CIMAvax-EGF® in metastatic asymptomatic or mildly symptomatic Castration Resistant Prostate Cancer patients. Phase II-III Clinical Trial

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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:

Safety and Efficacy assessment of Therapeutic Vaccine CIMAvax-EGF® in metastatic asymptomatic or mildly symptomatic Castration Resistant Prostate Cancer patients. Phase II-III Clinical Trial

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)

Reference number:

In process

Principal investigator

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

First name:

Rosa

Midle name:

Maria

Last name:

Amador Gonzalez

Medical Specialty :

Second degree specialist in Oncology

Affiliation:

“III Congreso" Hospital

Postal address:

Calle 2da, Reparto Casanova. Alt. Central

City:

Pinar del Rio

País:

Cuba

Zip Code:

20100

Telephone:

+53-48768460

Email address:

rosyamador@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 aplicable

Research ethics committees:

III Congreso Hospital, March 28th, 2018

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

01/10/2018

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:

Castration resistant prostate cancer

Health condition(s) code:

Prostatic Neoplasms, Castration-Resistant

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Prostatic Diseases

Genital Diseases, Male

Male Urogenital Diseases

Intervention(s):

Group 1 (Experimental). CIMAvax EGF vaccine + Second Line Standard Hormone Therapy Pre-treatment: Ciclophosphamide: Day 1 (200 mg/m2) One dose. 72 hours before start CIMAvax-EGF treatment. CIMAvax-EGF treatment: In every immunization patients will receive, 2.4 mg of the vaccine formulate, administered in 4 sites of injection (both deltoid region and both gluteal región), EGF amount equivalent to 0.6 mg in 1.2 mL, in each site. The first 4 immunizations will receive every 14 days and, the rest will receive every month until patient’s condition allow it; according to medical researcher criteria, until patient refusal to continue treatment or any withdrawal criteria appear. Second Line Standard Hormone Therapy: First Generation of Androgen Receptor Inhibitors. Bicalutamide: 50 -150 mg/d orally. According to availability and sites Protocol, other second line hormone therapy will be allowed. Docetaxel: When symptoms appear. Doses: 75 mg/m2 intravenously, after pre-medication with prednisone 10 mg orally, while Chemotherapy continues. The 10th cycle of CT will end at Day 21 of Docetaxel administration, when the patient finished 21 days treatment corresponding to prednisone. If toxicity to Docetaxel, dose will be adjusted up to a 75% of the dose to be administered according to the level of toxicity. Mode of administration: will be administered in infusion lasting 2 hours. Treatment duration: 10 cycles, every 21 days each one Group 2 (Control): Placebo + Second Line Standard Hormone Therapy. Placebo. El route and the frequency of the placebo will be identical to CIMAvax-EGF. Second Line Standard Hormone Therapy. It will be identical to experimental group.

Intervention code:

Antineoplastic Combined Chemotherapy Protocols

Androgen Receptor Antagonists

Androgen Antagonists

Cyclophosphamide

Prednisone

Placebos

Tablets

Injections, Intramuscular

Infusions, Intravenous

Administration, Oral

Immunization

Single Dose

Intervention keyword:

Docetaxel Bicalutamida CIMAvax EGF vaccine

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):

Overall survival (Time from randomization until death from any cause). Measurement time: monthly for 3 years.

Key secondary outcomes:

1. Progression Free Survival-PFS (Time from randomization to progression or death from any cause). Time to measurement: every 3 months for 3 years. 2. Time to progression-TTP (Time from randomization until objective tumor progression). Time to measurement: every 3 months for 3 years. 3. Time to appears symptoms (Time from the start of treatment until the date in which any of the following symptoms appear: Pain, worsening of quality of life (according to scales defined in the protocol) and, development of urinary or digestive symptoms related to the underlying disease indicative of commitment of the urinary or digestive tracts respectively). Time to measurement: every 3 months for 3 years. 4. Objective response (Complete response, Partial Response, Stable Disease, Progressive disease). Time to measure: every 3 months for 3 years. 5. Immunological Response (titer of anti-egf antibodies). Time to measurement: every 2 weeks during the 4 induction doses; monthly for 3 years. 6. Drug requirements (Analgesics, Opioids, Bisphosphonates). Time to measurement: at baseline, monthly for 3 years. 7. Immunogenicity (Good antibody response, Super good antibody response, Poor antibody response). Every 2 weeks during the 4 induction doses; monthly for 3 years. 8. IgG Subclass: (Type of IgG). Time to measurement: Every 2 weeks during the 4 induction doses; monthly for 3 years. 9. Immunodominance of the response against EGF (Cellular subpopulation phenotype in peripheral blood). Time to measurement: at baseline, every 3 months for 3 years. 10. Plasmatic EGF concentration (EGF concentration). Time to measurement: Every 2 weeks during the 4 induction doses; monthly for 3 years. 11. Urine EGF concentration. (EGF concentration). Time to measurement: Every 2 weeks during the 4 induction doses; monthly for 3 years. 12. Quality of life (EORTC QLQ-C30 and EORTC QLQ-PR25). Time to measurement: at baseline, every 3 months for 3 years. 13. Adverse Events (AE). (Measurable by: -Occurrence of any AE (Yes, No) -Description of the AE (Name of the adverse events) - -Intensity of the AE (Mild, Moderate, Severe, Extremely Severe, Death) -Severity (Serious, No serious) -Result (Recovered, Enhanced, Persists or squeals) -Attitude towards treatment (Unchanged, Dose modification, Temporary interruption, Definitive interruption) -Causality relationship (Very Likely, Probable, Possible, Unlikely, not related, Unknown)). Time to measurement: monthly during 3 years.

