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Neoplasms, Head and Neck clinical trials

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NCT ID: NCT06256588 Recruiting - Clinical trials for Neoplasms, Head and Neck

A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma

JADE
Start date: March 21, 2024
Phase: Phase 3
Study type: Interventional

The goal of this study is to assess the safety and effectiveness of Dostarlimab compared to Placebo in adult participants with HNSCC (Head and Neck Squamous Cell Carcinoma)

NCT ID: NCT06062420 Recruiting - Clinical trials for Neoplasms, Head and Neck

Phase 2 Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants With PD-L1 Positive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Start date: November 14, 2023
Phase: Phase 2
Study type: Interventional

The primary purpose of the study is to evaluate the antitumor activity and safety of novel immunotherapy combinations compared with dostarlimab in participants with Programmed death ligand 1 (PD-L1) positive Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC).

NCT ID: NCT04428333 Terminated - Clinical trials for Neoplasms, Head and Neck

Study of GSK3359609 With Pembrolizumab and 5-fluorouracil (5-FU)-Platinum Chemotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

INDUCE-4
Start date: August 13, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate if the addition of GSK3359609 to pembrolizumab in combination with 5FU-platinum based chemotherapy improves the efficacy of the pembrolizumab combination with 5FU-platinum based chemotherapy in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). This randomized, double-blinded, Phase II/III study will compare the combination of GSK3359609 with pembrolizumab and 5FU-platinum chemotherapy to placebo in combination with pembrolizumab and 5FU-platinum chemotherapy in participants with recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx or larynx.

NCT ID: NCT04260126 Active, not recruiting - Clinical trials for HPV Positive Oropharyngeal Squamous Cell Carcinoma

Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC

VERSATILE002
Start date: March 29, 2021
Phase: Phase 2
Study type: Interventional

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).

NCT ID: NCT04128696 Terminated - Clinical trials for Neoplasms, Head and Neck

Study of GSK3359609 and Pembrolizumab in Programmed Death Receptor 1-ligand 1 (PD-L1) Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

INDUCE-3
Start date: November 21, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of study is to evaluate if the addition of GSK3359609 to pembrolizumab as first-line treatment improves the efficacy of pembrolizumab in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma/cancer (HNSCC).This is a randomized, double-blind, adaptive Phase II/III study comparing a combination of GSK3359609 inducible T cell co-stimulatory receptor (ICOS) agonist and pembrolizumab to pembrolizumab plus placebo in participants with programmed death receptor 1-ligand 1 (PD-L1) combined positive score (CPS) >=1 R/M HNSCC.

NCT ID: NCT03356093 Completed - Clinical trials for Neoplasms, Head and Neck

Change in Symptom Clusters in HNC Patients

Start date: January 1, 2015
Phase: N/A
Study type: Observational

Head and neck cancer (HNC) is the sixth most common malignancy worldwide, causing more than 379,000 deaths in 2015 notwithstanding the breakthrough in cancer screening and medical treatment. The primary treatment for HNC is a combination of surgery and radiotherapy, either delivered preoperatively or postoperatively. Although these treatments, especially the postoperative radiotherapy can greatly improve the survival of patients, they still have to pay a high price for numerous symptoms induced by radiation. On the other hand, research on symptoms clusters is an emerging field in oncology which aims to understand the complexity of multiple symptoms experienced by cancer patients. A thorough understanding of symptom clusters help informs the development of comprehensive care plans which target a group of symptoms that is likely to coexist, thus easing the total symptom burden in cancer patients.To date, there has been a paucity of evidence regarding symptom clusters of HNC. To address the gap in existing literature, this study described the symptom clusters among HNC patients who were treated with surgery with a combination of postoperative radiotherapy. In addition, a longitudinal approach was employed to examine the change in symptom clusters throughout the treatment course.

