NCT03646461

Trial of Ibrutinib Combined With Nivolumab or Cetuximab to Treat Recurrent/Metastatic HNSCC

Active, enrolled Phase 2 Last updated 6 April 2025

What this trial tests

Phase 2 trial testing Ibrutinib 560mg PO daily (Imbruvica) in Head and Neck Cancer in 5 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

17 October 2018

Primary endpoint
11 December 2025

30 December 2025

Quick facts

Lead sponsor	University of California, San Diego
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	17 October 2018
Primary completion	11 December 2025
Estimated completion	30 December 2025
Sites	1 location across United States

Drugs / interventions tested

• Ibrutinib 560mg PO daily (Imbruvica) — full drug profile →
• Cetuximab (cetuximab) — full drug profile →
• Nivolumab (nivolumab) — full drug profile →

Conditions studied

• Head and Neck Cancer — all drugs for Head and Neck Cancer →
• Squamous Cell Carcinoma of the Head and Neck — all drugs for Squamous Cell Carcinoma of the Head and Neck →

Sponsor

University of California, San Diego

Who can join

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

Sponsor's own description

This is an open-label, randomized, phase II trial to test the efficacy of Ibrutinib in combination with either Nivolumab or Cetuximab in the treatment of recurrent and/or metastatic head an neck squamous cell carcinoma

Publications & conference data

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

1. Targeting the Immune Microenvironment in the Treatment of Head and Neck Squamous Cell Carcinoma.
   Wang HC, Chan LP, Cho SF. · · 2019 · cited 68× · PMID 31681613 · DOI 10.3389/fonc.2019.01084
2. Immune Evasion by Head and Neck Cancer: Foundations for Combination Therapy.
   Horton JD, Knochelmann HM, Day TA, Paulos CM, et al · · 2019 · cited 65× · PMID 30961829 · DOI 10.1016/j.trecan.2019.02.007
3. Combination Strategies to Augment Immune Check Point Inhibitors Efficacy - Implications for Translational Research.
   Varayathu H, Sarathy V, Thomas BE, Mufti SS, et al · · 2021 · cited 62× · PMID 34123767 · DOI 10.3389/fonc.2021.559161
4. Immune deserts in head and neck squamous cell carcinoma: A review of challenges and opportunities for modulating the tumor immune microenvironment.
   Farlow JL, Brenner JC, Lei YL, Chinn SB. · · 2021 · cited 34× · PMID 34218062 · DOI 10.1016/j.oraloncology.2021.105420
5. Bruton's tyrosine kinase: an emerging targeted therapy in myeloid cells within the tumor microenvironment.
   Good L, Benner B, Carson WE. · · 2021 · cited 30× · PMID 33818636 · DOI 10.1007/s00262-021-02908-5
6. Programmed cell death in tumor immunity: mechanistic insights and clinical implications.
   Wang M, Yu F, Zhang Y, Li P. · · 2023 · cited 26× · PMID 38283351 · DOI 10.3389/fimmu.2023.1309635
7. Trial Watch: combination of tyrosine kinase inhibitors (TKIs) and immunotherapy.
   Petrazzuolo A, Maiuri MC, Zitvogel L, Kroemer G, et al · · 2022 · cited 23× · PMID 35655707 · DOI 10.1080/2162402x.2022.2077898
8. Clinical Trials of the BTK Inhibitors Ibrutinib and Acalabrutinib in Human Diseases Beyond B Cell Malignancies.
   Zhu S, Jung J, Victor E, Arceo J, et al · · 2021 · cited 23× · PMID 34778053 · DOI 10.3389/fonc.2021.737943