Trimelvax001TRIMELVax Vaccine for Stage IIIC and IV Melanoma Patients
TRIMELVAX
Melanoma+9
+ Neoplasms
+ Neoplasms by Histologic Type
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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
Faculty of Medicine, University of Chile
Santiago, Chile