Status:
UNKNOWN
Phase 1 Study Using TRIMELVax for Stage IIIC / IV Melanoma Patients
Lead Sponsor:
University of Chile
Collaborating Sponsors:
Hospital del Salvador
Conditions:
Melanoma Stage IIIc
Melanoma Stage IV
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 t...
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 res...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
May 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06556004
Start Date
May 2 2021
End Date
March 31 2025
Last Update
August 15 2024
Active Locations (2)
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1
Hospital Salvador
Santiago, RM, Chile, 7510916
2
Faculty of Medicine, University of Chile
Santiago, RM, Chile, 8380000