Therapy Detail

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Therapy Name Temozolomide
Synonyms
Therapy Description

Temodar (temozolomide) is a dacarbazine analog and cytotoxic alkylating agent (NCI Drug Dictionary).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Temozolomide Temodar Methazolastone|TMZ Chemotherapy - Alkylating 18 Temodar (temozolomide) is a dacarbazine analog and cytotoxic alkylating agent (NCI Drug Dictionary).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
MSH6 T1219I glioblastoma resistant Temozolomide Preclinical Actionable In a preclinical study, glioblastoma cells harboring a MSH6 T1219I mutation were resistant to Temodar (temozolomide) in cell culture (PMID: 19584161). 19584161

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04396860 Phase II Temozolomide Ipilimumab + Nivolumab Testing the Use of the Immunotherapy Drugs Ipilimumab and Nivolumab Plus Radiation Therapy Compared to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Unmethylated Glioblastoma Active, not recruiting USA 0
NCT02343406 Phase II Lomustine Depatuxizumab mafodotin Temozolomide ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma Completed USA | POL | NLD | ITA | IRL | HUN | GBR | FRA | FIN | ESP | DEU | CZE | CHE | CAN | BEL | AUT | AUS 4
NCT01977677 Phase Ib/II Temozolomide Plerixafor Plerixafor After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed High Grade Glioma Completed USA 0
NCT06413706 Phase II Abemaciclib + Temozolomide Temozolomide A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy Recruiting USA | ROU | NLD | ITA | FRA | ESP | DNK | BEL | AUS 1
NCT06388733 Phase III Niraparib Temozolomide A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma Recruiting USA 0
NCT04421378 Phase Ib/II Lomustine + Selinexor Lomustine Selinexor + Temozolomide Temozolomide Selinexor A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma Terminated USA | CAN 0
NCT02311920 Phase I Temozolomide Nivolumab Ipilimumab Temozolomide in Combination With Ipilimumab and/or Nivolumab in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma Completed USA 0
NCT02655601 Phase Ib/II BMX-001 + Temozolomide Temozolomide Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001 Active, not recruiting USA 0
NCT02052648 Phase Ib/II Temozolomide Indoximod Study of IDO Inhibitor and Temozolomide for Adult Patients With Primary Malignant Brain Tumors Completed USA 0
NCT00492687 Phase II Carboplatin Temozolomide Tamoxifen Radiation Therapy, Temozolomide, Tamoxifen, and Carboplatin in Treating Patients With Malignant Gliomas Unknown status USA 0
NCT03425292 Phase I Temozolomide Ipilimumab + Nivolumab Nivolumab A Longitudinal Assessment of Tumor Evolution in Patients With Brain Cancer Completed USA 0
NCT01409174 Phase Ib/II Cisplatin Ipilimumab Aldesleukin Temozolomide Interferon alpha-2b IPI Biochemotherapy for Chemonaive Patients With Metastatic Melanoma Terminated USA 0
NCT01638546 Phase II Temozolomide Veliparib Temozolomide With or Without Veliparib in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer Completed USA 0
NCT02392793 Phase I Irinotecan + Talazoparib Temozolomide Talazoparib Plus Irinotecan With or Without Temozolomide in Children With Refractory or Recurrent Solid Malignancies Completed USA 0
NCT04443010 Phase Ib/II Temozolomide Onfekafusp alfa + Temozolomide Safety and Efficacy of L19TNF Plus Temozolomide Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma (GLIOSUN) Recruiting CHE 0
NCT02446704 Phase Ib/II Olaparib Temozolomide Study of Olaparib and Temozolomide in Patients With Recurrent Small Cell Lung Cancer Following Failure of Prior Chemotherapy Unknown status USA 0
NCT04485949 Phase II Temozolomide IGV-001 + Temozolomide A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma - the ImmuneSense Study Active, not recruiting USA 0
NCT01514201 Phase Ib/II Temozolomide Veliparib Veliparib, Radiation Therapy, and Temozolomide in Treating Younger Patients With Newly Diagnosed Diffuse Pontine Gliomas Completed USA 0
NCT04555577 Phase I Peposertib Temozolomide Peposertib and Radiation Therapy, Followed by Temozolomide for the Treatment of Patients With Newly Diagnosed MGMT Unmethylated Glioblastoma or Gliosarcoma Recruiting USA 0
