Study of Tumor and Blood Markers in Adults With Recurrent or Metastatic Upper Aerodigestive Tract Squamous Cell Carcinoma Receiving Immunotherapy

What this Trial Is About

Researchers are investigating squamous cell carcinoma of the upper aerodigestive tract CEVADS, a common and serious cancer with poor long-term survival despite current treatments like radiotherapy, surgery, and chemotherapy. This trial aims to better understand why only about 20% of patients respond well to PD-1 inhibitor immunotherapies by studying tumor markers, immune cells, and bacteria in the tumor environment. The study focuses on improving patient selection for immunotherapy and exploring resistance mechanisms to develop better treatment strategies. Participants will receive immunotherapy, and after starting treatment, an ENT surgeon will perform a cervico-facial tumor biopsy between 30 and 180 days if the tumor is accessible and the procedure is safe. This biopsy includes superficial sampling of the external tumor lesion under local anesthesia. Additionally, blood and saliva samples will be collected to analyze immune responses and the presence of Fusobacterium nucleatum bacteria in the oral microbiota. Throughout the study, researchers will monitor histological markers linked to treatment benefit, survival, and PD-L1 expression, as well as immune responses to F. nucleatum. The main outcome will be assessed at six months. Participants will be involved in biopsies, blood and saliva sample collection, and clinical evaluations. The study will help identify factors influencing response or resistance to immunotherapy in CEVADS patients.

Identification of Individual Histological and Blood Markers in Patients With Recurrent or Metastatic Upper Aerodigestive Tract Squamous Cell Carcinoma in Response to Immunotherapies