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

NCT05854498 | Recruiting Phase 2 DMC FDA Drug

• 5 other identifiers: 2023-0449Protocol Version 12/6/2025UW23016SMPH/MEDICINE/HEM-ONCNCI-2023-05190
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS is defined as the time from D1 of treatment with the study combination until the criteria for disease progression is met as defined by RECIST 1.1 criteria or death as a result of any cause.

  up to 2 years

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  up to 2 years

• Number of Participants Experiencing Grade 3 and 4 Toxicities

  up to 30 days post-treatment (approximately 6 months on study)

• Summary of Grade 3 and 4 Toxicities by Count of participants

  up to 30 days post-treatment (approximately 6 months on study)

• Efficacy of irinotecan measured by PFS for patients with and without irinotecan containing regimens

  up to 2 years

Study Arms (1)

Participants with Metastatic or Unresectable Colorectal Cancer

EXPERIMENTAL

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

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

Interventions

Liposomal irinotecan DRUG

50mg/m2 IV on days 1 and 15

Participants with Metastatic or Unresectable Colorectal Cancer

TAS102 DRUG

35mg/m2 PO BID on days 1-5 and 15-19

Participants with Metastatic or Unresectable Colorectal Cancer

Bevacizumab DRUG

5mg/kg IV on days 1 and 15

Participants with Metastatic or Unresectable Colorectal Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Ipsen: collaborator

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 52792, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

irinotecan sucrosofate; trifluridine tipiracil drug combination; Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Dustin Deming, MD

  UW Carbone Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer Connect

CONTACT

800-622-8922; clinicaltrials@cancer.wisc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a nonrandomized, single arm, open-label study of the combination of liposomal irinotecan with TAS102 and bevacizumab in patients with treatment refractory metastatic colorectal cancer.

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 11, 2023
• Study Start: October 13, 2023
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)