Table 4.

Use of TLR3 agonists as adjuvant in a selection of active clinical trials (*www.clinicaltrials.gov).

Number	*NCT number and title	Cancer type(number of subjects to enroll)	Intervention(s)	Trial type	Status	Sponsor/collaborators
1	NCT02643303 A Phase 1/2 Study of In Situ Vaccination With Tremelimumab and IV Durvalumab Plus Poly-ICLC in Subjects With Advanced, Measurable, Biopsy- accessibleCancers	Head and neck squamous cell carcinoma, Breast, prostate, renal and bladder carcinomas, melanoma sarcoma, Merkel cell and cutaneous T cell lymphoma (102)	• TLR3 agonist-Poly-ICLC • Durvalumab • Tremelimumab (human IgG2 anti-   cytotoxic T-lymphocyte - associated   antigen 4 [CTLA-4] monoclonal   antibody)	• Phase I/II, non-   randomized and open-   label.	• Recruiting. • Start date: 28th   Dec 2016 • Completion date:   Aug 2022	• Ludwig Institute for   Cancer Research • MedImmune LLC • Cancer Research Institute,   New York City
2	NCT03162562 The Safety and Antitumor Activity of the Combination of Oregovomab and Hiltonol in Recurrent Advanced Ovarian Cancer	Stage III-IV and recurrent ovarian carcinoma (10)	• TLR3 agonist-Poly-ICLC • Oregovomab (murineanti-CA125   monoclonal antibody)	• Phase I, single group and   open-label	• Recruiting. • Start date: 30th   May 2017 • Completion date:   Sept 2021	• OncoQuest Inc.
3	NCT02834052 Pembrolizumab + Poly-ICLC in MRP Colon Cancer	Metastatic colorectal carcinoma (42)	• TLR3 agonist-Poly-ICLC • Pembrolizumab	• Phase I/II, non-   randomized single group   assignment and open-   label.	• Recruiting. • Start date: 10th   Jan 2018 • Completion date:   Jan 2021	• Asha Nayak • Oncovir, Inc. • Merck Sharp & Dohme   Corp. • Augusta University
4	NCT02126579 Phase I/II Trial of a Long Peptide Vaccine (LPV7) Plus TLR Agonists	Melanoma (58)	• TLR3 agonist - Poly-ICLC and   TLR7/8 agonist - Resiquimod • Peptide vaccine (LPV7) + Tetanus   peptide • Incomplete Freund’s adjuvant (IFA)	• Phase I/II, randomized   and open-label	• Recruiting. • Study Start: April   2014 • Completion date:   Dec 2018	• Craig L Slingluff, Jr • University of Virginia
5	NCT01976585 In Situ Vaccine for Low-Grade Lymphoma: Combination of Intratumoral Flt3L and Poly-ICLC With Low-Dose Radiotherapy	Low-Grade B-cell Lymphoma (30)	• TLR3 agonist - Poly-ICLC • Recombinant human (rhu) Flt3   ligand (CDX-301)	• Phase I/II, single group   assignment and open-   label.	• Recruiting. • Start date: Dec   2013 • Completion date:   Nov 2018	• Joshua Brody • Icahn School of Medicine   at Mount Sinai
6	NCT01720836 Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer	Non-small cell lung cancer (NSCLC) (30)	• TLR3 agonist - Poly-ICLC   (Hiltonol®) • Mucin 1 (MUC1) peptide	• Phase I/II, non-   randomized and open-   label	• Recruiting • Start date: Nov   2012 • Completion date:   Sept 2020	• Olivera Finn • University of Pittsburgh
7	NCT03262103 Neoadjuvant Hiltonol® (PolyICLC) for Prostate Cancer	Prostate cancer (24)	• TLR3 agonist - Poly-ICLC   (Hiltonol®)given intratumorally   (0.5 mg or 1.0 mg) or   intramuscularly • Radical prostatectomy	• Phase I, non-randomized   and open-label	• Recruiting • Start date: May   2017 • Completion date:   May 2020	• Ashutosh Kumar Tewari • Oncovir, Inc. • Icahn School of Medicine   at Mount Sinai
8	NCT02721043 Safety and Immunogenicity of Personalized Genomic Vaccine to Treat Malignancies	Solid tumors (20)	• TLR3 agonist - Poly-ICLC   (Hiltolon®) • Synthetic peptides • Lenalidomide (a thalidomide   analog)	• Phase I, single • group assignment and   open-label.	• Recruiting • Start date: April   2016 • Completion date:    July 2020	• Nina Bhardwaj • Icahn School of Medicine   at Mount Sinai
9	NCT02061449 PolyICLC, Radiation, and Romidepsin for Advanced Cutaneous T Cell Lymphoma	Cutaneous T-cell Lymphoma (3)	• TLR3 agonist - Poly-ICLC   (Hiltonol®) • Romidepsin (antibiotic) • Focal lesional radiation	• Phase I/II, non-   randomized and open-   labeled	• Active, not   recruiting. • Start date: Mar   2014 • Completion date:   June 2018	• New York University,   School of Medicine • Ludwig Institute for   Cancer Research
10	NCT01204684 Dendritic Cell Vaccine for Patients With Brain Tumors	Glioma, glioblastoma, anaplastic astrocytoma and Astrooligodendro-glioma (60)	• Autologous tumor lysate-pulsed DC   vaccination in combination with   either • TLR3 agonist - Poly-ICLC   (Hiltonol®), or • 0.2% Resiquimod	• Phase II, randomized   and open-labeled	• Active, not   recruiting. • Start date:8th   Oct 2010 • Completion date:   Oct 2019	• Jonsson Comprehensive   Cancer Center