Head and Neck Tumor clinical trials at UCSF

This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.

This trial evaluates how well a new therapeutic device works in managing trismus in patients who received radiation treatment for head and neck cancer. Radiation therapy is a common form of treatment in patients with head and neck cancers. However, changes to surrounding tissue following radiation therapy may lead to trismus, an inability to open the mouth fully. This can create significant functional impairment leading to malnutrition due to impaired chewing, risk of dental infections due to impaired oral hygiene, difficulty with speech, and decreased health-related quality of life. Exercise therapy is the mainstay of treatment for post-radiation trismus to help improve mobility and flexibility and increase range of mouth opening. This new device is non-invasive and is similar to other jaw stretching devices where a mouthpiece is placed between the teeth and a hand-lever is used to spread open the upper and lower jaw. However, it will also have additional sensors to measure pressure exerted by the hands and jaw as well as the distance to open the mouth which could help guide therapy. This study may help doctors customize a device to patient-specific needs, provide real-time feedback, and encourage compliance for trismus exercise therapy.

This phase II/III trial studies how well radiation therapy works with durvalumab or cetuximab in treating patients with head and neck cancer that has spread to a local and/or regional area of the body who cannot take cisplatin. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. It is not known if radiation therapy with durvalumab will work better than the usual therapy of radiation therapy with cetuximab in treating patients with head and neck cancer.

VERSATILE-002 is a Phase 2, open-label, multicenter study of the efficacy and safety of PDS0101 administered in combination with pembrolizumab in adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

The purpose of this study is to determine the efficacy and safety of pembrolizumab given concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT in participants with locally advanced head and neck squamous cell carcinoma (LA HNSCC). The primary hypothesis is that pembrolizumab in combination with CRT is superior to placebo in combination with CRT with respect to event-free survival (EFS).