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

Program Status

Recruiting

Phase

Phase 1

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

Yes

Drugs

fluorouracil, Irinotecan, Leucovorin, oxaliplatin

Tags

MSI-H/ MMRd, MSS/ MMRp

Comments

Trial at Roswell Park Cancer Institute (Buffalo, New York). For KRAS/NRAS/BRAF (V600) wild-type (having those mutations is *not* allowed).

Patients will received a vaccine, CIMAvaxEGF® (also known as the “Cuban vaccine for lung cancer”), in combination with standard therapies used in the treatment of advanced colorectal cancer.
CIMAvaxEGF® vaccine might be immunogenic –that is, may induce an anti-tumor immune response.
For patients without prior systemic therapy for advanced disease (prior adjuvant chemotherapy completed >12 months before is allowed) or with one prior line of therapy but no more than 2 prior lines of therapy for advanced disease. That is, a trial to explore *before* exhausting standard of care.

CIMAvaxEGF®: recombinant Human EGF-rP64K/Montanide ISA 51 vaccine; EGF-depleting therapy — that is, it is intended to induce antibodies against self-EGF that block the EGF-EGFR interaction. CIMAvax-EGF is a lung cancer treatment that was developed in Cuba. It is a type of immunotherapy that harnesses the body’s immune system to fight lung cancer.

Location Location Status
United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York 14263
Recruiting

Contacts

Deepak Vadehra
Contact
716-845-2300 askroswell@roswellpark.org

Inclusion Criteria

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 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 tumor biopsy tissue while on study (cohort A and B) or allow tissue to be taken during surgery (cohort C)

Exclusion Criteria

Exclusion Criteria:

Toxicity ≥Grade 2 from prior chemotherapy.
Other cancer requiring active treatment.
Prior exposure to anti-EGFR monoclonal antibody (i.e. cetuximab or panitumumab) for colorectal cancer treatment.
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 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.

NCT ID

NCT06011772

Date Trial Added

2023-08-25

Updated Date

2024-05-03