant with maintenance TMZ plus placebo"}
Secondary endpoints
- {"endpoint_text":"- 1. PFS per RANO 2.0 as assessed by investigator","definition_or_measurement_approach":"Progression-free survival per response assessment in neuro-oncology criteria 2.0 (RANO 2.0) as assessed locally by the investigator"}
- {"endpoint_text":"- 2. PFS per RANO as assessed by investigator","definition_or_measurement_approach":"Progression-free survival per response assessment in neuro-oncology criteria (RANO) as assessed locally by the investigator"}
- {"endpoint_text":"- 3. PFS6m and PFS12m per RANO 2.0 as assessed by investigator","definition_or_measurement_approach":"PFS rate at 6 months and 12 months per RANO 2.0 as assessed locally by the investigator"}
- {"endpoint_text":"- 4. PFS2 per RANO 2.0 as assessed by investigator","definition_or_measurement_approach":"Next progression-free survival (PFS2) per RANO 2.0 as assessed locally by the investigator"}
- {"endpoint_text":"- 5. 1- and 2-year survival rates","definition_or_measurement_approach":"Proportion of subjects alive at 1 year and 2 years"}
- {"endpoint_text":"- 6. The EORTC QLQ-C30 with BN20 module score","definition_or_measurement_approach":"Health-Related Quality of Life assessment using EORTC QLQ-C30 with BN20 brain module scores"}
- {"endpoint_text":"- 7. Subjects experiencing AEs","definition_or_measurement_approach":"Safety assessed by proportion and severity of adverse events (AEs)"}
Recruitment
- Digital Remote Recruitment
- True, recruitment materials include website text and online/media kit materials; eCOA and online patient-facing documents are provided for electronic capture and subject interaction
- Planned Sample Size
- 461
- Recruitment Window Months
- 41
- Consent Approach
- Documented informed consent is required from the participant or a legally acceptable representative ("The participant (or legally acceptable representative) has provided documented informed consent for the study."). Participants must be ≥18 years old. Informed consent and subject information documents are available in multiple languages (document titles indicate availability in EN, FR, ES, IT, PL, CZ, DE and country-specific versions).
Methods
- Website text / online information (documents titled 'Website Text' / country-specific Website Text documents) for public-facing recruitment information
- Media kit / advertisement materials (documents titled 'Media Kit' / 'Advertisement material') for outreach
- Referral letters and GP letters (documents titled 'Referral Letter', 'GP Letter') to engage referring physicians
- Participant-facing materials and patient information sheets (multiple Subject Information Sheet and ICF documents) provided at sites
- Printed recruitment materials and patient diaries (Media Kit, Patient Diary, Patient Card, Flyers) for site distribution
Geography
- Total Number Of Sites
- 32
- Total Number Of Participants
- 280
Poland
- Earliest CTIS Part Ii Submission Date
- 19-02-2025
- Latest Decision Or Authorization Date
- 30-11-2025
- Processing Time Days
- 284
- Number Of Sites
- 3
- Number Of Participants
- 21
Sites
- Site Name
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
- Department Name
- Zakład Teleradioterapii
- Principal Investigator Name
- Jacek Fijuth
- Principal Investigator Email
- jacekf@kopernik.lodz.pl
- Contact Person Name
- Jacek Fijuth
- Contact Person Email
- jacekf@kopernik.lodz.pl
- Site Name
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
- Department Name
- Zakład Neuroonkologii i Radiochirurgii
- Principal Investigator Name
- Maciej Harat
- Principal Investigator Email
- haratm@co.bydgoszcz.pl
- Contact Person Name
- Maciej Harat
- Contact Person Email
- haratm@co.bydgoszcz.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- III Klinika Radioterapii i Chemioterapii
