NCT02423863 (Poly-ICLC) is a Phase 2 clinical trial of Hiltonol in Melanoma, sponsored by Oncovir, Inc..

Who is sponsoring NCT02423863?

NCT02423863 is sponsored by Oncovir, Inc..

What drugs are being tested in NCT02423863?

Interventions in NCT02423863: Hiltonol.

What condition does NCT02423863 study?

NCT02423863 studies Melanoma, Head and Neck Cancer, Sarcoma, Non-Melanoma Skin Cancers.

Is NCT02423863 still recruiting?

NCT02423863 is currently completed. Last updated 15 December 2020.

Last reviewed 2020-12-15 · How we verify

NCT02423863: Poly-ICLC

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

In Situ, Autologous Therapeutic Vaccination Against Solid Cancers With Intratumoral Hiltonol® (Poly-ICLC): An Adaptive, Multicenter, Phase II Clinical Study

Completed Phase 2 Last updated 15 December 2020

What this trial tests

Phase 2 trial testing Hiltonol in Melanoma in 26 participants. Completed in 31 August 2020.

Timeline

1 March 2015

Primary endpoint
31 August 2020

31 August 2020

Quick facts

Lead sponsor	Oncovir, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	1 March 2015
Primary completion	31 August 2020
Estimated completion	31 August 2020
Sites	5 locations across United States

Drugs / interventions tested

Hiltonol — full drug profile →

Conditions studied

Melanoma — all drugs for Melanoma →
Head and Neck Cancer — all drugs for Head and Neck Cancer →
Sarcoma — all drugs for Sarcoma →
Non-Melanoma Skin Cancers — all drugs for Non-Melanoma Skin Cancers →

Sponsor

Oncovir, Inc. — full company profile →

Who can join

18 and older, any sex, with Melanoma or Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Evaluate safety of intratumoral (IT) plus intramuscular (IM) Polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethylcellulose (poly-ICLC, Hiltonol®) for treatment of patients with accessible solid tumors, with or with
Time frame: Evaluation of response wk 26
Wk 26 study subject's response will be defined as BOR (CR, PR, SD) or PD.
Evaluate therapeutic efficacy assessed by Disease Control (CR, PR, or SD) as defined by the RECIST 1.1 Criteria.
Time frame: 6 months
Week 26 tumor assessment will be performed, an optional biopsy may be performed.

Sponsor's own description

The purpose of this study is to evaluate the safety of sequential intratumoral (IT) plus intramuscular (IM) Polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethylcellulose (poly-ICLC, Hiltonol®) for treatment of study subjects with accessible solid tumors, with or without checkpoint blockers. Enrolled study subjects will receive Poly-ICLC (Hiltonol®) treatment alone or in combination with anti-PD-1 (Nivolumab, Pembrolizumab or Cemiplimab) or anti-PD-L1 (Atezolizumab or Durvalumab) over 6 months as defined in study treatment described below. MRI or CT imaging will be done per SOC at screening, 3 and 6-month time points.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Intestinal Akkermansia muciniphila predicts clinical response to PD-1 blockade in patients with advanced non-small-cell lung cancer.
Derosa L, Routy B, Thomas AM, Iebba V, et al · · 2022 · cited 505× · PMID 35115705 · DOI 10.1038/s41591-021-01655-5
Intratumoural administration and tumour tissue targeting of cancer immunotherapies.
Melero I, Castanon E, Alvarez M, Champiat S, et al · · 2021 · cited 358× · PMID 34006998 · DOI 10.1038/s41571-021-00507-y
Poly(α-l-lysine)-based nanomaterials for versatile biomedical applications: Current advances and perspectives.
Zheng M, Pan M, Zhang W, Lin H, et al · · 2021 · cited 119× · PMID 33364529 · DOI 10.1016/j.bioactmat.2020.12.001
Immunotherapeutic effects of intratumoral nanoplexed poly I:C.
Aznar MA, Planelles L, Perez-Olivares M, Molina C, et al · · 2019 · cited 109× · PMID 31046839 · DOI 10.1186/s40425-019-0568-2
Therapeutic Immune Modulation against Solid Cancers with Intratumoral Poly-ICLC: A Pilot Trial.
Kyi C, Roudko V, Sabado R, Saenger Y, et al · · 2018 · cited 99× · PMID 29950349 · DOI 10.1158/1078-0432.ccr-17-1866
Trial Watch: Immunostimulation with Toll-like receptor agonists in cancer therapy.
Iribarren K, Bloy N, Buqué A, Cremer I, et al · · 2016 · cited 98× · PMID 27141345 · DOI 10.1080/2162402x.2015.1088631
Targeting Innate Immunity in Cancer Therapy.
Rameshbabu S, Labadie BW, Argulian A, Patnaik A. · · 2021 · cited 90× · PMID 33572196 · DOI 10.3390/vaccines9020138
Immunotherapy in soft-tissue sarcoma.
Ayodele O, Razak ARA. · · 2020 · cited 80× · PMID 32174754 · DOI 10.3747/co.27.5407

Verify or expand the search:

Other trials of Hiltonol

Trials testing the same drug.

NCT05283109 — ETAPA I: Peptide-based Tumor Associated Antigen Vaccine in GBM · Phase 1 · active not recruiting
NCT02873819 — Safety and Efficacy Study of GL-0817 (With Cyclophosphamide) for the Prevention of Recurrence of Squamous Cell Carcinoma · Phase 2 · completed
NCT02886065 — A Study of PVX-410, a Cancer Vaccine, and Citarinostat +/- Lenalidomide for Smoldering MM · Phase 1 · active not recruiting

Other recruiting trials for Melanoma

Currently open trials in the same condition.

NCT07524114 — Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception · recruiting
NCT07224425 — A Study in People With Advanced Cancer (Solid Tumours) to Test Different Doses of BI 3810944 and to Find Out Whether it · Phase 1 · recruiting
NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
NCT07225036 — Promoting Immunotherapy Efficacy With Low-Dose Liver RT · NA · recruiting
NCT07379138 — Studying Quality of Life Inclusive of Mental Health and Cognitive Behavioral Therapy for Cancer Distress for the Improve · NA · recruiting

Other Oncovir, Inc. trials

Trials by the same sponsor.

NCT04672291 — Nasal Poly-ICLC (Hiltonol®) in Healthy COVID-19 Vaccinated Adults · Phase 1 · completed
NCT04525859 — Poly-ICLC (Hiltonol®) Vaccine In Malignant Pleural Mesothelioma · Phase 1 · completed
NCT03721679 — Poly-ICLC (Hiltonol) and Anti-PD1 or Anti-PD-L1 · Phase 1, PHASE2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02423863 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Oncovir, Inc.
Last refreshed: 15 December 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02423863.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing