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NCT Number: NCT05854498

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

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.

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 52792, United States

Location status: Recruiting

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

liposomal irinotecan

Drug

50mg/m2 IV on days 1 and 15

TAS102

Drug

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

Bevacizumab

Drug

5mg/kg IV on days 1 and 15

Primary outcomes

  1. Progression Free Survival (PFS)

    Time frame: up to 2 years

    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.

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: up to 2 years

    ORR will include confirmed complete response (CR) + confirmed partial response (PR) per RECIST 1.1 divided by the number of patients receiving at least one dose of proposed combination.

  2. Number of Participants Experiencing Grade 3 and 4 Toxicities

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

    Grade 3 and 4 toxicities as defined by the NCI Common Terminology Criteria for Adverse Events (version 5.0) (CTCAE v5.0)

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

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

    Grade 3 and 4 toxicities as defined by the NCI Common Terminology Criteria for Adverse Events (version 5.0) (CTCAE v5.0)

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

    Time frame: up to 2 years

    PFS will be compared between those subjects who were treated in the last 4 months with an irinotecan containing regimen versus those who were not

Study contacts

Contact information is provided by the study sponsor or research team.

Cancer Connect

CONTACT

[email protected]

800-622-8922

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Ipsen

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
May 11, 2023
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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