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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
Nasopharyngeal Cancer Recurrent
Interventions
Toripalimab, Cisplatin, Gemcitabine, Carboplatin
Drug
Lead sponsor
Coherus Oncology, Inc.
Industry
Eligibility
12 Years and older
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
12
States / cities
Little Rock, Arkansas • Irvine, California • San Francisco, California + 9 more
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
Advanced Malignant Neoplasm, Castleman Disease, Digestive System Carcinoma, Erdheim-Chester Disease, Lip and Oral Cavity Carcinoma, Lymphangioleiomyomatosis, Malignant Endocrine Neoplasm, Malignant Female Reproductive System Neoplasm, Malignant Male Reproductive System Neoplasm, Malignant Neoplasm, Malignant Respiratory Tract Neoplasm, Malignant Thoracic Neoplasm, Malignant Urinary System Neoplasm, Mesothelial Neoplasm, Metastatic Malignant Neoplasm, Metastatic Urothelial Carcinoma, Neurofibromatosis Type 2, Recurrent Adult Soft Tissue Sarcoma, Recurrent Breast Carcinoma, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Digestive System Carcinoma, Recurrent Female Reproductive System Carcinoma, Recurrent Male Reproductive System Carcinoma, Recurrent Malignant Neoplasm, Recurrent Pharyngeal Carcinoma, Recurrent Thyroid Gland Carcinoma, Refractory Malignant Neoplasm, Soft Tissue Neoplasm, Stage III Breast Cancer AJCC v7, Stage III Pharyngeal Cancer, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7, Stage IV Breast Cancer AJCC v6 and v7, Stage IV Pharyngeal Cancer, Stage IVA Pharyngeal Cancer, Stage IVB Pharyngeal Cancer, Stage IVC Pharyngeal Cancer, Thyroid Gland Neoplasm
Interventions
Bevacizumab, Cetuximab, Laboratory Biomarker Analysis, Pharmacological Study, Temsirolimus, Valproic Acid
Biological · Other · Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
Not listed
Enrollment
154 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2026
U.S. locations
1
States / cities
Houston, Texas
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
Appendix Adenocarcinoma, Human Papillomavirus-Related Anal Squamous Cell Carcinoma, Human Papillomavirus-Related Cervical Squamous Cell Carcinoma, Human Papillomavirus-Related Squamous Cell Carcinoma of the Penis, Human Papillomavirus-Related Vulvar Squamous Cell Carcinoma, Neuroendocrine Carcinoma, Pancreatic Neuroendocrine Tumor, Recurrent Merkel Cell Carcinoma, Recurrent Nasopharynx Carcinoma, Recurrent Peritoneal Malignant Mesothelioma, Recurrent Pleural Malignant Mesothelioma, Stage III Merkel Cell Carcinoma AJCC v7, Stage III Nasopharyngeal Carcinoma AJCC v7, Stage III Pleural Malignant Mesothelioma AJCC v7, Stage IV Merkel Cell Carcinoma AJCC v7, Stage IV Nasopharyngeal Carcinoma AJCC v7, Stage IV Pleural Malignant Mesothelioma AJCC v7, Stage IVA Nasopharyngeal Carcinoma AJCC v7, Stage IVB Nasopharyngeal Carcinoma AJCC v7, Stage IVC Nasopharyngeal Carcinoma AJCC v7, Vaginal Squamous Cell Carcinoma, Not Otherwise Specified
Interventions
Atezolizumab, Bevacizumab, Laboratory Biomarker Analysis, Pharmacological Study
Drug · Biological · Other
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
133 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2027
U.S. locations
1
States / cities
Houston, Texas
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
FGFR Gene Amplification, FGFR1 Gene Amplification, FGFR2 Gene Amplification, FGFR2 Gene Mutation, FGFR3 Gene Mutation, Head and Neck Squamous Cell Carcinoma, Human Papillomavirus Infection, Recurrent Head and Neck Carcinoma, Recurrent Nasopharynx Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma
Interventions
BGJ398
Drug
Lead sponsor
University of Chicago
Other
Eligibility
18 Years and older
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2019
U.S. locations
1
States / cities
Chicago, Illinois
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
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma, Stage IV Nasopharyngeal Carcinoma AJCC v8
Interventions
Biospecimen Collection, Bone Scan, Carboplatin, Cisplatin, Computed Tomography, Gemcitabine, Magnetic Resonance Imaging, Nivolumab, Positron Emission Tomography, Relatlimab
Procedure · Drug · Biological
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
156 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
83
States / cities
Dublin, California • Fremont, California • Fresno, California + 62 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
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
Dysphagia, Head and Neck Cancer, Mucositis, Xerostomia
Interventions
