Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Phase 2NCT06532279
Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patients With Head and Neck Cancer
A Phase 2 study testing Best Practice, Biospecimen Collection and Cisplatin in people with Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, run by NRG Oncology at 153 sites in United States.
Trial summary
This phase II trial compares the effectiveness of adding BMX-001 to usual symptom management versus usual symptom management alone for reducing oral mucositis in patients who are receiving chemoradiation for head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- What is being tested?
- Best Practice, Biospecimen Collection and Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 153 sitesUnited States
- Study dates
- 23 Jun 2025to 1 Jan 2032
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be planned to receive radiation and concurrent cisplatin chemotherapy as definitive therapy. Patients planned to receive concurrent cisplatin and radiation therapy in the adjuvant setting are not eligible.
- At least two subsites (buccal mucosa, lips, retromolar trigone, floor of mouth, oral tongue, tonsil, soft palate, or hard palate) must have at least 1cc or 1% of the subsite volume receiving >= 50 Gy. In cases of uncertainty, the enrolling clinician can ensure coverage by inspecting the 50 Gy isodose line and using the table describing the anatomic boundaries of the individual subsites contained within the extended cavity contour. The two or more subsites receiving >= 50 Gy must be documented by the enrolling physician.
- Pathologically confirmed (histologically or cytologically) squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharynx, or oral cavity.
- P16 and/or human papillomavirus (HPV) status (via polymerase chain reaction [PCR] or in situ hybridization [ISH]) must be documented for patients with oropharynx cancer.
- No patients with T0/Tx/unknown primary disease.
- No definitive clinical or radiologic evidence of metastatic (M1) disease related to current diagnosis.
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- Able to receive intensity-modulated radiation therapy (IMRT) delivered as daily fractions of 2.0 Gy once per weekday with a cumulative radiation dose of 70 Gy.
- Age >= 18.
- Zubrod performance status of 0-2.
- Potassium ≥ institutional lower limit of normal (LLN) and magnesium ≥ institutional LLN. Oral or intravenous (IV) replacement therapy of potassium or magnesium is permitted if parameters can be met after repletion.
- Absolute neutrophil count (ANC) >= 1,500 cells/mm^3.
- Platelets >= 100,000 cells/mm^3.
- Hemoglobin >= 9.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is acceptable).
- Adequate renal function defined as creatinine clearance (CrCL) > 50 mL/min by the Cockcroft-Gault formula.
- Total bilirubin =< 2 x institutional upper limit of normal (ULN) (not applicable to patients with known Gilbert's syndrome).
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN.
- No prior radiotherapy that would result in overlap of radiation treatment fields with planned treatment for study cancer, e.g., breast cancer with irradiation of the supraclavicular fossa/level 4 neck.
- No concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure.
- No prior history of gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. In other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed.
- No current treatment of adjuvant post-operative (op) chemoradiation.
- No systemic treatment with inducers or strong inhibitors of cytochrome P450 =< 4 days before registration. Note: Patients undergoing steroid treatment as a component of the anti-emetic regimen for cisplatin are eligible for the study. Treatment with the antifungal medications, nystatin, fluconazole , miconazole and clotrimazole are allowed.
- No prior induction chemotherapy treatment.
- No prior unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ, basal cell skin carcinoma, resected T1-2N0M0 differentiated thyroid cancers, Ta bladder cancers, or low risk prostate cancer.
- No clinically significant hearing impairment that precludes cisplatin, as per physician assessment.
- No serious cardiovascular disease or cerebrovascular disease in the last 6 months prior to study enrollment; defined as a cerebrovascular accident, myocardial infarction, unstable angina, serious cardiac arrhythmia uncontrolled by medication or with the potential to interfere with protocol treatment, or current New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), or admission within last 6 months for CHF exacerbation; (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification).
- No valvular heart disease.
- No significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to enrollment.
- No history or evidence upon physical/neurological examination of central nervous system disease (e.g., seizures) unrelated to cancer unless adequately controlled by medication.
- No acute bacterial, viral, or fungal infection requiring intravenous antimicrobials within 7 days of enrollment.
- No history of chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration.
