Phase 1 Study Using TRIMELVax for Stage IIIC / IV Melanoma Patients
NCT Number: NCT06556004
Acronym: Trimelvax001
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Melanoma Stage IIIc|Melanoma Stage IV
Interventions: BIOLOGICAL: TRIMELVAX
Sponsor: University of Chile
Collaborators: Hospital del Salvador
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-05-02
Completion Date: 2025-03-31
Locations: Hospital Salvador, Santiago, RM, 7510916, Chile|Faculty of Medicine, University of Chile, Santiago, RM, 8380000, Chile

Summary:
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.

Primary Outcome Measures: Safety of treatment, The main objective is the safety of the therapy that will be evaluated in medical controls by a medical oncologist. Adverse events will be measured according to CTCAE 5.0.

The CTAE criteria is a descriptive terminology most used in the world to report adverse events in trial therapies and that determines a severity scale for each reported adverse event. These criteria define an adverse event as any involuntary and unfavorable sign, symptom, or illness temporarily associated with the use of this therapy or procedure and that may or may not be related to it., 1 year
Secondary Outcome Measures: Specific immune response, To evaluate the induction of a specific systemic immune response, peripheral blood will be drawn from the patients before each treatment administration and monthly during the first year of follow-up. Different surface and intracellular markers will be measured on CD8+ and CD4+ T lymphocytes. This group of markers was named the "rescue score," and it follows the proposal of Huang et al. (2017) and Sarhan et al. (2017) to evaluate immune responses to immunotherapies in humans. In addition, the Delayed Hypersensitivity or DTH test will be used thirty days after the last immunization to evaluate the in vivo immune response as described in López et al. (2009)., 1 year|Objective tumor response, Tumor response will be measured by PET CT or CT of the thorax, abdomen, and pelvis, using the RECIST 1.1 criteria to evaluate the best response. There will be a baseline image (maximum one month prior to the start of the protocol), another at the end of the four administrations, and then every three months or until progression.

The clinical response will also be evaluated in lesions visible on physical examination, and their progression will be sufficient to classify the patient as having progressive disease., 1 year|Progression-free survival (PFS) and overall survival (OS), PFS It will be measured from the date the first cycle was administered until progression, whether evidenced by physical examination or images. OS It will be measured from the date that the first cycle was administered until the patient's death., 2 years