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Monoclonal Antibody

Combination Chemotherapy for Colorectal Cancer

Phase 2

Recruiting

Led By Dustin Deming, MD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

The cancer must be mismatch repair proficient.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial tests a new combination therapy to treat advanced colorectal cancer that hasn't responded to other treatments.

Who is the study for?

This trial is for adults over 18 with metastatic colorectal cancer that's resistant to standard treatments. They must have tried certain chemotherapies and, if applicable, targeted therapies based on their cancer's genetic features. People can't join if they have specific mutations (BRAF V600), high microsatellite instability, or are using strong CYP3A4 affecting drugs.Check my eligibility

What is being tested?

The study tests a combination of three drugs: Liposomal Irinotecan, TAS102, and Bevacizumab in patients with advanced colorectal cancer who haven't responded to previous treatments. It aims to see if this mix offers any benefit over existing options.See study design

What are the potential side effects?

Possible side effects include fatigue, nausea, diarrhea from TAS102; high blood pressure and bleeding from Bevacizumab; and hair loss, vomiting from Liposomal Irinotecan. Each drug also has its own unique risks which will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My colorectal cancer is confirmed and cannot be removed by surgery.

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My cancer is not caused by a mismatch repair deficiency.

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I am 18 years old or older.

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I can carry out all my daily activities without help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival (PFS)

Secondary outcome measures

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

Number of Participants Experiencing Grade 3 and 4 Toxicities

Objective Response Rate (ORR)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants with Metastatic or Unresectable Colorectal CancerExperimental Treatment3 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5280

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

IpsenIndustry Sponsor

346 Previous Clinical Trials

73,275 Total Patients Enrolled

University of Wisconsin, MadisonLead Sponsor

1,189 Previous Clinical Trials

3,169,506 Total Patients Enrolled

Dustin Deming, MDPrincipal InvestigatorUW Carbone Cancer Center

1 Previous Clinical Trials

71 Total Patients Enrolled

Media Library

Bevacizumab (Monoclonal Antibody) Clinical Trial Eligibility Overview. Trial Name: NCT05854498 — Phase 2

Bevacizumab (Monoclonal Antibody) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05854498 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial actively seeking participants at present?

"According to clinicaltrials.gov, this experimental medical study is no longer recruiting participants; it was initially posted on July 1st 2023 and last updated in May 2nd 2023. Nonetheless, there are still 914 other actively recruitment trials available for patients seeking treatment at this moment in time."

Answered by AI

Does the FDA sanction Participants with Metastatic or Unresectable Colorectal Cancer?

"After careful consideration, we concluded that the safety of Participants with Metastatic or Unresectable Colorectal cancer was a rating 2 due to only having limited evidence for its security but no data regarding efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05854498.