14 recruiting, 8 active not recruiting, 2 completed, 2 not yet recruiting. 28 Phase 2, 6 Phase 1, 1 Phase 3.
Follow ivosidenib: new trials by email Literature Review of ivosidenib trials Research Report on ivosidenib
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study Evaluating the Efficacy and Safety of the Addition of Ivosidenib to Oral Azacitidine (Onureg®) in Patients Over 55 With Acute Myeloid Leukemia (AML) and IDH1 Mutation, in Complete Remission After Intensive Chemotherapy. Ivosidenib + oral azacitidine - Acute Myeloid Leukemia | Phase 2 | Not yet recruiting | French Innovative Leukemia Organisation | 60 | 2026-09-01 | 2026-03-11 |
| Oral Decitabine Plus Ivosidenib as First Line for Older/Unfit Adult AML Patients Decitabine/Cedazuridine 35 Mg-100 Mg ORAL TABLET, Ivosidenib Oral Tablet, Hydroxyurea - Acute Myeloid Leukemia With Gene Mutations | Phase 2 | Recruiting | PETHEMA Foundation | 50 | 2026-06-12 | 2026-09-22 |
| Ivosidenib as Maintenance Therapy in Transplant-Ineligible IDH1-mutated AML and HR-MDS Ivosidenib - AML (Acute Myeloid Leukemia), MDS (Myelodysplastic Syndrome) | Phase 2 | Recruiting | Ruijin Hospital | 20 | 2026-05-22 | 2026-05-26 |
| Study of SA+X in the Treatment of Newly Diagnosed AML Anthracycline, Ivosidenib, Gilteritinib - Acute Myeloid Leukemia | Phase 2 | Recruiting | Ruijin Hospital | 205 | 2026-05-01 | 2026-07-30 |
| A Study of the Combination of Ivosidenib, Azacitidine, and Venetoclax Followed by Ivosidenib Alone in People With Acute Myeloid Leukemia Ivosidenib, Azacitidine, Venetoclax - Acute Myeloid Leukemia | Phase 2 | Recruiting | Memorial Sloan Kettering Cancer Center | 45 | 2026-01-27 | 2026-10-06 |
| Ivosidenib as Post-HSCT Maintenance for AML Ivosidenib, Placebo - IDH1 Mutation, Acute Myeloid Leukemia (AML) | Phase 2 | Recruiting | Massachusetts General Hospital | 75 | 2026-01-16 | 2026-10-05 |
| Phase II Study Evaluating Ivosidenib Maintenance After SOC Adjuvant Chemotherapy in Curative mIDH1 Cholangiocarcinoma Ivosidenib - Cholangiocarcinoma, IDH Mutation | Phase 2 | Recruiting | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | 40 | 2025-11-18 | 2026-08-12 |
| Venetoclax in Combination With Ivosidenib and Azacitidine for Newly Diagnosed IDH1-Mutated AML Ivosidenib, Venetoclax, Azacitidine - AML, IDH1 Mutation | Phase 1 / Phase 2 | Recruiting | Institute of Hematology & Blood Diseases Hospital, China | 23 | 2025-10-17 | 2026-05-13 |
| Prospective Evaluation of Ivosidenib Maintenance Following Allogeneic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Neoplasia With IDH1 (Isocitrate Dehydrogenase 1) Mutation Ivosidenib 250 MG (milligram) - AML, MDS | Phase 2 | Recruiting | Technische Universität Dresden | 76 | 2025-06-17 | 2026-08-26 |
| Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation Ivosidenib, Durvalumab (for the first 8, 21-day, cycles), Gemcitabine (for the first 8, 21-day, cycles) - Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation | Phase 1 / Phase 2 | Active not recruiting | Institut de Recherches Internationales Servier | 55 | 2024-12-16 | 2026-10-13 |
| Lvosidenib (AK112) Combined With CapeOX and Radiotherapy in Patients With Unresectable Metastatic MSS-type Colorectal Cancer Ivosidenib (AK112) - CRC, MSS | Phase 2 | Not yet recruiting | Fudan University | 36 | 2024-11-01 | 2024-09-19 |
| An Exploratory Study on the Use of Ivosidenib for the Precise Treatment of Advanced Biliary Tract Malignancies With IDH1 Mutations in the Later Line of Therapy. Ivosidenib, Lenvatinib, PD-1/PD-L1 inhibitor - Biliary Tract Cancer | Phase 2 | Recruiting | Peking Union Medical College Hospital | 300 | 2024-05-01 | 2025-12-15 |
| Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma Ivosidenib, Nivolumab, Ipilimumab - IDH1-mutant Cholangiocarcinoma | Phase 1 / Phase 2 | Terminated | Servier Bio-Innovation LLC | 7 | 2023-10-23 | 2026-04-20 |
| A Phase 2 Study of Ivosidenib in Previously Treated Japanese Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation Ivosidenib - Cholangiocarcinoma Non-resectable, Cholangiocarcinoma Metastatic | Phase 2 | Active not recruiting | Servier | 12 | 2023-10-10 | 2025-12-09 |
| IDH Targeted/Non- Targeted vs Non-targeted/IDH-targeted Approaches in the Treatment of Newly Diagnosed IDH Mutated AML Patients Not Candidates for Intensive Induction Therapy (I- DATA Study) Azacitidine, Biopsy, Enasidenib - Acute Myeloid Leukemia | Phase 2 | Recruiting | Alice Mims | 125 | 2022-09-13 | 2026-06-23 |
| Ivosidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH1 Ivosidenib - Clonal Cytopenia of Undetermined Significance | Phase 2 | Active not recruiting | Washington University School of Medicine | 20 | 2022-04-01 | 2026-08-12 |
| Ivosidenib (AG-120) With Nivolumab in IDH1 Mutant Tumors ivosidenib and nivolumab - Advanced Solid Tumor, IDH1 Mutation | Phase 2 | Completed | Jason J. Luke, MD | 15 | 2021-09-20 | 2025-02-27 |
| Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Decitabine and Cedazuridine, Enasidenib, Ivosidenib - Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia | Phase 1 / Phase 2 | Recruiting | M.D. Anderson Cancer Center | 84 | 2021-05-24 | 2026-05-20 |
| CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome Ivosidenib, Liposome-encapsulated Daunorubicin-Cytarabine - Acute Myeloid Leukemia With Gene Mutations, Myelodysplastic Syndrome | Phase 2 | Recruiting | M.D. Anderson Cancer Center | 30 | 2020-12-30 | 2026-08-25 |
| Ivosidenib in Treating Patients With Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With IDH1 Mutations (A Pediatric MATCH Treatment Trial) Ivosidenib - Recurrent Ependymoma, Recurrent Ewing Sarcoma | Phase 2 | Active not recruiting | National Cancer Institute (NCI) | 3 | 2020-07-20 | 2026-07-01 |
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Leukemia, Myeloid, Acute (12) · Myelodysplastic Syndromes (4) · Glioma (3) · Ependymoma (2) · Hepatoblastoma (2) · Histiocytosis, Langerhans-Cell (2) · Lymphoma, Non-Hodgkin (2) · Medulloblastoma (2) · Myeloproliferative Disorders (2) · Neuroblastoma (2) · Neuroectodermal Tumors, Primitive, Peripheral (2) · Osteosarcoma (2) · Rhabdoid Tumor (2) · Rhabdomyosarcoma (2) · Sarcoma (2)
M.D. Anderson Cancer Center (3) · Memorial Sloan Kettering Cancer Center (2) · National Cancer Institute (NCI) (2) · Ruijin Hospital (2) · Alice Mims (1) · Beat AML, LLC (1) · Celgene (1) · French Innovative Leukemia Organisation (1) · Fudan University (1) · Groupe Francophone des Myelodysplasies (1) · Hoffmann-La Roche (1) · Institut de Recherches Internationales Servier (1) · Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest (1) · Institute of Hematology & Blood Diseases Hospital, China (1) · Jason J. Luke, MD (1)
United States (16) · Australia (5) · China (5) · France (5) · Germany (5) · Spain (4) · Canada (3) · Italy (3) · Japan (3) · Portugal (3) · South Korea (3) · United Kingdom (3) · Brazil (2) · Netherlands (2) · Puerto Rico (2)
Courtney DiNardo, MD (3) · Alice Mims, MD (1) · Alice S Mims, MD (1) · Amir T Fathi, MD (1) · Ciara M Kelly, MBBCh, BAO (1) · Donald W Parsons (1) · Elizabeth D Alva (1) · Hui Wei, MD (1) · Jason J Luke, MD, PhD (1) · Kelly Bolton, M.D., Ph.D. (1) · Kuo-Kai Chin, MD (1)
PMID 40073835, PMID 40513054, PMID 33119479, PMID 33591402, PMID 34672961, PMID 34889407, PMID 35353553, PMID 38010220, PMID 38446419, PMID 38507688, PMID 39096924, PMID 40504618, PMID 40557912, PMID 40778139, PMID 41138165, PMID 41166674, PMID 42642621, PMID 42686334, PMID 42691436
U10CA180886 (2), 2015 (1), 2017 (1), R01CA262496 (1)