Revisions for CIMAvax-EGF in patients at high risk of lung cancer | Registro Público Cubano de Ensayos Clínicos

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CIMAvax-EGF in patients at high risk of lung cancer

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Phase I study in patients at high risk of lung cancer and early-stage lung cancer survivors treated with the therapeutic vaccine CIMAvax®

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Center of Molecular Immunology (CIM) / Ministry of Public Health (MINSAP)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Authorization date :

25/02/2020

Reference number:

05-008-19B

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Pedro

Midle name:

Pablo

Last name:

Pino Alfonso

Medical Specialty :

II Degree Specialist in Pneumologist

Affiliation:

Hermanos Ameijeiras Hospital

Postal address:

Calle San Lazaro 701 , esq. Belascoain

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78761436

+53-78761437

Email address:

broncoscopia@hha.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

20/01/2021

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Lung cancer

Health condition(s) code:

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Intervention(s):

CIMAvax®-EGF. 2.4 mg per dose. The first 4 doses will be administered every 14 days and the remaining 4 doses, every 28 days until reaching 8 doses. The duration of the treatment will be 6 months. The product will be administered intramuscularly divided into 4 subdoses, equivalent to 0.6 mg of EGF at each site of inoculation (both deltoid regions and both gluteus).

Intervention code:

Immunotherapy, Active

Epidermal Growth Factor

Injections, Intramuscular

Intervention keyword:

CIMAvax-EGF.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

1. EGF concentration (The concentration of EGF in patients' blood will be determined in pg / mL). Time of measurement: At baseline, at 14 days (+3) after the end of the induction phase (4th dose of the vaccine) and at 14 days (+3) of the evaluation at the end of the treatment under study (8th dose of the vaccine). 2. Anti-EGF antibody titers (In each patient the antibody titres will be determined in response to short-term vaccination and it will be determined if it is ≥ 1: 4000). Time of measurment: At baseline, 14 days (+3) after the end of the induction phase (4th dose of the vaccine) and, 14 days (+3) of the evaluation at the end of the treatment under study (8th dose of the vaccine).

Key secondary outcomes:

1. Serum IL-6 concentration (pg / ml). Measurement time: At baseline and, weeks 8 and 24. 2. Total bilirubin (mg / dL). Measurement time: At baseline and, weeks 8 and 24. 3. Neutrophil / lymphocyte ratio (neutrophil / lymphocyte ratio). Measurement time: At baseline and, weeks 8 and 24. 4. Platelet / lymphocyte ratio (platelet / lymphocyte ratio). Measurement time: At baseline and, weeks 8 and 24. 5. Myeloid suppressor cell frequency (MDSC) (%). Measurement time: At baseline and, weeks 8 and 24. 6. Absolute count and frequency of CD4 + T cells (total and %). Measurement time: At baseline and, weeks 8 and 24. 7. Absolute count and frequency of CD8 + T cells (total and %). Measurement time: At baseline and, weeks 8 and 24. 8. CD8 + CD28- T cell frequency (%). Measurement time: At baseline and, weeks 8 and 24. 9. CD4 / CD8 Index (CD4 / CD8 Ratio). Measurement time: At baseline and, weeks 8 and 24. 10. Grade 3, 4 or 5 toxicity attributable to the therapeutic vaccine CIMAvax®-EGF (The occurrence of Adverse events intensity grade 3 (severe), 4 (severe threatening or disabling) or 5 (severe that causes death will be evaluated in each patient) that is attributable (definitive, very probable, probable, possible) to the therapeutic vaccine CIMAvax®-EGF). Measurement time: Weeks 0, 2, 4, 6, 8, 10, 14, 18, 22, 24 and 30. 11. Adverse events-AE (Occurrence of some AE (Yes, No), Type of AE (according to the CTC version 5), Duration of the EA (Time between the start and end dates of the AE), AE intensity (Light, Moderate, Severe, Serious that threatens or incapacitates, Serious that produces death according to CTC version 5.0), Causality of AE (Definitive, Highly probable, Probable, Possible, Unrelated, Unknown), Severity of AE (Yes, No. In case of severity it will be classified according to the categories of: causes the death of the patient, threatens life, requires hospitalization or prolongs an existing hospitalization, produces a disability, significant or persistent disability , produces a birth defect or congenital anomaly), Attitude towards the treatment under study (Without changes, Dose modification, Temporary interruption of treatment, Definitive interruption of treatment, according to the attitude decided by the clinical investigator), Result of the AE (Recovered, Improved, Persists, Squeals)). Measurement time: Weeks 0, Week 2, Week 4, Week 6, Week 8, Week 10, Week 14, Week 18, Week 22, Week 24, Week 30. 12. Clinical response (For patients included in Cohort A, it will be evaluated through the respiratory function test and the COPD status will be collected at the end of treatment according to the GOLD criteria. For patients included in Cohort B, it will be evaluated through imaging and will collect the control of the disease in local relapse or relapse at a distance). Measurement time: at any time during the treatment and follow-up time.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

