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Immunotherapy with AlloStim for Metastatic Colorectal Cancer (STIMVAX Trial)
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.
STIMVAX Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSTIMVAX Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.STIMVAX Trial Design
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Who is running the clinical trial?
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- I have had two chemotherapy treatments that did not work.My cancer has spread to my brain or its coverings.I am at high risk for bowel blockage due to my tumor.My cancer has spread to other parts of my body.I may or may not be receiving bevacizumab treatment.I have had a bone marrow, stem cell, or organ transplant in the past.You have had a bad reaction to a blood transfusion in the past.I need treatment for severe fluid buildup in my abdomen.I am fully active or can carry out light work.I am unable to give consent for medical procedures by myself.I am using topical corticosteroids.I haven't taken high doses of steroids for more than 2 weeks in the last month.I am receiving treatment after surgery to prevent cancer return or for cancer that has spread.I have been treated with chemotherapy that included oxaliplatin and irinotecan.You have had a serious allergic reaction to drugs called monoclonal antibodies in the past.I am between 18 and 80 years old.I have been diagnosed with an autoimmune disease like rheumatoid arthritis.My cancer worsened during or within 30 days after my last treatment for advanced disease.I have signed the study consent form in my native language.My organs are functioning well.I can stop taking medications like aspirin or ibuprofen before a biopsy if needed.I have KRAS wild type cancer and have been treated with anti-EGFR therapy before.I have heart problems that cause symptoms.I have severe lung issues needing treatment or my oxygen levels are below 92% without aid.I have been diagnosed with HIV/AIDS.I am currently fighting a worsening viral or bacterial infection.I have not taken Bevacizumab within 6 weeks before my planned biopsy.I have symptoms from asthma or COPD.My Type I diabetes is well managed.My blood counts are within a healthy range.I haven't had a fever or taken antibiotics for at least 7 days.You have received experimental treatments in the past.I have a mood disorder, such as depression or a history of suicidal thoughts or attempts.I am between 18 and 80 years old.I am not pregnant or breastfeeding.You have a mental health or addiction condition that the researcher believes would make it difficult for you to take part in the study.I may or may not be receiving bevacizumab treatment.My previous cancer treatment didn't work due to worsening condition or side effects.My previous treatment didn’t work due to worsening condition or side effects.My cancer has spread to the lining of my abdomen.My cancer is MSI-H.I have been treated with both oxaliplatin and irinotecan-based chemotherapy.My diagnosis is colorectal adenocarcinoma.My original tumor is either still there or was removed.My cancer has spread to my liver or another area that can be safely biopsied.
- Group 1: AlloStim
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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