Temozolomide clinical trials
Also written Temodar, Temodal, SCH 52365 and Methazolastone.
How each study uses Temozolomide is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study
Get an email when these change. Save the Temozolomide studies recruiting or about to start — once a week, free: studies that open, close, add sites or post results.
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Example · made-up studies
Breast cancer · Recruiting: 2 came in, 3 changed
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· Enrollment: 300 → 450 participants
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Approvals
The first approval found in each region, with its record
- United States
- 11 Aug 1999 · TEMODAR · NDA 021029 (FDA, Drugs@FDA)
- European Union
- 26 Jan 1999 · Temodal · EMEA/H/C/000229 (EMA)
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
How studies write it
Studies that test it under each name
Studies by the year they started
575 studies that test it; most in 2007 (38); 3 more planned to start later
| Year | Studies |
|---|---|
| 1997 | 3 |
| 1998 | 10 |
| 1999 | 9 |
| 2000 | 22 |
| 2001 | 9 |
| 2002 | 16 |
| 2003 | 11 |
| 2004 | 21 |
| 2005 | 36 |
| 2006 | 29 |
| 2007 | 38 |
| 2008 | 26 |
| 2009 | 31 |
| 2010 | 22 |
| 2011 | 14 |
| 2012 | 16 |
| 2013 | 22 |
| 2014 | 19 |
| 2015 | 19 |
| 2016 | 23 |
| 2017 | 24 |
| 2018 | 22 |
| 2019 | 20 |
| 2020 | 22 |
| 2021 | 18 |
| 2022 | 21 |
| 2023 | 11 |
| 2024 | 15 |
| 2025 | 14 |
| 2026 | 12 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 65 · Other 515
National Cancer Institute (NCI) (30) · M.D. Anderson Cancer Center (23) · Duke University (22) · Memorial Sloan Kettering Cancer Center (21) · Merck Sharp & Dohme LLC (15) · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (14) · Children's Oncology Group (11) · European Organisation for Research and Treatment of Cancer - EORTC (11)
Often tested with
Tested in the same studies.
Irinotecan (64) · Bevacizumab (41) · Carboplatin (19) · Vincristine (17) · Capecitabine (16) · Cisplatin (15) · Lomustine (14) · Thalidomide (13)
Related medicines
As reviewed, each with the page that says it.
- One of Alkylating agents source
Coming up
From the study records. Dates are the sponsors’ own estimates and often move.
Tested against it · 10 phase 3 studies under way
Temozolomide is the comparator. A study of two new drugs counts under both.
- 1Carboplatin · CarThera · next primary completion Jan 2028
- 1Niraparib · Ivy Brain Tumor Center · next primary completion Dec 2027
- 1Naporafenib · Erasca, Inc. · next primary completion Apr 2028
- 1Vebreltinib · Beijing Pearl Biotechnology Limited Liability Company
- 1Pucotenlimab · Taizhou Hanzhong biomedical co. LTD
- 1Regorafenib · Global Coalition for Adaptive Research · next primary completion Jun 2028
- 1GDC-0084 · Global Coalition for Adaptive Research · next primary completion Jun 2028
- 1Dianhydrogalactitol · Global Coalition for Adaptive Research · next primary completion Jun 2028
Reaching primary completion within a year · 28, 3 in phase 3
Studies that test Temozolomide, phase 3 first.
