Treatment Trials

475 Clinical Trials for Various Conditions

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ACTIVE_NOT_RECRUITING
Tadalafil and Pembrolizumab in Recurrent or Metastatic Head and Neck Cancer
Description

This study will examine the combination of pembrolizumab and tadalafil for safety and efficacy in advanced head and neck cancer.

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

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

TERMINATED
A Study of ADXS-NEO Expressing Personalized Tumor Antigens
Description

This is a Phase 1, open-label, multicenter study of ADXS-NEO administered alone and in combination with pembrolizumab in participants with select advanced or metastatic solid tumors. This study will be performed in 2 phases, a safety phase (Part A and Part B) and an efficacy phase (Part C).

ACTIVE_NOT_RECRUITING
Study Evaluating a Stereotactic Boost/Treatment for Recurrent or Metastatic Cancer of the Head and Neck
Description

This research study seeks to gain new knowledge about the addition of a carefully targeted "boost" dose of radiation as a possible treatment for recurrent or metastatic head or neck cancer. The name of the study intervention involved in this study is stereotactic body radiotherapy, which is a way of delivering radiation in a more precisely targeted way and with a higher dose than conventional radiotherapy.

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

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.

COMPLETED
SU5416 and Paclitaxel in Treating Patients With Recurrent, Locally Advanced or Metastatic Cancer of the Head and Neck
Description

RATIONALE: SU5416 may stop the growth of head and neck cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining SU5416 with chemotherapy may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of SU5416 and paclitaxel in treating patients who have recurrent, locally advanced, or metastatic cancer of the head and neck.

RECRUITING
Lovastatin and Pembrolizumab for the Treatment of Patients with Recurrent or Metastatic Head and Neck Cancer, LAPP Trial
Description

This phase II trial tests how well lovastatin and pembrolizumab work in treating patients with head and neck cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Lovastatin is a drug used to lower the amount of cholesterol in the blood and may also cause tumor cell death. In addition, studies have shown that lovastatin may make the tumor cells more sensitive to immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lovastatin and pembrolizumab may kill more tumor cells in patients with recurrent or metastatic head and neck cancer.

RECRUITING
A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Recurrent/Metastatic Head and Neck Cancer
Description

The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, amivantamab in addition to paclitaxel and amivantamab in addition to pembrolizumab and carboplatin in participants with recurrent/metastatic head and neck cancer. The study will also confirm the recommended Phase 2 combination dose (RP2CD) for amivantamab in addition to paclitaxel.

TERMINATED
Non-invasive Measurement of PD-L1 Levels With Positron Emission Tomography (PET) in Head and Neck Malignancies and Intracranial Metastases
Description

This study aims to determine the feasibility of non-invasive quantitative PD-L1 measurement using \[a novel PD-L1 positron emission tomography (PET) tracer and perform immunohistochemistry based measurement of PD-L1 levels within resected lesions in head and neck cancer and brain metastases.

SUSPENDED
Intensive Symptom Surveillance Guided by Machine Learning-Directed Risk Stratification in Patients With Non-Metastatic Head and Neck Cancer, The INSIGHT Trial
Description

This clinical trial compares intensive symptom evaluation with supportive care to standard symptom management in patients with head and neck cancer that has not spread to other places in the body (non-metastatic). Standard symptom management involves symptom management during and after radiation therapy, using problem-focused history and physical examination followed by appropriate symptomatic management as appropriate per treating physician's discretion. Intensive symptom management with monitoring patient reported outcomes is performed among patients with metastatic cancers receiving systemic therapies and with various cancers receiving radiation therapy. This trial may help researchers determine the impact of intensive symptom surveillance in patients with non-metastatic head and neck cancers.

ACTIVE_NOT_RECRUITING
Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer
Description

This is a randomized, double-blind, multicenter, global Phase 3 study to assess the efficacy and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in Participants with recurrent or metastatic head and neck cancer.

ACTIVE_NOT_RECRUITING
Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients
Description

The purpose of this study is to determine anti-tumor activity by measuring overall response rate in recurrent and/or metastatic HNSCC patients receiving the combination of metformin and pembrolizumab.

WITHDRAWN
SPEARHEAD 2 Study in Subjects With Recurrent or Metastatic Head and Neck Cancer
Description

This is a study to investigate the efficacy and safety of ADP-A2M4 in combination with pembrolizumab in HLA-A\*02 eligible and MAGE-A4 positive subjects with recurrent or metastatic Head and Neck cancer.

