24 recruiting, 14 active not recruiting, 12 completed, 3 not yet recruiting. 28 Phase 2, 25 Phase 1, 10 Phase 3, 2 Not applicable.
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 |
|---|---|---|---|---|---|---|
| Investigating Precision Medicine in the Adjuvant Setting in Biliary Tract Cancer Futibatinib, Ivosidenib + Capecitabine, Zanidatamab + Capecitabine - Biliary Tract Cancer (BTC) | Phase 3 | Not yet recruiting | UNICANCER | 990 | 2027-01-02 | 2026-08-04 |
| 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 |
| A Study of an IDH1m Inhibitor in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment Ivosidenib Oral Tablet - IDH1-Mutated Malignancies | Phase 1 | Recruiting | Servier Bio-Innovation LLC | 30 | 2026-01-14 | 2026-08-06 |
| 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 |
| Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation Ivosidenib, Azacitidine - Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS), Myelodysplastic Syndromes (MDS) | Phase 3 | Recruiting | Institut de Recherches Internationales Servier | 48 | 2024-12-03 | 2026-09-03 |
| 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 |
| Ivosidenib and Ruxolitinib in Patients With Advanced Myeloproliferative Neoplasms (MPNs) That Have an IDH1 Gene Mutation Ivosidenib, Ruxolitinib - Myeloproliferative Neoplasms | Phase 1 | Recruiting | University of Chicago | 18 | 2024-09-19 | 2026-09-01 |
| Personalized Medicine for Advanced Biliary Cancer Patients Futibatinib, Ivosidenib, Zanidatamab - Biliary Tract Neoplasms | Phase 3 | Recruiting | UNICANCER | 800 | 2024-07-18 | 2026-05-19 |
| Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 or 2 Systemic Treatment Regimens Ivosidenib 500mg, Placebo - Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen | Phase 3 | Recruiting | Servier Bio-Innovation LLC | 156 | 2024-07-09 | 2026-10-28 |
| MRD-positive AML Clinical Study Ivosidenib, Gilteritinib, Venetoclax - AML, Adult | Not applicable | Recruiting | Institute of Hematology & Blood Diseases Hospital, China | 537 | 2024-05-11 | 2026-08-10 |
| 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 |
| Multicenter, Platform-type Clinical Study of Refractory/Recurrent Acute Myeloid Leukemia Ivosidenib, Venetoclax, Gilteritinib - AML, Refractory | Not applicable | Recruiting | Institute of Hematology & Blood Diseases Hospital, China | 458 | 2024-02-22 | 2026-08-07 |
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Leukemia, Myeloid, Acute (25) · Myelodysplastic Syndromes (7) · Cholangiocarcinoma (6) · Glioma (5) · Myeloproliferative Disorders (5) · Biliary Tract Neoplasms (3) · Leukemia (3) · Recurrence (3) · Chondrosarcoma (2) · Ependymoma (2) · Hematologic Neoplasms (2) · Hepatoblastoma (2) · Histiocytosis, Langerhans-Cell (2) · Lymphoma, Non-Hodgkin (2) · Medulloblastoma (2)
Institut de Recherches Internationales Servier (8) · Agios Pharmaceuticals, Inc. (5) · M.D. Anderson Cancer Center (4) · Institute of Hematology & Blood Diseases Hospital, China (3) · Memorial Sloan Kettering Cancer Center (3) · Servier Bio-Innovation LLC (3) · Massachusetts General Hospital (2) · National Cancer Institute (NCI) (2) · Ruijin Hospital (2) · Servier Affaires Médicales (2) · UNICANCER (2) · University of Chicago (2) · Academic and Community Cancer Research United (1) · Alice Mims (1) · Beat AML, LLC (1)
United States (38) · France (15) · Germany (12) · Australia (11) · Spain (11) · China (10) · Italy (9) · Netherlands (9) · United Kingdom (9) · South Korea (8) · Japan (7) · Brazil (6) · Canada (6) · Austria (5) · Belgium (5)
Courtney DiNardo, MD (3) · Amir T Fathi, MD (2) · Julien Edeline, MD (2) · Alice Mims, MD (1) · Alice S Mims, MD (1) · Anand Patel (1) · B.J. Wouters (1) · Ciara M Kelly, MBBCh, BAO (1) · David Bajor, MD (1) · Donald W Parsons (1) · Elizabeth D Alva (1) · Eytan Stein, MD (1)
PMID 33394722, PMID 38010220, PMID 38507688, PMID 40073835, PMID 40513054, PMID 27245312, PMID 29860938, PMID 31028664, PMID 31300360, PMID 31841594, PMID 32208957, PMID 32296873, PMID 32380538, PMID 32530764, PMID 32648303, PMID 33119479, PMID 33493392, PMID 33591402, PMID 33709779, PMID 34554208, PMID 34672961, PMID 34751786, PMID 34889407, PMID 35166065, PMID 35353553, PMID 37034685, PMID 38278871, PMID 38446419, PMID 38640348, PMID 39096924, PMID 40100120, PMID 40504618, PMID 40557912, PMID 40706052, PMID 40778139, PMID 41138165, PMID 41166674, PMID 41241779, PMID 41646284, PMID 41678089, PMID 42642621, PMID 42686334, PMID 42691436
2015 (2), U10CA180886 (2), 2017 (1), 2018 (1), 2023 (1), 2025 (1), P30CA015083 (1), P30CA033572 (1), P30CA060553 (1), R01CA262496 (1)