NCT05854498

Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer

Phase II Study of Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to see if combining liposomal irinotecan with TAS102 and bevacizumab confers clinical benefit for patients with treatment refractory metastatic colorectal cancer.

Detailed description

This prospective phase II, single arm, single site trial will evaluate the efficacy of the combination of liposomal irinotecan (nal-IRI), TAS102, and bevacizumab for the treatment of patients with mismatch repair proficient, metastatic or unresectable colorectal cancer that has previously been treated with 5-fluorouracil, oxaliplatin, irinotecan and if RAS wild-type an anti-EGFR agent. A total of 25 patients will be accrued at UW Carbone Cancer Center. Subject enrollment will occur over 12 months with the total duration of the trial expected to be 3 years. Primary Objective * To determine the progression free survival (PFS) of patients with metastatic colorectal cancer treated in the treatment refractory setting with liposomal irinotecan in combination with TAS102 and bevacizumab. Secondary Objectives * To evaluate the objective response rate (ORR) of liposomal irinotecan in combination with bevacizumab and TAS102. * To assess the safety and tolerability of these regimens in this setting. * To determine the impact of the timing of irinotecan use in prior lines of therapy on the ORR and PFS observed with these nal-IRI containing treatment regimens

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Liposomal irinotecan	50mg/m2 IV on days 1 and 15
DRUG	TAS102	35mg/m2 PO BID on days 1-5 and 15-19
DRUG	Bevacizumab	5mg/kg IV on days 1 and 15

Timeline

• Start date: 2023-10-13
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2023-05-11
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study