Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06556004
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Phase 1 Study Using TRIMELVax for Stage IIIC IV Melanoma Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 1 Clinical Trial to Determine the Safety of TRIMELVax for Stage IIIC and IV Melanoma Patients in Progression to Immunotherapy Treatment Checkpoint Inhibitors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Trimelvax001
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 bodys 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 studys main goals are to assess potential side effects and measure the vaccines impact on the patients 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 vaccines 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 vaccines safety and understanding its impact on the immune system
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 studys main goals are to assess potential side effects and measure the vaccines impact on the patients 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 vaccines 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 vaccines safety and understanding its impact on the immune system
Detailed Description:
Cancer vaccines emerge as a promising treatment alternative for patients refractory to immune checkpoint blockers ICBs because vaccination can break the tolerance generating new specific immune responses capable of modulating the tumor microenvironment TRIMELVax is a new immunogenic formulation prototype developed for treating solid tumors It is obtained from heat-conditioned melanoma tumor cell lysates combined with a natural adjuvant Preclinical studies showed tumor regression in murine models challenged with melanoma and colorectal cancer activating a robust immune response against these tumors The present vaccine is based on three allogeneic melanoma cell lysates pre-activated by a heat shock which includes the direct subcutaneous injection as a vaccine combined with an adjuvant derived from a mollusk hemocyanin in one cycle of four injections The present phase I clinical study entitled Phase 1 Clinical Trial to Determine the Safety of TRIMELVax for Stage IIIC and IV Melanoma Patients in Progression to Immunotherapy Treatment Checkpoint Inhibitors will include 20 stage IV melanoma patients according to the following inclusion criteria People over 18 years old with histological confirmation of AJCC malignant melanoma Stage IIIC or IV Performance Status 0 or 1 on the Eastern Cooperative Oncology Group ECOG scale Life expectancy over 3 months Disease progression after anti-PD1 immune checkpoint blockers treatment or who have presented unacceptable toxicity to the treatment Patients will be recruited in the Hospital del Salvador Oncology Service where they will receive their experimental treatment and standard cancer care support
Primary Objectives Possible adverse effects should be evaluated to ensure the safety of the treatment and follow the CTCAE criteria Common Terminology Criteria for Adverse Events version 50 Due to the many adverse events that will be monitored the CTCAE criteria are listed at the end of the trial protocol
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
Primary Objectives Possible adverse effects should be evaluated to ensure the safety of the treatment and follow the CTCAE criteria Common Terminology Criteria for Adverse Events version 50 Due to the many adverse events that will be monitored the CTCAE criteria are listed at the end of the trial protocol
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None