Selection criterias

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

Gender:

Male

Minimum age:

18 years

Maximum age:

79 years

Inclusion criteria:

1. Patients who have signed informed consent. 2. Patients who meet the diagnostic criterion of metastatic castration-resistant prostate adenocarcinoma (patient who after receiving surgical or biochemical castration (Testosterone < 50 ng/DL) progresses to a M1 stage corresponding to the IVb phase Of the disease according to the classification proposed by the AJCC in its eighth edition of the 2017 (any T, any N, M1, any grade group, any PSA). 3. Asymptomatic or minimally symptomatic patients. (Low pain levels measured by the Brief pain investigational Short Form Scale (BPI-SF) between 0-1 (asymptomatic) and 2-3 (minimally symptomatic) alleviated with acetaminophen or other non-steroidal anti-inflammatory drugs (CUA, 2015). 4. Patients with imaging study and clinical documentation to corroborate the existence of metastatic lesions prior to the onset of treatment for their metastatic disease, according to RECIST criteria (version 1.1). 5. Patients aged between 18 and 79 years. 6. Patients with life expectancy of 6 months or more. 7. Patients with functional status according to ECOG ≤ 2. 8. Patients with organ and bone marrow functioning defined by the following parameters: Hemoglobin ≥90 g/L (patients with lower Hb levels should be transfused prior to inclusion), Total leukocyte Count ≥ to 3.0 x 109/L, neutrophil count ≥ 1.5 x 109/L, Platelet count≥100 x 109/L, Bilirrubin: Within normal limits for each institution, Glycemia within normal limits for each institution, ALP: Up to 2.5 times the normal upper limit for each institution, GOT/GPT: up to 2.5 times the normal upper limit for each institution, Creatinine: Within normal limits for each institution.

Exclusion criteria:

1. Patients with cerebral metastases, history of primary CNS tumor, uncontrolled convulsions with standard therapy or history of brain vascular accident. 2. Patients with bone pain requiring treatment with opioids. 3. Patients with previous history of demyelinating or inflammatory diseases of the CNS or peripheral. 4. Patients with previous malignant diseases, except skin cancer (non-melanoma), properly treated. 5. Patients with acute allergic states, history of severe allergic reactions or autoimmune diseases. 6. Patients who are receiving another product in research. 7. Patients with a history of allergy attributed to compounds of chemical or biological composition similar to the product under study and/or the proposed Oncoespecífico treatment. 8. Patients carrying uncontrolled intercurrent illnesses, including, but not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and psychiatric illnesses that may Limit adherence to test requirements. 9. Patients with symptoms at the time of diagnosis.

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:

Single Blind

Control group:

Placebo

Study design:

Parallel

Phase:

2-3

Target sample size:

Phase II: 80 Phase III: To be adapted according Phase II results

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:

2nd Degree Specialist in Pharmacology

Affiliation:

Center of Molecular Immunology

Postal Address:

216 street and 17 Ave, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

53-72717933, ext. 3489

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:

2nd Degree Specialist in Pharmacology

Affiliation:

Center of Molecular Immunology

Postal Address:

216 street and 17 Ave, Atabey, Playa

City:

Havana City

País:

Cuba

Zip Code:

11600

Telephone:

+537 2717933 ext. 3489

Email :

orestesm@cim.sld.cu

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:

RPCEC00000291

Date of Registration in Primary Registry:

17/10/2018

Record Verification Date:

2018/10/17

Next update date:

2019/10/17

Link to the spanish version:

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CIMAvax-EGF® in metastatic asymptomatic or mildly symptomatic Castration Resistant Prostate Cancer patients. Phase II-III Clinical Trial

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