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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
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
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
Advanced Head and Neck Squamous Cell Carcinoma, Advanced Hypopharyngeal Squamous Cell Carcinoma, Advanced Laryngeal Squamous Cell Carcinoma, Advanced Oropharyngeal Squamous Cell Carcinoma, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Interventions
Cisplatin, Computed Tomography, Magnetic Resonance Imaging, Positron Emission Tomography, Quality-of-Life Assessment, Questionnaire Administration, Radiation Therapy
Drug · Procedure · Other + 1 more
Lead sponsor
NRG Oncology
Other
Eligibility
18 Years and older
Enrollment
1,714 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
361
States / cities
Mobile, Alabama • Jonesboro, Arkansas • Little Rock, Arkansas + 264 more
Conditions
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Locally Advanced Oropharyngeal Squamous Cell Carcinoma, Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Interventions
Fludeoxyglucose F-18, Positron Emission Tomography
Radiation · Procedure
Lead sponsor
Ohio State University Comprehensive Cancer Center
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
1
States / cities
Columbus, Ohio
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
Clinical Stage III Human Papillomavirus (HPV)-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Locally Advanced Head and Neck Squamous Cell Carcinoma, Locally Advanced Hypopharyngeal Squamous Cell Carcinoma, Locally Advanced Laryngeal Squamous Cell Carcinoma, Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Advanced Oropharyngeal Squamous Cell Carcinoma, Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Pathologic Stage IV HPV-Mediated (p16-Positive) Oropharyngeal 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 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, 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 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 IVC Hypopharyngeal Carcinoma AJCC v8, Stage IVC Laryngeal Cancer AJCC v8, Stage IVC Lip and Oral Cavity Cancer AJCC v8, Stage IVC Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Interventions
Cisplatin, Hearing Handicap Inventory for Adults - Screening, Radiation Therapy, Sodium Thiosulfate
Drug · Other · Radiation
Lead sponsor
Hyunseok Kang, MD
Other
Eligibility
18 Years and older
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
1
States / cities
San Francisco, California
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 I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma, Nasopharyngeal Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Stage 0 Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage 0 Hypopharyngeal Carcinoma AJCC v8, Stage 0 Nasopharyngeal Carcinoma AJCC v8, Stage 0 Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage I Hypopharyngeal Carcinoma AJCC v8, Stage I Laryngeal Cancer AJCC v8, Stage I Lip and Oral Cavity Cancer AJCC v8, Stage I Nasopharyngeal Carcinoma AJCC v8, Stage I Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage II Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage II Hypopharyngeal Carcinoma AJCC v8, Stage II Laryngeal Cancer AJCC v8, Stage II Lip and Oral Cavity Cancer AJCC v8, Stage II Nasopharyngeal Carcinoma AJCC v8, Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8, 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 Nasopharyngeal Carcinoma AJCC v8, Stage III Oropharyngeal (p16-Negative) 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 Nasopharyngeal Carcinoma AJCC v8, Stage IVA Oropharyngeal (p16-Negative) Carcinoma 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, Stomatitis
Interventions
Best Practice, Biospecimen Collection, Cisplatin, Computed Tomography, Image Guided Radiation Therapy, Intensity-Modulated Radiation Therapy, Magnetic Resonance Imaging, MnSOD Mimetic BMX-001, Placebo Administration, Questionnaire Administration
Other · Procedure · Drug + 1 more
Lead sponsor
NRG Oncology
Other
Eligibility
18 Years and older
Enrollment
98 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
153
States / cities
Gilbert, Arizona • Peoria, Arizona • Phoenix, Arizona + 126 more
Conditions
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Human Papillomavirus-Related Carcinoma, Locally Advanced Oropharyngeal Carcinoma, Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Interventions
Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101, Pembrolizumab, Computed Tomography, FDG-Positron Emission Tomography, Biospecimen Collection, Biopsy
Biological · Procedure
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
1
States / cities
Rochester, Minnesota
Conditions
Locally Advanced Head and Neck Squamous Cell Carcinoma, Locally Advanced Hypopharyngeal Squamous Cell Carcinoma, Locally Advanced Laryngeal Squamous Cell Carcinoma, Locally Advanced Nasopharyngeal Squamous Cell Carcinoma, Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Advanced Oropharyngeal Squamous Cell Carcinoma, Malignant Posterior Tongue Neoplasm, Stage II Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, Stage II Hypopharyngeal Carcinoma AJCC v8, Stage II Laryngeal Cancer AJCC v8, Stage II Nasopharyngeal Carcinoma AJCC v8, Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, Stage III Hypopharyngeal Carcinoma AJCC v8, Stage III Laryngeal Cancer AJCC v8, Stage III Nasopharyngeal Carcinoma AJCC v8, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Unresectable Head and Neck Squamous Cell Carcinoma, Unresectable Oropharyngeal Squamous Cell Carcinoma
