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144 active trials for Head and Neck Squamous Cell Carcinoma

Cell-free Tumor DNA in Head and Neck Cancer Patients

This study investigates if head and neck squamous cell carcinoma can be tracked with cell-free tumor DNA, RNA or HPV-DNA, in blood samples from patients referred with suspicion of cancer, and if it can be used in detecting recurrence in patients already diagnosed and treated for head and neck squamous cell carcinoma.

Start: February 2017

Vaccine Therapy and Pembrolizumab in Treating Patients With Solid Tumors That Have Failed Prior Therapy

This phase I trial studies the side effects of vaccine therapy and pembrolizumab in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment, that have failed prior therapy, and that cannot be removed by surgery. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Giving vaccine therapy together with pembrolizumab may be a better treatment in patients with solid tumors.

Start: June 2016

Combination Therapy With Intravenous VSV-IFN?-NIS and Pembrolizumab in Refractory NSCLC and HNSCC

This is a phase I/II safety run-in study designed to determine the safety of VSV-IFN?-NIS in combination with pembrolizumab, followed by dose expansion in patients with refractory NSCLC or HNSCC. The safety run-in portion of this study is designed to identify the optimal dose of VSV-IFN?-NIS in combination with the approved dose of pembrolizumab in patients with solid tumors and follows the 3+3 design. The expansion portion will use one-sample binomial designs to assess the efficacy of the combination in patients with refractory NSCLC or HNSCC. The optimal dose (recommended phase 2 dose, RP2D) determined in the dose escalation portion of the trial will be used for the expansion portion.

Start: April 2019

De-escalation of Adjuvant Radio (Chemo) Therapy for HPV-positive Head-neck Squamous Cell Carcinomas

In patients with squamous cell carcinoma of the oral cavity, the oropharynx and larynx with local advanced tumors (pathologic stage T3 = pT3) and or lymph node involvement (pN+) postoperative radio - or radiochemotherapy is the standard of care. Postoperative radiochemotherapy is indicated in patients with multiple lymph node metastasis, lymph node metastasis with extracapsular spread and / or residual tumor (R1-Status) after resection. Oropharyngeal cancer caused by HPV (human papillomavirus 16 or 18) is a distinct subgroup with a known sensitivity to radiotherapy (RTx) or radiochemotherapy (RCTx). Additionally a superior outcome after R(C)Tx over HPV negative patients was shown for patients treated with primary or adjuvant RCTx. To date it is unknown if the total dose of the radiotherapy can be safely reduced with the aim to decrease the therapy associated late effects. Patients with a HPV associated carcinoma that take part in the study will be treated with a reduced radiotherapy dose, chemotherapy will be prescribed based on clinical factors (number of affected lymph node, presence of extracapsular spread or residual tumor). Radiation dose will be reduced in two steps.

Start: September 2018

Identifying the Predictive Factors of Response to PD-1 or PD-L1 Antagonists

This is a prospective cohort study which aims to identify predictive factors of response to PD-1 and PD L1 antagonists authorised for use in France in treatment of melanoma, NSCLC, or HNSCC.

Start: June 2018

Pembrolizumab in HNSCC With Residual Disease After Radiation

This is a phase II study for patients with squamous cell carcinoma of the head and neck who have residual disease following definitive therapy with radiation (with or without systemic therapy). Patients must be diagnosed with residual disease within 24 weeks of completion of radiation therapy. Residual disease must be biopsy proven before the patient can consent to the trial, and can be either from lymph nodes in the neck, or from the primary tumor site. Prior to beginning study therapy patients are evaluated by an ENT to determine if they have disease amenable to surgical resection. Both resectable and unresectable patients will be eligible for participation in the study.

Start: November 2016

Ribociclib and Spartalizumab in R/M HNSCC

This study examines the safety and efficacy of ribociclib (CDK 4/6 inhibitors) and spartalizumab (anti-PD1) in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC).

Start: March 2020

Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients

This is a single-arm prospective clinical trial to determine the safety and feasibility of using transdermal buprenorphine in alleviation of radiation induced mucositis pain in head and neck cancer patients.

Start: June 2021

Viral Therapy In Treating Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Cancer or Metastatic Breast Cancer

This phase I trial studies the side effects and the best dose of viral therapy in treating patients with squamous cell carcinoma of the head and neck that has returned (come back) after a period of improvement or has spread to other parts of the body or breast cancer that has spread to other parts of the body. A virus called encoding thyroidal sodium iodide symporter, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells.

Start: April 2013

Phase I/II Study OF Metformin in Combination With Cisplatin and Radiation in Head and Neck Squamous Cell Carcinoma

The purpose of this research is to see whether metformin can improve the response rate in patients undergoing chemotherapy and radiation for squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx. The purpose of this research is also to see the effects, good and bad, of metformin therapy for this disease. Researchers will also analyze tumor and blood samples from study patients to test and understand the characteristics of tumors which respond to metformin.

