GcGM3/VSSP in Metastatic melanoma

Phase 2

Recruiting

• Conditions: Metastatic melanoma; Melanoma; Nevi and Melanomas; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue

• Registration Number: RPCEC00000223
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival (time from randomization until death from any cause). Measuring time: 24 months. <br>