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ClinicalTrials.gov public records Last synced Oct 15, 2026, 6:08 AM EDT

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Showing 289–312 of 1,526 matching trials from the live ClinicalTrials.gov search.
Filters: Condition: Squamous Cell Carcinoma, Head And Neck Clear all
Active, not recruiting Phase 2 Interventional

Nab-Paclitaxel in Combination With Nivolumab to Treat Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma That Progressed on a PD-1 or PD-L1 Inhibitor

NCT04831320
View directory record Official record
Conditions
Metastatic Head-and-neck Squamous-cell Carcinoma
Interventions
nab-paclitaxel, Nivolumab
Drug
Lead sponsor
Washington University School of Medicine
Other
Eligibility
18 Years and older
Enrollment
46 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2028
U.S. locations
1
States / cities
St Louis, Missouri
Source: ClinicalTrials.gov public record
Updated Jul 6, 2026 · Synced Oct 15, 2026, 6:08 AM EDT
Completed Early Phase 1 Interventional

3'-Deoxy-3'-[18F] Fluorothymidine and Fludeoxyglucose F 18 PET Scans in Evaluating Response to Cetuximab, Cisplatin, and Radiation Therapy in Patients With Advanced Cancer of the Oropharynx, Larynx, or Hypopharynx

NCT00757549
View directory record Official record
Conditions
Head and Neck Cancer
Interventions
cetuximab, cisplatin, TdT-mediated dUTP nick end labeling assay, 3'-deoxy-3'-[18F]fluorothymidine, immunohistochemistry staining method, laboratory biomarker analysis, fludeoxyglucose F 18, radiation therapy
Biological · Drug · Genetic + 2 more
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years to 120 Years
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2017
U.S. locations
1
States / cities
Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Oct 31, 2017 · Synced Oct 15, 2026, 6:08 AM EDT
Terminated Phase 1 Interventional

NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery

NCT04588038
View directory record Official record
Conditions
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, Resectable Oropharyngeal Squamous Cell Carcinoma
Interventions
Efineptakin alfa
Biological
Lead sponsor
Hyunseok Kang, MD
Other
Eligibility
18 Years and older
Enrollment
4 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Feb 14, 2025 · Synced Oct 15, 2026, 6:08 AM EDT
Terminated Phase 2 Interventional

SWOG-9451, Combination Chemo & RT For Patients With Stage III/Stage IV Cancer of the Hypopharynx or Tongue

NCT00002735
View directory record Official record
Conditions
Head and Neck Cancer
Interventions
Induction chemotherapy, cisplatin, fluorouracil, low-LET cobalt-60 gamma ray therapy
Drug · Radiation
Lead sponsor
SWOG Cancer Research Network
Network
Eligibility
18 Years to 120 Years
Enrollment
68 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1996 – 2005
U.S. locations
18
States / cities
Little Rock, Arkansas • Los Angeles, California • Denver, Colorado + 10 more
Source: ClinicalTrials.gov public record
Updated Sep 30, 2015 · Synced Oct 15, 2026, 6:08 AM EDT
Not yet recruiting Phase 1Phase 2 Interventional

Lattice-Based Radiotherapy and Chemoimmunotherapy for Oropharyngeal Squamous Cell Carcinoma

NCT07428148
View directory record Official record
Conditions
Oropharyngeal Squamous Cell Carcinoma
Interventions
Induction Chemo-Immunotherapy, Lattice Radiotherapy
Drug · Radiation
Lead sponsor
NYU Langone Health
Other
Eligibility
18 Years and older
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2033
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Feb 23, 2026 · Synced Oct 15, 2026, 6:08 AM EDT
Recruiting Not applicable Interventional

ctHPVDNA in HPV Positive Squamous Cell Carcinoma of the Oropharynx

NCT06915038
View directory record Official record
Conditions
Squamous Cell Carcinoma of Oropharynx, HPV Positive Cancer, Throat Cancer, Tonsil Cancer
Interventions
NavDx, Adjuvant Radiation 30 Gray, Adjuvant Radiation 40 Gray
Diagnostic Test · Radiation
Lead sponsor
Indiana University
Other
Eligibility
18 Years and older
Enrollment
120 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
2
States / cities
Carmel, Indiana • Indianapolis, Indiana
Source: ClinicalTrials.gov public record
Updated Aug 11, 2026 · Synced Oct 15, 2026, 6:08 AM EDT
Terminated Phase 3 Interventional Results available