TERMINATED
Study of Proton SBRT and Immunotherapy for Recurrent/Progressive Locoregional or Metastatic Head and Neck Cancer
Description

This study observes the clinical efficacy of combining proton SBRT with PD-1 blockade immunotherapy in both the locoregionally recurrent and metastatic settings.

COMPLETED
Safety and Efficacy of MEDI0457 and Durvalumab in Participants With Human Papilloma Virus (HPV) Associated Recurrent/Metastatic Head and Neck Cancer
Description

This is a Phase 1b/2a, open-label, multi-center study to evaluate the safety and tolerability, anti-tumor activity, and immunogenicity of MEDI0457 (also known as INO 3112) a HPV Deoxyribonucleic Acid (DNA) vaccine in combination with durvalumab (also known as MEDI4736) which is a human monoclonal antibody directed against Programmed Death Ligand 1 (PD-L1), which blocks the interaction of PD-L1 with PD-1 and Cluster of differentiation 80 (CD80). An initial three to 12 participants (Safety Analysis Run-in participants) will be enrolled and assessed for safety before additional participants are enrolled. The initial safety analysis run-in participants along with an approximate total of 50 participants with human papilloma virus associated recurrent or metastatic head and neck squamous cell cancer (HNSCC) will be enrolled in this study and evaluated also for anti-tumor efficacy to MEDI0457 in combination with durvalumab.

ACTIVE_NOT_RECRUITING
Oral Decitabine (ASTX727) and Durvalumab in Recurrent and/or Metastatic Head and Neck Cancer Patients
Description

This is a non-randomized, open-label, Phase IbI study to assess the safety and efficacy of oral decitabine (ASTX727) and durvalumab (MEDI4736) combination therapy in the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) who have progressed during or after treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 monotherapy for recurrent and/or metastatic disease. The clinical trial is studying drugs that can boost the participant's immune system against the cancer cells as a possible treatment for head and neck cancer. The study interventions involved in this study are: * Oral Decitabine (ASTX 727) * Durvalumab (MEDI4736)

RECRUITING
Blood Tests and Questionnaires in Studying Adherence to Preventative Swallowing Exercises in Participants With Metastatic Head and Neck Cancer
Description

This trial uses blood tests and questionnaires to study how well participants with head and neck cancer that has spread to other places in the body adhere to swallowing exercises to prevent future disease. Using blood tests to study cytokines (proteins related to the immune system) may help doctors learn if certain levels of cytokines affect whether or not side effects occur and if they put participants at risk for future disease. Questionnaires may help doctors learn about the reasons head and neck cancer participants may or may not follow the swallowing exercises that they are asked to perform after receiving radiation treatments.

Conditions
Carcinoma of Unknown PrimaryClinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Metastatic Head and Neck CarcinomaMetastatic Malignant Neoplasm in the Uterine CervixPathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Stage I Hypopharyngeal Carcinoma AJCC v8Stage I Nasopharyngeal Carcinoma AJCC v8Stage II Hypopharyngeal Carcinoma AJCC v8Stage II Laryngeal Cancer AJCC v8Stage II Nasopharyngeal Carcinoma AJCC v8Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage III Hypopharyngeal Carcinoma AJCC v8Stage III Laryngeal Cancer AJCC v8Stage III Nasopharyngeal Carcinoma AJCC v8Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IV Hypopharyngeal Carcinoma AJCC v8Stage IV Laryngeal Cancer AJCC v8Stage IV Nasopharyngeal Carcinoma AJCC v8Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IVA Hypopharyngeal Carcinoma AJCC v8Stage IVA Laryngeal Cancer AJCC v8Stage IVA Nasopharyngeal Carcinoma AJCC v8Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IVB Hypopharyngeal Carcinoma AJCC v8Stage IVB Laryngeal Cancer AJCC v8Stage IVB Nasopharyngeal Carcinoma AJCC v8Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8
COMPLETED
Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer
Description

This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior systemic chemotherapy for recurrent or metastatic disease.

