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Recruiting No phase listed Observational

Oropharynx (OPX) Biomarker Trial

NCT06356272
Conditions
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Oropharyngeal Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Head and Neck Carcinoma, Head and Neck Neoplasm, Salivary Gland Neoplasms, Thyroid Gland Neoplasm
Interventions
Non-Interventional Study
Other
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years and older
Enrollment
560 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2029
U.S. locations
1
States / cities
Rochester, Minnesota
Conditions
Breast Cancer, Chronic Myeloproliferative Disorders, Colorectal Cancer, Head and Neck Cancer, Leukemia, Lung Cancer, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic/Myeloproliferative Diseases, Prostate Cancer, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Interventions
doxorubicin hydrochloride, motexafin gadolinium
Drug
Lead sponsor
University of Wisconsin, Madison
Other
Eligibility
18 Years to 120 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2002
U.S. locations
2
States / cities
Pittsburgh, Pennsylvania • Madison, Wisconsin
Conditions
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Human Papillomavirus-Related Neck Squamous Cell Carcinoma of Unknown Primary, Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma, Metastatic Laryngeal Squamous Cell Carcinoma, Metastatic Nasopharyngeal Squamous Cell Carcinoma, Metastatic Oral Cavity Squamous Cell Carcinoma, Metastatic Oropharyngeal Squamous Cell Carcinoma, Metastatic Paranasal Sinus Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Nasopharyngeal Squamous Cell Carcinoma, Recurrent Oral Cavity Squamous Cell Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Recurrent Paranasal Sinus Squamous Cell Carcinoma, Stage IV Hypopharyngeal Carcinoma AJCC v8, Stage IV Laryngeal Cancer AJCC v8, Stage IV Lip and Oral Cavity Cancer AJCC v8, Stage IV Nasopharyngeal Carcinoma AJCC v8, Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IV Sinonasal Cancer AJCC v8
Interventions
Biospecimen Collection, Computed Tomography, Lovastatin, Magnetic Resonance Imaging, Pembrolizumab, Positron Emission Tomography
Procedure · Drug · Biological
Lead sponsor
Emory University
Other
Eligibility
18 Years and older
Enrollment
28 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
2
States / cities
Atlanta, Georgia
Conditions
Head and Neck Cancer, Human Papilloma Virus
Interventions
MEDI0457, CELLECTRA®5P device, Durvalumab
Drug · Device
Lead sponsor
MedImmune LLC
Industry
Eligibility
18 Years to 99 Years
Enrollment
35 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2021
U.S. locations
14
States / cities
San Francisco, California • Orlando, Florida • Atlanta, Georgia + 10 more
Conditions
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Locally Recurrent Head and Neck Squamous Cell Carcinoma, Locally Recurrent Hypopharyngeal Squamous Cell Carcinoma, Locally Recurrent Laryngeal Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oropharyngeal Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma, Metastatic Laryngeal Squamous Cell Carcinoma, Metastatic Melanoma, Metastatic Oral Cavity Squamous Cell Carcinoma, Metastatic Oropharyngeal Squamous Cell Carcinoma, Recurrent Melanoma, Stage III Hypopharyngeal Carcinoma AJCC v8, Stage III Laryngeal Cancer AJCC v8, Stage III Lip and Oral Cavity Cancer AJCC v8, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IV Hypopharyngeal Carcinoma AJCC v8, Stage IV Laryngeal Cancer AJCC v8, Stage IV Lip and Oral Cavity Cancer AJCC v8, Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Unresectable Melanoma
Interventions
Biopsy Procedure, Biospecimen Collection, Cabozantinib S-malate, Computed Tomography, Magnetic Resonance Imaging, Nivolumab
Procedure · Drug · Biological
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
222
States / cities
Phoenix, Arizona • Little Rock, Arkansas • Beverly Hills, California + 173 more
Conditions
Melanoma, Cervical Carcinoma, Pancreatic Carcinoma, Triple Negative Breast Cancer, Hepatocellular Carcinoma, Urothelial Carcinoma, Squamous Cell Carcinoma of the Head and Neck, Nasopharyngeal Carcinoma, Renal Cell Carcinoma, Non-small Cell Lung Carcinoma, Small Cell Lung Carcinoma, Gastric or Gastroesophageal Junction Adenocarcinoma, Advanced or Metastatic Solid Tumors, Prostate Carcinoma, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Intrahepatic Cholangiocarcinoma, Squamous Cell Anal Cancer, Squamous Cell Penile Carcinoma, Squamous Cell Vulvar Carcinoma, Colorectal Carcinoma, Endometrial Carcinoma
Interventions
XmAb®22841, Pembrolizumab (Keytruda®)
Biological
Lead sponsor
Xencor, Inc.
