- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04298606
A Vaccine (CIMAvax-EGF) for the Prevention of Lung Cancer Development or Recurrence
A Phase 0 Study of CIMAvax-EGF Vaccine in Patients Who Are at High Risk for Lung Cancer and Lung Cancer Survivors at Risk for Recurrence
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the efficacy of the vaccine based on circulating EGF and anti-EGF antibodies.
II. To access the molecular profile of blood, bronchial and nasal brushes, and bronchial biopsies to identify molecular markers associated with treatment and response.
III. To establish the safety of recombinant human EGF-rP64K/montanide ISA 51 vaccine (CIMAvax-EGF) treatment in cancer-free individuals using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 5).
SECONDARY OBJECTIVE:
I. To evaluate quality of life score changes using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core 30 (C30) in patients who are at high risk for development of lung cancer or recurrence during CIMAvax-EGF treatment.
OUTLINE:
LOADING PHASE: Patients receive recombinant human EGF-rP64K/montanide ISA 51 vaccine intramuscularly (IM) at 0, 2, 4 and 6 weeks in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Patients receive recombinant human EGF-rP64K/montanide ISA 51 vaccine IM once every 4 weeks (Q4W) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 60 days.
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14263
- Recruiting
- Roswell Park Cancer Institute
-
Contact:
- Mary Reid, PhD
- Phone Number: 716-845-1209
- Email: Mary.Reid@roswellpark.org
-
Principal Investigator:
- Mary Reid, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Confirmed no evidence of cancer on computed tomography (CT) scan within 6 months prior to starting treatment
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- Patients must have platelets >= 100 x 10^9/L
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
- PATIENTS AT HIGH-RISK FOR LUNG CANCER COHORT ONLY (COHORT A)
Must have documented at least one risk factor for lung cancer which includes:
- Moderate to severe chronic obstructive pulmonary disease (COPD) defined as FEV1/FVC ratio <=75%
- Positive family history of lung cancer defined as a first degree relative
- Low body mass index (BMI)
- History of pneumonia within the last 5 years prior to enrollment
- Occupational exposure such as asbestos, radon and any other that investigator would deem high risk
- Must have quit smoking =< 15 years ago or be a current smoker
- Must have at least 30 pack year smoking history
- Must have documented pulmonary function test within the last 3 years prior to enrollment. If a patient cannot tolerate a pulmonary function test, an incentive spirometry will be acceptable in place of a pulmonary function test
- LUNG CANCER SURVIVOR COHORT ONLY (COHORT B)
- 1. If patient received surgery or any adjuvant therapy for initial diagnosis of lung cancer, it must have been completed at least 3 months prior to enrollment. Prior surgery or any therapy is not required for eligibility
- Confirmed non-small cell lung cancer (NSCLC) stage IA through 3A at initial diagnosis
Exclusion Criteria:
- Clinically inappropriate to have a bronchoscopy procedure
- Known uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, history of clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or nursing female participants
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
- Received an investigational agent within 30 days prior to enrollment
- Has known immunosuppressive disease (e.g. human immunodeficiency virus [HIV], acquired immunodeficiency syndrome [AIDS] or other immune depressing disease). Testing is not mandatory
- Patient has known hypersensitivity to the components of the study drugs or any analogs
- History of autoimmune disorder, with exception of patients with vitiligo or endocrine-related autoimmune conditions receiving appropriate hormonal supplementation who are eligible. Systemic use of immunosuppressant drugs such as steroids (except as hormone replacement therapy or short-course supportive medication such as chemotherapy or drug allergy, etc.), azathioprine, tacrolimus, cyclosporine, etc. within 4 weeks before recruitment
The following special populations are excluded from this study:
- Cognitively impaired adults/adults with impaired decision-making capacity
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
- Pregnant women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Prevention (recombinant human EGF-rP64K/montanide ISA 51)
LOADING PHASE: Patients receive recombinant human EGF-rP64K/montanide ISA 51 vaccine IM at 0, 2, 4 and 6 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive recombinant human EGF-rP64K/montanide ISA 51 vaccine IM Q4W in the absence of disease progression or unacceptable toxicity. |
Ancillary studies
Other Names:
Ancillary studies
Given IM
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of participants with antibody titers >= 1:4000 in response to vaccination
Time Frame: Up to 60 days post treatment
|
The response to the vaccine will be measured using circulating EGF and anti-EGF antibodies replicating the results from the Cuban and Roswell trials.
Human EGF will be determined by the Roswell Park Flow and Image Cytometry CCSG supported Resource using a commercial enzyme-linked immunosorbent assay (ELISA) assay (R&D Systems, Minneapolis, MN).
EGF antibodies will also be determined, by the Roswell Park Flow and Image Cytometry Resource using an in-house assay developed in cooperation with the Centro de Immunologia Molecular in La Habana, Cuba.
|
Up to 60 days post treatment
|
Molecular biomarker analysis
Time Frame: Up to 60 days post treatment
|
Will access the molecular profile of blood, bronchial brushes, and bronchial biopsies to identify molecular markers associated with treatment and response.
