Clinical and pathological response of pre-operative intratumoral and intramuscular Poly-ICLC (Hiltonol) for cutaneous melanoma stage 2 and 3

Phase 1

• Conditions: poly-ICLC; neoantigen; cutaneous melanoma stage 2 and 3; cutaneous melanoma; Hiltonol; therapeutic cancer vaccine; melanoma stage 2 and 3; immunotherapy

• Registration Number: TCTR20220202004
• Lead Sponsor: /A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-02
• Study Completion: 2023-02-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: nknown
• Sex: All
• Target Recruitment: 12

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
11. prenant women or lactation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunologic response of Poly-ICLC (Hiltonol) in treatment of cutaneous melanoma stage 2 and 3 5 weeks MDSC, ULP-WGS, ELISpot, cytokine panel, tumor size in cm,Recurrent risk, overall survival rate and long term complication of IT poly-ICLC (Hiltonol) to cutaneous melanima stage 2 and 3 12 months Percent recurrent risk, survival rate and complication

Secondary Outcome Measures

Name	Time	Method
Recurrent risk, overall survival rate and long term complication of IT poly-ICLC (Hiltonol) to cutaneous melanima stage 2 and 3 12 months Percent of recurrent risk, survival rate and complication