Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants with Locally Advanced or Metastatic Cholangiocarcinoma with an IDH1 Mutation
| ClinicalTrials.gov Identifier |
| https://clinicaltrials.gov/study/NCT06501625#participation-criteria |
| Institution Name |
| Institut de Recherches Internationales Servier (I.R.I.S.) Clinical Studies Department |
| Full Institution Address |
|
50 Rue Carnot SURESNES 92150 United States |
| Institution Phone |
| +33 1 55 72 60 00 |
| Additional Institutions |
| See list of participating sites on the clinical trial listing on clinicaltrials.gov. |
| Principal Investigator |
| James Harding, MD and Do-Youn Oh, MD |
| Principal Investigator Phone |
| 646-439-3745 |
| Principal Investigator Email |
| scientificinformation@servier.com |
| Study Coordinator |
| Sergey Grankov |
| Study Coordinator Phone |
| +33 1 55 72 60 00 |
| Study Coordinator Email |
| S095031-210@servier.com |
| Study Overview |
| The study will investigate the safety and effectiveness of ivosidenib in combination with durvalumab and gemcitabine/cisplatin in participants with cholangiocarcinoma (CCA, a type of cancer that forms in the tubes [bile ducts] that carry the digestive fluid bile) with an IDH1 gene mutation that is locally advanced, cannot be removed with surgery (unresectable) or has spread to other places in the body (metastatic). |
| Enrollment Information |
| 52 |
| Study Start Date |
| 2024-12-16 |
| Study End Date |
| 2026-07-23 |
| Study Purpose |
| The aim of this study is to investigate the safety and effectiveness of ivosidenib in combination with durvalumab and gemcitabine/cisplatin in participants with cholangiocarcinoma (CCA, a type of cancer that forms in the tubes [bile ducts] that carry the digestive fluid bile) with an IDH1 gene mutation that is locally advanced, cannot be removed with surgery (unresectable) or has spread to other places in the body (metastatic). |
| Inclusion Criteria |
|
Have a histopathological confirmed diagnosis consistent with locally advanced unresectable or metastatic cholangiocarcinoma. Have documented IDH1 gene-mutated cholangiocarcinoma based on local or central laboratory testing (R132C/L/G/H/S mutation variants tested). Have at least one evaluable and measurable lesion as defined by RECIST v1.1. Have adequate bone marrow function as evidenced by: Absolute neutrophil count ≥ 1,500/mm3 or 1.5 ×109/L Hemoglobin ≥ 9 g/dL Platelet count ≥ 100,000/mm3 or 100 × 109/L Have adequate hepatic function as evidenced by: Serum bilirubin ≤ 2.0 × the upper limit of normal (ULN); this will not apply to patients with confirmed Gilbert's syndrome. Any clinically significant biliary obstruction should be resolved before randomization Aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤ 2.5 × ULN; for patients with hepatic metastases, ALT and AST ≤ 5.0 × ULN Have adequate renal function, defined as: creatinine clearance > 60 mL/min per 24 hour urine or as calculated on the Cockcroft-Gault formula (using actual body weight): Creatine CL (mL/min)= (140 - Age) × (weight in kg) × (0.85 if female)/72 × serum creatinine (mg/dL) |
| Exclusion Criteria |
|
Received treatment for locally advanced, unresectable or metastatic disease with the following exceptions: Treatment with up to one cycle of durvalumab plus gemcitabine/cisplatin treatment is permitted before study participation. Note: For the Safety Lead-In Phase, participants who received one prior cycle of durvalumab plus gemcitabine/cisplatin and required dose modifications for treatment-related toxicity are excluded. Patients who developed recurrent disease > 6 months after surgery with curative intent, and, if given, > 6 months after the completion of adjuvant (chemotherapy and/or radiation). Prior exposure to immune-mediated therapy, including, but not limited to, anti-PD-1or other anti-PD-L1, and anti-PD-L2, anti-CTLA-4 antibodies, excluding therapeutic anticancer vaccines. Unresolved Grade ≥2 adverse events from a previous anticancer therapy, with the exception of alopecia and vitiligo and the laboratory values listed in the inclusion criteria. Patients with Grade ≥2 neuropathy to be evaluated on a case-by-case basis after consultation with the medical monitor Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with ivosidenib may be included only after consultation with the medical monitor Participation in another interventional study at the same time or within 14 days prior to the first study medication (triple combination treatment) administration. For patients having participated to another prior interventional study, the first dose of ivosidenib should occur after a period greater than or equal to 5 half-lives or 28 days, whichever is shorter of the last dose of the prior investigational product. Active or prior documented autoimmune or inflammatory disorders including: inflammatory bowel disease (e.g., colitis or Crohn's disease) diverticulitis (with the exception of diverticulosis) systemic lupus erythematosus Sarcoidosis syndrome Wegener syndrome (granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.) |
| Required Tests Prior to Study |
| See list of required tests on the clinical trial listing on clinicaltrials.gov. |
| Potential Side Effects |
| See Clinical Trial listing on clinicaltrial.gov. |
| Financial Assistance Available |
| Yes |