exercise intervention, amifostine trihydrate, therapeutic dietary intervention
Behavioral · Drug · Procedure
Lead sponsor
Vanderbilt-Ingram Cancer Center
Other
Eligibility
21 Years and older
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2008
U.S. locations
1
States / cities
Nashville, Tennessee
Conditions
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Oral Cavity Squamous Cell Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Recurrent Paranasal Sinus Squamous Cell Carcinoma, Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, 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 III Sinonasal Cancer AJCC v8, Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage IVA Hypopharyngeal Carcinoma AJCC v8, Stage IVA Laryngeal Cancer AJCC v8, Stage IVA Lip and Oral Cavity Cancer AJCC v8, Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVA Sinonasal Cancer AJCC v8, Stage IVB Hypopharyngeal Carcinoma AJCC v8, Stage IVB Laryngeal Cancer AJCC v8, Stage IVB Lip and Oral Cavity Cancer AJCC v8, Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVB Sinonasal Cancer AJCC v8, Unresectable Head and Neck Squamous Cell Carcinoma, Unresectable Hypopharyngeal Squamous Cell Carcinoma, Unresectable Laryngeal Squamous Cell Carcinoma, Unresectable Oral Cavity Squamous Cell Carcinoma, Unresectable Oropharyngeal Squamous Cell Carcinoma, Unresectable Paranasal Sinus Squamous Cell Carcinoma
Interventions
Biospecimen Collection, Camonsertib, Computed Tomography, Positron Emission Tomography, Stereotactic Body Radiation Therapy
Procedure · Drug · Radiation
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
39 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2027 – 2029
U.S. locations
1
States / cities
Pittsburgh, Pennsylvania
Conditions
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Nasal Cavity and Paranasal Sinus Carcinoma, Oral Cavity Carcinoma, Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Pathologic Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Recurrent Hypopharyngeal Carcinoma, Recurrent Laryngeal Carcinoma, Recurrent Nasal Cavity and Paranasal Sinus Carcinoma, Recurrent Oral Cavity Carcinoma, Recurrent Oropharyngeal Carcinoma, Stage III Hypopharyngeal Carcinoma AJCC v8, Stage III Laryngeal 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 Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVA Hypopharyngeal Carcinoma AJCC v8, Stage IVA Laryngeal Cancer AJCC v8, Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVB Hypopharyngeal Carcinoma AJCC v8, Stage IVB Laryngeal Cancer AJCC v8, Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVC Hypopharyngeal Carcinoma AJCC v8, Stage IVC Laryngeal Cancer AJCC v8, Stage IVC Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Interventions
Celecoxib, Placebo, Quality-of-Life Assessment, Questionnaire Administration
Drug · Other
Lead sponsor
University of Utah
Other
Eligibility
18 Years and older
Enrollment
13 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2023
U.S. locations
1
States / cities
Salt Lake City, Utah
Conditions
Head and Neck Cancer
Interventions
Antineoplaston therapy (Atengenal + Astugenal)
Drug
Lead sponsor
Burzynski Research Institute
Other
Eligibility
16 Years to 99 Years
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1996 – 1998
U.S. locations
1
States / cities
Houston, Texas
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
Head and Neck Cancer
Interventions
amifostine trihydrate, cisplatin, fluorouracil, surgical procedure, radiation therapy
Drug · Procedure · Radiation
Lead sponsor
Abramson Cancer Center at Penn Medicine
Other
Eligibility
18 Years to 120 Years
Enrollment
35 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1998 – 2001
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Conditions
Head and Neck Cancer
Interventions
autologous EBV specific CTLs
Biological
Lead sponsor
Baylor College of Medicine
Other
Eligibility
Not listed
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2001 – 2012
U.S. locations
2
States / cities
Houston, Texas
Conditions
Nasopharyngeal Carcinoma
Interventions
Penpulimab, placebo
Drug
Lead sponsor
Akeso
Industry
Eligibility
12 Years to 75 Years
Enrollment
296 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2026
U.S. locations
5
States / cities
Duarte, California • Atlanta, Georgia • Ann Arbor, Michigan + 1 more
Conditions
Head and Neck Cancer
Interventions
ethynyluracil, fluorouracil, hydroxyurea, radiation therapy
Drug · Radiation
Lead sponsor
Robert H. Lurie Cancer Center
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
1999 – 2004
U.S. locations
2
States / cities
Chicago, Illinois