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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
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.
DiagnosisRecurrent/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 ClinicalTrials.gov