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CIMAvax-EGF in different maintenance schemes
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12 May 2021 - 10:56am
by Gladys
19 July 2023 - 3:26pm
by Gladys
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Revision of 19 July 2023 - 3:26pm:
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)
Primary sponsor:
Center of Molecular Immunology (CIM)
Secondary sponsor:
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:
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
Data Sharing
Section to complete the data related to the data sharing plan.
Data sharing plan:
Yes
Description of Data Sharing Plan:
Data set to share: All data collected in the study. When: After the scientific publication of the study results How: By contacting the person listed on this form in the section CONTACT FOR PUBLIC QUERIES
Additional information to share:
None
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
Date of available results:
20/09/2025
Date of first publication:
30/09/2025
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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