- Nov 2026High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)Phase 3 · Gustave Roussy, Cancer Campus, Grand Paris
- Dec 2026Chemoimmunotherapy Combined With Autologous NK Cell Therapy for Pediatric Patients With Refractory and Relapsed High-Risk Neuroblastoma and GanglioneuroblastomaPhase 3 · Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- Dec 2026Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade GliomaPhase 3 · Eastern Cooperative Oncology Group
- Nov 2026Multiparametric MR-Guided High Dose Adaptive Radiotherapy With Concurrent Temozolomide in Patients With Newly Diagnosed GlioblastomaPhase 2 · University of Michigan Rogel Cancer Center
- Dec 2026NK Cells Infusions With Irinotecan, Temozolomide, and DinutuximabPhase 1/2 · Nationwide Children's Hospital
- Dec 2026Study of Acetazolamide With Temozolomide in Adults With Newly Diagnosed or Recurrent Malignant GliomaPhase 1 · University of Chicago
- Dec 2026Short Course Chemo-Radiation Therapy for Patients With Newly Diagnosed GlioblastomaPhase 1/2 · John Flickinger
- Dec 2026Niraparib and Temozolomide in Patients GlioblastomaPhase 1/2 · Armando Santoro, MD
- Dec 2026The Efficacy and Safety of Temozolomide in SDH-deficient GISTPhase 2 · Asan Medical Center
- Dec 2026Chemotherapy and Radiation Therapy for the Treatment of IDH Wildtype Gliomas or Non-histological (Molecular) GlioblastomasPhase 2 · M.D. Anderson Cancer Center
Studies
Open first, then newest update. How each study uses Temozolomide is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 580
- Naxitamab Enabled Transplant-Free Study in High-Risk NeuroblastomaRecruitingPhase 2Giselle ShollerNCT07932808Written as Naxitamab and GM-CSF in combination with irinotecan and temozolomide
- Combination ADI-PEG 20, TMZ, and RT for Treatment of Newly Diagnosed High-grade Glioma (HGG)Not yet recruitingPhase 1/2Sabine Mueller, MD, PhDNCT07389278Written as Temozolomide (TMZ)
- A Study of Zedoresertib (Debio 0123) in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Zedoresertib (Debio 0123) in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed GlioblastomaRecruitingPhase 1/2Debiopharm International SANCT05765812Written as Temozolomide
- A Single-Arm, Open-Label, Multicenter Clinical Study of Teniposide Combined With Temozolomide for the Treatment of Newly Diagnosed Glioblastoma (nGBM) With MGMT Promotor Region UnmethylatedNot yet recruitingNot applicableSun Yat-sen UniversityNCT07894549Written as Teniposide Combined with Temozolomide
- Temozolomide, With or Without WSD0922-FU, for the Treatment of EGFR-Mutant, IDH-Wildtype GlioblastomaRecruitingPhase 2Mayo ClinicNCT07708961Written as Temozolomide
- Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine CarcinomasNot yet recruitingPhase 2Roswell Park Cancer InstituteNCT06202066Written as Temozolomide
- Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma, ATRT and Rare CNS TumorsRecruitingPhase 2Medical University of ViennaNCT01356290Written as Temozolomide (TMZ)
- CapTemY90 for Grade 2/3 NET Liver MetastasesRecruitingPhase 2Abramson Cancer Center at Penn MedicineNCT04339036Written as Temozolomide Oral Product
- Metronomic Temozolomide With Dexbrompheniramine for Recurrent High-Grade Glioma/GlioblastomaNot yet recruitingPhase 1/2University of NebraskaNCT07859059Written as Temozolomide
- Medication Combinations of Dasatinib, Quercetin, Fisetin, Temozolomide, LMP744, and Autologous TLPO Vaccine for the Treatment of Previously Treated Glioma With Residual DiseaseRecruitingEarly Phase 1Mayo ClinicNCT07025226Written as Temozolomide
- Preoperative Radiosurgery for the Treatment of High Grade Glioma, NeoGlioma TrialRecruitingPhase 1Mayo ClinicNCT05030298Written as Temozolomide
- Metastatic Ewing's Trial Testing Schedule Enhancement to Improve OutcomesRecruitingPhase 1H. Lee Moffitt Cancer Center and Research InstituteNCT07194044Written as Temozolomide
- Combination of Tarlatamab and Temozolomide in Patients With Central Nervous System TumorsRecruitingPhase 1/2Centre Leon BerardNCT07243470Written as Temozolomide (TMZ)
- Triapine in Combination With Temozolomide for the Treatment of Patients With Recurrent GlioblastomaRecruitingPhase 1Northwestern UniversityNCT06410248Written as Temozolomide
- Study of ABBV-637 or ABBV-155 With ERAS-801 for People With GlioblastomaRecruitingPhase 1Memorial Sloan Kettering Cancer CenterNCT06934889Written as Temozolomide
