EGF-Depleting Therapy CIMAvax-EGF in Combination With Standard Therapy for RAS- and BRAF Wild-Type Metastatic Colorectal Cancer
NCT ID: NCT06011772
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
EARLY_PHASE1
2 participants
INTERVENTIONAL
2023-12-18
2026-12-04
Brief Summary
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Detailed Description
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\- Determine the immunogenicity of CIMAvax in patients with metastatic, KRAS/NRAS/BRAF wild type CRC in combination with Chemotherapy plus appropriate biologic agent in 1st or 2nd/3rd line setting and chemotherapy plus anti-EGFR therapy in 2nd/3rd line setting.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A
LOADING PHASE: Patients receive CIMAvax-EGF IM on days 1 and 15. Treatment repeats every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Patients receive CIMAvax-EGF IM on day 15. Treatment repeats every 28 days for 10 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive chemotherapy consisting of leucovorin IV, oxaliplatin IV over 2 hours, and fluorouracil IV and bevacizumab IV over 10 minutes on days 1 and 15. Treatment repeats every 2 weeks for 10 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo collection of blood samples throughout the trial.
Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine
Given IM
Leucovorin
Given IV
Oxaliplatin
Given IV
Fluorouracil
Given IV
Bevacizumab
Given IV
Irinotecan
Given IV
Cetuximab
Given IV
Biospecimen collection
Undergo collection of blood samples
Computed Tomography
Undergo CT
Panitumumbab
Given IV
Cohort B
LOADING PHASE: Patients receive CIMAvax-EGF IM on days 1 and 15. Treatment repeats every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Patients receive CIMAvax-EGF IM on day 15. Treatment repeats every 28 days for 10 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive FOLFIRI consisting of irinotecan IV, leucovorin IV over 90 minutes, and fluorouracil IV and cetuximab IV over 120 minutes on days 1 and 15. Treatment repeats every 2 weeks for 10 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo collection of blood samples throughout the trial.
Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine
Given IM
Leucovorin
Given IV
Oxaliplatin
Given IV
Fluorouracil
Given IV
Bevacizumab
Given IV
Irinotecan
Given IV
Cetuximab
Given IV
Biospecimen collection
Undergo collection of blood samples
Computed Tomography
Undergo CT
Panitumumbab
Given IV
Cohort C
Description LOADING PHASE: Patients receive CIMAvax-EGF IM on days 1 and 15. Treatment repeats every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Patients receive CIMAvax-EGF IM on day 15. Treatment repeats every 28 days for 10 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive mFOLFOX6 and cetuximab, FOLFOX6 and bevacizumab, or mFOLFOX6 per investigators preference. Treatment repeats every 2 weeks for 10 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo metastasectomy 4-8 weeks after first maintenance phase dose. Patients undergo collection of blood samples throughout the trial.
Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine
Given IM
Leucovorin
Given IV
Bevacizumab
Given IV
Cetuximab
Given IV
Metastasectomy
Undergo metastasectomy
Biospecimen collection
Undergo collection of blood samples
Interventions
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Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine
Given IM
Leucovorin
Given IV
Oxaliplatin
Given IV
Fluorouracil
Given IV
Bevacizumab
Given IV
Irinotecan
Given IV
Cetuximab
Given IV
Metastasectomy
Undergo metastasectomy
Biospecimen collection
Undergo collection of blood samples
Computed Tomography
Undergo CT
Panitumumbab
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Deepak Vadehra
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Comprehensive Cancer Center
Locations
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Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Countries
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Other Identifiers
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I 1578122
Identifier Type: -
Identifier Source: org_study_id
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