What side effects are associated with this type of intervention?

Common treatments for cholangiocarcinoma, such as Ivosidenib (an IDH1 inhibitor) and immunotherapy agents like nivolumab and ipilimumab, have distinct side effect profiles. Ivosidenib is generally well-tolerated but can cause side effects such as fatigue, nausea, diarrhea, and leukocytosis. Immunotherapy agents, on the other hand, can lead to immune-related adverse events including skin reactions, endocrine disorders, pneumonitis, colitis, and hepatitis. When combined, these treatments may increase the risk of these side effects, necessitating close monitoring and management by healthcare providers.

What prior FDA approvals exist?

Ivosidenib, an IDH1 inhibitor, has been approved by the FDA for the treatment of IDH1-mutant cholangiocarcinoma. This approval is based on its ability to target specific genetic mutations in the cancer cells. In addition to targeted therapies like Ivosidenib, immune checkpoint inhibitors such as pembrolizumab and nivolumab have shown promise in treating cholangiocarcinoma by modulating the immune system to recognize and attack cancer cells. These treatments represent a significant advancement in the management of cholangiocarcinoma, particularly for patients with specific genetic mutations or those who have progressed on standard chemotherapy.

What other types of research exist?

Promising alternatives to Ivosidenib in combination with immunotherapy for cholangiocarcinoma patients include: 1) Durvalumab plus gemcitabine and cisplatin, which has shown efficacy in advanced biliary tract cancer. 2) Dabrafenib plus trametinib for patients with BRAFV600E mutations, as indicated by results from the ROAR and NCI-MATCH trials. These combinations have demonstrated potential in clinical trials and may offer effective treatment options in 2024.

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Checkpoint Inhibitor

Ivosidenib + Immunotherapy for Bile Duct Cancer

Phase 1 & 2

Waitlist Available

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

No Placebo-Only Group

Summary

This trial tests a combination of a cancer-targeting drug and immune system treatment in patients with advanced bile duct cancer. The goal is to see if this combination is safe and effective.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2015

Completed Phase 3

~4010

Ipilimumab

2015

Completed Phase 3

~3070

Ivosidenib

2019

Completed Phase 1

~20

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for cholangiocarcinoma include IDH1 inhibitors and immunotherapy. IDH1 inhibitors, such as ivosidenib, target specific genetic mutations in the IDH1 gene that promote cancer growth, thereby reducing tumor proliferation. Immunotherapy, including checkpoint inhibitors like nivolumab and ipilimumab, enhances the immune system's ability to recognize and attack cancer cells by blocking proteins that inhibit immune responses. This combination of targeting genetic mutations and boosting immune activity is significant for cholangiocarcinoma patients as it offers a multifaceted approach to controlling tumor growth and improving outcomes.

Chemotherapy for Biliary Tract Cancer in 2021.