Study To Compare Avelumab In Combination With Standard of Care Chemoradiotherapy (SoC CRT) Versus SoC CRT for Definitive Treatment In Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (JAVELIN HEAD AND NECK 100)

NCT02952586
View directory record Official record
Conditions
Squamous Cell Carcinoma of the Head and Neck
Interventions
Avelumab, Chemoradiation
Drug · Other
Lead sponsor
Pfizer
Industry
Eligibility
18 Years and older
Enrollment
697 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
139
States / cities
Fayetteville, Arkansas • Rogers, Arkansas • Springdale, Arkansas + 91 more
Source: ClinicalTrials.gov public record
Updated Sep 22, 2021 · Synced Oct 15, 2026, 6:08 AM EDT
Completed Phase 2 Interventional

Radiation Therapy and Cisplatin in Treating Patients With Advanced Head and Neck Cancer

NCT00005088
View directory record Official record
Conditions
Head and Neck Cancer
Interventions
cisplatin, radiation therapy
Drug · Radiation
Lead sponsor
Radiation Therapy Oncology Group
Network
Eligibility
0 Years to 120 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2000
U.S. locations
239
States / cities
Birmingham, Alabama • Huntsville, Alabama • Mobile, Alabama + 182 more
Source: ClinicalTrials.gov public record
Updated Oct 22, 2020 · Synced Oct 15, 2026, 6:08 AM EDT
Recruiting Phase 3 Interventional

Head and Neck Cancer Study Project in the Geriatric Population

NCT06998069
View directory record Official record
Conditions
Head and Neck Neoplasms
Interventions
Arm I Carboplatin, Paclitaxel, Pembrolizumab, Arm II Carboplatin, Paclitaxel, Cetuximab, Arm III Pembrolizumab
Drug
Lead sponsor
Brown University
Other
Eligibility
65 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
1
States / cities
Providence, Rhode Island
Source: ClinicalTrials.gov public record
Updated Aug 20, 2026 · Synced Oct 15, 2026, 6:08 AM EDT
Recruiting Phase 1 Interventional

Testing the Addition of an Anti-Cancer Drug, Camonsertib, to Radiation Therapy for Recurrent Head and Neck Squamous Cell Carcinoma

NCT07156227
View directory record Official record
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
3
States / cities
Duarte, California • Irvine, California • Pittsburgh, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Sep 3, 2026 · Synced Oct 15, 2026, 6:08 AM EDT
Recruiting Phase 1 Interventional

Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors, Receiving Intravenous Infusion of Azirkitug Alone or in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan

NCT05005403
View directory record Official record
Conditions
Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Micro Satellite Stable Colorectal Cancer, Gastric/Esophageal Cancer, High-Grade Serous Ovarian Cancer, Pancreatic Cancer, Triple Negative Breast Cancer
Interventions
Azirkitug, Budigalimab, Bevacizumab, Telisotuzumab Adizutecan
Drug
Lead sponsor
AbbVie
Industry
Eligibility
18 Years and older
Enrollment
694 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
20
States / cities
Duarte, California • Irvine, California • Los Angeles, California + 15 more
Source: ClinicalTrials.gov public record
Updated Jun 23, 2026 · Synced Oct 15, 2026, 6:08 AM EDT
Recruiting Phase 2Phase 3 Interventional

A Study Evaluating the Safety and Efficacy of PRV111, PRV211, and PRV131 in Subjects With Oral and Lung Cancers

NCT05893888
View directory record Official record
Conditions
Oral Squamous Cell Carcinoma
Interventions
PRV211 (Intraoperative Cisplatin System), PRV111 (Cisplatin Transmucosal System), PRV131 (Cisplatin Intratumoral Injectable)
Drug
Lead sponsor
Privo Technologies
Industry
Eligibility
18 Years to 100 Years
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
4
States / cities
Duarte, California • Miami, Florida • Chicago, Illinois + 1 more
Source: ClinicalTrials.gov public record
Updated Apr 23, 2026 · Synced Oct 15, 2026, 6:08 AM EDT
Terminated Not applicable Interventional