- Trial of Temozolomide in BAP1 Mutated Patients With Advanced or Metastatic Cutaneous MelanomaNot yet recruitingPhase 2Assistance Publique Hopitaux De MarseilleNCT07807878Written as Temozolomide (TMZ)
- Study of Olutasidenib and Temozolomide in HGGRecruitingPhase 2Rigel PharmaceuticalsNCT06161974Written as Olutasidenib + TMZ
- N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With NeuroblastomaRecruitingPhase 2Memorial Sloan Kettering Cancer CenterNCT06528496Written as Temozolomide
- INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)RecruitingPhase 2David Reardon, MDNCT02977780Written as Temozolomide
- Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent SarcomaRecruitingNot applicableM.D. Anderson Cancer CenterNCT04199026Written as Temozolomide
See all 580 studies that test Temozolomide →
Given beside what is tested · 278 — Temozolomide is usual care or a partner of the new treatment
- Advanced Imaging-Guided Standard Versus Dose-Intensified Radiation Therapy for the Treatment of Newly Diagnosed Glioblastoma, SAGA 2.0 TrialNot yet recruitingPhase 3Mayo ClinicNCT07935889Written as Temozolomide
- Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid TumorsRecruitingPhase 1/2Milton S. Hershey Medical CenterNCT06541262Written as Temozolomide
- Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIIIRecruitingPhase 2Black Diamond Therapeutics, Inc.NCT07326566Written as silevertinib in combination with temozolomide
- Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous TreatmentRecruitingPhase 1/2National Cancer Institute (NCI)NCT05432804Written as Temozolomide
- Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of CareRecruitingPhase 3GT Medical Technologies, Inc.NCT07195591Written as Temozolomide
- Pan Tumor Rollover StudyRecruitingPhase 2Bristol-Myers SquibbNCT03899155Written as Temozolomide
- A Study of the Efficacy and Safety of Lisocabtagene Maraleucel (Liso-cel) as First-Line Therapy in Adults With Transplant-Ineligible Primary Central Nervous System LymphomaRecruitingPhase 2Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyNCT07015242Written as Temozolomide
- A Study of Navlimetostat (BMS-986504) Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)RecruitingPhase 2Bristol-Myers SquibbNCT07492680Written as Temozolomide
- Testing Addition of an Anti-cancer Drug, Vorasidenib to Temozolomide, After Radiation for Advanced Brain CancerRecruitingPhase 3Alliance for Clinical Trials in OncologyNCT07215910Written as Temozolomide
- TRINITY TRIAL; Trial Of PRRT Plus CAPTEM Vs CAPTEM Alone In Well Differentiated GEP NETSNot yet recruitingPhase 3Tata Memorial HospitalNCT07910760Written as Temozolomide (TMZ)
- Chemo-immunotherapy Using Ibrutinib Plus Indoximod for Patients With Pediatric Brain CancerRecruitingPhase 1Theodore S. JohnsonNCT05106296Written as Temozolomide
- Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post ConsolidationRecruitingEarly Phase 1C17 CouncilNCT06942039Written as Temozolomide
- Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk NeuroblastomaRecruitingPhase 3National Cancer Institute (NCI)NCT06172296Written as Temozolomide
- A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent GlioblastomaRecruitingPhase 2BioNTech SENCT07297212Written as Temozolomide
- Pembrolizumab + Chemotherapy in Newly Diagnosed PCNSLRecruitingPhase 1Dana-Farber Cancer InstituteNCT06475235Written as Temozolomide
- IDH1-vac in Patients With Newly Diagnosed IDH1R132H-positive High-grade AstrocytomasNot yet recruitingPhase 2German Cancer Research CenterNCT07888647Written as Temozolomide (TMZ)
- Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Children and Young Adults With Relapsed/Refractory NeuroblastomaRecruitingPhase 1National Cancer Institute (NCI)NCT06995872Written as Temozolomide
- A Phase 0/1 Study of BDTX-1535 in Recurrent High-Grade Glioma (rHGG) and Newly Diagnosed Glioblastoma (nGBM) Participants With EGFR Alterations or FusionsRecruitingEarly Phase 1St. Joseph's Hospital and Medical Center, PhoenixNCT06072586Written as BDTX-1535 combined with temozolomide and radiation therapy
- Tris-CAR-T Cell Therapy Targeting CD44 and CD133 in Newly Diagnosed GlioblastomaNot yet recruitingPhase 2/3Beijing Tiantan HospitalNCT07873996Written as Temozolomide (TMZ)
- ONO-4538 Phase II Rollover Study (ONO-4538-98)RecruitingPhase 2Ono Pharmaceutical Co., Ltd.NCT04566380Written as temozolomide
Showing 20 of 278.
