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AbbVie M19-894

Trial Overview

Official Title

A Phase 1B, Multicenter, Open-Label Study To Determine The Safety, Tolerability, Pharmacokinetics, And Preliminary Efficacy Of Abbv-368 Plus Tilsotolimod And Other Therapy Combinations In Subjects With Recurrent/Metastatic Head And Neck Squamous Cell Carcinoma

Study Purpose

This study will evaluate the effect the combination therapies have on the patient’s body and evaluate the tumor activity and use biomarker tests and imaging results to determine the effects of the combination therapy the patients are assigned to.


Recurrent/metastatic head and neck squamous cell carcinoma (HNSCC)


Must not have received any prior anti-cancer immunotherapy other than a PD-(L)1 inhibitor.

No uncontrolled metastases to the central nervous system.

Patients must sign an approved informed consent and authorization permitting release of personal health information.


This study will consist of three different treatment combinations:

  • ARM 1: ABBV-368 + tilsotolimod
  • ARM 2: ABBV-368 + tilsotolimod + nab-paclitaxel
  • ARM 3: ABBV-368 + tilsotolimod + nab-paclitaxel + ABBV-181

Depending on when you enroll into this study will determine which combination therapy you are assigned. 

Patients will remain on treatment until their cancer worsens, your doctor takes you off treatment or you withdraw consent.

For more information, visit

Key Participation Requirements
Male or Female
19 years and older
Enrollment Status
Phase IB
Methodist Health System Trial Code
AbbVie M19-894