Fairhaven

Researchers are evaluating the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma LA-HNSCC who have not progressed after receiving definitive concurrent chemoradiotherapy cCRT. This phase III, randomized, open-label global study aims to assess whether volrustomig can improve outcomes in this patient population. Participants are randomly assigned to one of two groups those who receive volrustomig as sequential therapy, and those who undergo observation without additional treatment. The study compares these two approaches following prior curative concurrent chemoradiotherapy. The trial includes long-term follow-up to monitor patient outcomes. During the study, participants will be regularly assessed for progression-free survival, overall survival, physical functioning, and quality of life. Researchers will also monitor for the presence of anti-drug antibodies and adverse events related to volrustomig. Follow-up evaluations may continue for up to approximately eight years to fully understand the treatment impact and safety profile.

Researchers are evaluating participants with cancer in a non-interventional, multicenter, multicohort study to observe plasma circulating tumor DNA ctDNA biomarker changes over time. This study aims to gather valuable data alongside participants standard cancer treatments to better understand cancer biology. The study is sponsored by Tempus AI and focuses on various cancer types including KRAS mutated colorectal, pancreatic, and lung cancers, gastric cancer, metastatic prostate cancer, and others. Participants in this observational study will not receive any study interventions or treatments. Instead, they will provide blood samples at specific time points throughout their treatment journey for ctDNA analysis and other molecular studies. The study includes multiple cohorts representing different cancer types, but no additional therapies are assigned by the study team. During the study, participants will undergo regular blood draws to monitor ctDNA levels at baseline, during treatment, and after treatment for up to five years. Researchers will also generate DNA, RNA, immune, and other molecular datasets from these samples. The study involves no experimental treatments, focusing on data collection to support future cancer research. Participation may last up to five years, with ongoing monitoring of biomarker changes and data generation.

Researchers are evaluating how a new combination treatment of Sigvotatug Vedotin plus pembrolizumab works compared to pembrolizumab alone in adults with non-small cell lung cancer NSCLC who have high levels of the PD-L1 protein. This protein can limit the bodys immune response to cancer. The study includes participants with advanced NSCLC who meet specific molecular and staging criteria and aims to assess the treatments effects on survival and disease progression. Participants receive pembrolizumab as an intravenous infusion once every 6 weeks at the clinic. Half of the participants will also receive Sigvotatug Vedotin intravenously every 2 weeks alongside pembrolizumab. Pembrolizumab treatment may continue for up to about two years, whereas Sigvotatug Vedotin administration can continue until the cancer no longer responds. The trial is randomized and controlled, comparing the combination treatment to pembrolizumab alone. During the study, participants attend regular clinic visits for treatment and monitoring. Researchers will evaluate overall survival and progression-free survival over approximately two years, along with additional measures such as response rates, duration of response, safety, and drug levels in the blood. The study includes ongoing assessments to observe how participants respond to treatment and manage side effects, with a total participation time that may extend up to several years.