NGcGM3/VSSP in Metastatic melanoma

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000223
• Date of registration: 07/12/2016
• Prospective Registration: No
• Primary sponsor: Center of Molecular Immunology (CIM)
• Public title: NGcGM3/VSSP in Metastatic melanoma
• Scientific title: Specific active immunotherapy with the vaccine preparation NGcGM3/VSSP in the treatment of patients with metastatic cutaneous melanoma
• Date of first enrolment: 11/03/2014
• Target sample size: 160
• Recruitment status: Recruiting
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000223-En
• Study type: Interventional
• Study design: Allocation: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment
• Phase: 2

Countries of recruitment

Cuba

Contacts

• Name: Marta Osorio Rodriguez
• Affiliation: National Institute of Oncology and Radiobiology (INOR)

• Name: Aliz Mathild Vega Rodriguez
• Affiliation: Center of Molecular Immunology

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients who received first-line onco-specific therapy according to the treatment guidelines and who completed the different protocols between 4 and 8 weeks prior to inclusion in the trial.
2. Patients older than 18 years
3. Patients with life expectancy of 6 months or more.
4. Patients with functional capacity assessment less than or equal to 2, according to ECOG criteria.
5. Informed Consent signed.


Exclusion criteria: 1.Patients who are pregnant or breastfeeding.
2.Patients with brain metastases.
3.Patients with acute or chronic infectious diseases.
4.Patients with a history of allergy attributed to compounds of chemical or biological composition similar to the vaccine .
5.Patients with autoimmune diseases.
6.Patients with descompensated chronic diseases.

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

Health Condition(s) or Problem(s) studied

Neuroendocrine Tumors

Melanoma

Neoplasms, Nerve Tissue

Neuroectodermal Tumors

Metastatic melanoma

Neoplasms, Germ Cell and Embryonal

Nevi and Melanomas

Intervention(s)

G(M3) Ganglioside

Antineoplastic Agents

Placebos

Gangliosides

NGcGM3/VSSP

Group 1 (experimental): standard treatment + 900 mg of the NGcGM3/VSSP vaccine (subcutaneous), the first 5 doses every 14 days and subsequent doses every 28 days until one year of treatment.
Group 2 (control): standard treatment + placebo (subcutaneous), the first 5 doses every 14 days and subsequent doses every 28 days until one year of treatment.

Adjuvants, Immunologic

Immunotherapy, Active

Proteolipids

Injections, Subcutaneous

Primary Outcome(s)

Overall survival (time from randomization until death from any cause). Measuring time: 24 months.

Secondary Outcome(s)

Antitumor response (RECIST (version 1.1) scale). Measuring time: 3, 6, 9, 12, 15, 18, 21, 24 months.
Safety
Adverse Events-AE (AE description (Name of the AE), AE Intensity (mild, moderate, severe, life-threatening, death) Causality relationship (very probable, probable, possible, unlikely, not related, not evaluable), Gravity (serious, non serious), Previous knowledge (expected, non expected) Result (recovered, improved, sequelae, death), Treatment (none, medication, surgical procedure, transfusion, other). Measuring time: 3, 6, 9, 12, 15, 18, 21, 24 months.
Immunogenicity
IgM and IgG against NGcGM3 ganglioside (ELISA). Measuring time: At baseline, 85, 169, 337 days.
Recognition and lytic capacity of IgM and IgG antibodies induced by vaccination and directed to NGcGM3 on tumor lines expressing ganglioside (flow cytometry). Measuring time: At baseline, 85, 169, 337 days
peripheral blood cells: CD3+, CD3+/CD4+, CD3+/CD8+, T reguladoras (CD4+/CD25+/Foxp3+), CD19+ (células B), NK (CD3-/CD16+/CD56+/CD69+), NKT (CD3+/CD56+). Flow cytometry. At baseline, months 3, 6 and 9.
Myeloide derived suppressor cells MDSC: (HLADRlow-/LIN-/CD11b+/CD 14+/CD33+).Flow cytometry. At baseline, months 3, 6 and 9.
Anti-HLA-A2: HLA-A2 NY-ESO 1, HLA-A2 Tyrisnase, HLA-A2 GP 100, HLA-A2 Mart-1, HLA-A2 MAGE A1, and MAGE A3 response
Flow cytometry. At baseline, months 3, 6 and 9.
IL-6 y IL-8. ELISA. At baseline, months 3, 6 and 9.

Secondary ID(s)

Not applicable

Source(s) of Monetary Support

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

Secondary Sponsor(s)

Not applicable