Melanoma Stage IIIcPhase 1Trimelvax001NCT06556004
Phase 1 Study Using TRIMELVax for Stage IIIC / IV Melanoma Patients
A Phase 1 study testing TRIMELVAX in people with Melanoma Stage IIIc and Melanoma Stage IV, run by University of Chile at 2 sites in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma Stage IIIc, Melanoma Stage IV
- What is being tested?
- TRIMELVAX
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChile
- Study dates
- 2 May 2021to 31 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Hospital Salvador
Santiago, RM, 7510916
Faculty of Medicine, University of Chile
Santiago, RM, 8380000
About this study
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)
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.
Read more
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.
Read the 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 5.0. 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).
- Conditions
- Melanoma Stage IIIc, Melanoma Stage IV
- Being tested
- TRIMELVAX
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRIMELVAXBiological
The safety of this immunotherapeutic compound will be tested in patients with advanced melanoma and will secondarily evaluate the induced immune response.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: TRIMELVAX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start2 May 2021
- Primary completion31 Dec 2023
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Melanoma Stage IIIcStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital del Salvador
- Responsible party
- Sponsor
- Investigators
- Flavio Salazar, PhD, Study chair, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556004
- Sponsor's protocol ID
- UCHIT19I0061
- Other IDs
- IT19I0061
- Acronym
- Trimelvax001
- Status last verified
- Oct 2023
- First submitted
- 12 Aug 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized protocol data will be shared upon request by other researchers via the researchers' email addresses. Applicants will be asked to provide information about their request. Information to review the results will be shared; information to carry out other studies must be reviewed by the ethics committee before delivery. A research team meeting with the applicants will be considered for an adequate response to the requests.
Publications
Estay R, Cortes A, Muller B, Tempio F, Merino C, Fuentes C, Rebolledo A, Ramirez N, Contalba P, Bustos K, Pereda C, Gleisner MA, Flores I, Gonzalez FE, Tittarelli A, Achour A, Hidalgo S, Lladser A, Becker MI, Salazar-Onfray F, Lopez MN. Phase I trial of a heat-conditioned tumor lysate vaccine (TRIMELVax) in anti-PD-1 refractory melanoma: safety and immunological aspects (NCT06556004). Br J Cancer. 2026 Aug;135(3):436-444. doi: 10.1038/s41416-026-03459-1. Epub 2026 Apr 30.
PubMed 42062531
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06556004
- Acronym / sponsor ID
- Trimelvax001 / UCHIT19I0061
- Conditions
- Melanoma Stage IIIc, Melanoma Stage IV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Hospital del Salvador
- Study start
- 2 May 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 5.0. 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Stage IIIC and IV melanoma patients | Experimental | Biological: TRIMELVAXTRIMELVax 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRIMELVAXThe safety of this immunotherapeutic compound will be tested in patients with advanced melanoma and will secondarily evaluate the induced immune response. | Biological | Stage IIIC and IV melanoma patients |
Primary outcome
Safety of treatment
Time frame: 1 year
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.
3 secondary outcomes
Specific immune response
Time frame: 1 year
Objective tumor response
Time frame: 1 year
Progression-free survival (PFS) and overall survival (OS)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Derived from this study: PubMed 42062531Estay R, Cortes A, Muller B, Tempio F, Merino C, Fuentes C, Rebolledo A, Ramirez N, Contalba P, Bustos K, Pereda C, Gleisner MA, Flores I, Gonzalez FE, Tittarelli A, Achour A, Hidalgo S, Lladser A, Becker MI, Salazar-Onfray F, Lopez MN. Phase I trial of a heat-conditioned tumor lysate vaccine (TRIMELVax) in anti-PD-1 refractory melanoma: safety and immunological aspects (NCT06556004). Br J Cancer. 2026 Aug;135(3):436-444. doi: 10.1038/s41416-026-03459-1. Epub 2026 Apr 30.
- Common Terminology Criteria for Adverse Events (CTCAE)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized protocol data will be shared upon request by other researchers via the researchers' email addresses. Applicants will be asked to provide information about their request. Information to review the results will be shared; information to carry out other studies must be reviewed by the ethics committee before delivery. A research team meeting with the applicants will be considered for an adequate response to the requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flavio Salazar, PhD study chair
University of Chile
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TRIMELVAX in people with Melanoma Stage IIIc and Melanoma Stage IV, run by University of Chile at 2 sites in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of treatment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06556004, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.