COMPLETED
Radiation Therapy and MK-3475 for Patients With Recurrent/Metastatic Head and Neck Cancer, Renal Cell Cancer, Melanoma, and Lung Cancer
Description

This randomized clinical trial studies radiation therapy and MK-3475 in treating patients with head and neck cancer, kidney cancer, melanoma, or lung cancer that has returned, has spread to other parts of the body, or cannot be removed by surgery. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as MK-3475, may block tumor growth by targeting certain cells and causing the immune system to attack the tumor. Studying the effects of MK-3475 with radiation therapy on the body may help doctors learn whether it may be an effective treatment for these solid tumors.

COMPLETED
Combination Study of Urelumab and Cetuximab in Patients With Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Head and Neck Cancer
Description

The purpose of the study is to determine the safety, tolerability and maximum tolerated dose of Urelumab in combination with Cetuximab in patients with Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Squamous Cell Carcinoma of the Head and Neck.

WITHDRAWN
A Phase II Trial of Proton Pump Inhibitors With Chemotherapy in Patients With Metastatic Head and Neck Cancer
Description

The purpose of this study is to determine if the addition of proton pump inhibitors (PPIs) to standard chemotherapy can improve progression free survival in patients with head and neck cancer.

TERMINATED
Study of Efficacy and Safety of Buparlisib (BKM120) Plus Paclitaxel Versus Placebo Plus Paclitaxel in Recurrent or Metastatic Head and Neck Cancer Previously Pre-treated With a Platinum Therapy
Description

Phase II Study of efficacy and safety of buparlisib (BKM120) plus paclitaxel versus placebo plus paclitaxel in recurrent or metastatic Head and Neck cancer previously pre-treated with a platinum therapy.The primary endpoint was PFS and the key secondary endpoint was Overall Survival.

COMPLETED
PI3K Inhibitor BKM120 and Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Description

This pilot randomized phase I/II trial studies the side effects and best dose of PI3K inhibitor BKM120 when given together with cetuximab and to see how well it works in treating patients with recurrent or metastatic head and neck cancer. PI3K inhibitor BKM120 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumors to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving PI3K inhibitor BKM120 together with cetuximab may kill more tumor cells

Conditions
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell CarcinomaRecurrent Metastatic Squamous Neck Cancer With Occult PrimaryRecurrent Salivary Gland CancerRecurrent Squamous Cell Carcinoma of the HypopharynxRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Squamous Cell Carcinoma of the NasopharynxRecurrent Squamous Cell Carcinoma of the OropharynxRecurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityRecurrent Verrucous Carcinoma of the LarynxRecurrent Verrucous Carcinoma of the Oral CavitySalivary Gland Squamous Cell CarcinomaStage IV Squamous Cell Carcinoma of the HypopharynxStage IV Squamous Cell Carcinoma of the NasopharynxStage IVA Salivary Gland CancerStage IVA Squamous Cell Carcinoma of the LarynxStage IVA Squamous Cell Carcinoma of the Lip and Oral CavityStage IVA Squamous Cell Carcinoma of the OropharynxStage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVA Verrucous Carcinoma of the LarynxStage IVA Verrucous Carcinoma of the Oral CavityStage IVB Salivary Gland CancerStage IVB Squamous Cell Carcinoma of the LarynxStage IVB Squamous Cell Carcinoma of the Lip and Oral CavityStage IVB Squamous Cell Carcinoma of the OropharynxStage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVB Verrucous Carcinoma of the LarynxStage IVB Verrucous Carcinoma of the Oral CavityStage IVC Salivary Gland CancerStage IVC Squamous Cell Carcinoma of the LarynxStage IVC Squamous Cell Carcinoma of the Lip and Oral CavityStage IVC Squamous Cell Carcinoma of the OropharynxStage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVC Verrucous Carcinoma of the LarynxStage IVC Verrucous Carcinoma of the Oral CavityTongue Cancer
COMPLETED
Phase II Trial Evaluating Axitinib In Patients With Unresectable, Recurrent Or Metastatic Head And Neck Cancer
Description

