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Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma

Code de protocole Servier: CL1-95031-006 Sponsor: Servier Bio-Innovation LLC Identifiant Clinicaltrials.gov: NCT05921760

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Comment participer à l'étude ?
Si vous pensez être éligible pour cette étude (voir
critères d'éligibilité
ci-dessous), vous pouvez identifier le site le plus proche de chez vous et le contacter directement. Si vous ne trouvez pas de site près de chez vous, veuillez contacter l'Institut de Recherches Internationales Servier (I.R.I.S.).
Nom: Institut de Recherches Internationales Servier, Département des études cliniques
Numéro de téléphone: +33 1 55 72 60 00
L'étude a 5 centres

Description de l'étude

The aim of this study is to see if the test drug S05762, combined with dapagliflozin, is safe and works well for people with type 2 diabetes.

Type 2 diabetes is a disease where the body can’t use insulin properly, causing high blood sugar. It’s important to control blood sugar to avoid serious problems with blood vessels, nerves, eyes, and kidneys.

Different drugs can be used together to help control blood sugar.

S05762, also called gliclazide modified release, has been used since 2008 to treat high blood sugar in type 2 diabetes. It helps the pancreas make more insulin.

Dapagliflozin has been used since 2012 to treat high blood sugar in type 2 diabetes. It helps remove sugar from the body through urine.

If participants are already taking metformin, S05762 and dapagliflozin will be added to their treatment.

The main goals of this study are:

  • To see if S05762 combined with dapagliflozin works well for treating type 2 diabetes.
  • To check if S05762 combined with dapagliflozin is safe.
Titre officiel: A Phase 1/2, Safety Lead-in and Dose Expansion, Open-label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Activity of Ivosidenib in Combination With Nivolumab and Ipilimumab in Previously Treated Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
Indications
IDH1-mutant Cholangiocarcinoma
Interventions / Traitements
  • Ivosidenib
  • Recommended Combination Dose (RCD) of ivosidenib
  • Nivolumab
  • Ipilimumab
Autres numéros d'identification
  • CL1-95031-006

Critères d'éligibilité

Age éligible pour l’étude

18 ans et plus (Adulte, Adulte plus âgé)

Sexes

Homme/Femme

Accepte les volontaires en bonne santé

Non

To take part in the study, participants have to:

  • be at least 18 years old.
  • have a Body Mass Index (BMI) between 25 and 40.
  • have Type 2 diabetes, which was diagnosed more than 6 months ago.
  • be following a stable diet and exercise plan.
  • be currently taking metformin alone at a daily dose of at least 1500 mg for the past 12 weeks, or dapagliflozin or empagliflozin alone or with metformin at a daily dose of at least 1500 mg for the past 12 weeks.
  • use effective birth control methods during the study and for a specified period after the last dose of the study medication to prevent pregnancy.

Participants will not be able to join the study if they:

  • cannot swallow pills or are unlikely to cooperate with the study or study procedures.
  • are currently participating or have participated in another drug study within the past 3 months.
  • have type 1 diabetes or have used certain diabetes medications recently.
  • have used certain other medications recently, including weight loss drugs.
  • have serious heart problems, high blood pressure, or liver disease.
  • have a weakened immune system, diabetic complications, or serious eye problems.
  • have had significant gastrointestinal surgery or issues.
  • have had cancer within the past 3 years (except treated skin cancer).
  • have mental health issues, drug/alcohol abuse, or psychiatric disorders that are not well-controlled.
  • have any condition that the study doctor believes makes it unsafe to participate.
  • are allergic to gliclazide or dapagliflozin, or their ingredients.
  • have donated blood, lost a lot of blood, or had a blood transfusion recently.

Comment l'étude est-elle conçue ?

Allocation
Randomisé
Modèle d'étude interventionnelle
Parallèle
Groupe de participants / Bras de traitement
Expérimental: Glicazide MR (S05762)

Glicazide MR

Intervention / Traitement
Traitement: Glicazide MR

Glicazide MR 60 mg tablets

0.5-1 oral tablet once a day at breakfast meal

Traitement: Dapagliflozin with or without metformin

Dapagliflozin 10 mg with or without metformin

1 oral tablet once a day at breakfast meal

Groupe de participants / Bras de traitement
Comparaison avec le placebo: Placebo

Matched placebo

Intervention / Traitement
Traitement: Placebo

Placebo tablets

0.5-1 oral tablet once a day at breakfast meal

Traitement: Dapagliflozin with or without metformin

Dapagliflozin 10 mg with or without metformin

1 oral tablet once a day at breakfast meal