Start: January 2017

A Phase 1/2 Study of In Situ Vaccination With Tremelimumab and IV Durvalumab Plus PolyICLC in Subjects With Advanced, Measurable, Biopsy-accessible Cancers

This is an open-label, multicenter Phase 1/2 study of the CTLA-4 antibody, tremelimumab, and the PD-L1 antibody, durvalumab (MEDI4736), in combination with the tumor microenvironment (TME) modulator polyICLC, a TLR3 agonist, in subjects with advanced, measurable, biopsy-accessible cancers.

Start: December 2016

Platinum-Cetuximab Combined With Docetaxel or With 5FU in Patients With Recurrent/Metastatic HNSCC

This study evaluates the efficacy of the new docetaxel-cisplatin-cetuximab regimen (TPEx) versus the standard platinum-5FU-cetuximab EXTREME regimen as a first-line treatment in recurrent and/or metastatic HNSCC. Half of patients will be treated by TPEx regimen, while the other half will be treated by EXTREME regimen.

Start: October 2014

Stereotactic Radiotherapy Combined With Chemotherapy or Not for Treatment of Oligometastases in HNSCC

The aim of this study is to evaluate the rate of living patients at 1 year with a quality of life criteria (no decrease) and reduced toxicities. This criteria will be compared in both groups., A cost effectiveness study is scheduled also.

Start: September 2015

Study of Pembrolizumab in the First Line Therapy for R/M HNSCC in China

This trial is main evaluate the efficacy and safety of pembrolizumab in the first-line treatment of Chinese patients with recurrent or metastatic head and neck squamous cell carcinoma with PD-L1 CPS?20.

Start: February 2021

Preoperative Immune Checkpoint Inhibitor for Patients With Primary Untreated or Recurrent/Metastatic SCCHN

Nivolumab (also known as BMS-936558) before surgery to people with newly diagnosed or recurrent squamous cell carcinoma of head and neck (SCCHN).

Start: July 2019

Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer

The purpose of this study is to compare any good or bad effects of using pembrolizumab (an experimental drug) and radiation therapy (RT), compared to using cisplatin chemotherapy and radiation therapy (RT) in the treatment of patients with head and neck squamous cell carcinoma (HNSCC).

Start: March 2018

Camrelizumab Combined With Apatinib Mesylate for Head and Neck Squamous Cell Carcinoma

This is a prospective, open-labelled study to evaluate the efficacy and safety of camrelizumab combined with apatinib mesylate in the induction treatment of patients with locally advanced head and neck squamous cell carcinoma who were judged surgically unresectable or appropriate for non-surgical definitive therapy. The objective response rate (ORR) and safety will be evaluated as the primary endpoints, the 2-year overall survival (OS) rate and progression free survival (PFS) rate will be the second endpoints.

Start: June 2020

Testing Lenvatinib and Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma and Cutaneous Squamous Cell Carcinoma

This is a phase I study, which tests the safety of different doses of lenvatinib in combination with cetuximab, to see which dose is the safest in people. This study will help find out if lenvatinib and cetuximab is a safe and useful combination for treating patients with HNSCC and cSCC.

Start: April 2018

Prospective Pilot Study Evaluating Dental Side Effects of Radiotherapy on Subjects Treated for Head and Neck Cancer

Multi-centric, one arm phase II study. The first phase of the study will consist of an evaluation of the initial dental state of each subject based on a stomatological examination, an orthopantomogram, two bitewing radiographs (right and left sides) and an evaluation of all potential risks of caries and fractures. For all of subjects, a dental decalcification, dental care and/or avulsion if necessary, and afterwards, a dental splint will be performed before the start of RT treatment. Our previously developed predictive model for dental dose in function of the localisation of tumour and suspect lymph nodes based on the stomatological examination and on the pre-treatment imaging. An estimation of the intensity-modulated radiotherapy (IMRT) teeth dose will be made and translated into a colour based form of the pre-RT dental status. A contouring of the teeth will be performed and the planned dose for each tooth of each subject will be recorded by a dose volume histogram (DVH) curve based on the pre-treatment imaging. In the same way the mean dose and the V25 (the volume receiving 25 Gy) of the homo- and the heterolateral parotid gland will be calculated. Based on our predictive model, every tooth which potentially will receive more than 40 Gy and for which long term survival is compromised will be avulsed at least 2 weeks before the start of RT. After RT, the subject will have clinical follow-up with dental evaluation every 6 months for 36 months in order to identify possible dental events. At each consultation, a stomatological examination will be performed as well as two bitewing radiographs. An orthopantomogram will be done once a year. Furthermore, periapical X-rays will be performed if there is a dental complain or to refine a lesion visible on orthopantomogram.

Start: November 2020

A Study of JAB-3312 in Adult Patients With Advanced Solid Tumors in China

This is a Phase 1, open-label dose-escalation study to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and assess the DLT of JAB-3312. It is anticipated that approximately 24 subjects will be enrolled in the dose-escalation phase of the study. JAB-3312 will be administered orally once daily (QD) in 21-day treatment cycles.

Start: June 2020