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Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
600 patients around the world
Available in Chile, Argentina, Colombia, Brazil, Mexico
Exelixis
17Research sites
600Patients around the world
This study is for people with
Head and neck cancer
Squamous cell carcinoma of the head and neck
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Histologically or cytologically-confirmed R/M HNSCC that is considered incurable by local therapy.Subjects should not have had prior systemic therapy administered in the recurrent or metastatic setting. Systemic therapy which was completed more than 6 months prior to randomization if given as part of multimodal treatment for locally advanced disease is allowed.The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, and larynx.PD-L1 expression level Combined Positive Score (CPS) ≥ 1 by immunohistochemistry (IHC) testing.Have human papilloma virus (HPV) testing result for oropharyngeal cancer defined as p16 IHC testing.Measurable disease according to RECIST 1.1 determined by the Investigator.Tumor samples (archival or fresh tumor biopsy) are required. If archival tissue is unavailable, must provide fresh tumor tissue biopsy prior to randomization.Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from adverse events (AEs) related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.Age 18 years or older on the day of consent.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.Adequate organ and marrow function.
- Nasopharynx, salivary gland or occult primary site (regardless of p16 status).Has disease that is suitable for local therapy administered with curative intent.Has received prior therapy with zanzalintinib, any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).Life expectancy < 3 months.Had progressive disease within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.Radiation therapy for bone metastases within 2 weeks, any other radiation therapy within 4 weeks prior to randomization.Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to randomization.Positive hepatitis B surface antigen (HBsAg) test.Positive hepatitis C virus (HCV) antibody test.Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 8 weeks prior to randomization. Complete wound healing from major or minor surgery must have occurred at least prior to randomization.Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per electrocardiogram (ECG) within 28 days before randomization.Pregnant or lactating females.Administration of a live, attenuated vaccine within 30 days before randomization.
Sites
Centro Médico Privado CEMAIC - Córdoba
Recruiting
Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires
Recruiting
Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
Recruiting
Organización Médica de Investigación (OMI)
Recruiting
Isis Clínica Especializada - Santa Fe
Recruiting
Sanatorio Allende (Nueva Córdoba)
Recruiting
Centro de Investigación Pergamino SA
Recruiting
Fleni - sede Belgrano
Recruiting
Instituto de Oncología de Rosario - IOR
Recruiting
Centro de Investigación Clínica Bradford Hill - Santiago, Región Metropolitana
Recruiting
StudySTELLAR-305
SponsorExelixis
Conditions
Squamous cell carcinoma of the head and neck
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06082167