79 years

Inclusion criteria:

1. Patients who meet the diagnostic criteria according to the cohort to which they belong. 2. Patients aged ≥ 18 years for survivors of lung cancer and between 50 and 79 years for patients at high risk of lung cancer. 3. Patients who do not have imaging evidence of lung cancer, evaluated by CT according to RECIST criteria. 4. Patients of childbearing age who consent to the use of appropriate contraceptive methods (for example, hormonal or barrier contraceptive methods, withdrawal) before being included in the study. If a woman becomes pregnant or suspects that she is pregnant while she or her partner is participating in this study, she should inform her doctor immediately. 5. Patients who give their informed consent to participate in writing. In addition to the above criteria, patients must meet the following specific criteria of the cohort in which they will be included: Patients at high risk of lung cancer (Cohort A). 1. Document the presence of any of these risk factors • Moderate or severe COPD. • Family history of lung cancer. • Low body mass index. • Recent pneumonia. 2. Have quit smoking in the last 10 years or be a current smoker. 3. Have a history of smoking at least 50 packages / year. 4. Have the lung function test in the last 3 months before inclusion. Survivors of early stage lung cancer (Cohort B). 1. Having completed 3 months before inclusion, adjuvant therapy for lung cancer after surgery, with no evidence of early disease progression. 2. CPCNP confirmed in stage IB to IIIA in the initial diagnosis (TNM 8th edition).

Exclusion criteria:

1. Patients not clinically fit to undergo the bronchoscopy procedure. 2. Patients with uncontrolled intercurrent diseases that include, among others, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia. 3. Patients with stage IIIA who are not surgical. 4. Patients with mild or very severe COPD. 5. Patients with psychiatric illness and / or social situations that would limit compliance with the study requirements. 6. Pregnant or breastfeeding patients. 7. Patients with another malignant disease in the previous 5 years, except skin cancer (not melanoma). 8. Patients who have received another product under investigation within 30 days prior to inclusion. 9. Patients who have received treatment for their disease with immunotherapy. 10. Patients with known immunosuppressive disease (for example, HIV, AIDS or other immunosuppressive disease). The test is not mandatory. 11. Patients with known hypersensitivity to the vaccine components under study or any analogue. 12. Patients requiring steroid treatment equivalent to doses greater than 20 mg of prednisone daily. 13. Patients reluctant or unable to follow the requirements of the protocol.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Prevention

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

1

Target sample size:

60

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Orestes

Last Name:

Santos Morales

Specialty:

Pharmacology. Second Degree Specialist

Affiliation:

Center of Molecular Immunology

Postal Address:

216 Street and 15 street, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72717933

Email :

orestesm@cim.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Orestes

Last Name:

Santos Morales

Specialty:

Pharmacologist. Second degree Specialist

Affiliation:

Center of Molecular Immunology

Postal Address:

216 street and 15 street. Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72717933

Email :

orestesm@cim.sld.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Hermanos Ameijeiras hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

01/07/2019

Postal address of Ethic Committee :

Calle San Lazaro # 701 esq. a Belascoain, Centro Habana, La Habana, C.P:10400, Cuba

Telephone:

+53-78761000

Email:

hha@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

30/07/2022

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000339

Date of Registration in Primary Registry:

22/10/2020

Record Verification Date:

2020/10/28

Next update date:

2021/10/28

Link to the spanish version:

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