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

Phase 1

Active, not recruiting

• Conditions: IDH1-mutant Cholangiocarcinoma

• Registration Number: NCT05921760
• Lead Sponsor: Servier Bio-Innovation LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-4-21
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Inclusion Criteria:<br><br> - Male of female participant age = 18 years old<br><br> - Have documented IDH1 gene-mutated disease based on local testing procedure<br> (R132C/L/G/H/S mutations variants tested)<br><br> - Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1<br><br> - Has a histopathological diagnosis consistent with nonresectable or metastatic<br> cholangiocarcinoma and are not eligible for curative resection, transplantation, or<br> ablative therapies<br><br> - Participants must have at least one measurable lesion as defined by RECIST Version<br> 1.1. Subjects who have received prior local therapy (including but not limited to<br> embolization, chemoembolization, radiofrequency ablation, or radiation therapy) are<br> eligible provided measurable disease falls outside of the treatment field or if<br> within the field but has shown = 20% growth in size post-treatment assessment.<br><br>Exclusion Criteria:<br><br> - Received prior treatment with an IDH inhibitor or prior treatment with an immune<br> checkpoint inhibitor other than anti-PD1/L1<br><br> - Have active autoimmune disease or any condition requiring systemic treatment with<br> either corticosteroids (> 10 mg daily of prednisone equivalents) or other<br> immunosuppressive medications within 14 days of study treatment<br><br> - Participants who have not recovered from toxicity of previous anticancer therapy,<br> including Grade = 1 non-hematologic toxicity, according to the National Cancer<br> Institute Common Terminology Criteria for Adverse Events v5.0, prior to the first<br> IMP administration. Residual Grade = 2 toxicity from chemotherapy (e.g., alopecia,<br> neuropathy) may be allowed.<br><br> - Have known symptomatic brain metastases requiring steroids. Subjects with previously<br> diagnosed brain metastases are eligible if they have completed their treatment and<br> have recovered from the acute effects of radiation therapy or surgery prior to study<br> entry, have discontinued corticosteroid treatment for these metastases for at least<br> 4 weeks, and have radiographically stable disease for at least 3 months prior to<br> study entry. Note: Up to 10 mg per day of prednisone equivalent will be allowed.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety Phase: To determine the recommended combination dose (RDC) of ivosidenib in combination of immunotherapy;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 dose limiting toxicities (DLTs) associated with study drug regimen, during the first 2 cycles of treatment;Safety Phase: Number of Adverse Events (AEs);Safety Phase: Number of Adverse Events of Special Interests (AESIs);Safety Phase: Number of Serious Adverse Events (SAEs)