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Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion/Amplification

Liver Cancer Clinical Trial

Official title:
Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion/Amplification

Clinical Trial Summary

To find the highest tolerable dose of infigratinib that can be given in combination with bevacizumab and atezolizumab to patients with advanced/metastatic CCA with a FGFR2 mutation.

Clinical Trial Description

PRIMARY OBJECTIVE(S): • To determine the safety and maximum tolerated dose (MTD) of the triple combination of infigratinib with bevacizumab and atezolizumab in patients with FGFR-altered metastatic CCA. SECONDARY OBJECTIVE(S): - To determine the overall response rate (ORR), as assessed by the treating Investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. - To evaluate the duration of response in subjects with best overall response of complete response (CR) or partial response (PR). - To evaluate PFS defined as the time from the start of study treatment to disease progression or death, whichever occurs first. - To evaluate the duration of OS defined as the time from the start of study treatment to death from any cause. - To evaluate the clinical benefit rate defined as the proportion of subjects with best overall response of CR, PR, or stable disease EXPLORATORY OBJECTIVE: • To examine the change of the immune microenvironment with this treatment combination in tumor and blood samplesusing a validated immune biomarker panel and liquid biopsy (end-of-treatment genomic markers using cfDNA analysis) to study resistance to infigratinib and identify response markers from trial medications. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05510427
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Withdrawn
Phase Phase 1
Start date August 7, 2023
Completion date August 7, 2023
View Details
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