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

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

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

TCTR

Registry ID

TCTR20220202004

Enrollment

Registered

2022-02-02

Start date

2022-03-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cutaneous melanoma stage 2 and 3 cutaneous melanoma melanoma stage 2 and 3 Hiltonol poly-ICLC immunotherapy neoantigen therapeutic cancer vaccine

Interventions

the patient will receive Poly-ICLC (Hiltonol) 1 mg (0. 5 ml) intratumoral injection 3 times/week in first 2 weeks, then Poly-ICLC (Hiltonol) 1 mg (0. 5 ml) intramuscular injection 2 timess/week in f

Experimental Biological/Vaccine

Poly-ICLC (Hiltonol)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Thailand

Contacts

Public ContactApichai Angspatt

Plastic and reconstructive unit, surgery department, faculty of medicine, chulalongkorn university

aangspatt@hotmail.com0816368888

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026