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Cell Therapy

Immunotherapy with AlloStim for Metastatic Colorectal Cancer (STIMVAX Trial)

Phase 2
Recruiting
Research Sponsored by Immunovative Therapies, Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Previous treatment failure of two previous lines of active systemic chemotherapy
Presenting with metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up date of death from any cause, whichever came first, assessed up to 12 months from accrual
Awards & highlights

STIMVAX Trial Summary

This trial is testing a new immunotherapy for colorectal cancer that has spread. The therapy is derived from blood cells of healthy donors.

Who is the study for?
Adults aged 18-80 with metastatic colorectal cancer that has worsened after two previous chemotherapy treatments can join this trial. They must have an ECOG score of 0-1, indicating they are fully active or restricted in physically strenuous activity but ambulatory and able to carry out work. Participants need normal organ function and blood counts, not be pregnant or breastfeeding, agree to use contraception if capable of childbearing, and cannot have certain conditions like brain metastasis or severe heart disease.Check my eligibility
What is being tested?
The study is testing AlloStim, an immunotherapy made from healthy donor blood cells. It's for patients whose cancer has spread even after treatment with common chemo regimens (FOLFOX/FOLFIRI) and possibly targeted drugs (anti-EGFR). This Phase IIB trial is open-label at multiple sites where everyone knows what treatment they're getting.See study design
What are the potential side effects?
While specific side effects for AlloStim aren't listed here, similar immunotherapies can cause flu-like symptoms such as fever and chills, fatigue, weakness, nausea, vomiting; potential reactions at the infusion site; allergic reactions; autoimmune responses; or changes in liver enzymes.

STIMVAX Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had two chemotherapy treatments that did not work.
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My cancer has spread to other parts of my body.
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I may or may not be receiving bevacizumab treatment.
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I am fully active or can carry out light work.
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I am receiving treatment after surgery to prevent cancer return or for cancer that has spread.
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I have been treated with chemotherapy that included oxaliplatin and irinotecan.
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I am between 18 and 80 years old.
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My cancer worsened during or within 30 days after my last treatment for advanced disease.
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I have signed the study consent form in my native language.
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My organs are functioning well.
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I have KRAS wild type cancer and have been treated with anti-EGFR therapy before.
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My blood counts are within a healthy range.
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I am between 18 and 80 years old.
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I am not pregnant or breastfeeding.
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I may or may not be receiving bevacizumab treatment.
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My previous cancer treatment didn't work due to worsening condition or side effects.
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My previous treatment didn’t work due to worsening condition or side effects.
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I have been treated with both oxaliplatin and irinotecan-based chemotherapy.
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My diagnosis is colorectal adenocarcinoma.
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My original tumor is either still there or was removed.
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My cancer has spread to my liver or another area that can be safely biopsied.

STIMVAX Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date of death from any cause, whichever came first, assessed up to 12 months from accrual
This trial's timeline: 3 weeks for screening, Varies for treatment, and date of death from any cause, whichever came first, assessed up to 12 months from accrual for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidents of Adverse Events (AE)
Overall Survival

STIMVAX Trial Design

1Treatment groups
Experimental Treatment
Group I: AlloStimExperimental Treatment1 Intervention
AlloStim is administered in three cycles: Cycle 1 Day 0: 0.5ml ID AlloStim® Day 7: 0.5ml ID AlloStim® Day 14: 0.5ml ID AlloStim® Day 21: 0.5ml ID AlloStim® Day 28: 0.5ml ID AlloStim® Cycle 2 Day 42: 0.5ml ID AlloStim® Day 49: 0.5ml ID AlloStim® Day 56: 0.5ml ID AlloStim® Day 63: 0.5ml ID AlloStim® Day 70: 0.5ml ID AlloStim® + 3ml IV AlloStim® Cycle 3 Day 84: 0.5ml ID AlloStim® Day 91: 0.5ml ID AlloStim® Day 98: 0.5ml ID AlloStim® Day 105: 0.5ml ID AlloStim® Day 112: 0.5ml ID AlloStim® + 3ml IV AlloStim®
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AlloStim
2016
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

Mirror Biologics, Inc.UNKNOWN
2 Previous Clinical Trials
190 Total Patients Enrolled
Immunovative Therapies, Ltd.Lead Sponsor
13 Previous Clinical Trials
287 Total Patients Enrolled

Media Library

AlloStim (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04444622 — Phase 2
Colorectal Cancer Research Study Groups: AlloStim
Colorectal Cancer Clinical Trial 2023: AlloStim Highlights & Side Effects. Trial Name: NCT04444622 — Phase 2
AlloStim (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04444622 — 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 research still open for enrollment?

"Confirmed. According to information presented on clinicaltrials.gov, this medical trial is in the process of recruiting participants since it was made public on July 12th 2021 with its most recent update occurring August 30th 2022."

Answered by AI

How many volunteers are being enrolled in this trial?

"In order to progress with this study, 24 qualified participants must be gathered. Immunovative Therapies Ltd will oversee the trial from Summit Health in Florham Park, New jersey and Hirschfield Oncology Centre in Houston, Texas."

Answered by AI

To what extent is AlloStim a risk-free solution for individuals?

"Due to the lack of evidence-based efficacy, AlloStim was given a rating of 2 for safety. However, there is some data indicating it's not unsafe."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Hirschfield Oncology Center
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
~4 spots leftby Nov 2024