CIMAvax-EGF vaccine Predictor Phase IV

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000205
• Date of registration: 14/12/2015
• Prospective Registration: Yes
• Primary sponsor: Center of Molecular Immunology (CIM)
• Public title: CIMAvax-EGF vaccine Predictor Phase IV
• Scientific title: Security of CIMAvax-EGF® vaccine for the treatment of patients with NSCLC in advanced stages. Effectiveness exploration according to baseline concentrations of EGF. phase IV
• Date of first enrolment: 14/12/2015
• Target sample size: Patients to be recruited in two years
• Recruitment status: Complete
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000205-En
• Study type: Interventional
• Study design: Allocation: N/A: single arm study. Masking: Open. Control group: Uncontrolled. Assignment: Single group. Purpose: Treatment
• Phase: 4

Countries of recruitment

Cuba

Contacts

• Name: Pedro Pablo Guerra Chaviano
• Affiliation: National Coordinating Center for Clinical Trials

• Name: Geidy Lorenzo Monteagudo
• Affiliation: Center for Molecular Immunology

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients of either sex and greater than or equal to 18 years.
2. Patients who met the diagnostic criteria.
3. Non-eligible patients for chemotherapy or radiotherapy or who have received the treatment oncospecific available and have no other treatment option.
4. Patients who have signed informed consent for research.
5. Patients with clinical criteria status (ECOG) 0 to 3.
6. Patients with a life expectancy greater than or equal to 3 months.
Exclusion criteria: 1. Patients participating in another clinical trial.
2. Patients who have been treated with specific immunotherapy CIMAvax-EGF in the previous 6 months.
3. Patients who present a history of hypersensitivity to compounds similar to the vaccine or other component of the product formulation biological or chemical composition.
4. Patients of childbearing age who are not using an appropriate method of contraception (intrauterine devices, hormonal contraceptives, barrier methods or tubal ligation). If male (vasectomy, condoms) during treatment
5. Patients who are pregnant, breastfeeding or postpartum.
6. Patients with brain metastases.

Age minimum: 18 years
Age maximum: None
Gender: Male/Female

Health Condition(s) or Problem(s) studied

Lung Neoplasms

Bronchial Neoplasms

Carcinoma, Non-Small-Cell Lung

Advanced non small cell lung cancer (NSCLC)

Carcinoma, Bronchogenic

Intervention(s)

Experimental group: CIMAvax-EGF therapeutic vaccine. The vaccine will be administrated by intramuscular route, a dose of 2,4 mg. The first four doses (induction stage) will be administered every 14 days and the other doses (maintenance stage) every 28 days until the patients clinical conditions allow. Prior to the first dose of the vaccine, immunomodulatory dose cyclophosphamide (200 mg / m2, will be administered by intravenous route

CIMAvax-EGF vaccine

Primary Outcome(s)

Serious Adverse Event, expected or unexpected, with definite or probable causality relationship with the study product. Measuring time: monthly for two years.

Secondary Outcome(s)

Security Related:
Adverse Events (AE): Measuring time: inclusion and monthly for two years. Measured as:
1. Occurrence of any AE (yes, no)
2. Description of AE(name of adverse event).
3. Time of onset of AE(difference between start and completion of the EA)
4. Seriousness of AE (1. Serius, 2 No serious)
5. Intensity of AE (1. Light, 2. Moderate 3. Severe, 4. Very severe 5. Death)
6. Causality relationship (1.Very Likely/Safe/final, 2. Likely 3. Possible, 4. Unlikely 5. unrelated 6. Unknown)
7. Attitude followed by the appearance of AE (1. No change 2. Modification of dose 4. 3.Interrupción temporary or definitive interruption)
8. Result of the AE (1. Recovered, 2. Improved , 3. Persists or Consequences.)
9. Batch of vaccine CIMAvax-EGF® (Batch Number of the vaccine)
-Hemoglobin (Numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18 and 24 months
-White blood cell count with differential (Numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months
-Hematocrit (Numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months
-Platelets (Numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months
-Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT) (numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months
-Glycemic (Nnumeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months
-Bilirubin (Numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months
-Alkaline phosphatase (Numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months
Related effectiveness
-Time Overall survival (time between inclusion and the date of death of the patient). Measuring time: at baseline, and monthly for two years.
-Quality Of life (Questionnaires EORTC QLQ-C30 and EORTC QLQ-CC 13). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months
-First-line treatment response (Complete response, Partial response, stable desease, Progesion, Not evaluable accoridng to RECIST version 1.1, 2009). Measuring time: at baseline

Secondary ID(s)

IICRD-EC-157

Source(s) of Monetary Support

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

Secondary Sponsor(s)

Not applicable

Results

• Results available: Yes
• Date Posted: 30/04/2022
• Date Completed: 30/04/2022