Industry
Eligibility
18 Years and older
Enrollment
78 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2023
U.S. locations
28
States / cities
Encinitas, California • La Jolla, California • Los Angeles, California + 15 more
Conditions
Lip and Oral Cavity Cancer, Head and Neck Cancer, Oropharyngeal Cancer
Interventions
cisplatin, fluorouracil, ONYX-015
Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years to 79 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 1999
U.S. locations
2
States / cities
Boston, Massachusetts
Conditions
Head and Neck Squamous Cell Carcinoma, Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Recurrent Nasopharynx Carcinoma, Recurrent Salivary Gland Carcinoma, Squamous Cell Carcinoma Metastatic in the Neck With Occult Primary, Stage III Major Salivary Gland Carcinoma, Stage III Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Stage III Nasopharyngeal Carcinoma, Stage IV Nasopharyngeal Carcinoma, Stage IVA Major Salivary Gland Carcinoma, Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Stage IVB Major Salivary Gland Carcinoma, Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Stage IVC Major Salivary Gland Carcinoma, Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
Interventions
Laboratory Biomarker Analysis, Pembrolizumab, Vorinostat
Other · Biological · Drug
Lead sponsor
University of Washington
Other
Eligibility
18 Years and older
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2023
U.S. locations
1
States / cities
Seattle, Washington
Conditions
Head and Neck Cancer
Interventions
Docetaxel, Capecitabine
Drug
Lead sponsor
University of Michigan Rogel Cancer Center
Other
Eligibility
18 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2002 – 2010
U.S. locations
1
States / cities
Ann Arbor, Michigan
Conditions
Head and Neck Carcinoma, Adenoid Cystic Carcinoma, Lung Cancer, Non-Small Cell Lung Cancer, Pancreatic Cancer, Mesothelioma, Esophageal Cancer, Any Solid Tumors Progressed After a Prior Immunotherapy, Head and Neck Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma HNSCC, Salivary Gland Carcinomas, Head and Neck Cancers - Salivary Gland, Head and Neck Cancers - Nasopharyngeal, Head and Neck Cancers - Throat, Small Cell Lung Cancer ( SCLC ), Lung Cancer (Locally Advanced or Metastatic), Head and Neck Cancers - Tonsils, Head and Neck Cancers Hypopharynx, Head and Neck Cancers Larynx, Head and Neck Cancers Lip, Head and Neck Cancers Nasopharynx, Head and Neck Cancers Oral Cavity, Head and Neck Cancers, Head and Neck Cancers Oropharynx, Head and Neck Cancers Trachea
Interventions
VMD-928 100 mg Tablet, VMD-928 Tablet and Pembrolizumab (200 mg)
Drug
Lead sponsor
VM Oncology, LLC
Industry
Eligibility
18 Years to 80 Years
Enrollment
242 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2028
U.S. locations
14
States / cities
Santa Rosa, California • Hartford, Connecticut • Washington D.C., District of Columbia + 11 more
Conditions
Solid Tumor, Non-Small Cell Lung Cancer, Head and Neck Cancer, Melanoma, Gastric Cancer, Renal Cell Carcinoma, Urothelial Carcinoma
Interventions
INBRX-106 - Hexavalent OX40 agonist antibody, pembrolizumab 200 mg, pembrolizumab 400 mg, Carboplatin AUC-5, Carboplatin AUC-6, Pemetrexed 500 mg/m2, Cisplatin 75mg/m2, Paclitaxel 200mg/m2, Nab paclitaxel 100mg/m2
Drug
Lead sponsor
Inhibrx Biosciences, Inc
Industry
Eligibility
18 Years and older
Enrollment
296 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2027
U.S. locations
30
States / cities
Duarte, California • Glendale, California • Los Angeles, California + 25 more
Conditions
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Paranasal Sinus Neoplasms, Nasopharyngeal Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Hypopharyngeal Cancer, Carcinoma of Larynx, Oral Squamous Cell Carcinoma, Salivary Gland Cancer, Adenoid Cystic Carcinoma, Prostate Cancer, Metastatic Castration Resistant Prostate Cancer
Interventions
SX-682, DTX
Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years to 120 Years
Enrollment
120 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2037
U.S. locations
1
States / cities
Bethesda, Maryland
Conditions
Head and Neck Cancer
Interventions
ZD1839 (IRESSA)
Drug
Lead sponsor
University of Chicago
Other
