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

NCT06556004 | Unknown Phase 1 DMC

• 2 other identifiers: UCHIT19I0061IT19I0061
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Specific immune response

  1 year

• Objective tumor response

  1 year

• Progression-free survival (PFS) and overall survival (OS)

  2 years

Study Arms (1)

Stage IIIC and IV melanoma patients

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.

Biological: TRIMELVAX

Interventions

TRIMELVAX BIOLOGICAL

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

Stage IIIC and IV melanoma patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Prior to the beginning of the study, participants should be aware of the risk information and express their willingness to participate by a written consent.
• Disease progression after the use of checkpoint inhibitors immunotherapy.

You may not qualify if:

• 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.
• Adrenal insufficiency, requiring the use of corticosteroids, at any dose.
• Presence of symptomatic cardiac arrythmias, atrial fibrillation or prolongation of the QT-interval.
• Arterial hypertension that is not under control (systolic pressure higher than 160 mmHg and or diastolic pressure higher than 100 mmHg.
• History of symptomatic cardiovascular diseases over the last 12 months (unstable coronary disease, symptomatic vascular disease, heart failure/ functional capacity III or IV according to the New York Heart Association, history of cerebrovascular accident including transient ischemic attack, untreated deep vein thrombosis, pulmonary embolism).
• History of HIV, HBV and / or HCV infections
• Major surgery over the last 28 days
• History of splenectomy
• Uncontrolled infection or any known medical condition, that according to the investigator's interpretation may increase the risk involved in the participation of the study, or interfere with treatment or follow ups, or interfere with the interpretation of safety results.
• Inability to carry out the informed consent process.
• History of allogeneic bone marrow transplant.
• Ongoing pregnancy or breastfeeding

Sponsors & Collaborators

• University of Chile: lead
• Hospital del Salvador: collaborator

Study Sites (2)

Hospital Salvador

Santiago, RM, 7510916, Chile

Location

Faculty of Medicine, University of Chile

Santiago, RM, 8380000, Chile

Location

Related Links

• Common Terminology Criteria for Adverse Events (CTCAE)

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Flavio Salazar, PhD

  University of Chile

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this trial, 20 patients will be enrolled and treated with TRIMELVax (subcutaneous). The patients will be recruited from a hospital in the Metropolitan Region: The oncology section of Hospital del Salvador. This center currently treats patients diagnosed with unresectable or metastatic melanoma with checkpoint inhibitors immunotherapy (mainly with Nivolumab). If a patient withdraws consent to participate in the study (including the use of data and samples already collected) or does not start treatment due to absence or death, he or she will be replaced by another participant until the number of 20 treated participants is completed.

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 15, 2024
• Study Start: May 2, 2021
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2025
• Last Updated: August 15, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The data will be shared when requested by other researchers, starting in 2025, for two years.
• Access Criteria: Requests to check published results with original data. Requests to perform other analyses before approval of the ethics committee. A meeting with the applicants will be considered to clarify the information.

Locations

CL (2)