The purpose of this study is to investigate a new agent Axitinib in the treatment of head and neck cancer. This is a new drug that is given as a pill twice a day to treat cancer. This is one of the new, "smart" drugs. It binds to a protein on the surface of the cancer cell called VEGFR, and this way it slows down the growth of cancer cells and kills them. Head and neck cancer cells are known to carry this protein on their surface. Research in animals and in patients with other kinds of cancer showed that Axitinib can be effective at killing cancer cells, or stopping their growth, by this mechanism. It is generally a safe drug that is given by mouth. The investigators do not know, however, whether Axitinib is effective in head and neck cancer. This research study is being conducted to learn if Axitinib works in head and neck cancer, and also to learn to predict who would benefit from it. Four blood draws will be done to check special blood tests while the subjects are treated with Axitinib. These will be drawn at the same time as your routine labs, and there will not be additional sticks needed. A biopsy of the tumor before and after 1 month of treatment may be obtained to test how the cancer cells are responding to treatment. By testing these blood and tissue samples, the researchers will look at special tests (protein molecules) to try to determine what kind of head and neck patients would best respond to this drug. This is an open-label study, meaning that all subjects are on the active drug and there is no placebo (sugar pill).

COMPLETED
Akt Inhibitor MK2206 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Description

This phase II trial is studying how well Akt inhibitor MK2206 works in treating patients with recurrent or metastatic head and neck cancer. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

TERMINATED
Capecitabine and Vorinostat in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer
Description

This partially randomized phase II trial studies giving capecitabine and vorinostat in treating patients with head and neck cancer that has come back after previous treatment or that has spread to other areas in the body. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving capecitabine together with vorinostat is more effective than capecitabine alone in treating patients with cancer of the head and neck cancer.

COMPLETED
Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy
Description

This phase II trial studies how well giving temsirolimus together with cetuximab works compared to temsirolimus alone in treating patients with recurrent and/or metastatic head and neck cancer who did not respond to previous therapy. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving temsirolimus together with cetuximab is more effective than giving temsirolimus alone.

Conditions
Recurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Laryngeal Verrucous CarcinomaRecurrent Lip and Oral Cavity Squamous Cell CarcinomaRecurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult PrimaryRecurrent Nasal Cavity and Paranasal Sinus Squamous Cell CarcinomaRecurrent Nasopharyngeal Keratinizing Squamous Cell CarcinomaRecurrent Oral Cavity Verrucous CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaRecurrent Salivary Gland CarcinomaSalivary Gland Squamous Cell CarcinomaSquamous Cell Carcinoma Metastatic in the Neck With Occult PrimaryStage IV Hypopharyngeal Squamous Cell CarcinomaStage IV Nasopharyngeal Keratinizing Squamous Cell CarcinomaStage IVA Laryngeal Squamous Cell CarcinomaStage IVA Laryngeal Verrucous CarcinomaStage IVA Lip and Oral Cavity Squamous Cell CarcinomaStage IVA Major Salivary Gland CarcinomaStage IVA Nasal Cavity and Paranasal Sinus Squamous Cell CarcinomaStage IVA Oral Cavity Verrucous CarcinomaStage IVA Oropharyngeal Squamous Cell CarcinomaStage IVB Laryngeal Squamous Cell CarcinomaStage IVB Laryngeal Verrucous CarcinomaStage IVB Lip and Oral Cavity Squamous Cell CarcinomaStage IVB Major Salivary Gland CarcinomaStage IVB Nasal Cavity and Paranasal Sinus Squamous Cell CarcinomaStage IVB Oral Cavity Verrucous CarcinomaStage IVB Oropharyngeal Squamous Cell CarcinomaStage IVC Laryngeal Squamous Cell CarcinomaStage IVC Laryngeal Verrucous CarcinomaStage IVC Lip and Oral Cavity Squamous Cell CarcinomaStage IVC Major Salivary Gland CarcinomaStage IVC Nasal Cavity and Paranasal Sinus Squamous Cell CarcinomaStage IVC Oral Cavity Verrucous CarcinomaStage IVC Oropharyngeal Squamous Cell CarcinomaTongue Carcinoma
TERMINATED
Gene and Protein Expression Patterns in Predicting Response to Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer
Description

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how will patients respond to treatment. PURPOSE: This research study is looking at gene and protein expression patterns in predicting response to cetuximab in patients with recurrent and/or metastatic head and neck cancer.

COMPLETED
Irinotecan and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Description

RATIONALE: Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: To determine if CPT-11 given together with cisplatin is effective in treating recurrent or metastatic head and neck cancer.

TERMINATED
Oxaliplatin and Docetaxel for Recurrent or Metastatic Head and Neck Cancer
Description

Patient receiving oxaliplatin and docetaxel will have longer progression free survival than those patients receiving standard care.