Fairhaven

The trial investigates the use of volrustomig in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). The study aims to evaluate the efficacy and safety of volrustomig compared to observation in this patient population. Participants have tumors that express PD-L1 and the study is conducted as a Phase III, randomized, open-label, multi-center global trial. Participants are assigned to receive either volrustomig as sequential therapy following cCRT or to an observation group. The treatment period involves monitoring participants who have completed definitive cCRT but remain unresected and have no evidence of metastatic disease. The study focuses on participants with Stage III, IVA, or IVB LA-HNSCC according to AJCC criteria, who have not undergone tumor resection before cCRT and have not been treated with radiotherapy alone. During the study, participants are regularly evaluated for progression-free survival, with follow-up lasting up to approximately 8 years to assess long-term outcomes. Researchers will monitor safety and disease progression closely. The overall participation duration includes screening, treatment or observation, and extended follow-up to capture both efficacy and safety data over time.

Researchers are evaluating a non-interventional study that includes multiple centers and cohorts, focusing on people diagnosed with cancer. The study aims to collect and analyze blood samples over time to profile circulating tumor DNA (ctDNA) biomarkers alongside the participants' standard cancer treatments. This approach helps to observe how ctDNA levels change during and after treatment. Participants will undergo regular blood sample collection at specific times throughout the study to monitor ctDNA biomarkers. There is no experimental treatment given as part of this study; instead, the study observes changes in ctDNA in addition to the usual care provided by their healthcare team. This design allows researchers to gather important data while participants continue their standard cancer therapies. Throughout the study, participants will provide blood samples at baseline, during treatment, and after treatment for up to five years. Researchers will analyze these samples to track changes in ctDNA over time. The study focuses on measuring these biomarker changes to enhance understanding of cancer progression and treatment response. Participants' safety and standard care are maintained, and no additional interventions are required beyond blood sample collection.