- Principal Investigator Name
- Elżbieta Nowicka
- Principal Investigator Email
- elzbieta.nowicka@gliwice.nio.gov.pl
- Contact Person Name
- Elżbieta Nowicka
- Contact Person Email
- elzbieta.nowicka@gliwice.nio.gov.pl
France
- Earliest CTIS Part Ii Submission Date
- 27-01-2025
- Latest Decision Or Authorization Date
- 25-11-2025
- Processing Time Days
- 302
- Number Of Sites
- 5
- Number Of Participants
- 55
Sites
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Marseille Center of Earlier Phase in Oncology
- Principal Investigator Name
- Emeline Tabouret
- Principal Investigator Email
- emeline.tabouret@ap-hm.fr
- Contact Person Name
- Emeline Tabouret
- Contact Person Email
- emeline.tabouret@ap-hm.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Neuro-Oncology
- Principal Investigator Name
- François Ducray
- Principal Investigator Email
- francois.ducray@chu-lyon.fr
- Contact Person Name
- François Ducray
- Contact Person Email
- francois.ducray@chu-lyon.fr
- Site Name
- Oncopole Claudius Regaud
- Department Name
- Radiotherapy
- Principal Investigator Name
- Elizabeth Moyal
- Principal Investigator Email
- moyal.elizabeth@iuct-oncopole.fr
- Contact Person Name
- Elizabeth Moyal
- Contact Person Email
- moyal.elizabeth@iuct-oncopole.fr
- Site Name
- Hopital Saint Louis
- Department Name
- Neurology
- Principal Investigator Name
- Stephania Cuzzubo
- Principal Investigator Email
- stefania.cuzzubbo@aphp.fr
- Contact Person Name
- Stephania Cuzzubo
- Contact Person Email
- stefania.cuzzubbo@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Neurology
- Principal Investigator Name
- Khe Hoang-Xuan
- Principal Investigator Email
- khe.hoang-xuan@aphp.fr
- Contact Person Name
- Khe Hoang-Xuan
- Contact Person Email
- khe.hoang-xuan@aphp.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 29-01-2025
- Latest Decision Or Authorization Date
- 26-11-2025
- Processing Time Days
- 301
- Number Of Sites
- 10
- Number Of Participants
- 71
Sites
- Site Name
- Hospital Universitario La Paz
- Department Name
- Oncology
- Principal Investigator Name
- Virginia Martinez Marin
- Principal Investigator Email
- virgimarin9@hotmail.com
- Contact Person Name
- Virginia Martinez Marin
- Contact Person Email
- virgimarin9@hotmail.com
- Site Name
- Hospital Universitario Virgen De Las Nieves
- Department Name
- Oncology
- Principal Investigator Name
- Raquel Luque Caro
- Principal Investigator Email
- rluquecaro@gmail.com
- Contact Person Name
- Raquel Luque Caro
- Contact Person Email
- rluquecaro@gmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncology
- Principal Investigator Name
- Maria Angeles Vaz Salgado
- Principal Investigator Email
- mavaz4@gmail.com
- Contact Person Name
- Maria Angeles Vaz Salgado
- Contact Person Email
- mavaz4@gmail.com
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Oncology
- Principal Investigator Name
- Pedro Perez Segura
- Principal Investigator Email
- pedro.perez@salud.madrid.org
- Contact Person Name
- Pedro Perez Segura
- Contact Person Email
- pedro.perez@salud.madrid.org
- Site Name
- ICO L'HOSPITALET HOSPITAL DURAN I REYNALS
- Department Name
- Neurology
- Principal Investigator Name
- Jordi Bruna Escuer
- Principal Investigator Email
- miguelamosteiro@iconcologia.net
- Contact Person Name
- Jordi Bruna Escuer
- Contact Person Email
- miguelamosteiro@iconcologia.net
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Oncology
- Principal Investigator Name
- Regina Girones Sarrio
- Principal Investigator Email
- girones_reg@gva.es
- Contact Person Name
- Regina Girones Sarrio
- Contact Person Email
- girones_reg@gva.es
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncology
- Principal Investigator Name
- Miriam Alonso Garcia
- Principal Investigator Email
