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Brief Title: Pembrolizumab, INCB081776, and Radiation Therapy for Head and Neck Squamous Cell Carcinoma
Official Title: Pilot Study of INCB081776 Together With Palliative Radiation and Anti-PD-1 Checkpoint Blockade With Pembrolizumab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Study ID: NCT06308913
Brief Summary: This study is evaluating INCB081776 when given in combination with the checkpoint inhibitor pembrolizumab and palliative radiation therapy in patients with metastatic or recurrent metastatic or recurrent head and neck squamous cell carcinoma (HNSCC). 12 participants will be enrolled and can expect to be on study for up to 12 months.
Detailed Description: Primary Objective • To evaluate the safety and tolerability of INCB081776 in combination with pembrolizumab and standard palliative radiation therapy in subjects with recurrent/metastatic squamous cell carcinoma of the head and neck. Secondary Objectives • To determine the preliminary efficacy of INCB081776 in combination with pembrolizumab plus palliative radiation therapy in subjects with recurrent/metastatic squamous cell carcinoma of the head and neck. The irradiated lesion (lesion A) will not be included in the analysis.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UW Carbone Cancer Center, Madison, Wisconsin, United States
Name: Justine Bruce, MD
Affiliation: University of Wisconsin, Madison
Role: PRINCIPAL_INVESTIGATOR
Name: Deric Wheeler, PhD
Affiliation: University of Wisconsin, Madison
Role: PRINCIPAL_INVESTIGATOR