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Therapy Name | Temozolomide |
Synonyms | |
Therapy Description |
Temodar (temozolomide) is a dacarbazine analog and cytotoxic alkylating agent (NCI Drug Dictionary). |
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). |
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 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT01638546 | Phase II | Temozolomide Veliparib | Temozolomide With or Without Veliparib in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer | Active, not recruiting | USA | 0 |
NCT02152982 | Phase II | Veliparib Temozolomide | Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme | Active, not recruiting | USA | 1 |
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 |
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 |
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 |
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 |
NCT03556384 | Phase II | Temozolomide | Temozolomide (TMZ) in Advanced Succinate Dehydrogenase (SDH)-Mutant/Deficient Gastrointestinal Stromal Tumor (GIST) | 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 |
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 |
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 |
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 |
NCT01514201 | Phase Ib/II | Temozolomide Veliparib | Veliparib, Radiation Therapy, and Temozolomide in Treating Younger Patients With Newly Diagnosed Diffuse Pontine Gliomas | Completed | 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 |
NCT01800695 | Phase I | Temozolomide Depatuxizumab mafodotin | Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme | Completed | 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 |
NCT01977677 | Phase Ib/II | Temozolomide Plerixafor | Plerixafor After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed High Grade Glioma | Completed | 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 |
NCT02052648 | Phase Ib/II | Temozolomide Indoximod | Study of IDO Inhibitor and Temozolomide for Adult Patients With Primary Malignant Brain Tumors | Completed | USA | 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 |
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 |
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 |
NCT02392793 | Phase I | Irinotecan + Talazoparib Temozolomide | Talazoparib Plus Irinotecan With or Without Temozolomide in Children With Refractory or Recurrent Solid Malignancies | Completed | USA | 0 |
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 |
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 |
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 |
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 |
NCT03425292 | Phase I | Temozolomide Ipilimumab + Nivolumab Nivolumab | A Longitudinal Assessment of Tumor Evolution in Patients With Brain Cancer | Completed | USA | 0 |
NCT03576612 | Phase I | AdV-tk Temozolomide Valacyclovir Nivolumab | GMCI, Nivolumab, and Radiation Therapy in Treating Patients With Newly Diagnosed High-Grade Gliomas (GMCI) | Completed | USA | 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 |
NCT03782415 | Phase Ib/II | Temozolomide Ibudilast + Temozolomide | Study to Evaluate Ibudilast and TMZ Combo Treatment in Recurrent GBM | Completed | 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 |
NCT06202066 | Phase II | Montanide ISA 51 + Sargramostim + SurVaxM + Temozolomide Temozolomide | Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Tumors | Not yet recruiting | USA | 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 |
NCT02977780 | Phase II | CC-115 Abemaciclib + Temozolomide Temozolomide Neratinib + Temozolomide | INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT) | Recruiting | 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 |
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 | Recruiting | USA | 0 |
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 |
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 |
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 |
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 |
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 |
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 |
NCT05629702 | Phase II | Nabiximols + Temozolomide Temozolomide | ARISTOCRAT: Blinded Trial of Temozolomide +/- Cannabinoids (ARISTOCRAT) | Recruiting | GBR | 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 |
NCT06388733 | Phase III | Niraparib Temozolomide | A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma | Recruiting | USA | NOR | NLD | FRA | ESP | 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 |
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 |
NCT06743126 | Phase III | Pembrolizumab Temozolomide Carboplatin + Paclitaxel Lifileucel Dacarbazine Nivolumab Paclitaxel Nivolumab and relatlimab-rmbw Nab-paclitaxel Ipilimumab IMA-203 | SUPRAME-ACTengine IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (SUPRAME) | Recruiting | USA | DEU | 0 |
NCT06805305 | Phase II | Temozolomide DOC1021 + Temozolomide | Dendritic Cell Immunotherapy for Treatment of Adult GBM | Recruiting | 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) | Suspended | USA | 0 |
NCT01409174 | Phase Ib/II | Cisplatin Ipilimumab Aldesleukin Temozolomide Interferon alpha-2b | IPI Biochemotherapy for Chemonaive Patients With Metastatic Melanoma | Terminated | USA | 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 | Terminated | USA | 0 |
NCT02023905 | Phase II | Temozolomide Everolimus | Everolimus With and Without Temozolomide in Adult Low Grade Glioma | Terminated | 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 |
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 |
NCT02510950 | Phase I | Sargramostim Poly ICLC Temozolomide | Neoepitope-based Personalized Vaccine Approach in Patients With Newly Diagnosed Glioblastoma | Terminated | USA | 0 |
NCT02530502 | Phase Ib/II | Temozolomide Pembrolizumab | Radiation Therapy With Temozolomide and Pembrolizumab in Treating Patients With Newly Diagnosed Glioblastoma | Terminated | 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 |
NCT00492687 | Phase II | Carboplatin Temozolomide Tamoxifen | Radiation Therapy, Temozolomide, Tamoxifen, and Carboplatin in Treating Patients With Malignant Gliomas | Unknown status | USA | 0 |
NCT02137759 | Phase II | Vorinostat Temozolomide | MRSI to Predict Response to RT/TMZ and Vorinostat in GBM | Unknown status | USA | 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 |
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 |
NCT03879811 | Phase II | Nivolumab Temozolomide | Determining the Effects of Temozolomide Followed by Nivolumab in Patients With Colorectal Cancer | Withdrawn | 0 |
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