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Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma
Servier Protocol Code:
CL1-95031-006
Sponsor:
Servier Bio-Innovation LLC
Clinicaltrials.gov Identifier:
NCT05921760
EU Trial (CTIS) Number:
2023-503236-41-00
Find a recruiting site
How to participate to the study?
If you think you are eligible for this study (see
below), you can identify the location closest to you and contact them directly. If you don’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
eligibility criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Name:
Institut de Recherches Internationales Servier, Département des études cliniques
Phone number:
+33 1 55 72 60 00
The study has 5 locations
Study description
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.
Official title: 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
Conditions
IDH1-mutant Cholangiocarcinoma
Interventions / Treatments
The treatment(s) given to the participants in the study.
- Ivosidenib
- Recommended Combination Dose (RCD) of ivosidenib
- Nivolumab
- Ipilimumab
Other study id numbers
Other identification numbers the study may be known by.
- CL1-95031-006
Eligibility Criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligible age for the study
18 years and older
(Adult, Older Adult)
Sexes
Male/FemaleAccepts Healthy Volunteers
No- * 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.
- * 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.
How is the study designed?
Allocation
How participants are assigned to different groups. Allocation can be random (randomized) or predetermined (non-randomized). Randomized means that participants are assigned at random to their participant group / arm.
Interventional study model
How treatments are given and tested in a study.
Parallel
A parallel study design compares two or more groups at the same time, with each group receiving a different treatment. Researchers then compare the results to determine which treatment is more effective.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Intervention / Treatment
The treatment(s) given to the participants in the study.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Experimental:
Safety Lead-In Phase - ivosidenib
First phase of the study.
Intervention / Treatment
The treatment(s) given to the participants in the study.
Drug:
Ivosidenib
ivosidenib taken once daily
Drug:
Nivolumab
Nivolumab taken by intravenous infusion
Drug:
Ipilimumab
Ipilimumab taken by intravenous infusion
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Experimental:
Experimental Phase - Cohort 1
Second phase of the study. Cohort 1 will include the anti-PD1/L1-naïve subpopulation.
Intervention / Treatment
The treatment(s) given to the participants in the study.
Drug:
Recommended Combination Dose (RCD) of ivosidenib
The RCD of ivosidenib taken once daily
Drug:
Nivolumab
Nivolumab taken by intravenous infusion
Drug:
Ipilimumab
Ipilimumab taken by intravenous infusion
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Experimental:
Experimental Phase - Cohort 2
Second phase of the study. Cohort 2 will include the anti-PD1/L1 previously treated subpopulation.
Intervention / Treatment
The treatment(s) given to the participants in the study.
Drug:
Recommended Combination Dose (RCD) of ivosidenib
The RCD of ivosidenib taken once daily
Drug:
Nivolumab
Nivolumab taken by intravenous infusion
Drug:
Ipilimumab
Ipilimumab taken by intravenous infusion