Monitoring of Oral Human Papillomavirus Infection (HPV) in HPV-positive Oropharyngeal Squamous Cell Carcinoma (OPSCC)

NCT02045186
View directory record Official record
Conditions
Carcinoma, Squamous Cell, Head and Neck Neoplasms, Oropharyngeal Neoplasms
Interventions
Assessment of Oral HPV Infection
Other
Lead sponsor
UNC Lineberger Comprehensive Cancer Center
Other
Eligibility
18 Years to 99 Years
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
1
States / cities
Chapel Hill, North Carolina
Source: ClinicalTrials.gov public record
Updated May 4, 2017 · Synced Oct 15, 2026, 6:08 AM EDT
Active, not recruiting Phase 1 Interventional

First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors

NCT05277051
View directory record Official record
Conditions
Neoplasms
Interventions
Remzistotug, Dostarlimab, Belrestotug, Nelistotug, GSK5764227
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
18 Years and older
Enrollment
152 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
7
States / cities
San Francisco, California • Charlotte, North Carolina • Oklahoma City, Oklahoma + 4 more
Source: ClinicalTrials.gov public record
Updated Jun 25, 2026 · Synced Oct 15, 2026, 6:08 AM EDT
Completed Phase 1Phase 2 Interventional

Gene Therapy in Treating Patients With Unresectable, Recurrent, or Refractory Head and Neck Cancer

NCT00004070
View directory record Official record
Conditions
Head and Neck Cancer
Interventions
IL-12
Biological
Lead sponsor
Dana-Farber Cancer Institute
Other
Eligibility
18 Years and older
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1999 – 2000
U.S. locations
2
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Apr 20, 2017 · Synced Oct 15, 2026, 6:08 AM EDT
Active, not recruiting Phase 1Phase 2 Interventional

CIMAvax Vaccine, Nivolumab, and Pembrolizumab in Treating Patients With Advanced Non-small Cell Lung Cancer or Squamous Head and Neck Cancer

NCT02955290
View directory record Official record
Conditions
Advanced Head and Neck Squamous Cell Carcinoma, Lung Non-Small Cell Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, PD-L1 Positive, Recurrent Head and Neck Squamous Cell Carcinoma, Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, Unresectable Lung Non-Small Cell Carcinoma, Advanced Squamous Non-Small Cell Lung Carcinoma
Interventions
Laboratory Biomarker Analysis, Nivolumab, Pembrolizumab, Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine
Other · Biological
Lead sponsor
Roswell Park Cancer Institute
Other
Eligibility
18 Years and older
Enrollment
51 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2027
U.S. locations
5
States / cities
Indianapolis, Indiana • Buffalo, New York • Roslyn, New York + 2 more
Source: ClinicalTrials.gov public record
Updated Aug 10, 2026 · Synced Oct 15, 2026, 6:08 AM EDT
Recruiting Phase 1 Interventional

Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Cancer

NCT05526924
View directory record Official record
Conditions
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Head and Neck Carcinoma, Head and Neck Cancer Stage IV, Head and Neck Cancers - Throat
Interventions
Chemoradiation, Pamiparib, Hydroxyurea, Fluorouracil (5FU), Tislelizumab
Radiation · Drug
Lead sponsor
University of Chicago
Other
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2028
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Mar 4, 2026 · Synced Oct 15, 2026, 6:08 AM EDT
Completed Phase 1Phase 2 Interventional

Radiation Therapy, Combination Chemotherapy, and Amifostine in Treating Patients With Head and Neck Cancer

NCT00003582
View directory record Official record
Conditions
Carcinoma of Unknown Primary, Head and Neck Cancer
Interventions
amifostine trihydrate, cisplatin, fluorouracil, paclitaxel, quality-of-life assessment, radiation therapy
Drug · Procedure · Radiation
Lead sponsor
University of Miami
Other
Eligibility
18 Years to 120 Years
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1988 – 1996
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Dec 15, 2016 · Synced Oct 15, 2026, 6:08 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Pembrolizumab and Vorinostat in Treating Patients With Recurrent Squamous Cell Head and Neck Cancer or Salivary Gland Cancer That Is Metastatic and/or Cannot Be Removed by Surgery