- No known personal or family history of long QT Syndrome; no marked baseline prolongation of QT/corrected QT (QTc) interval (i.e., ≥ 2 electrocardiograms [EKGs] in prior 3 months of a QTc interval > 450 milliseconds (ms) for males and > 470 ms for females using the specific/usual choice by clinical center for correction factor.
- Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities must be reversible to ≤ grade 1 with supplementation.
- No poorly controlled hypertension (systolic blood pressure [SBP] > 160 and/or diastolic blood pressure [DBP] > 95) over 2 repeated measures within 30 days prior to registration.
- No grade >= 2 oral mucositis per CTCAE version 5.0.
- No grade >= 2 hypotension per CTCAE v. 5.0.
- No medical necessity for anti-arrhythmics with significant risk of QTc prolongation such as class I and class III anti-arrhythmics. These include but are not limited to amiodarone, quinidine, dofetilide, sotalol, flecainide, and lidocaine.
- No medical necessity for medications listed as prohibited.
- For standard management of oral mucositis, clinicians may consult the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy. The only intervention against mucositis that is supported by level I evidence is low-level laser therapy (LLLT). Honey is rated at level II and benzydamine, which isn't available in the United States (US), is rated at level III. There are no other positively rated interventions.
- LLLT is prohibited in this study as its availability remains limited, it is not Food and Drug Administration (FDA) approved in the US, and it is considered investigational in many circumstances requiring enrollment in a dedicated protocol who requirements could conflict with this one. Therefore, institutions that use LLLT should only enroll patients who would not be eligible for (or do not want) that intervention. Honey is not on the list of prohibited medications for this study. Given the MASCC recommendation, benzydamine is allowed, although there is lack of availability in the United States of America (USA). The other listed prohibited medications are not recommended by MASCC and some are potentially harmful, such as glutamine, which is associated with mortality in patients receiving stem cell transplant.
- No history of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients).
- Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.
Who cannot join
None listed.
Trial locations and contacts
153 sites in 1 country. Contact the study team or a site near you to ask about taking part.
153 sites in 1 country
United States153 sites, 146 recruiting
- Recruiting
Summa Health System - Akron Campus
Akron, Ohio, 44304
Site Public Contact, 330-375-4221, cancerresearch@summahealth.org
Desiree E. Doncals
- Recruiting
Atrium Health Stanly/LCI-Albemarle
Albemarle, North Carolina, 28002
Site Public Contact, 800-804-9376
Matthew C. Ward
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
Moises Harari-Turquie
- Recruiting
McFarland Clinic - Ames
Ames, Iowa, 50010
Site Public Contact, 515-239-4734, ksoder@mcfarlandclinic.com
Joseph J. Merchant
- Recruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409
Site Public Contact, 715-623-9869, Juli.Alford@aspirus.org
Andrew J. Huang
- Recruiting
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, 54806
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Site Public Contact, 443-849-3706
Kruti Patel
- Recruiting
McLaren Cancer Institute-Bay City
Bay City, Michigan, 48706
Site Public Contact, 313-576-9790, ctoadmin@karmanos.org
Brian K. Yeh
- Recruiting
OSF Saint Joseph Medical Center
Bloomington, Illinois, 61701
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Site Public Contact, 617-638-8265
Minh T. Truong
- Suspended
Keck Medicine of USC Buena Park
Buena Park, California, 90621
- Recruiting
Illinois CancerCare-Canton
Canton, Illinois, 61520
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Aultman Health Foundation
Canton, Ohio, 44710
Site Public Contact, 330-363-7274, ClinicalReserachDept@aultman.com
Jessica L. Wobb
- Recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-334-2230, sfmc@sfmc.net
Bryan A. Faller
- Recruiting
Mercy Hospital
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-365-4673
Deborah W. Wilbur
- Recruiting
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-363-2690
Deborah W. Wilbur
- Recruiting
Chambersburg Hospital
Chambersburg, Pennsylvania, 17201
Site Public Contact, 412-339-5294, Roster@nrgoncology.org
Amit B. Shah
- Recruiting
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
Site Public Contact, 800-804-9376
Matthew C. Ward
- Recruiting
Atrium Health Pineville/LCI-Pineville
