5 recruiting, 3 active not recruiting, 1 completed, 1 not yet recruiting. 10 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 10 | Recruiting 5, Active not recruiting 3, Completed 1, Not yet recruiting 1 |
| Phase 2 | 1 | Recruiting 1 |
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 |
| 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 |
| 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 |
| An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy. Ivosidenib 500mg Oral Tablet, Azacitidine - Acute Myeloid Leukemia (AML) | Phase 3 | Recruiting | Servier Affaires Médicales | 245 | 2023-06-14 | 2026-05-08 |
| An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma Ivosidenib Oral Tablet - Cholangiocarcinoma | Phase 3 | Active not recruiting | Servier Affaires Médicales | 299 | 2023-05-03 | 2026-07-31 |
| A Study of Ivosidenib or Enasidenib in Combination With Induction Therapy and Consolidation Therapy, Followed by Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myedysplastic Syndrome EB2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy AG-120, Placebo for AG-120, AG-221 - Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blasts-2 | Phase 3 | Active not recruiting | Stichting Hemato-Oncologie voor Volwassenen Nederland | 968 | 2019-03-01 | 2026-09-22 |
| Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation AG-120, Placebo, Azacitidine - Newly Diagnosed Acute Myeloid Leukemia (AML), Untreated AML | Phase 3 | Active not recruiting | Institut de Recherches Internationales Servier | 146 | 2017-06-26 | 2026-06-29 |
| Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy) AG-120, Placebo - Advanced Cholangiocarcinoma, Metastatic Cholangiocarcinoma | Phase 3 | Completed | Institut de Recherches Internationales Servier | 187 | 2017-02-20 | 2024-08-20 |
| Study of Biomarker-Based Treatment of Acute Myeloid Leukemia Samalizumab (BAML-16-001-S1), BI 836858 (BAML-16-001-S2), Laboratory Biomarker Analysis - Previously Untreated Relapsed Refractory Acute Myeloid Leukemia | Phase 2 / Phase 3 | Recruiting | Beat AML, LLC | 3000 | 2016-11-01 | 2026-09-03 |
Cholangiocarcinoma (3) · Leukemia, Myeloid, Acute (3) · Biliary Tract Neoplasms (2) · Leukemia (1) · Myelodysplastic Syndromes (1) · Neoplasm Metastasis (1)
Institut de Recherches Internationales Servier (3) · Servier Affaires Médicales (2) · UNICANCER (2) · Beat AML, LLC (1) · Servier Bio-Innovation LLC (1) · Stichting Hemato-Oncologie voor Volwassenen Nederland (1)
France (8) · Italy (6) · Netherlands (6) · Spain (6) · United Kingdom (6) · Australia (5) · Germany (5) · United States (5) · Austria (4) · Belgium (4) · Japan (4) · South Korea (4) · Brazil (3) · Canada (3) · China (2)
Julien Edeline, MD (2) · Alice Mims, MD (1) · B.J. Wouters (1) · Ivan Borbath, MD (1) · John Bridgewater, MD (1) · Juan W Valle (1) · Malka David, MD (1)
PMID 34554208, PMID 38010220, PMID 38278871, PMID 40100120, PMID 40504618, PMID 40557912, PMID 40706052, PMID 41241779, PMID 41646284
2018 (1), 2023 (1), 2025 (1)