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

University of Wisconsin (UW)

Status and phase: Active, not recruiting; Phase 2

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: Bevacizumab; Drug: TAS102; Drug: Liposomal irinotecan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05854498

NCI-2023-05190 (Registry Identifier)

UW23016 (Other Identifier)

2023-0449

SMPH/MEDICINE/HEM-ONC (Other Identifier)

Protocol Version 2/16/2024 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Participants with Metastatic or Unresectable Colorectal Cancer

Experimental group

Description:

Male and females aged 18 years and older with histologically confirmed metastatic or unresectable (not amenable to curative therapy) colorectal cancer.

Treatment:

Drug: Liposomal irinotecan

Drug: TAS102

Drug: Bevacizumab