Colo-rectal CancerEarly Phase 1NCT06011772

EGF-Depleting Therapy CIMAvax-EGF in Combination With Standard Therapy for RAS- and BRAF Wild-Type Metastatic Colorectal Cancer

A Early Phase 1 study testing Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine, Leucovorin and Oxaliplatin in people with Colo-rectal Cancer, run by Roswell Park Cancer Institute at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The purpose of this study is to determine the immunogenicity of the CIMAvaxEGF® vaccine (that is, its effectiveness in inducing an anti-tumor immune response) in patients with metastatic KRAS/NRAS/BRAF wild-type gene colorectal cancer, when given in combination with standard therapies used in the treatment of advanced… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colo-rectal Cancer
What is being tested?: Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine, Leucovorin and Oxaliplatin
Type of treatment: Vaccines, Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteUnited States
Study dates: 18 Dec 2023to 5 Feb 2029
Phase: Early Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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)

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263

Other trials in United States

About this study

Official title: A Phase 0 Study of EGF-Depleting Therapy CIMAvax-EGF in Combination With Standard Therapy for RAS- and BRAF Wild-Type Metastatic Colorectal Cancer

Read the detailed description

Primary Objective

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: Colo-rectal Cancer
Being tested: Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine, Leucovorin, Oxaliplatin, Fluorouracil, Bevacizumab
Medical subject headings: Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Recombinant Human EGF-rP64K/Montanide ISA 51 VaccineBiological
Also called Cimavax, CIMAvax EGF, Epidermal Growth Factor (EGF) Vaccine
Given IM
LeucovorinDrug
Given IV
OxaliplatinDrug
Given IV
FluorouracilDrug
Given IV
BevacizumabBiological
Given IV
IrinotecanDrug
Given IV
CetuximabBiological
Given IV
MetastasectomyProcedure or surgery
Undergo metastasectomy
Biospecimen collectionProcedure or surgery
Undergo collection of blood samples
Computed TomographyProcedure or surgery
Also called CAT, CAT SCAN
Undergo CT
PanitumumbabBiological
Also called ABX-EGF, ABX-EGF Monoclonal Antibody
Given IV

Study groups in NCT06011772
Study group	Role	What they receive
Cohort A	Experimental	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. Receives: Biological: Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Fluorouracil; Biological: Bevacizumab; Drug: Irinotecan; Biological: Cetuximab; Procedure: Biospecimen collection; Procedure: Computed Tomography; Biological: Panitumumbab
Cohort B	Experimental	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. Receives: Biological: Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Fluorouracil; Biological: Bevacizumab; Drug: Irinotecan; Biological: Cetuximab; Procedure: Biospecimen collection; Procedure: Computed Tomography; Biological: Panitumumbab
Cohort C	Experimental	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. Receives: Biological: Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine; Drug: Leucovorin; Biological: Bevacizumab; Biological: Cetuximab; Procedure: Metastasectomy; Procedure: Biospecimen collection

What is being measured

The primary outcome is the main question the study is designed to answer.

Immunogencity of vaccine
Percentage of patients with antibody titers greater than or equal to 1:4000 using a 90% confidence interval obtained by Jeffery's prior method
Measured: up to 60 days after last dose

Secondary outcomes (1)

Progression free survival
Measured: time from treatment until disease progression, death or last follow up assesed up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Dec 20235 Feb 2029

First posted25 Aug 2023
Study start18 Dec 2023
Primary completion5 Feb 2026
Study completion5 Feb 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06011772
Sponsor's protocol ID: I 1578122
Status last verified: Aug 2026
First submitted: 21 Aug 2023
Last updated: 21 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Colo-rectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 0 Study of EGF-Depleting Therapy CIMAvax-EGF in Combination With Standard Therapy for RAS- and BRAF Wild-Type Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT06011772
Acronym / sponsor ID: I 1578122
Conditions: Colo-rectal Cancer
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 2 participants (actual)
Lead sponsor: Roswell Park Cancer InstituteUniversity, hospital or other
Study start: 18 Dec 2023 (actual)
Primary completion: 5 Feb 2026 (actual)
Study completion: 5 Feb 2029 (estimated)
First posted: 25 Aug 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Primary Objective

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Cohort A	Experimental	Biological: Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine, Drug: Leucovorin, Drug: Oxaliplatin, Drug: Fluorouracil, Biological: Bevacizumab, Drug: Irinotecan, Biological: Cetuximab, Procedure: Biospecimen collection, Procedure: Computed Tomography, Biological: PanitumumbabLOADING 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.
Cohort B	Experimental	Biological: Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine, Drug: Leucovorin, Drug: Oxaliplatin, Drug: Fluorouracil, Biological: Bevacizumab, Drug: Irinotecan, Biological: Cetuximab, Procedure: Biospecimen collection, Procedure: Computed Tomography, Biological: PanitumumbabLOADING 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.
Cohort C	Experimental	Biological: Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine, Drug: Leucovorin, Biological: Bevacizumab, Biological: Cetuximab, Procedure: Metastasectomy, Procedure: Biospecimen collectionDescription 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

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).
KRAS/NRAS/BRAF wild-type.
Have an ECOG Performance Status of 0-2
Patients must have adequate organ and marrow function as defined below:
Have measurable disease per RECIST 1.1 criteria present.

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Recombinant Human EGF-rP64K/Montanide ISA 51 VaccineAlso: Cimavax, CIMAvax EGF, Epidermal Growth Factor (EGF) VaccineGiven IM	Biological	Cohort A, Cohort B, Cohort C
LeucovorinGiven IV	Drug	Cohort A, Cohort B, Cohort C
OxaliplatinGiven IV	Drug	Cohort A, Cohort B
FluorouracilGiven IV	Drug	Cohort A, Cohort B
BevacizumabGiven IV	Biological	Cohort A, Cohort B, Cohort C
IrinotecanGiven IV	Drug	Cohort A, Cohort B
CetuximabGiven IV	Biological	Cohort A, Cohort B, Cohort C
MetastasectomyUndergo metastasectomy	Procedure or surgery	Cohort C
Biospecimen collectionUndergo collection of blood samples	Procedure or surgery	Cohort A, Cohort B, Cohort C
Computed TomographyAlso: CAT, CAT SCANUndergo CT	Procedure or surgery	Cohort A, Cohort B
PanitumumbabAlso: ABX-EGF, ABX-EGF Monoclonal AntibodyGiven IV	Biological	Cohort A, Cohort B

Primary outcome

Immunogencity of vaccine
Time frame: up to 60 days after last dose
Percentage of patients with antibody titers greater than or equal to 1:4000 using a 90% confidence interval obtained by Jeffery's prior method

1 secondary outcome

Progression free survival
Time frame: time from treatment until disease progression, death or last follow up assesed up to 2 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anuradha Krishnamurthy, MBBS principal investigator

Roswell Park Comprehensive Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immunogencity of vaccine (time frame: up to 60 days after last dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06011772.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.