Metastatic Colorectal CancerPhase 2NCT05854498
Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer
A Phase 2 study testing Liposomal irinotecan, TAS102 and Bevacizumab in people with Metastatic Colorectal Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Liposomal irinotecan, TAS102 and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2023to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 52792
About this study
Official title: Phase II Study of 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.
Read the 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
- Being tested
- Liposomal irinotecan, TAS102, Bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal irinotecanDrug
50mg/m2 IV on days 1 and 15
TAS102Drug
35mg/m2 PO BID on days 1-5 and 15-19
BevacizumabDrug
5mg/kg IV on days 1 and 15
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Liposomal irinotecan; Drug: TAS102; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 years
Secondary outcomes (4)
Objective Response Rate (ORR)
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.
Measured: up to 2 years
Number of Participants Experiencing Grade 3 and 4 Toxicities
Grade 3 and 4 toxicities as defined by the NCI Common Terminology Criteria for Adverse Events (version 5.0) (CTCAE v5.0)
Measured: up to 30 days post-treatment (approximately 6 months on study)
Summary of Grade 3 and 4 Toxicities by Count of participants
Grade 3 and 4 toxicities as defined by the NCI Common Terminology Criteria for Adverse Events (version 5.0) (CTCAE v5.0)
Measured: 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
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
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start13 Oct 2023
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Ipsen
- Responsible party
- Sponsor
- Investigators
- Dustin Deming, MD, Principal investigator, UW Carbone Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854498
- Sponsor's protocol ID
- 2023-0449
- Other IDs
- Protocol Version 12/6/2025, UW23016, SMPH/MEDICINE/HEM-ONC, NCI-2023-05190
- Status last verified
- Sep 2026
- First submitted
- 2 May 2023
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05854498
- Acronym / sponsor ID
- 2023-0449
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Ipsen
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Participants with Metastatic or Unresectable Colorectal Cancer | Experimental | Drug: Liposomal irinotecan, Drug: TAS102, Drug: BevacizumabMale and females aged 18 years and older with histologically confirmed metastatic or unresectable (not amenable to curative therapy) colorectal cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal irinotecan50mg/m2 IV on days 1 and 15 | Drug | Participants with Metastatic or Unresectable Colorectal Cancer |
| TAS10235mg/m2 PO BID on days 1-5 and 15-19 | Drug | Participants with Metastatic or Unresectable Colorectal Cancer |
| Bevacizumab5mg/kg IV on days 1 and 15 | Drug | Participants with Metastatic or Unresectable Colorectal Cancer |
Primary outcome
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.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: up to 2 years
Number of Participants Experiencing Grade 3 and 4 Toxicities
Time frame: up to 30 days post-treatment (approximately 6 months on study)
Summary of Grade 3 and 4 Toxicities by Count of participants
Time frame: 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
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dustin Deming, MD principal investigator
UW Carbone Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liposomal irinotecan, TAS102 and Bevacizumab in people with Metastatic Colorectal Cancer, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer Connect (800-622-8922, clinicaltrials@cancer.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.