- miriamag3@hotmail.com
- Contact Person Name
- Miriam Alonso Garcia
- Contact Person Email
- miriamag3@hotmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Maria Vieito Villar
- Principal Investigator Email
- mvieito@vhio.net
- Contact Person Name
- Maria Vieito Villar
- Contact Person Email
- mvieito@vhio.net
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Oncology
- Principal Investigator Name
- Raquel Serrano Blanch
- Principal Investigator Email
- rsblanch@hotmail.com
- Contact Person Name
- Raquel Serrano Blanch
- Contact Person Email
- rsblanch@hotmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Neuro-Oncology
- Principal Investigator Name
- Juan Manuel Sepulveda Sanchez
- Principal Investigator Email
- jmsepulveda76@gmail.com
- Contact Person Name
- Juan Manuel Sepulveda Sanchez
- Contact Person Email
- jmsepulveda76@gmail.com
Czechia
- Earliest CTIS Part Ii Submission Date
- 30-01-2025
- Latest Decision Or Authorization Date
- 25-11-2025
- Processing Time Days
- 299
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- Nemocnice Na Homolce
- Department Name
- Radiodiagnosticke oddeleni
- Principal Investigator Name
- Josef Vymazal
- Principal Investigator Email
- josef.vymazal@homolka.cz
- Contact Person Name
- Josef Vymazal
- Contact Person Email
- josef.vymazal@homolka.cz
Germany
- Earliest CTIS Part Ii Submission Date
- 20-02-2025
- Latest Decision Or Authorization Date
- 28-11-2025
- Processing Time Days
- 281
- Number Of Sites
- 4
- Number Of Participants
- 35
Sites
- Site Name
- Universitaetsklinikum Muenster AöR
- Department Name
- department of Neurology with Institute of Translational Neurology
- Principal Investigator Name
- Oliver Grauer
- Principal Investigator Email
- oliver.grauer@ukmuenster.de
- Contact Person Name
- Oliver Grauer
- Contact Person Email
- oliver.grauer@ukmuenster.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- department of Neurosurgery
- Principal Investigator Name
- Martin Misch
- Principal Investigator Email
- martin.misch@charite.de
- Contact Person Name
- Martin Misch
- Contact Person Email
- martin.misch@charite.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- department of Neurology
- Principal Investigator Name
- Sied Kebir
- Principal Investigator Email
- sied.kebir@uk-essen.de
- Contact Person Name
- Sied Kebir
- Contact Person Email
- sied.kebir@uk-essen.de
- Site Name
- Goethe University Frankfurt
- Department Name
- department for Neurology and Neurosurgery
- Principal Investigator Name
- Michael Burger
- Principal Investigator Email
- burger@med.uni-frankfurt.de
- Contact Person Name
- Michael Burger
- Contact Person Email
- burger@med.uni-frankfurt.de
Italy
- Earliest CTIS Part Ii Submission Date
- 21-06-2024
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 591
- Number Of Sites
- 9
- Number Of Participants
- 78
Sites
- Site Name
- Azienda Unita Sanitaria Locale Di Bologna
- Department Name
- Oncologia
- Principal Investigator Name
- Enrico Franceschi
- Principal Investigator Email
- e.franceschi@isnb.it
- Contact Person Name
- Enrico Franceschi
- Contact Person Email
- e.franceschi@isnb.it
- Site Name
- Azienda Sanitaria Locale Napoli 1 Centro
- Department Name
- Oncology
- Principal Investigator Name
- Bruno Daniele
- Principal Investigator Email
- bruno.daniele@aslnapoli1centro.it
- Contact Person Name
- Bruno Daniele
- Contact Person Email
- bruno.daniele@aslnapoli1centro.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Operating Unit of Oncology and Hematology
- Principal Investigator Name
- Matteo Simonelli
- Principal Investigator Email
- matteo.simonelli@cancercenter.humanitas.it
- Contact Person Name
- Matteo Simonelli
- Contact Person Email
- matteo.simonelli@cancercenter.humanitas.it
- Site Name