As the comparator · 40 — what is tested is compared with Temozolomide
- Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIIIRecruitingPhase 2Black Diamond Therapeutics, Inc.NCT07326566Written as silevertinib in combination with temozolomide
- A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent GlioblastomaRecruitingPhase 2/3Global Coalition for Adaptive ResearchNCT03970447Written as Temozolomide
- SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous MelanomaRecruitingPhase 3Immatics US, Inc.NCT06743126Written as temozolomide
- IGNITE: Study of Tirabrutinib vs Rituximab and Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)RecruitingPhase 3Ono Pharmaceutical Co., Ltd.NCT07104032Written as Temozolomide
- A Phase II Trial of LM103 in Advanced MelanomaRecruitingPhase 2Suzhou BlueHorse Therapeutics Co., Ltd.NCT07310784Written as Dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin
- Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBMRecruitingPhase 3Northwell HealthNCT05271240Written as Temozolomide and Radiation Alone
- Doxorubicin Hydrochloride Liposome Combined With Irinotecan (AI Regimen) Versus VIT Regimen in the Treatment of Relapsed and Refractory Pediatric Rhabdomyosarcoma: a Prospective, Open-label, Randomized Controlled, Multicenter, Phase II Clinical StudyRecruitingPhase 2Sun Yat-sen UniversityNCT05457829Written as Temozolomide+Irinotecan+Vincristine
- A Randomized Controlled Study Comparing the Safety and Efficacy of Irinotecan Hydrochloride Liposome Injection Combined With Temozolomide and Vincristine (NALIRI-VT) Versus Irinotecan Combined With Temozolomide and Vincristine (VIT) in Patients With Advanced Ewing's SarcomaNot yet recruitingPhase 2Tang XiaodongNCT07092306Written as Irinotecan Combined with Temozolomide and Vincristine (VIT)
- Study on The Sensitizing Effect of Sonodynamic Therapy on The Treatment of Brainstem Glioma With Radiotherapy and Chemotherapy and Survival AnalysisEnrolling by invitationPhase 2Yingjuan ZhengNCT06999148Written as Radiotherapy plus temozolomide
- Vebreltinib Combined With Temozolomide for Glioblastoma (GBM) After SurgeryNot yet recruitingPhase 2Huashan HospitalNCT06780592Written as Vebreltinib + Temozolomide
- Clinical Trial of VIM With VIT in Children With Relapsed and Refractory Soft Tissue Sarcoma.RecruitingPhase 2Yizhuo ZhangNCT06514313Written as Temozolomide+Irinotecan+Vincristine
- FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcomaRecruitingPhase 1/2University of BirminghamNCT04625907Written as Temozolomide
- Dendritic Cell Immunotherapy Against Cancer Stem Cells in Glioblastoma Patients Receiving Standard TherapyRecruitingPhase 2/3Oslo University HospitalNCT03548571Written as Adjuvant temozolomide
- A Study of HX008 Plus Transcatheter Arterial Chemoembolization (TACE) in the First-Line Treatment of Subjects With Stage IV (M1c) Melanoma That is Metastatic to the LiverNot yet recruitingPhase 3Taizhou Hanzhong biomedical co. LTDNCT05647954Written as Temozolomide + TACE
- 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 GlioblastomaCompletedPhase 2/3National Cancer Institute (NCI)NCT04396860Written as Temozolomide
- Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBMActive, not recruitingPhase 3CarTheraNCT05902169Written as Temozolomide
- A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated GlioblastomaActive, not recruitingPhase 3Ivy Brain Tumor CenterNCT06388733Written as Temozolomide
- A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2)Active, not recruitingPhase 3Erasca, Inc.NCT06346067Written as Temozolomide
- A Study of PLB1001 Enteric Capsules in the Treatment of sGBM/IDH Mutant Glioblastoma Patients With the ZM Fusion Gene (FUGEN).Active, not recruitingPhase 2/3Beijing Pearl Biotechnology Limited Liability CompanyNCT06105619Written as Temozolomide
- Evaluation of Fluoxetine and Cytotoxic Lysosomal Stress in Glioma (FLIRT)Active, not recruitingEarly Phase 1Duke UniversityNCT05634707Written as Temozolomide
Showing 20 of 40.
What changed recently
From the registry's own updates since Oct 15, 2026.
Started recruiting1
Newly registered2
- Naxitamab Enabled Transplant-Free Study in High-Risk NeuroblastomaNov 12, 2026NCT07932808
- A Single-Arm, Open-Label, Multicenter Clinical Study of Teniposide Combined With Temozolomide for the Treatment of Newly Diagnosed Glioblastoma (nGBM) With MGMT Promotor Region UnmethylatedOct 26, 2026NCT07894549
Codes
What other systems call Temozolomide · ClinicalTrials.gg INT006660
- MeSH (NLM) D000077204TemozolomideConfirmed ClinicalTrials.gov, NLM, Wikidata
- UNII (FDA) YF1K15M17YTEMOZOLOMIDEConfirmed FDA, NLM, Wikidata
- RxNorm 37776Confirmed FDA, Wikidata
- Wikidata Q425088temozolomideConfirmed FDA, NLM, Wikidata
- NCI Thesaurus C1244TemozolomideOne source FDA
- DrugBank DB00853One source Wikidata
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | D000077204 | Temozolomide | Confirmed ClinicalTrials.gov, NLM, Wikidata |
| UNII (FDA) | YF1K15M17Y | TEMOZOLOMIDE | Confirmed FDA, NLM, Wikidata |
| RxNorm | 37776 | — | Confirmed FDA, Wikidata |
| Wikidata | Q425088 | temozolomide | Confirmed FDA, NLM, Wikidata |
| NCI Thesaurus | C1244 | Temozolomide | One source FDA |
| DrugBank | DB00853 | — | One source Wikidata |
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.