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HNSCC clinical trials

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NCT ID: NCT05581004 Recruiting - Gastric Cancer Clinical Trials

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

Start date: October 20, 2022
Phase: Phase 1
Study type: Interventional

This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of RO7502175 when administered as a single agent and in combination with atezolizumab in adult participants with locally advanced or metastatic solid tumors, including non-small-cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.

NCT ID: NCT05337631 Recruiting - Oropharynx Cancer Clinical Trials

Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy

SENIOR
Start date: June 1, 2021
Phase:
Study type: Observational

The number of elderly head-and-neck squamous cell carcinoma (HNSCC) patients is increasing; however, the evidence regarding the ideal treatment for this often vulnerable and frail patient cohort is limited. Although the benefit of concomitant chemotherapy has been reported to decrease in elderly HNSCC patients based on the MACH-NC meta-analysis, it remains unknown whether state-of-the art radiotherapy techniques such as intensity-modulated radiotherapy (IMRT), modern supportive treatments and alternative chemotherapy fractionation (e.g., cisplatin weekly) may have altered this observation. The objective of this retrospective multinational multicenter study is to determine the oncological outcomes of elderly patients (≥65 years) with locally advanced HNSCCs undergoing definitive (chemo-)radiation and to investigate the influence of concomitant chemotherapy on overall survival and progression-free survival after adjusting for potential confounder variables such as age, performance status and comorbidity burden.

NCT ID: NCT05192655 Recruiting - HNSCC Clinical Trials

Artificial Intelligence in Functional Imaging for Individualized Treatment of Head and Neck Squamous Cell Carcinoma Patients

KIVAL-KHT
Start date: December 1, 2021
Phase:
Study type: Observational

The 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.

NCT ID: NCT04997902 Recruiting - HNSCC Clinical Trials

Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

Start date: December 7, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This phase 1/2 combination trial of tipifarnib, a farnesyltransferase inhibitor, and alpelisib, a PI3K inhibitor in participants with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) whose tumors overexpress the HRAS protein and/or are PIK3CA-mutated and/or PIK3CA-amplified.

NCT ID: NCT04892849 Recruiting - Esophageal Cancer Clinical Trials

Clinical Benefit and Biomarker Analysis of Combination of PD-1/PD-L1 Immune Checkpoint Inhibitors and Radiotherapy

ST-ICI02
Start date: April 30, 2021
Phase:
Study type: Observational

Inhibitors of the programmed cell death protein 1 (PD-1)/PD-L1 immune checkpoint signaling pathway are already approved in the treatment of various tumor entities in relapsed or metastatic stages. Different exploratory trials suggest that the combination of radiotherapy and PD-1/PD-L1 inhibitors is highly effective, especially in oligometastatic stages and if all lesions are treated with ablative radiotherapy. In addition, the role of predictive biomarkers is becoming increasingly important for future therapy algorithms. First data, also from our group, indicate clearly that dynamic changes of immune cells and their activation markers in the peripheral blood (immune matrix) can be used as predictive biomarkers. During the planned STICI-02 trial predictive immune matrix derived from the STICI01 trial (NCT03453892) will be validated in the groups of patient suffering from HNSCC (palliative), NSCLC (separately palliative and adjuvant) and "other solid tumors" (including in particular esophageal carcinomas, urothelial and renal carcinomas, small cell bronchial carcinomas and squamous cell carcinomas of the skin [depending on the current drug approval]). Within the framework of scientific accompanying projects, the predictive value of markers in tumor tissue and of pattern radiomics analyses will be analyzed accompanying the immunophenotyping in peripheral blood. The side effects

NCT ID: NCT04861467 Not yet recruiting - HNSCC Clinical Trials

Camrelizumab as a Maintenance Therapy After Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

Start date: June 1, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study was to evaluate the efficacy and safety of Camrelizumab as maintenance therapy in newly diagnosed locally advanced head and neck squamous cell carcinoma subjects after chemoradiation.

NCT ID: NCT04831450 Withdrawn - Clinical trials for Head and Neck Squamous Cell Carcinoma

Phase 2 Trial of Maintenance Cemiplimab for Head and Neck Squamous Cell Carcinoma (HNSCC)

Start date: July 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the experimental immunotherapy agent cemiplimab-rwlc when given after completion of chemotherapy and radiation treatment and determine if it will improve progression free survival and cure rates in patients with PD-L1 positive locally advanced head and neck cancer.

NCT ID: NCT04811027 Active, not recruiting - HNSCC Clinical Trials

Combination Study With Eftilagimod Alpha (a Soluble LAG-3 Fusion Protein) and Pembrolizumab in Patients With Recurrent or Metastatic HNSCC

TACTI-003
Start date: August 27, 2021
Phase: Phase 2
Study type: Interventional

Evaluate the safety and efficacy of eftilagimod alpha in combination with pembrolizumab against pembrolizumab alone in 1st line metastatic or recurrent HNSCC with PD-L1 positive (CPS ≥1) tumors, and determine the efficacy and safety of efti plus pembrolizumab in patients with PD-L1 negative tumors.

NCT ID: NCT04722523 Recruiting - Clinical trials for Head and Neck Cancer

A Study of Cemiplimab With Chemotherapy and Immunotherapy in People With Head and Neck Cancer

Start date: January 20, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to find out whether combining the standard chemotherapy for head and neck cancer with the immunotherapy drugs cetuximab and cemiplimab (the study drug) is a safe treatment for head and neck cancer, and whether receiving this combination treatment before surgery may allow participants to forgo the standard radiation treatment after surgery.

NCT ID: NCT04606940 Completed - Clinical trials for Head and Neck Cancer

Study of Circulating Tumor DNA (ctDNA) Kinetics in Immuno-oncology (IO-KIN)

Start date: October 19, 2020
Phase:
Study type: Observational

This study aims to study the kinetics of ctDNA levels after the first dose of immune checkpoint inhibitor in patients with recurrent or metastatic head and neck cancer. This is an important study to understand the optimal timing for ctDNA quantitation for future studies in immunotherapy, though further validation would be needed in other tumor types. It may help standardize the most relevant blood collection time points so that patients will not be subjected to multiple blood draws at random time points in future liquid biopsy trials.