Interventions
Proton Beam Radiation Therapy, Quality-of-Life Assessment, Questionnaire Administration
Radiation · Other
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
3 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
1
States / cities
Houston, Texas
Conditions
Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma, Spindle Cell Variant, Lip and Oral Cavity Squamous Cell Carcinoma, p16INK4a Negative Oropharyngeal Squamous Cell Carcinoma, Stage III Hypopharyngeal Carcinoma AJCC v8, Stage III Laryngeal Cancer AJCC v8, Stage III Lip and Oral Cavity Cancer AJCC v8, Stage III Oral Cavity Verrucous Carcinoma, Stage III Oropharyngeal (p16-Negative) 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 Oral Cavity Verrucous Carcinoma, Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Interventions
Cisplatin, Intensity-Modulated Radiation Therapy, Laboratory Biomarker Analysis
Drug · Radiation · Other
Lead sponsor
ECOG-ACRIN Cancer Research Group
Network
Eligibility
18 Years and older
Enrollment
189 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2027
U.S. locations
676
States / cities
Birmingham, Alabama • Anchorage, Alaska • Phoenix, Arizona + 446 more
Conditions
Squamous Cell Carcinoma of the Head and Neck, Squamous Cell Carcinoma, Head and Neck
Interventions
Mitomycin-C, Pegfilgrastim
Drug
Lead sponsor
Washington University School of Medicine
Other
Eligibility
18 Years and older
Enrollment
48 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2024
U.S. locations
1
States / cities
St Louis, Missouri
Conditions
Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Stage III Hypopharyngeal Carcinoma AJCC v8, Stage III Laryngeal Cancer AJCC v8, Stage III 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
Interventions
Computed Tomography, Fludeoxyglucose F-18, Intensity-Modulated Proton Therapy, Intensity-Modulated Radiation Therapy, Positron Emission Tomography, Sodium Fluoride F-18
Procedure · Other · Radiation + 1 more
Lead sponsor
Emory University
Other
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
1
States / cities
Atlanta, Georgia
Conditions
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, Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Neck Squamous Cell Carcinoma of Unknown Primary, Recurrent Oral Cavity Squamous Cell Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Refractory Head and Neck Squamous Cell Carcinoma, Refractory Hypopharyngeal Squamous Cell Carcinoma, Refractory Laryngeal Squamous Cell Carcinoma, Refractory Oral Cavity Squamous Cell Carcinoma, Refractory Oropharyngeal Squamous Cell Carcinoma, Stage IV Head and Neck Cutaneous Squamous Cell 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
Interventions
Biospecimen Collection, Cetuximab, Computed Tomography, Magnetic Resonance Imaging, Pembrolizumab, Positron Emission Tomography
Procedure · Biological
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
158 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
177
States / cities
Little Rock, Arkansas • Marysville, California • Palo Alto, California + 143 more
Conditions
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck, 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, Recurrent Salivary Gland Carcinoma, Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck 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 Major Salivary Gland Cancer AJCC v8, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage III Sinonasal Cancer AJCC v8, 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 Major Salivary Gland Cancer AJCC v8, Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IV Sinonasal Cancer AJCC v8, Unresectable Cutaneous Squamous Cell Carcinoma of the Head and Neck, 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, Unresectable Salivary Gland Squamous Cell Carcinoma
Interventions
Biospecimen Collection, Computed Tomography, Elimusertib, Pembrolizumab, Positron Emission Tomography, Quality-of-Life Assessment, Stereotactic Body Radiation Therapy
Procedure · Drug · Biological + 2 more
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
11
States / cities
Los Angeles, California • Chicago, Illinois • Ann Arbor, Michigan + 6 more
Conditions
Oropharyngeal p16INK4a-Negative Squamous Cell Carcinoma, Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7, Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7, Stage III Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7, Stage IV Laryngeal Squamous Cell Carcinoma AJCC v7, Stage IV Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IV Oropharyngeal Squamous Cell Carcinoma AJCC v7
Interventions
Atezolizumab, Biopsy Procedure, Biospecimen Collection, Cetuximab, Cisplatin, Computed Tomography, Docetaxel, Intensity-Modulated Radiation Therapy, Magnetic Resonance Imaging, Survey Administration
Drug · Procedure · Biological + 2 more
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
613 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2027
U.S. locations
338
States / cities
Birmingham, Alabama • Tucson, Arizona • Little Rock, Arkansas + 266 more
Conditions