NCT02538510
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Nov 26, 2024 · Synced Oct 15, 2026, 6:08 AM EDT
Completed Phase 2 Interventional Results available

Phase II Study of Tipifarnib in Squamous Head and Neck Cancer With HRAS Mutations

NCT02383927
View directory record Official record
Conditions
Thyroid Cancer, Squamous Cell Carcinoma Head and Neck Cancer (HNSCC), HRAS Mutant Tumor, Other Squamous Cell Carcinoma (SCC) With HRAS Mutant Tumor
Interventions
Tipifarnib
Drug
Lead sponsor
Kura Oncology, Inc.
Industry
Eligibility
18 Years and older
Enrollment
63 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2020
U.S. locations
9
States / cities
Los Angeles, California • Atlanta, Georgia • Boston, Massachusetts + 6 more
Source: ClinicalTrials.gov public record
Updated Jul 11, 2024 · Synced Oct 15, 2026, 6:08 AM EDT
Completed Phase 1 Interventional

FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors

NCT03841110
View directory record Official record
Conditions
Advanced Solid Tumors, Lymphoma, Gastric Cancer, Colorectal Cancer, Head and Neck Cancer, Squamous Cell Carcinoma, EGFR Positive Solid Tumor, HER2-positive Breast Cancer, Hepatocellular Carcinoma, Small Cell Lung Cancer, Renal Cell Carcinoma, Pancreas Cancer, Melanoma, NSCLC, Urothelial Carcinoma, Cervical Cancer, Microsatellite Instability, Merkel Cell Carcinoma
Interventions
FT500, Nivolumab, Pembrolizumab, Atezolizumab, Cyclophosphamide, Fludarabine, IL-2
Drug
Lead sponsor
Fate Therapeutics
Industry
Eligibility
18 Years and older
Enrollment
37 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
4
States / cities
San Diego, California • Minneapolis, Minnesota • Hackensack, New Jersey + 1 more
Source: ClinicalTrials.gov public record
Updated May 1, 2023 · Synced Oct 15, 2026, 6:08 AM EDT
Completed No phase listed Observational Accepts healthy volunteers

Developing a Checklist of Lymphedema Symptoms in Patients With Head and Neck Cancer

NCT00840814
View directory record Official record
Conditions
Head and Neck Cancer, Lymphedema
Interventions
Not listed
Lead sponsor
Vanderbilt University
Other
Eligibility
20 Years and older
Enrollment
55 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008 – 2012
U.S. locations
3
States / cities
Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Apr 7, 2017 · Synced Oct 15, 2026, 6:08 AM EDT
Terminated Early Phase 1 Interventional

Intratumoral Microdosing of Motolimod in HNSCC

NCT04272333
View directory record Official record
Conditions
HNSCC
Interventions
Motolimod, Nivolumab, Motolimod + Nivolumab
Drug · Biological · Combination Product
Lead sponsor
Presage Biosciences
Industry
Eligibility
18 Years and older
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
5
States / cities
San Francisco, California • Chicago, Illinois • Winston-Salem, North Carolina + 1 more
Source: ClinicalTrials.gov public record
Updated Apr 14, 2022 · Synced Oct 15, 2026, 6:08 AM EDT
Completed Phase 2 Interventional

A Study of OSI-7904L as Treatment in Patients With Head and Neck Cancer Who Have Failed First-Line Therapy

NCT00116909
View directory record Official record
Conditions
Locally Recurrent or Metastatic Cancer of the Head and Neck, Must Have Failed First-Line Therapy
Interventions
OSI 7904L
Drug
Lead sponsor
OSI Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
85 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2005
U.S. locations
4
States / cities
Boston, Massachusetts • Stony Brook, New York • Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Mar 14, 2007 · Synced Oct 15, 2026, 6:08 AM EDT