- IRCCS Foundation Istituto Neurologico Carlo Besta
- Department Name
- Neuro-oncologia
- Principal Investigator Name
- Antonio Silvani
- Principal Investigator Email
- antonio.silvani@istituto-besta.it
- Contact Person Name
- Antonio Silvani
- Contact Person Email
- antonio.silvani@istituto-besta.it
- Site Name
- Azienda Ospedaliera Universitaria Senese
- Department Name
- UOC Immunoterapia oncologica
- Principal Investigator Name
- Michele Maio
- Principal Investigator Email
- mmaiocro@gmail.com
- Contact Person Name
- Michele Maio
- Contact Person Email
- mmaiocro@gmail.com
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Radiation Therapy
- Principal Investigator Name
- Silvia Chiesa
- Principal Investigator Email
- silvia.chiesa@policlinicogemelli.it
- Contact Person Name
- Silvia Chiesa
- Contact Person Email
- silvia.chiesa@policlinicogemelli.it
- Site Name
- Istituto Oncologico Veneto
- Department Name
- Oncology 1 Unit
- Principal Investigator Name
- Giuseppe Lombardi
- Principal Investigator Email
- giuseppe.lombardi@iov.veneto.it
- Contact Person Name
- Giuseppe Lombardi
- Contact Person Email
- giuseppe.lombardi@iov.veneto.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- Neuro-oncology
- Principal Investigator Name
- Roberta Rudà
- Principal Investigator Email
- roberta.ruda@unito.it
- Contact Person Name
- Roberta Rudà
- Contact Person Email
- roberta.ruda@unito.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino (additional listing)
Sponsor
Primary sponsor
- Full Name
- Novocure GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Almac Clinical Services Limited
- Responsibilities
- Drug Product Secondary Production, Storage, Distribution, Returns and Destruction
- Name
- IQVIA Limited
- Responsibilities
- roles/codes: 1,11,12,2,5,6,8 (as listed in sponsor thirdParty duties)
- Name
- Q Squared Solutions Limited
- Responsibilities
- code: 4 (as listed in sponsor thirdParty duties)
- Name
- Medidata Solutions Inc.
- Responsibilities
- roles/codes: 3,7 (as listed in sponsor thirdParty duties)
- Name
- Bioclinica Inc.
- Responsibilities
- Imaging
- Name
- Mayo Collaborative Services LLC
- Responsibilities
- MGMT analysis
Third parties
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"Drug Product Secondary Production, Storage, Distribution, Returns and Destruction","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"code: 4","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"codes: 1,11,12,2,5,6,8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Mayo Collaborative Services LLC","duties_or_roles":"MGMT analysis; code: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging; code: 13","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"codes: 3,7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"Drug Product Storage, Distribution, Returns and Destruction for Switzerland sites","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- KEYTRUDA 25 mg/mL concentrate for solution for infusion
- Active Substance
- PEMBROLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- Marketing authorisation: EU/1/15/1024/002
- Maximum Dose
- 200 mg (maxDailyDoseAmount 200 mg)
- Investigational Product Name
- TEMOZOLOMIDE
- Active Substance
- TEMOZOLOMIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- EU product (euMpNumber SCP131007)
- Starting Dose
- 150-200 mg/m^2 daily x 5, Q28 days (maintenance dosing as stated in protocol inclusion)
- Dose Levels
- 150-200 mg/m^2 daily x 5, Q28 days
- Frequency
- Daily x 5 every 28 days
- Maximum Dose
- 200 mg/m2 (maxDailyDoseAmount 200)
- Investigational Product Name
- saline solution for infusion
- Modality
- Other
- Routes Of Administration
- Intravenous (placebo)
- Route
- Intravenous infusion
- Combination Treatment
- Yes
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