Eligibility
18 Years and older
Enrollment
46 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2002 – 2010
U.S. locations
1
States / cities
Chicago, Illinois
Conditions
Squamous Cell Carcinoma of Head and Neck (SCCHN), Metastatic Colorectal Cancer
Interventions
INC280, cetuximab
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
13 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2017
U.S. locations
3
States / cities
Boston, Massachusetts • New York, New York • Salt Lake City, Utah
Conditions
Pancreatic Cancer, Hepatocellular Cancer, Mesothelioma, Breast Cancer, Gastric Cancer, Esophageal Cancer, Nasopharyngeal Cancer, Kidney Cancer, Squamous Cell Cancer of Head and Neck (SCCHN), Non-small Cell Lung Cancer (NSCLC), Non-squamous
Interventions
TAK-500, Pembrolizumab, Tocilizumab, Dexamethasone
Drug
Lead sponsor
Takeda
Industry
Eligibility
18 Years and older
Enrollment
61 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
12
States / cities
Birmingham, Alabama • Duarte, California • La Jolla, California + 9 more
Conditions
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma, Metastatic Laryngeal Squamous Cell Carcinoma, Metastatic Oral Cavity Squamous Cell Carcinoma, Metastatic Oropharyngeal Squamous Cell Carcinoma, Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, Stage IV Hypopharyngeal Carcinoma AJCC v8, Stage IV Laryngeal Cancer AJCC v8, Stage IV Lip and Oral Cavity Cancer AJCC v8, Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Interventions
Carboplatin, Cisplatin, Computed Tomography, Fluorouracil, Magnetic Resonance Imaging, Paclitaxel, Pembrolizumab, Positron Emission Tomography, Quality-of-Life Assessment, Radiation Therapy
Drug · Procedure · Biological + 2 more
Lead sponsor
ECOG-ACRIN Cancer Research Group
Network
Eligibility
18 Years and older
Enrollment
290 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2030
U.S. locations
51
States / cities
Tampa, Florida • Atlanta, Georgia • Boise, Idaho + 39 more
Conditions
Head and Neck Cancer, Mucositis Oral, Radiation Toxicity, Tongue Cancer
Interventions
sargramostim, oral salt and soda mouthwash
Biological · Other
Lead sponsor
Marilyn Dodd
Other
Eligibility
18 Years and older
Enrollment
91 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2009
U.S. locations
1
States / cities
San Francisco, California
Conditions
Head and Neck Carcinoma, Head and Neck Carcinoma of Unknown Primary, Hypopharyngeal Carcinoma, Laryngeal Carcinoma, Metastatic Malignant Neoplasm in the Lymph Nodes, Nasal Cavity Carcinoma, Oral Cavity Carcinoma, Oropharyngeal Carcinoma, Paranasal Sinus Carcinoma, Salivary Gland Carcinoma, Cutaneous Squamous Cell Carcinoma of the Head and Neck, Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck
Interventions
Cisplatin, Intensity-Modulated Proton Therapy, Quality-of-Life Assessment, Questionnaire Administration, Computed Tomography, Magnetic Resonance Imaging, Positron Emission Tomography, Biospecimen Collection, Intensity-Modulated Radiation Therapy
Drug · Procedure · Other + 1 more
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years and older
Enrollment
174 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2035
U.S. locations
9
States / cities
Phoenix, Arizona • Scottsdale, Arizona • Jacksonville, Florida + 6 more
Conditions
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, Salivary Gland Squamous Cell Carcinoma, Stage 0 Hypopharyngeal Cancer, Stage 0 Laryngeal Cancer, Stage 0 Lip and Oral Cavity Cancer, Stage 0 Nasopharyngeal Cancer, Stage 0 Oropharyngeal Cancer, Stage 0 Paranasal Sinus and Nasal Cavity Cancer, Stage I Salivary Gland Cancer, Stage I Squamous Cell Carcinoma of the Hypopharynx, Stage I Squamous Cell Carcinoma of the Larynx, Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage I Squamous Cell Carcinoma of the Nasopharynx, Stage I Squamous Cell Carcinoma of the Oropharynx, Stage I Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage I Verrucous Carcinoma of the Larynx, Stage I Verrucous Carcinoma of the Oral Cavity, Stage II Salivary Gland Cancer, Stage II Squamous Cell Carcinoma of the Hypopharynx, Stage II Squamous Cell Carcinoma of the Larynx, Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage II Squamous Cell Carcinoma of the