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Checkpoint Inhibitor

Ivosidenib + Immunotherapy for Bile Duct Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Servier Bio-Innovation LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial tests a drug combo to treat cholangiocarcinoma. Safety and effectiveness of the combo will be evaluated. Treatment continues until toxicity, progression, or other criteria are met.

Who is the study for?

This trial is for adults over 18 with nonresectable or metastatic cholangiocarcinoma (bile duct cancer) that can't be removed by surgery. Participants must have IDH1 gene mutations and be in good physical condition, with a performance status of 0 or 1. They should have at least one measurable tumor lesion.Check my eligibility

What is being tested?

The study tests Ivosidenib combined with immunotherapies Nivolumab and Ipilimumab in two phases: first to find the safest dose combo, then to see how well it works. Treatment continues unless there's too much toxicity, disease progression, or other reasons to stop.See study design

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs like the liver or lungs, infusion reactions from the drugs being given into veins, fatigue, skin issues like rash or itching, digestive problems such as diarrhea or colitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Expansion Phase: To assess the Objective Response (confirmed complete response [CR] or confirmed partial response [PR]) of antitumor activity using RECIST v1.1)

Safety Phase: Number of Adverse Events (AEs)

Safety Phase: Number of Adverse Events of Special Interests (AESIs)

+3 more

Secondary outcome measures

Expansion Phase : area under the concentration-vs-time curve (AUC) from 0 to time of last measurable concentration (AUC0-t)

Expansion Phase: AUC over 1 dosing interval at steady state (AUCtau,ss)

Expansion Phase: Duration of response (DOR)

+21 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Safety Lead-In Phase - ivosidenibExperimental Treatment3 Interventions

First phase of the study.

Group II: Experimental Phase - Cohort 2Experimental Treatment3 Interventions

Second phase of the study. Cohort 2 will include the anti-PD1/L1 previously treated subpopulation.

Group III: Experimental Phase - Cohort 1Experimental Treatment3 Interventions

Second phase of the study. Cohort 1 will include the anti-PD1/L1-naïve subpopulation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~4750

Ipilimumab

2014

Completed Phase 3

~2620

Ivosidenib

2019

Completed Phase 1

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Institut de Recherches Internationales ServierOTHER

86 Previous Clinical Trials

67,044 Total Patients Enrolled

2 Trials studying Cholangiocarcinoma

361 Patients Enrolled for Cholangiocarcinoma

Servier Bio-Innovation LLCLead Sponsor

6 Previous Clinical Trials

565 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have signed up for this research trial?

"Affirmative. Clinicaltrials.gov records indicate that this experiment, which was initially released on October 23rd 2023, is actively seeking participants. 92 individuals from 1 health facility need to be enrolled in the study."

Answered by AI

What outcomes is this clinical trial attempting to achieve?

"This clinical trial's primary outcome will be evaluated over a 42 day period and consists of adverse events. Secondary outcomes include the concentration-to-time curve (AUC) from 0 to last measurable value both during the expansion phase and safety lead in, as well as trough concentrations occurring only during the expansion stage."

Answered by AI

Are further participants being accepted for this trial currently?

"As of now, the clinical trial is actively searching for participants as indicated by data hosted on clinicaltrials.gov; it first became publically available on October 23rd 2023 and was recently updated November 16th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05921760.

All > Intrahepatic Cholangiocarcinoma > Bile Duct Cancer