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Squamous Cell Carcinoma of Unknown Primary, 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 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 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
Interventions
Cetuximab, Durvalumab, Intensity-Modulated Radiation Therapy, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration
Biological · Radiation · Other
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
196 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2025
U.S. locations
252
States / cities
Birmingham, Alabama • Mobile, Alabama • Gilbert, Arizona + 193 more
Conditions
Head and Neck Cancer, Head and Neck Carcinoma, Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma
Interventions
18F-FMISO PET/CT scan, Chemoradiation therapy, Carboplatin
Diagnostic Test · Radiation · Drug
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years and older
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
6
States / cities
Basking Ridge, New Jersey • Middletown, New Jersey • Montvale, New Jersey + 3 more
Conditions
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III 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, Stage II Laryngeal Cancer AJCC v8, Stage II Lip and Oral Cavity Cancer AJCC v8, Stage II Oropharyngeal (p16-Negative) 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 IVA Laryngeal Cancer AJCC v8, Stage IVA Lip and Oral Cavity Cancer AJCC v8, Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVB Laryngeal Cancer AJCC v8, Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Interventions
Biospecimen Collection, Carboplatin, Cemiplimab, Cisplatin, Computed Tomography, Paclitaxel, Positron Emission Tomography, Radiation Therapy, Salvage Surgery
Procedure · Drug · Biological + 1 more
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
180 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2033
U.S. locations
83
States / cities
Tucson, Arizona • Los Angeles, California • Sacramento, California + 57 more
Conditions
Advanced Head and Neck Squamous Cell Carcinoma, Advanced Hypopharyngeal Squamous Cell Carcinoma, Advanced Laryngeal Squamous Cell Carcinoma, Advanced Oral Cavity Squamous Cell Carcinoma, Advanced Oropharyngeal Squamous Cell Carcinoma, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal 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 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 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
Interventions
Computed Tomography, Fludeoxyglucose F-18, Intensity-Modulated Radiation Therapy, Magnetic Resonance Imaging, Peposertib, Positron Emission Tomography
Procedure · Other · Radiation + 1 more
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2026
U.S. locations
27
States / cities
Gilbert, Arizona • Phoenix, Arizona • Tucson, Arizona + 20 more
Conditions
Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma, Nasal Cavity Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Nasal Cavity Squamous Cell Carcinoma, Recurrent Oral Cavity Squamous Cell Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Stage III Laryngeal Cancer AJCC v8, Stage III Lip and Oral Cavity Cancer AJCC v8, Stage III Nasopharyngeal Carcinoma AJCC v8, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVA Laryngeal Cancer AJCC v8, Stage IVA Lip and Oral Cavity Cancer AJCC v8, Stage IVA Nasopharyngeal Carcinoma AJCC v8, Stage IVB Laryngeal Cancer AJCC v8, Stage IVB Lip and Oral Cavity Cancer AJCC v8
Interventions
Anti-CD40 Agonist Monoclonal Antibody CDX-1140, Biopsy Procedure, Biospecimen Collection, Cemiplimab, Computed Tomography, Positron Emission Tomography, Tumor Resection
Biological · Procedure
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
44 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
6
States / cities
Irvine, California • Orange, California • Atlanta, Georgia + 3 more
Conditions
Head and Neck Squamous Cell Carcinoma, 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, 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, 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
Biopsy Procedure, Biospecimen Collection, Computed Tomography, Ipatasertib, Pembrolizumab
Procedure · Drug · Biological
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
52 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
20
States / cities
Duarte, California • Irvine, California • Lancaster, California + 12 more
Conditions
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Cutaneous Squamous Cell Carcinoma of the Head and Neck, Head and Neck Carcinoma of Unknown Primary, Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma, Metastatic Cutaneous Squamous Cell Carcinoma of the Head and Neck, 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, Nasopharyngeal Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Paranasal Sinus Squamous Cell Carcinoma, Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck, 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 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 Nasopharyngeal Carcinoma AJCC v8, Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IV Sinonasal Cancer AJCC v8
Interventions
Audiometric Test, Interview
Procedure · Other
Lead sponsor
Emory University
Other
Eligibility
18 Years and older
Enrollment
118 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
1
States / cities
Atlanta, Georgia