Revisions for Phyisician Led CIMAvax-EGF lung biomarkers | Registro Público Cubano de Ensayos Clínicos

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Revision of 24 March 2023 - 8:24am:

Phyisician Led CIMAvax-EGF lung biomarkers

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.

Acronym of Public Title:

CIMAvax-EGF vaccine lung Biomarkers

Scientific title:

Evaluation of biomarkers associated with clinical efficacy of CIMAvax-EGF® vaccine in patients with advanced stages (IIIB and IV) of non-small cell lung cancer who have been treated with this therapy. Physician Led

Acronym of Scientific Title:

CIMAvax-EGF vaccine lung Biomarkers

Secondary indentifying numbers:

FL-EC-0026

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Center of Molecular Immunology, Cuban Ministry of Public Health (MINSAP), Innovative Immunotherapy Alliance (IIA)

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:

Only approved by Ethics Committees

Principal investigator

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

First name:

Ramon

Midle name:

Alberto

Last name:

Ortiz Carrodeguas

Medical Specialty :

MD, First degree specialist in Oncology

Affiliation:

“Celestino Hernandez Robau” Hospital

Postal address:

Cuba No. 564 entre Barcelona y Hospital

City:

Santa Clara, Villa Clara

Country:

Cuba

Zip Code:

50100

Telephone:

+53-42271202

+53-42279442

Email address:

raortizcarrodeguas@gmail.com

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:

Pinar del Rio, “III Congreso” Hospital, Dr. Liudmila Herrera Rodriguez, MD, Second Degree specialist in Oncology

Matanzas, “Faustino Perez” Hospital, Dra. Kirenia Camacho Sosa. MD, Second Degree specialist in Oncology

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

12/03/2021

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:

Advanced non small cell 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 therapeutic vaccine, 2.4 mg by intramuscular route. Indication: induction stage, four weekly administrations every 14 days, maintenance stage, administration every 28 days until the patient's clinical conditions allow. Prior to the first dose of the vaccine, immunomodulatory dose cyclophosphamide (200 mg / m2, intravenous) will be administered.

Intervention code:

Biomarkers, Tumor

Immunotherapy, Active

Epidermal Growth Factor

Cyclophosphamide

Injections, Intramuscular

Administration, Intravenous

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-Expression of biomarkers in paraffin biopsies or cytology (EGFR mutations, KRAS mutations, BRAF mutations by molecular biology) and (ALK, ROS1 and PD-L1 expression by immunohistochemistry). Measurement time: At diagnosis of the disease 2-EGFR mutations in liquid biopsies (KRAS and BRAF mutations by molecular biology (cfDNA)). Measurement time: during the maintenance phase with CIMAvax-EGF, every 6 months or 1 year after the previous extraction; for a period of 2 years. 3-Genetic profile of the nasal epithelium by brushing (Genetic Profile). Measurement time: during the maintenance phase with CIMAvax-EGF, every 6 months or 1 year after the previous extraction; for a period of 2 years. 4-EGFR cytosine and growth factor concentration (EGF concentration, TGF alpha concentration, IL8 concentration, IL4 concentration, IL 13 concentration, other cytosine concentration) Measurement time: during the maintenance phase with CIMAvax-EGF, every 6 months or 1 year after the previous extraction; for a period of 2 years. 5- Antibody response vs EGF (Titer of Ab Anti EGF). Measurement time: during the maintenance phase with CIMAvax-EGF, every 6 months or 1 year after the previous extraction; for a period of 2 years. 6- Percentage of lymphocyte subpopulations in circulating peripheral mononuclear cells (PBMC). (% CD8 naive T,% CD8 effector cells,% CD4 naive T cells,% CD4 effector T cells,% th17 T cells,% Tregs cells,% CD19 + B cells,% CD4 + T cells,% CD8 + T cells,% CD8 + CD28 T cells -, CD4/CD8 index) Measurement time: during the maintenance phase with CIMAvax-EGF, every 6 months or 1 year after the previous extraction; for a period of 2 years. 7- Global survival time (Time between the begining of CIMAvax-EGF treatment and the date of death of the patient or date of last news). Measurement time: At baseline and, monthly for 2 years. 8-Treatment evaluation for progression (Complete Response, Partial Response, Stable Disease, Progression Disease): Measurement time: at baseline and, every 6 months for 2 years.

Key secondary outcomes:

Not applicable

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:

None

Inclusion criteria:

1. Patients of any sex and age greater than or equal to 18 years. 2. Patients who have signed the informed consent for the research. 3. Patients who meet the diagnostic criteria. 4. Patients with at least stable disease after 1st line chemotherapy, who have been included in clinical trials with the CIMAvax-EGF vaccine or have been treated as part of routine medical practice. 5. Patients who have completed the induction stage with the CIMAvax-EGF® vaccine and are receiving the vaccine as maintenance therapy. 6. Patients with clinical status criteria (ECOG) from 0 to 2

Exclusion criteria:

1. Patients of childbearing potential who are not using adequate contraception (intrauterine devices, hormonal contraceptives, barrier methods or tubal ligation). In the case of males (vasectomy, use of condoms) while the treatment lasts 2. Pregnant, lactating or postpartum patients. 3. Patients with uncontrolled intercurrent illnesses including, but not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes mellitus, arterial hypertension and psychiatric illnesses that imply the incompetence of the subject. 4. Patients with brain metastases. 5. Patients with acute allergic states or history of severe allergic reactions.

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:

Other

Other purpose:

Evaluation of biomarkers of efficacy of CIMAvax-EGF vaccine

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

N/A

Target sample size:

140

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:

Geidy

Last Name:

Lorenzo Monteagudo

Specialty:

BSc. in Pharmaceutical Sciences

Affiliation:

Center of Molecular Immunology

Postal Address:

Calle 216 Esquina 15, Atabey, Playa.

City:

Havana

Country:

Cuba

Zip Code:

16040, Box 11600

Telephone:

+53-53806987

Email :

geydi@cim.sld.cu

geidylm72@gmail.com

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:

Zaima

Last Name:

Mazorra Herrera

Specialty:

DrC. in Biological Sciences

Affiliation:

Innovative Immunotherapy Allience (IIA)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

16040, Box 11600

Telephone:

+53-72717933 ext 3391

Email :

zaima1972@gmail.com

Research Ethics Committees

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

Name of Research Ethics Committees:

III Congreso Hospital

Celestino Hernandez Hospital

Faustino Perez Hospital

Status of evaluation:

Approved

In review

Status of evaluation date of Ethic Committee:

22/01/2021

05/01/2021

01/03/2021

Postal address of Ethic Committee :

Calle 2da y 26 de Julio. Pinar del Rio. ZC: 20100, Cuba

Cuba No. 564 entre Barcelona y Hospital. Santa Clara, Villa Clara. ZC:50100, Cuba

Carretera Central Km 101. Matanzas. ZC:40100, Cuba

Telephone:

+53-48762473

+53-42279401

+53-4547016, 256001, 256002

Email:

liudmyhr@infomed.sld.cu

direccion@hchr.vcl.sld.cu

bibliotfaustinop.mtz@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

12/03/2024

Date of available results:

12/06/2024

Date of first publication:

12/12/2024

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:

RPCEC00000355

Date of Registration in Primary Registry:

11/03/2021

Record Verification Date:

2021/03/15

Next update date:

2022/03/15

Link to the spanish version:

Click here

Registered Trials

Registration process

Phyisician Led CIMAvax-EGF lung biomarkers

About the RPCEC

Useful resources