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Trimelvax001TRIMELVax Vaccine for Stage IIIC and IV Melanoma Patients

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What is being tested

TRIMELVAX

Biological
Who is being recruted

Melanoma+9

+ Neoplasms

+ Neoplasms by Histologic Type

Over 18 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: May 2021
See protocol details

Summary

Principal SponsorUniversity of Chile
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 2, 2021

Actual date on which the first participant was enrolled.

Cancer vaccines offer a new hope for patients with advanced melanoma who have not responded well to other treatments like immune checkpoint blockers. TRIMELVax is an innovative vaccine being tested for its safety in people with late-stage melanoma. This vaccine is created from specially treated melanoma cells combined with a natural booster to help the body recognize and fight the cancer. The study focuses on adults over 18 with stage IIIC or IV melanoma who have either not benefited from or experienced serious side effects from existing treatments. By exploring this vaccine, the study aims to improve treatment options and potentially offer a new pathway for those battling advanced melanoma. In this study, participants will receive TRIMELVax through a series of four shots given under the skin. Researchers will closely monitor for any side effects using established criteria to ensure that the treatment is safe. To understand how the vaccine works, blood samples will be collected from participants before and after treatment to check how the immune system is responding. Additionally, a test will be performed a month after the last injection to further assess the body's immune response. Through these methods, the study aims to gather detailed information about the vaccine's impact on the immune system and its overall safety for patients.

Official TitlePhase 1 Clinical Trial to Determine the Safety of TRIMELVax for Stage IIIC and IV Melanoma Patients in Progression to Immunotherapy Treatment (Checkpoint Inhibitors)
NCT06556004
Principal SponsorUniversity of Chile
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

MelanomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueSkin DiseasesSkin NeoplasmsSkin and Connective Tissue DiseasesNeuroectodermal TumorsNevi and MelanomasNeuroendocrine Tumors

Criteria

6 inclusion criteria required to participate
People over 18 years old

Histological confirmation of AJCC malignant melanoma Stage IIIC or IV.

Performance Status 0 or 1 in the scale of Eastern Cooperative Oncology Group (ECOG).

Life expectancy over 3 months

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15 exclusion criteria prevent from participating
History of other cancers diagnosed in a period of less than 5 years, except for squamous or basal cell skin cancer, cervical cancer in situ or superficial bladder cancer, properly treated and cured.

Ocular melanoma.

Old or recent story of autoimmune disease.

Systemic use of corticosteroids or immunosuppressants within 28 days prior to the start of the study. The use of inhalation corticosteroids is allowed.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
TRIMELVax will be administered from 10x106 melanoma cells / mL. The dose schedule considers 4 immunizations distributed as follows: the first dose on day 0, the second dose on day 28, the third dose on day 56, and the fourth dose on day 84. Conditioned tumor lysate from 10x106 melanoma cells / mL will be administered s.c. at 500 µL / dose.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Hospital Salvador

Santiago, ChileOpen Hospital Salvador in Google Maps
Suspended

Faculty of Medicine, University of Chile

Santiago, Chile
Suspended2 Study Centers