Nasopharynx, Stage II Squamous Cell Carcinoma of the Oropharynx, Stage II Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage II Verrucous Carcinoma of the Larynx, Stage II Verrucous Carcinoma of the Oral Cavity, Stage III Salivary Gland Cancer, Stage III Squamous Cell Carcinoma of the Hypopharynx, Stage III Squamous Cell Carcinoma of the Larynx, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Squamous Cell Carcinoma of the Nasopharynx, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage III Verrucous Carcinoma of the Larynx, Stage III Verrucous Carcinoma of the Oral Cavity, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Nasopharynx, Stage IVA Salivary Gland Cancer, Stage IVA Squamous Cell Carcinoma of the Larynx, Stage IVA Oral Cavity Squamous Cell Carcinoma, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Stage IVA Nasal Cavity and Paranasal Sinus Cancer, Stage IVA Verrucous Carcinoma of the Larynx, Stage IVA Verrucous Carcinoma of the Oral Cavity, Stage IVB Salivary Gland Cancer, Stage IVB Squamous Cell Carcinoma of the Larynx, Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVB Squamous Cell Carcinoma of the Oropharynx, Stage IVB Oral Cavity Squamous Cell Carcinoma, Stage IVB Verrucous Carcinoma of the Larynx, Stage IVB Verrucous Carcinoma of the Oral Cavity, Stage IVC Salivary Gland Cancer, Stage IVC Squamous Cell Carcinoma of the Larynx, Stage IVC Oral Cavity Squamous Cell Carcinoma, Stage IVC Squamous Cell Carcinoma of the Oropharynx, Paranasal Sinus and Nasal Cavity Squamous Cell Carcinoma, Stage IVC Verrucous Carcinoma of the Larynx, Stage IVC Verrucous Carcinoma of the Oral Cavity, Tongue Cancer
Interventions
placebo, laboratory biomarker analysis, questionnaire administration, chemoprevention
Other · Drug
Lead sponsor
Ohio State University Comprehensive Cancer Center
Other
Eligibility
21 Years and older
Enrollment
70 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2014
U.S. locations
1
States / cities
Columbus, Ohio
Conditions
Head and Neck Cancer
Interventions
cetuximab, cisplatin, intensity-modulated radiation therapy, Nab-Paclitaxel
Drug · Radiation
Lead sponsor
University of Texas Southwestern Medical Center
Other
Eligibility
18 Years to 120 Years
Enrollment
37 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2016
U.S. locations
4
States / cities
Cleveland, Ohio • Dallas, Texas • Milwaukee, Wisconsin
Conditions
Oropharyngeal Cancer, HPV-Related Squamous Cell Carcinoma
Interventions
Gabapentin
Drug
Lead sponsor
University of Chicago
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2022
U.S. locations
1
States / cities
Chicago, Illinois
Conditions
Neurocognitive Impairment, Delirium, Esophageal Cancer, Head and Neck Cancer, Lung Cancer
Interventions
Assessment of therapy complications, Neurocognitive assessment, Quality-of-life assessment
Other
Lead sponsor
Vanderbilt University Medical Center
Other
Eligibility
21 Years and older
Enrollment
86 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2013
U.S. locations
4
States / cities
Nashville, Tennessee
Conditions
HNSCC, Lip SCC, Oral Cavity Cancer, Oropharynx Cancer, Larynx Cancer, Hypopharynx Cancer, Nasopharynx Cancer, Sinonasal Carcinoma, Cutaneous Squamous Cell Carcinoma, Head and Neck Neoplasms, Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Interventions
Pembrolizumab, Cetuximab
Drug
Lead sponsor
University of California, San Diego
Other
Eligibility
18 Years and older
Enrollment
78 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2025
U.S. locations
4
States / cities
La Jolla, California • Los Angeles, California • Ann Arbor, Michigan + 1 more
Conditions
Head and Neck Squamous Cell Carcinoma, Cancer, Cancer of Head and Neck, Cancer, Advanced, Cancer, Metastatic, Tumor, Tumor Recurrence, Tumor Neck, Tumor Metastasis, Oral Cancer, Oropharyngeal Cancer, Oropharynx Cancer, Oropharynx Cancer, Stage III, Oropharynx Cancer, Recurrent, Oropharynx Cancer, Metastatic
Interventions
Pembrolizumab, Radiation therapy, Cisplatin
Drug · Radiation
Lead sponsor
Loren Mell, MD
Other
Eligibility
18 Years and older
Enrollment
126 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2027
U.S. locations
6
States / cities
Tucson, Arizona • La Jolla, California • Tampa, Florida + 3 more