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Cancer Vaccine

AlloStim + Anti-PD-L1 for Colorectal Cancer (COMUNITY Trial)

Phase 2
Waitlist Available
Research Sponsored by Mirror Biologics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult male and female subjects aged 18-80 years at screening visit
Previous treatment failure of at least two lines of active systemic chemotherapy: Previous chemotherapy must have included a fluoropyrimidine, oxaliplatin (e.g. FOLFOX, CAPOX), and irinotecan-containing (e.g. FOLFIRI) regimens (single regimen of FOLFIRINOX satisfies). Administered in adjuvant setting or for treatment of metastatic disease. If KRAS wild type, must have at least one prior anti-EGFR therapy if left sided primary tumor
Must not have
Clinical evidence of brain metastasis or leptomeningeal involvement
Pulmonary lymphangitis or symptomatic pleural effusion (grade ≥ 2) that results in pulmonary dysfunction requiring active treatment; or, oxygen saturation <92% on room air
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new treatment for patients with advanced colorectal cancer who have not responded to standard chemotherapy or immunotherapy. They will receive a combination of a new immunotherapy drug called AlloSt

Who is the study for?
This trial is for patients with metastatic colorectal cancer that has not responded to chemotherapy or other immunotherapies and have progressed after, or cannot tolerate, treatments like Longsurf (TAS-102) with or without Avastin (bevacizumab), or Stivarga (regorafenib).
What is being tested?
The study is testing a new combination of experimental AlloStim immunotherapy with an anti-PD-L1 drug, which blocks a pathway cancers use to hide from the immune system. The goal is to see if this combo can help patients whose cancer hasn't responded to standard treatments.
What are the potential side effects?
Possible side effects may include typical reactions related to immunotherapy such as fatigue, skin reactions, flu-like symptoms, changes in liver function tests, and potential autoimmune responses where the body's immune system might attack normal cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I've had at least two chemotherapy treatments including specific drugs and, if applicable, an anti-EGFR therapy for my left-sided tumor.
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My blood counts meet the required levels for treatment.
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I am not pregnant or breastfeeding.
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My colorectal cancer is not MSI-H/dMMR.
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My cancer has spread, and my primary tumor may or may not have been removed.
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I am fully active or can carry out light work.
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My kidney, liver functions, and heart are within normal ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to my brain or the lining around my brain.
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I have severe lung issues needing treatment or my oxygen levels are below 92% without aid.
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My cancer has high microsatellite instability or mismatch repair deficiency.
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I am at high risk for bowel blockage due to my tumor.
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I am currently experiencing or recently had severe depression or thoughts of suicide.
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I have severe fluid buildup in my abdomen needing treatment.
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I have COPD.
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I am unable to give consent for medical procedures by myself.
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I have had a bone marrow, stem cell, or organ transplant in the past.
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I have been diagnosed with HIV/AIDS.
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I have heart problems that cause symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Tumor Response
Overall Survival
Secondary study objectives
circulating tumor DNA

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Find a Location

Who is running the clinical trial?

Mirror Biologics, Inc.Lead Sponsor
14 Previous Clinical Trials
311 Total Patients Enrolled
~33 spots leftby Jun 2025
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