Experimental vaccine aims to boost immune attack on colorectal cancer
NCT ID NCT06011772
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This early-phase trial tests whether adding the CIMAvax-EGF vaccine to standard chemotherapy and targeted drugs can trigger an immune response against metastatic colorectal cancer. Only 2 participants with a specific gene type (RAS/BRAF wild-type) were enrolled. The main goal is to see if the vaccine produces enough antibodies, with progression-free survival also tracked.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CIMAvax-EGF vaccine (a vaccine that targets epidermal growth factor)
- What this could lead to
- If it works, this could point toward a new way to boost the immune system against colorectal cancer when combined with standard treatments.
- What could go wrong
- This is a very early phase 0 trial with only 2 participants, so results are preliminary and may not apply to others. The vaccine may not trigger a strong enough immune response.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
2 people
The number who actually took part.
- Started
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Dec 2023
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically or cytologically confirmed metastatic adenocarcinoma of colon or rectum that cannot be removed by surgery without prior systemic therapy for advanced disease (prior adjuvant chemotherapy completed \>12 months from diagnosis of metastatic or advanced disease is allowed) for cohorts A and C and with one prior line of therapy but no more than 2 prior lines of therapy for advanced disease (prior adjuvant chemotherapy completed \<12 months from diagnosis of metastatic or advanced disease is considered one line of therapy). * Cohort A: May have received 1 cycle of chemotherapy± appropriate biologic agent pending results of RAS and BRAF. If results determine patient is eligible, the patient will be enrolled and will receive the addition of CIMAvax + Bevacizumab or CIMAvax+ anti-EGFR therapy in their second cycle. * Cohort B: Patients with RAS- and BRAF wild-type metastatic CRC who have received at least one but no more than 2 prior therapies for advanced disease * Cohort C: Patients with RAS- and BRAF wild-type metastatic CRC who have not received prior therapy for advanced disease and are candidates for metastatic disease resistant resection (one cycle of standard chemotherapy with or without appropriate biologic agent is allowed) * KRAS/NRAS/BRAF wild-type. * Have an ECOG Performance Status of 0-2 * Patients must have adequate organ and marrow function as defined below: * Absolute neutrophil count (ANC) ≥ 1.5 x 109/L * Platelets ≥ 75 x 10\^9/L * Hemoglobin ≥ 8 g/dL * Creatinine clearance\> 60 mL/min (Cockcroft-Gault Equation) * ALT and AST ≤ 3 x ULN (ALT and AST ≤ 5 x ULN is acceptable if liver metastases are present * Total bilirubin ≤ 1.5x ULN. For patients with well documented Gilbert's syndrome, total bilirubin ≤ 3x ULN with direct bilirubin within normal range * Have measurable disease per RECIST 1.1 criteria present. * Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure. * Participant agrees to provide paired-tumor biopsy tissue while on study (cohort A and B) or allow tissue to be taken during surgery (cohort C) Exclusion Criteria: * Toxicity ≥Grade 2 from prior chemotherapy with exception to Grade 2 peripheral neuropathy.. * Other cancer requiring active treatment. * Prior exposure to anti-EGFR monoclonal antibody (i.e. cetuximab or panitumumab) for colorectal cancer treatment is exclusionary to Cohort A and C only * Participants with Her2 positive mutational status * Had major surgery within 4 weeks prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered major surgery) resulting from a prior surgery. * Has known immunosuppressive disease (e.g. HIV, AIDS or other immune depressing disease). Testing is not mandatory. * Participants with known active brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. * Active, clinically serious infections or other serious uncontrolled medical conditions or psychiatric illness/social situations that would limit compliance with study requirements. * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator, including, but not limited to: * Myocardial infarction or arterial thromboembolic events within 6 months prior to baseline or severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease * History of documented congestive heart failure (New York Heart Association functional classification III or IV) within 6 months prior to baseline * Uncontrolled hypertension (SBP\>160/DBP\>100 despite medical intervention). * History of myocarditis of any etiology * History of ventricular arrhythmias * Active major or clinically significant bleeding based on the International Society on Thrombosis and Hemostasis definition. * Pregnant or nursing female participants.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263, United States
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Other studies related to the condition(s) this trial covers.
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