NCT06439485

Phase I/II Trial of Pemigatinib in Combination With Atezolizumab and Bevacizumab for Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if pemigatinib in combination with atezolizumab and bevacizumab can help to control cholangiocarcinoma.

Detailed description

Primary Objectives: • To assess the antitumor activity of the treatment combinations based on objective response rate (ORR) Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. This assessment will be confirmed in the next scheduled scan. Secondary Objectives: 1. To determine the safety and recommended phase 2 dose (RP2D) of the triple combination of pemigatinib with bevacizumab and atezolizumab in participants with FGFR-altered metastatic CCA. 2. To evaluate the duration of response in participants with best overall response of complete response (CR) or partial response (PR). 3. To evaluate PFS defined as the time from the start of study treatment to disease progression or death, whichever occurs first. 4. To evaluate the duration of OS defined as the time from the start of study treatment to death from any cause. 5. To evaluate the clinical benefit rate defined as the proportion of participants with best overall response of CR, PR, or stable disease. 6. To evaluate safety and endpoints 2-5 with the doublet of pemigatinib with atezolizumab. Exploratory Objectives: • To examine the change of the immune microenvironment on treatment by the combination using a validated immune biomarker panel and end-of-treatment genomic markers using cfDNA to study resistance to pemigatinib and response markers from trial medications.

Conditions

• Advanced Cholangiocarcinoma
• FGFR2 Fusion

Interventions

Type	Name	Description
DRUG	Pemigatinib	Given by PO
DRUG	Atezolizumab	Given by PO and IV
DRUG	Bevacizumab	Given by PO and IV

Timeline

• Start date: 2024-11-19
• Primary completion: 2028-02-22
• Completion: 2030-02-22
• First posted: 2024-06-03
• Last updated: 2026-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study