NCT ID: NCT03178110 Completed - Trismus Clinical Trials

Manual Therapy and Use of the Dynasplint for Trismus in Patients With Head and Neck Cancer

Start date: October 4, 2018
Phase: N/A
Study type: Interventional

The objectives of this pilot study are to determine the effectiveness of a manual therapy (MT) protocol plus the use of a dynamic jaw opening device on the maximal interincisor distance; on trismus symptoms; on pain-disability outcomes and on the quality of life, anxiety, and depression in subjects with trismus. The proposed pilot study will comprise a single subject design with multiple baseline measures and during treatment phases to determine the effectiveness of the treatment protocol. A minimum sample of 10 subjects will be recruited. The Health Research Ethics Board of Alberta Cancer Committee will approve this study. Participants will receive a MT protocol plus exercises and the use of the DTS device for 8 weeks. The first two weeks of treatment will involve only MT and opening exercises.After this initial 2 weeks, the DTS will be introduced. The participants will receive a session of 30-45 minutes of MT three/two times per week, for 8 weeks. All participants will be instructed how to use the Dynasplint® Trismus System at home. Analyses: Visual analyses will be performed on participant before, during, and after the intervention. The 2-standard deviation band method will be used to analyze the behavior of each participant on the outcome of interest before, during, and after the treatment. The minimally important difference levels in order to determine clinical relevance will be done. Two effect size indexes will be used: the percentage of non-overlapping data, and the percentage of improvement rate difference.

NCT ID: NCT02573493 Active, not recruiting - Clinical trials for Head and Neck Cancer

Nab-Paclitaxel and Cisplatin or Nab-paclitaxel as Induction Therapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (HNSCC)

APA
Start date: April 13, 2016
Phase: Phase 2
Study type: Interventional

In this trial, the objectives are to determine the efficacy and toxicity of induction chemotherapy (IC) with nab-paclitaxel + cisplatin (Arm 1: AP) and with nab-paclitaxel (Arm 2: A) alone in patients with HNSCC, and to compare these data to nab-paclitaxel, cisplatin, and 5-FU (APF). The investigators also hypothesize that the high anti-tumor efficacy of nab-paclitaxel in HNSCC is due to the upregulation of macropinocytosis, a result of the frequent presence of Ras and PI3K (and epidermal growth factor receptor -EGFR) activation in this cancer. Amendment to Add Arm 3: In this amendment, the investigators retain the AP + concurrent chemoradiation therapy (CRT) backbone but de-escalate the dose of radiation therapy (RT) from 70 Gy to 42 Gy. The investigators also plan to administer one dose (vs three) of cisplatin during RT. This novel treatment approach will be evaluated in patients with HPV-related oropharyngeal squamous cell carcinoma (OPSCC) (Arm 3), a sub-group with a very favorable prognosis.

NCT ID: NCT02557048 Recruiting - Clinical trials for Head and Neck Cancer

Head and Neck Cancer in Children: A Retrospective Study

Start date: January 10, 2019
Phase:
Study type: Observational

The aim of the study is to identify demographic characteristics, various histopathologies, and site preferences for each disease entity of malignant head and neck tumors in pediatric oncology patients & treatment outcomes in these patients, according to experience at South Egypt Cancer Institute which is the largest referral site in Upper Egypt.

NCT ID: NCT02376699 Terminated - Lymphoma Clinical Trials

Safety Study of SEA-CD40 in Cancer Patients

Start date: February 28, 2015
Phase: Phase 1
Study type: Interventional

This study is being done to find out if SEA-CD40 is safe and effective when given alone, in combination with pembrolizumab, and in combination with pembrolizumab, gemcitabine, and nab-paclitaxel. The study will test increasing doses of SEA-CD40 given at least every 3 weeks to small groups of patients. The goal is to find the highest dose of SEA-CD40 that can be given to patients that does not cause unacceptable side effects. Different dose regimens will be evaluated. Different methods of administration may be evaluated. The pharmacokinetics, pharmacodynamic effects, biomarkers of response, and antitumor activity of SEA-CD40 will also be evaluated.