Biomarker scores will be analyzed for the molecular profile endpoint to test if they are significantly different post-treatment compared to pre-treatment (via paired t-test) or if a change in biomarker score (post-versus pre-) is significantly different among responders versus nonresponders (via t-test) as defined by histology and circulating levels of EGF ligand and anti-EGF antibodies.
In addition to these biomarkers, gene expression signatures will be analyzed.
These include gene expression signatures associated with EGFR activity, the high-grade lesion molecular subtype, and the immune-associated signature predictive of progressive/stable lesions compared with regressive lesions.
|
Up to 60 days post treatment
|
Number of patients with grade 3, 4 or 5 toxicities that are attributable to recombinant human EGF-rP64K/montanide ISA 51 vaccine (CIMAvax)
Time Frame: Up to 60 days post treatment
|
Measured according to Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5. The plausible range for the true (unobserved) event rate will be estimated by the upper one-sided, 95% Jeffrey's interval.
|
Up to 60 days post treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in quality of life scores
Time Frame: Baseline up to 12 months
|
Will be assessed using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core 30 (C30).
|
Baseline up to 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mary Reid, PhD, Roswell Park Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Disease Attributes
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Chronic Disease
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Recurrence
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Immunologic Factors
- Mitosis Modulators
- Adjuvants, Immunologic
- Vaccines
- Mitogens
- Monatide (IMS 3015)
Other Study ID Numbers
- I 511919 (Other Identifier: Roswell Park Cancer Institute)
- NCI-2019-08720 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pneumonia
-
King Edward Memorial HospitalCompletedNosocomial Pneumonia | Healthcare-Associated Pneumonia | Aspiration Pneumonia | Ventilator-Associated PneumoniaIndia
-
Melinta Therapeutics, Inc.WithdrawnHospital-Acquired Bacterial Pneumonia | Ventilator-Associated Bacterial Pneumonia | Hospital-Acquired Pneumonia | Ventilator-Associated Pneumonia
-
Venatorx Pharmaceuticals, Inc.Biomedical Advanced Research and Development AuthorityNot yet recruitingHospital-acquired Pneumonia | Ventilator-associated Pneumonia
-
Hannover Medical SchoolCharite University, Berlin, Germany; University of LeipzigUnknownCOVID-19 | Bacterial Pneumonia | Viral Pneumonia | Pneumonia Due to Streptococcus Pneumoniae | Pneumonia Due to H. Influenzae | Pneumonia, Organism Unspecified | Pneumonia in Diseases Classified Elsewhere | Pneumonia Due to Other Specified Infectious OrganismsGermany
-
Nantes University HospitalSociété Française d'Anesthésie et de RéanimationCompletedPneumonia | Sepsis | Ventilator-Associated Pneumonia | Hospital Acquired PneumoniaFrance
-
University Medical Centre LjubljanaUniversity of Ljubljana, Faculty of MedicineUnknownCommunity Acquired Pneumonia | Ventilator Associated Pneumonia | Hospital Acquired PneumoniaSlovenia
-
PfizerCompletedVentilator-associated Pneumonia (VAP) | Nosocomial Pneumonia (NP)Bulgaria, France, Italy, Korea, Republic of, Mexico, Peru, Poland, Russian Federation, Spain, Turkey, United Kingdom, Vietnam, Philippines, China, Ukraine, Argentina, Brazil, Hungary, Romania, India, Japan, Taiwan, Latvia, Czechia, Slov... and more
-
Arpida AGTerminatedHospital-Acquired Pneumonia | Ventilator-Associated Pneumonia | Health-Care-Associated Pneumonia
-
ShionogiCompletedHospital Acquired Pneumonia (HAP) | Healthcare-associated Pneumonia (HCAP) | Ventilator Associated Pneumonia (VAP)Israel, Spain, United States, Belgium, Canada, Czechia, Estonia, France, Georgia, Germany, Hungary, Japan, Latvia, Philippines, Puerto Rico, Russian Federation, Serbia, Taiwan, Ukraine
-
Methodist Health SystemCompletedHospital-acquired Pneumonia | Ventilator-associated PneumoniaUnited States
Clinical Trials on Quality-of-Life Assessment
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol Specific | Malignant NeoplasmUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)RecruitingChildhood Malignant NeoplasmUnited States, Canada, Puerto Rico, Australia, New Zealand
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditionsUnited States
-
Wake Forest University Health SciencesWithdrawnLung Metastases | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Recurrent Malignant Mesothelioma | Advanced Malignant Mesothelioma
-
City of Hope Medical CenterNational Cancer Institute (NCI)Recruiting
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | COVID-19 InfectionUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | COVID-19 InfectionUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | Neuropathy | COVID-19 InfectionUnited States
-
M.D. Anderson Cancer CenterActive, not recruitingCervical Carcinoma | Endometrial Carcinoma | Vaginal Carcinoma | Malignant Female Reproductive System Neoplasm | Vulvar CarcinomaUnited States
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)Active, not recruitingMetastatic Colorectal Carcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 and other conditionsUnited States