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

NCT06556004 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-08-15

No results posted yet for this study

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.

Conditions

  • Melanoma Stage IIIc
  • Melanoma Stage IV

Interventions

BIOLOGICAL

TRIMELVAX

The safety of this immunotherapeutic compound will be tested in patients with advanced melanoma and will secondarily evaluate the induced immune response.

Sponsors & Collaborators

  • Hospital del Salvador

    collaborator OTHER

  • University of Chile

    lead OTHER

Principal Investigators

  • Flavio Salazar, PhD · University of Chile

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-02
Primary Completion
2023-12-31
Completion
2025-03-31

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06556004 on ClinicalTrials.gov