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New treatment option for Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With...
Official title Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation
ClinicalTrials.gov ID: NCT06501625
What this study is testing
What is Ivosidenib?
Ivosidenib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for locally advanced, unresectable or metastatic cholangiocarcinoma with an idh1 mutation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The objective of this study is to investigate the safety, tolerability and preliminary activity of ivosidenib in combination with durvalumab and gemcitabine/cisplatin as first-line therapy in participants with locally advanced, unresectable or metastatic cholangiocarcinoma with an IDH1 mutation. The study will begin with a safety lead-in phase (Phase 1b study) to determine the recommended combination dose (RDC) and then will transition to an expansion phase (Phase 2 study) to assess the clinical activity of ivosidenib in combination with durvalumab and gemcitabine/cisplatin at the RCD.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Patients who developed recurrent disease \> 6 months after surgery with curative intent, and, if given, \> 6 months after the completion of adjuvant...
- 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...
- Unresolved Grade ≥2 adverse events from a previous anticancer therapy, with the exception of alopecia and vitiligo and the laboratory values listed...
- Patients with Grade ≥2 neuropathy to be evaluated on a case-by-case basis after consultation with the medical monitor
See the full eligibility 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...
- 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...
- 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 treatment 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 treatment...
- 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.) Note: in cases with no active disease for ≥ 5 years, patients may be considered for inclusion if...
- chronic skin condition that does not require systemic therapy
- vitiligo
- alopecia
- hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement therapy
- unmedicated celiac disease that is controlled by diet
- Have heart rate-corrected QT interval using Fridericia's formula (QTcF) of ≥ 450 msec or with other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family...
- Have an active infection, including:
- Hepatitis B (clinical evaluation includes: presence of hepatitis B surface antigen [HBsAg] and/or anti-HBcAb with detectable hepatitis B virus [HBV] DNA ≥ 10 IU/mL)
- Hepatitis C
- Tuberculosis (clinical evaluation includes: clinical history, physical examination and/or radiographic findings, and tuberculosis testing as per local practice)
- Human immunodeficiency virus (clinical evaluation includes: positive HIV 1/2 antibodies) Note: Patients with a resolved or past HBV infection (i.e., presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg)...
The study team makes the final eligibility decision.
Where it's taking place
- Los Alamitos, California, United States
- Los Angeles, California, United States
- Chicago, Illinois, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Spartanburg, South Carolina, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Melbourne, Australia
- Barretos, Brazil
- Belo Horizonte, Brazil
- Curitiba, Brazil
- São Paulo, Brazil
- Toronto, Canada
- Bordeaux, France
- Clichy, France
- Montpellier, France
- Berlin, Germany
- Düsseldorf, Germany
- Frankfurt, Germany
+ 10 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Alamitos, California, United States; Los Angeles, California, United States; Chicago, Illinois, United States; New York, New York, United States; Durham, North Carolina, United States; Spartanburg, South Carolina, United States and 24 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.