TCTR20220202004
Unknown
Phase 1
Clinical and pathological response of pre-operative Intratumoral and Intramuscular Poly-ICLC(Hiltonol) for cutaneous melanoma stage 2 and 3
/A0 sites12 target enrollmentFebruary 2, 2022
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- cutaneous melanoma stage 2 and 3
- Sponsor
- /A
- Enrollment
- 12
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. diagnosed with cutaneous melanoma stage 2 and 3
- •2\. age more than 18 years old
- •3\. expected life expectancy more than 6 months
- •4\. ECOG 0\-1
- •5\. inform\-consent to be part of the research
- •6\. normal liver and kidneys functions as state in the protocol
Exclusion Criteria
- •1\. allergy to poly\-ICLC
- •2\. melanoma at face
- •3\. autoimmune disease
- •4\. history of immunologic treatment except antibody treatment and discontinue the drug more than 4 weeks
- •5\. history of CMT, RT, or targeted therapy and discontinue less than 2 weeks
- •6\. history of others carcinoma except BCC or SCC which can be treat locally
- •7\. HIV infection
- •8\. receive live attenuated vaccine and killed vaccine within 28 days before receiving 1st dose of poly\-ICLC
- •9\. prescribed with prednisolone more than 10 mg per day except inhaled or intranasal corticosteroids
- •10\. any health issues the might interfere with the efficacy of the drug and/or harmful to one health associated with using poly\-ICLC
Outcomes
Primary Outcomes
Not specified
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