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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-23

Study Completion Date

2024-11-21

Brief Summary

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This is a Phase 1/2 study evaluating the safety, tolerability, and activity of ivosidenib in combination with immunotherapy in participants with nonresectable or metastatic cholangiocarcinoma. The study includes two phases: the safety lead-in phase to determine the recommended combination dose (RCD) of ivosidenib in combination with immunotherapy and the dose expansion phase to assess the efficacy of ivosidenib in combination with immunotherapy. Study treatment will be administered until participant experiences unacceptable toxicity, disease progression, or other discontinuation criteria are met.

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Detailed Description

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Conditions

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IDH1-mutant Cholangiocarcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Safety Lead-In Phase - ivosidenib

First phase of the study.

Group Type EXPERIMENTAL

Ivosidenib

Intervention Type DRUG

ivosidenib taken once daily

Nivolumab

Intervention Type DRUG

Nivolumab taken by intravenous infusion

Ipilimumab

Intervention Type DRUG

Ipilimumab taken by intravenous infusion

Experimental Phase - Cohort 1

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

Group Type EXPERIMENTAL

Recommended Combination Dose (RCD) of ivosidenib

Intervention Type DRUG

The RCD of ivosidenib taken once daily

Nivolumab

Intervention Type DRUG

Nivolumab taken by intravenous infusion

Ipilimumab

Intervention Type DRUG

Ipilimumab taken by intravenous infusion

Experimental Phase - Cohort 2

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

Group Type EXPERIMENTAL

Recommended Combination Dose (RCD) of ivosidenib

Intervention Type DRUG

The RCD of ivosidenib taken once daily

Nivolumab

Intervention Type DRUG

Nivolumab taken by intravenous infusion

Ipilimumab

Intervention Type DRUG

Ipilimumab taken by intravenous infusion

Interventions

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Ivosidenib

ivosidenib taken once daily

Intervention Type DRUG

Recommended Combination Dose (RCD) of ivosidenib

The RCD of ivosidenib taken once daily

Intervention Type DRUG

Nivolumab

Nivolumab taken by intravenous infusion

Intervention Type DRUG

Ipilimumab

Ipilimumab taken by intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male of female participant age ≥ 18 years old
* Have documented IDH1 gene-mutated disease based on local testing procedure (R132C/L/G/H/S mutations variants tested)
* Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1
* Has a histopathological diagnosis consistent with nonresectable or metastatic cholangiocarcinoma and are not eligible for curative resection, transplantation, or ablative therapies
* Participants must have at least one measurable lesion as defined by RECIST Version 1.1. Subjects who have received prior local therapy (including but not limited to embolization, chemoembolization, radiofrequency ablation, or radiation therapy) are eligible provided measurable disease falls outside of the treatment field or if within the field but has shown ≥ 20% growth in size post-treatment assessment.

Exclusion Criteria

* Received prior treatment with an IDH inhibitor or prior treatment with an immune checkpoint inhibitor other than anti-PD1/L1
* Have active autoimmune disease or any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily of prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment
* Participants who have not recovered from toxicity of previous anticancer therapy, including Grade ≥ 1 non-hematologic toxicity, according to the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0, prior to the first IMP administration. Residual Grade ≤ 2 toxicity from chemotherapy (e.g., alopecia, neuropathy) may be allowed.
* Have known symptomatic brain metastases requiring steroids. Subjects with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least 4 weeks, and have radiographically stable disease for at least 3 months prior to study entry. Note: Up to 10 mg per day of prednisone equivalent will be allowed.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No