NCT02573324 Phase II Temozolomide Depatuxizumab mafodotin + Temozolomide A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1) Completed USA | NZL | NLD | ITA | ISR | IRL | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BRA | BEL | AUT | AUS | ARG 10
NCT06528496 Phase II Irinotecan Doxorubicin Ifosfamide Sargramostim Etoposide Temozolomide Carboplatin Naxitamab Vincristine Sulfate Topotecan Cyclophosphamide N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma Recruiting USA 0
NCT03519412 Phase II Pembrolizumab Temozolomide Pembrolizumab + Temozolomide Pembrolizumab in MMR-Proficient Metastatic Colorectal Cancer Pharmacologically Primed to Trigger Hypermutation Status (ARETHUSA) Active, not recruiting ITA 0
NCT02152982 Phase II Veliparib Temozolomide Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Active, not recruiting USA 1
NCT03782415 Phase Ib/II Temozolomide Ibudilast + Temozolomide Study to Evaluate Ibudilast and TMZ Combo Treatment in Recurrent GBM Active, not recruiting USA 0
NCT02179086 Phase II Temozolomide Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Active, not recruiting USA | CAN 0
NCT02287428 Phase I NeoVax Pembrolizumab Temozolomide NeoVax + Pembrolizumab + Temozolomide NeoVax + Pembrolizumab Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With MGMT Unmethylated, Newly Diagnosed GBM Recruiting USA 0
NCT05128734 Phase II Olaparib + Temozolomide Temozolomide Temozolomide Monotherapy or in Combination With Olaparib in Patients With Triple Negative Breast Cancer (TNBC) Not yet recruiting CAN 0
NCT01800695 Phase I Temozolomide Depatuxizumab mafodotin Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme Completed 0
NCT06264180 Phase III Nab-paclitaxel Nivolumab + RP1 Paclitaxel Nivolumab and relatlimab-rmbw Nivolumab Dacarbazine Pembrolizumab Temozolomide VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs (IGNYTE-3) Recruiting USA 0
NCT06346067 Phase III LXH 254 + Trametinib Trametinib Dacarbazine Temozolomide A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2) Recruiting USA | NLD | ITA | GBR | FRA | ESP | CZE | CAN | AUS 0
NCT02617589 Phase III Nivolumab Temozolomide Study of Nivolumab Versus Temozolomide, Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer) (CheckMate 498) Completed USA | SWE | POL | NOR | NLD | ITA | ISR | GBR | FRA | ESP | DNK | DEU | CHE | CAN | BEL | AUT | AUS 2
NCT03607643 Phase Ib/II Temozolomide Bevacizumab + Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Bevacizumab + Cannabidiol + Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Bortezomib Bortezomib + Cannabidiol Cannabidiol + Gemcitabine Cannabidiol + Temozolomide Gemcitabine A Study of the Efficacy of Cannabidiol in Patients With Multiple Myeloma, Glioblastoma Multiforme, and GI Malignancies Unknown status USA 0
NCT05685004 Phase II Temozolomide Temozolomide + TVI-Brain-1 Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM) Recruiting USA 0
NCT01790503 Phase Ib/II Pexidartinib Temozolomide A Phase 1b/2 Study of PLX3397 + Radiation Therapy + Temozolomide in Patients With Newly Diagnosed Glioblastoma Completed USA 0
NCT03970447 Phase II Lomustine Regorafenib Temozolomide A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma (GBM AGILE) Recruiting USA | FRA | DEU | CHE | CAN | AUS 0
NCT02510950 Phase I Sargramostim Poly ICLC Temozolomide Neoepitope-based Personalized Vaccine Approach in Patients With Newly Diagnosed Glioblastoma Terminated USA 0
NCT05271240 Phase III Bevacizumab + Temozolomide Temozolomide Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM Recruiting USA 0
NCT02414165 Phase II Bevacizumab Lomustine Toca FC + Vocimagene amiretrorepvec Temozolomide P2/3 Randomized Study of Toca 511 & Toca FC Versus SOC in Subjects Undergoing Surgery for Recurrent GBM/AA (Toca5) Terminated USA | ISR | CAN 1
NCT02137759 Phase II Vorinostat Temozolomide MRSI to Predict Response to RT/TMZ and Vorinostat in GBM Active, not recruiting USA 0
NCT02010606 Phase I Bevacizumab Temozolomide Phase I Study of a Dendritic Cell Vaccine for Patients With Either Newly Diagnosed or Recurrent Glioblastoma Completed USA 0
NCT01835145 Phase II Dacarbazine Temozolomide Cabozantinib Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Melanoma of the Eye Completed USA | CAN 0
NCT04199026 Phase I Irinotecan Doxorubicin Ifosfamide Temozolomide Temsirolimus Ganitumab Pazopanib Everolimus Vincristine Sulfate Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma Not yet recruiting USA 0
