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

• Status: Not yet recruiting
• Trial end date: 2026-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborator: Ipsen
• Treatments: Bevacizumab; Irinotecan

Criteria

Inclusion Criteria:

• Patients must be ≥ 18 years of age

• Eastern Cooperative Oncology Group (ECOG) performance must be 0 or 1.

• Patients must have a histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma and be metastatic or unresectable.

• The cancer must be mismatch repair proficient.

• Patients must have had prior treatment with 5-fluorouracil, oxaliplatin, irinotecan containing regimens. If RAS wild-type must have received prior anti-EGFR therapy with either cetuximab or panitumumab. If RAS wild-type and HER2 positive then must have had a prior HER2 targeted therapy.

Exclusion Criteria:

• Uncontrolled concurrent medical illness that would not allow for the completion of the planned therapy.

• Patients whose cancers possess BRAF V600 mutations are excluded.

• Patients must stop the use of strong inducers/inhibitors of CYP3A4 at least 2 weeks before initiating therapy.

• Patients must not have mismatch repair deficient or microsatellite instability high cancers.

• Patients must not have received prior TAS102.