Trials / Withdrawn
WithdrawnNCT05510427
Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion/Amplification
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Infigratinib | Given by PO |
| DRUG | Atezolizumab | Given by (IV) vein |
| DRUG | Bevacizumab | Given by (IV) vein |
Timeline
- Start date
- 2023-08-07
- Primary completion
- 2023-08-07
- Completion
- 2023-08-07
- First posted
- 2022-08-22
- Last updated
- 2023-08-15
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05510427. Inclusion in this directory is not an endorsement.