NCT02530502 Phase Ib/II Temozolomide Pembrolizumab Radiation Therapy With Temozolomide and Pembrolizumab in Treating Patients With Newly Diagnosed Glioblastoma Terminated USA 0
NCT03879811 Phase II Nivolumab Temozolomide Determining the Effects of Temozolomide Followed by Nivolumab in Patients With Colorectal Cancer Withdrawn 0
NCT03576612 Phase I AdV-tk Temozolomide Valacyclovir Nivolumab GMCI, Nivolumab, and Radiation Therapy in Treating Patients With Newly Diagnosed High-Grade Gliomas (GMCI) Active, not recruiting USA 0
NCT02340156 Phase II SGT-53 Temozolomide Phase II Study of Combined Temozolomide and SGT-53 for Treatment of Recurrent Glioblastoma Terminated USA 1
NCT04394858 Phase II Olaparib + Temozolomide Temozolomide Testing the Addition of an Anticancer Drug, Olaparib, to the Usual Chemotherapy (Temozolomide) for Advanced Neuroendocrine Cancer Recruiting USA 0
NCT03556384 Phase II Temozolomide Temozolomide (TMZ) In Advanced Succinate Dehydrogenase (SDH)-Mutant/Deficient Gastrointestinal Stromal Tumor (GIST) Active, not recruiting USA 0
NCT02977780 Phase II CC-115 Abemaciclib + Temozolomide Temozolomide Neratinib + Temozolomide INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT) Recruiting USA 0
NCT02023905 Phase II Temozolomide Everolimus Everolimus With and Without Temozolomide in Adult Low Grade Glioma Terminated USA 0
NCT02667587 Phase II Temozolomide Nivolumab + Temozolomide Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer). Completed USA | SWE | POL | NOR | NLD | ITA | ISR | GBR | FRA | ESP | DNK | DEU | CHE | CAN | BEL | AUT | AUS 2
NCT05629702 Phase II Nabiximols + Temozolomide Temozolomide ARISTOCRAT: Blinded Trial of Temozolomide +/- Cannabinoids (ARISTOCRAT) Recruiting GBR 0
NCT03776071 Phase III Enzastaurin Temozolomide Enzastaurin + Temozolomide A Trial of Enzastaurin Plus Temozolomide During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma With or Without the Novel Genomic Biomarker, DGM1 Completed USA | CAN 1
NCT02502708 Phase I Indoximod Temozolomide Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Primary Malignant Brain Tumors Completed USA 0
NCT05432804 Phase Ib/II Selinexor + Temozolomide Temozolomide Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment Recruiting USA 0
NCT05554003 Phase II Temozolomide Metronomic Temozolomide in Unfit NENs Patients Metronomic Temozolomide in Unfit Patients With Advanced Neuroendocrine Neoplasms (NENs): MeTe Study (MeTe) Recruiting ITA 0
NCT02315534 Phase Ib/II Napabucasin Temozolomide A Study of BBI608 in Combination With Temozolomide in Adult Patients With Recurrent or Progressed Glioblastoma Completed USA | CAN 0
NCT01430351 Phase I Metformin + Temozolomide Mefloquine + Temozolomide Memantine + Metformin + Temozolomide Mefloquine + Memantine + Temozolomide Mefloquine + Memantine + Metformin + Temozolomide Temozolomide Mefloquine + Metformin + Temozolomide Memantine + Temozolomide Temozolomide, Memantine Hydrochloride, Mefloquine, and Metformin Hydrochloride in Treating Patients With Glioblastoma Multiforme After Radiation Therapy Active, not recruiting USA 0
NCT04195139 Phase II Nivolumab + Temozolomide Temozolomide Nivolumab and Temozolomide Versus Temozolomide Alone in Newly Diagnosed Elderly Patients With GBM (NUTMEG) Active, not recruiting USA | AUS 0
NCT02308527 Phase II Bevacizumab + Irinotecan + Temozolomide Temozolomide + Topotecan Bevacizumab + Temozolomide Bevacizumab + Temozolomide + Topotecan Dinutuximab beta + Temozolomide Temozolomide Dinutuximab beta + Temozolomide + Topotecan Irinotecan + Temozolomide Cyclophosphamide + Dinutuximab beta + Topotecan Activity Study of Bevacizumab With Temozolomide ± Irinotecan for Neuroblastoma in Children (BEACON) Active, not recruiting NLD | ITA | IRL | GBR | FRA | ESP | DNK | CHE | BEL | AUT 0
NCT01390948 Phase II Temozolomide Bevacizumab A Study of Avastin (Bevacizumab) in Combination With Temolozomide (TMZ) and Radiotherapy in Paediatric and Adolescent Patients With High-Grade Glioma Completed SWE | POL | NLD | ITA | HUN | GBR | FRA | ESP | DNK | CZE | CAN | BEL | AUT | AUS 0
NCT05083754 Phase I Retifanlimab Temozolomide Retifanlimab + Temozolomide Carmustine Wafer in Combination With Retifanlimab and Radiation With/Without Temozolomide in Subjects With Glioblastoma Recruiting USA 0


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