Revisions for CIMAvax-EGF in different maintenance schemes | Registro Público Cubano de Ensayos Clínicos

Current revision:

CIMAvax-EGF in different maintenance schemes

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:

Evaluation of the immune response generated after vaccination with CIMAvax-EGF using different maintenance schedules.

Secondary indentifying numbers:

CIM-PL024

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

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:

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:

Elia

Last name:

Neninger Vinageras

Medical Specialty :

Second Degree Specialist in Oncology

Affiliation:

"Hermanos Ameijeiras" Surgical Clinical Hospital

Postal address:

San Lazaro street, 701 corner Belascoain, Havana Center

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78761000

Email address:

nenin@infomed.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:

Recruiting

Date of first enrollment:

09/12/2019

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:

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

Health condition keyword:

NSCLC

Intervention(s):

Group I: Monthly immunization with CIMAvax-EGF after induction, up to two years.. Group II: Immunization with CIMAvax-EGF after induction, every two months, up to two years.. Group III: Immunization with CIMAvax-EGF after induction, every three months, up to two years.. For the 3 study groups: in each immunization, patients will receive 2.4 mg total of the vaccine preparation: rhEGF as active principle, administered intramuscularly, bound to the transporter protein rP64k and adjuvated in Montanide ISA 51 VG (SEPPIC, France). The vaccine will be administered at 4 inoculation sites. In each of the 4 inoculation sites the amount of EGF will be equivalent to 0.6 mg in a volume of 1.2 mL. Treatment with CIMAvax-EGF will be maintained until the appearance of unmanageable toxicity or the deterioration of the general condition of the patient.

Intervention code:

Immunotherapy, Active

Epidermal Growth Factor

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):

- Titer of antibodies against EGF. Measurement time: before the 1st immunization, and then monthly for 2 years. - Concentration of EGF in serum. Measurement time: before the 1st immunization, and then monthly for 2 years.

Key secondary outcomes:

- Survival Time (total time that the patient lives since the first immunization): Measurement time: from the date of inclusion to the date of death.

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 with a cytological / histological diagnosis of non-small cell lung carcinoma in all stages IIIb and IV, of any sex and age equal to or greater than 18 years, who have completed at least 2 cycles of first-line chemotherapy. 2. Patients who have signed the informed consent for the research. 3. Patients with clinical status criteria (ECOG) from 0 to 2.

Exclusion criteria:

1. Patients of childbearing potential who are not using an adequate method of 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.

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:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

N/A

Target sample size:

42

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:

Danay

Last Name:

Saavedra Hernandez

Specialty:

1st Degree Specialist in Immunology and Family medicine.

Affiliation:

Center of Molecular Immnunology (CIM)

Postal Address:

216 street corner 15, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+5372717933 ext: 3399

Email :

danays@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:

Jenysbel

Middle Name:

De la Caridad

Last Name:

Hernandez Reyes

Specialty:

Bachelior in Biochemistry and Molecular Biology

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

216 street corner 15, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+5372717933 ext: 3592

Email :

jenysbelh@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:

30/10/2019

Postal address of Ethic Committee :

San Lazaro 701 corner Belascoain, Centro Habana, Havana, ZC 10400, Cuba

Telephone:

+53 78761000

Email:

hha@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

29

Study completion date:

20/12/2024

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:

RPCEC00000368

Date of Registration in Primary Registry:

12/05/2021

Record Verification Date:

2021/06/15

Next update date:

2022/06/15

Link to the spanish version:

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19 July 2023 - 3:26pm by Gladys		8 January 2026 - 7:17am by Gladys
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