Study of Front Line Pembrolizumab and Valemetostat in PD-L1 Positive, HPV-Negative Recurrent/Metastatic...
Sinonasal CancerSquamous Non-small Cell Lung Cancer4 moreBackground: Head and neck squamous cell carcinoma (HNSCC) is the 6th most common cancer worldwide. These cancers have different causes, with smoking/tobacco exposure and human papilloma virus infection being the most common. . When HNSCC occurs in people who are not infected with HPV, the cancers are more likely to return after treatment; when this happens, overall survival is only about 10 months, thus better treatments are needed. Objective: To test a combination treatment using 2 drugs (valemetostat and pembrolizumab) in people with HNSCC. Phase 1b of the study will determine a recommended dose of the 2 drugs and evaluate how safe the combination is.; this will include patients with HPV-positive and HPV-negative HNSCC, as well as squamous cell NSCLC that have progressed on anti-PD-1/anti-PD-L1 therapies.Phase II will determine how effective the combination is and will focus on patients with HPV-negative HNSCC. Eligibility: People aged 18 years and older with HPV-negative HNSCC, sinonasal carcinoma of the head and neck, or squamous non-small cell lung cancer (NSCLC). Design: Participants will be screened. They will have a physical exam. They will have blood and urine tests and tests of their heart function. They will have imaging scans. They may have a biopsy: A small sample of tissue will be removed from the tumor. Treatment will be given in 21-day cycles. Pembrolizumab is administered through a tube attached to a needle inserted into a vein in the arm. Participants will receive pembrolizumab on the first day of each cycle. Valemetostat is a tablet taken by mouth. Participants will take the tablet once a day at home. They will record the date and time of each dose in a diary. They will also write down any adverse effects they experience. Participants may remain in the study up to 2 years.
Safety and Efficacy Study of PRV211 in Subjects With Oral Squamous Cell Carcinoma
Oral Squamous Cell CarcinomaPRV211 is a sterilized nano engineered delivery system intended for intraoperative chemotherapy treatment for all solid tumor surgeries immediately following surgical excision. The goal is to treat the tumor bed locally, eliminating any remaining micro metastases or close margins that are unable to be fully resected while avoiding system circulation. This study will enroll up to 40 subjects. In this study both safety and efficacy will be evaluated. All subjects will be monitored for possible DLTs.
Neoadjuvant Radiotherapy Combined With Toripalimab for Locally Advanced Head and Neck Squamous Cell...
Locally Advanced Head and Neck Squamous Cell CarcinomaThis is a phase II study. Twenty-three patients with locally advanced head and neck squamous cell carcinoma were planned to be enrolled to assess the efficacy and safety of neoadjuvant immunotherapy combined with radiotherapy.
Study of ALE.C04 in Patients With Head and Neck Cancer
Head and Neck CancerHead and Neck Squamous Cell CarcinomaThe purpose of this study is to evaluate the safety profile of ALE.C04 monotherapy and in combination with pembrolizumab, to characterize pharmacokinetics profile of ALE.C04, recommended Phase II dose (RP2D) for ALE.C04 in combination with pembrolizumab and as monotherapy and to assess anti-tumor activity of ALE.C04 monotherapy and in combination with pembrolizumab in patients with Head and Neck Cancer.
Artificial Intelligence in Functional Imaging for Individualized Treatment of Head and Neck Squamous...
HNSCCThe two curative treatment modalities for patients with HNSCC - primary chemoradiation (CRT) or primary surgery (often combined with postoperative (C)RT) - are both associated with serious side effects for which reason further stratification, optimization and personalization of treatment is urgently needed. As novel quantitative image analyses are a promising tool for further risk stratification, the investigators training a three-dimensional Convolutional Neural Network on 18F-Fluorodesoxyglucose (FDG) positron emission tomography (PET) imaging and clinical / histopathological data of a multicentric, retrospective cohort of 1200 patients treated with primary CRT and 800 patients treated with primary surgery at Charité and cooperation institutes in order to predict individual treatment-specific outcomes and identify patients with excellent outcome after primary CRT or primary surgery or unfavorable outcome for both. The trained algorithm of the artificial intelligence will be validated in a prospective trial to see if predicted loco-regional control and recommended treatment strategies are reliable. In total 250 curative HNSCC patients, treated with CRT or primary surgery, will be enrolled on this prospective validation trial with observational character, while biomarker, clinical and FDG-PET data are collected from these patients and follow-up visits will be concluded.
Correlation of Fecal Microbiome and Its Metabolites With Outcome of Radiotherapy in Head and Neck...
Head and Neck Squamous Cell CarcinomaPreclinical studies have shown that the response of solid tumors and normal tissues to radiotherapy can be regulated by gut microbiota and its metabolites. In this study, the composition of gut microbiota in patients with locally advanced head and neck cancers undergoing definitive radiotherapy will be analysed together with bacterial metabolites in stool and blood and a possible correlation with treatment outcome and treatment toxicity will be determined.
Vorinostat in Combination With Chemoradiation in Locally Advanced HPV Negative HNSCC
HPV-Related Squamous Cell CarcinomaSquamous Cell Carcinoma of the Oral Cavity3 moreThe purpose of this study is to learn more about a drug called Vorinostat (an experimental drug) in combination with chemoradiation. The intention of this study is to learn if this drug is safe for the participants and whether this drug with chemoradiation is able to further increase the clinical efficacy of chemoradiation which is approved therapy for your tumor condition. The main question it aims to answer is: How may Vorinostat interact with standard chemotherapy and radiation therapy in head and neck cancer? Participants will be in either one of two study groups: Group 1 will receive standard chemoradiation, while group 2 will receive the study drug (Vorinostat) as a pre-treatment, followed by standard chemoradiation.
E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers...
HPV-Associated Cervical CarcinomaHPV-Related Carcinoma15 moreThe goal of this study is to determine the feasibility of administration of a single dose of E7 TCR-T cells as induction therapy prior to definitive treatment (chemoradiation or surgery) of locoregionally advanced HPV-associated cancers. The intent of E7 TCR-T cell treatment is to shrink or eliminate tumors and thereby facilitate definitive therapy and increase overall survival. This study seeks to determine 1) if E7 TCR-T cell can be administered without undue delay in definitive treatment, 2) the tumor response rate to E7 TCR-T cell treatment, 3) and the disease-free survival rate at 2 and 5 years. Participants will undergo an apheresis procedure to obtain T cells that will be genetically engineered to generate E7 TCR-T cells. They will receive a conditioning regimen, a single infusion of their own E7 TCR-T cells, and adjuvant aldesleukin. Participants will follow up to assess safety and determine tumor response and will return to their primary oncology team for definitive therapy.
Phase I/II Open Label Study Evaluating the Safety and Efficacy of Combining STAT3 Inhibition (TTI-101)...
Head and Neck Squamous Cell CarcinomaTo review safety and efficacy of TTI-101 plus Pembrolizumab in patients the Recurrent and Metastatic head and Neck Squamous Cell Carcinoma.
Testing the Safety of Giving a Standard Dose of Radiation Over a Shorter Period of Time for Patients...
Head and Neck CancerHead and Neck Squamous Cell Carcinoma3 moreThis phase I trial is looking to determine if hypofractionated radiation therapy can be given safely after surgery for intermediate-risk head and neck cancer.