NCT03906526

A Study to Evaluate Immune Biomarker Modulation in Response to VTX-2337 in Combination With an Anti- PD-1 Inhibitor in Head and Neck Cancer

Terminated Phase 1 Last updated 24 February 2023

What this trial tests

Phase 1 trial testing VTX-2337 in Carcinoma, Squamous Cell in 15 participants. Terminated before completion.

Timeline

3 July 2019

Primary endpoint
24 January 2022

24 January 2022

Quick facts

Lead sponsor	Celgene
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	3 July 2019
Primary completion	24 January 2022
Estimated completion	24 January 2022
Sites	12 locations across United States

Drugs / interventions tested

• VTX-2337 — full drug profile →
• Nivolumab (nivolumab) — full drug profile →

Conditions studied

• Carcinoma, Squamous Cell — all drugs for Carcinoma, Squamous Cell →

Sponsor

Celgene — full company profile →

Who can join

18 and older, any sex, with Carcinoma, Squamous Cell. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open label, Phase 1b pre-operative window of opportunity biomarker trial to analyze the combination of intravenous (IV) anti-PD-1 inhibitor, nivolumab, given along with toll-like receptor 8 (TLR 8) agonist motolimod delivered either subcutaneously (SC) or by intratumoral injection (IT) in subjects with squamous cell carcinoma of the head and neck (SCCHN). Subjects with previously untreated, resectable SCCHN, will be recruited onto this trial and will initially undergo pre-treatment diagnostic imaging and biological sample collection. These subjects will undergo pre-operative study treatment for a 3 to 4-week period prior to a scheduled surgical resection.

Publications & conference data

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

1. Type I interferon-mediated tumor immunity and its role in immunotherapy.
   Yu R, Zhu B, Chen D. · · 2022 · cited 229× · PMID 35292881 · DOI 10.1007/s00018-022-04219-z
2. Harnessing innate immune pathways for therapeutic advancement in cancer.
   Hu A, Sun L, Lin H, Liao Y, et al · · 2024 · cited 150× · PMID 38523155 · DOI 10.1038/s41392-024-01765-9
3. Fueling the Fire: Inflammatory Forms of Cell Death and Implications for Cancer Immunotherapy.
   Rosenbaum SR, Wilski NA, Aplin AE. · · 2021 · cited 148× · PMID 33451983 · DOI 10.1158/2159-8290.cd-20-0805
4. Intratumoral Immunotherapy for Early-stage Solid Tumors.
   Hong WX, Haebe S, Lee AS, Westphalen CB, et al · · 2020 · cited 138× · PMID 32071116 · DOI 10.1158/1078-0432.ccr-19-3642
5. Defects in Macrophage Reprogramming in Cancer Therapy: The Negative Impact of PD-L1/PD-1.
   Cai H, Zhang Y, Wang J, Gu J. · · 2021 · cited 100× · PMID 34248982 · DOI 10.3389/fimmu.2021.690869
6. Targeting Innate Immunity in Cancer Therapy.
   Rameshbabu S, Labadie BW, Argulian A, Patnaik A. · · 2021 · cited 90× · PMID 33572196 · DOI 10.3390/vaccines9020138
7. Agonist and antagonist ligands of toll-like receptors 7 and 8: Ingenious tools for therapeutic purposes.
   Patinote C, Karroum NB, Moarbess G, Cirnat N, et al · · 2020 · cited 87× · PMID 32203790 · DOI 10.1016/j.ejmech.2020.112238
8. Targeting toll-like receptor 7/8 for immunotherapy: recent advances and prospectives.
   Sun H, Li Y, Zhang P, Xing H, et al · · 2022 · cited 86× · PMID 36476317 · DOI 10.1186/s40364-022-00436-7