NCT06556004: Trimelvax001

Phase 1 Study Using TRIMELVax for Stage IIIC / IV Melanoma Patients

Status unknown Phase 1 Last updated 15 August 2024

What this trial tests

Phase 1 trial testing TRIMELVAX in Melanoma Stage IIIc in 20 participants. Status unknown.

Timeline

2 May 2021

Primary endpoint
31 December 2023

31 March 2025

Quick facts

Lead sponsor	University of Chile
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	2 May 2021
Primary completion	31 December 2023
Estimated completion	31 March 2025
Sites	2 locations across Chile

Drugs / interventions tested

• TRIMELVAX — full drug profile →

Conditions studied

• Melanoma Stage IIIc — all drugs for Melanoma Stage IIIc →
• Melanoma Stage IV — all drugs for Melanoma Stage IV →

Sponsor

University of Chile

Who can join

18 and older, any sex, with Melanoma Stage IIIc or Melanoma Stage IV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A new cancer vaccine called TRIMELVax will be tested as a potential treatment for patients with unresectable stage III or stage IV melanoma who have progressed to anti-PD1 immune checkpoint blockers treatment or who have presented unacceptable toxicity to the treatment. This vaccine breaks the body's tolerance to cancer cells and triggers a specific immune response against tumors. It is made from heat-treated melanoma tumor cells combined with a natural booster. In tests with mice, the vaccine caused tumor shrinkage and activated a strong immune response against melanoma and colorectal cancer.

TRIMELVax consists of three types of human melanoma-destroyed cells that are heat-treated and mixed with a booster derived from a mollusk hemocyanin. Patients will receive four injections of the vaccine in one treatment cycle.

A Phase I clinical trial will be conducted to test the safety of TRIMELVax for stage IIIC and IV melanoma patients with unresectable stage III or stage IV melanoma who have progressed to anti-PD1 immune checkpoint blockers treatment or who have presented unacceptable toxicity to the treatment. The study includes 20 patients meeting specific criteria, such as being over 18 years old, having confirmed stage IIIC or IV melanoma, and having a good performance status.

The study's main goals are to assess potential side effects and measure the vaccine's impact on the patient's immune system. Blood samples will be taken before each treatment and monthly for the first year of follow-up. We will look for specific markers on certain immune cells to evaluate the vaccine's effectiveness. We will also conduct a test to evaluate the immune response one month after the last vaccine dose.

The study is conducted in two Chilean medical centers, the Oncology Service at the Hospital Salvador, where patients receive their standard cancer treatment and support. Our primary focus is ensuring the vaccine's safety and understanding its impact on the immune system.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Phase I trial of a heat-conditioned tumor lysate vaccine (TRIMELVax) in anti-PD-1 refractory melanoma: safety and immunological aspects (NCT06556004).
   Estay R, Cortés A, Müller B, Tempio F, et al · · 2026 · PMID 42062531 · DOI 10.1038/s41416-026-03459-1
2. PLGA Nanoencapsulation Enhances Immunogenicity of Heat-Shocked Melanoma Tumor Cell Lysates.
   Matheu KC, Araya BC, Diaz FT, Hassan N, et al · · 2025 · PMID 41439959 · DOI 10.3390/cells14241939