Charlotte, North Carolina, 28210
Site Public Contact, 980-442-2000
Matthew C. Ward
- Recruiting
Atrium Health University City/LCI-University
Charlotte, North Carolina, 28262
Site Public Contact, 800-804-9376
Matthew C. Ward
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Site Public Contact, 312-695-1301, cancer@northwestern.edu
Laila A. Gharzai
- Recruiting
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
Site Public Contact, 513-584-7698, cancer@uchealth.com
Sara Medek
- Recruiting
McLaren Cancer Institute-Clarkston
Clarkston, Michigan, 48346
Site Public Contact, 313-576-9790, ctoadmin@karmanos.org
Brian K. Yeh
- Recruiting
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Shelby Lane
- Recruiting
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Shelby Lane
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Site Public Contact, 800-293-5066, Jamesline@osumc.edu
Sung Jun Ma
- Recruiting
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, 28025
Site Public Contact, 800-804-9376
Matthew C. Ward
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Sinisa Stanic
- Recruiting
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Laila A. Gharzai
- Recruiting
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Site Public Contact, 515-241-6727
Seema Harichand-Herdt
- Recruiting
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
Site Public Contact, 800-527-6266, ctoadmin@karmanos.org
Brian K. Yeh
- Recruiting
Miller-Dwan Hospital
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Site Public Contact, 888-275-3853
Jared R. Robbins
- Recruiting
Shaw Cancer Center
Edwards, Colorado, 81632
Site Public Contact, 970-569-7429
Patricia H. Hardenbergh
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Sinisa Stanic
- Recruiting
Baptist Health Hardin
Elizabethtown, Kentucky, 42701
Site Public Contact, 270-706-5470
William A. Porter
- Recruiting
UC San Diego Health System - Encinitas
Encinitas, California, 92024
Site Public Contact, 760-536-7700
Karen M. Yun
- Recruiting
Ephrata Cancer Center
Ephrata, Pennsylvania, 17522
Site Public Contact, 717-721-4840
Amit B. Shah
- Recruiting
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505
Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu
Yvonne M. Mowery
- Recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
Site Public Contact, 313-576-9790, ctoadmin@karmanos.org
Brian K. Yeh
- Recruiting
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania, 16121
Site Public Contact, 412-339-5294, Roster@nrgoncology.org
Yvonne M. Mowery
- Recruiting
McLaren Cancer Institute-Flint
Flint, Michigan, 48532
Site Public Contact, 313-576-9790, ctoadmin@karmanos.org
Brian K. Yeh
- Recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
CaroMont Regional Medical Center
Gastonia, North Carolina, 28054
Site Public Contact, 704-834-2810, tammy.cozad@caromonthealth.org
Jeffrey G. Kuremsky
- Recruiting
Levine Cancer Institute-Gaston
Gastonia, North Carolina, 28054
Site Public Contact, 800-804-9376
Matthew C. Ward
- Recruiting
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Laila A. Gharzai
- Recruiting
Adams Cancer Center
Gettysburg, Pennsylvania, 17325
Site Public Contact, 877-441-7957
Amit B. Shah
- Recruiting
Arizona Center for Cancer Care - Gilbert
Gilbert, Arizona, 85297
Site Public Contact, 480-278-8261, penny.labriola@arizonaccc.com
Steven E. Sckolnik
- Recruiting
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601
Site Public Contact, 724-838-1900
Yvonne M. Mowery
- Recruiting
Baptist Cancer Center-Grenada
Grenada, Mississippi, 38901
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Shelby Lane
- Recruiting
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109
Site Public Contact, 717-724-6765, klitchfield@PINNACLEHEALTH.org
Yvonne M. Mowery
- Recruiting
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Site Public Contact, 717-531-3779, CTO@hmc.psu.edu
Min Yao
- Recruiting
Hayworth Cancer Center
High Point, North Carolina, 27262
Site Public Contact, 336-802-2500
Ryan T. Hughes
- Recruiting
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Site Public Contact, 800-237-1225
Carryn M. Anderson
- Recruiting
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401
Site Public Contact, 870-936-7066, Emily.Carvell@bmhcc.org
Shelby Lane
- Recruiting
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Christopher Lominska
- Recruiting
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
University of Tennessee - Knoxville
Knoxville, Tennessee, 37920
Site Public Contact, 865-544-9773
Christopher Brett
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Site Public Contact, 858-822-5354, cancercto@ucsd.edu
Karen M. Yun
- Recruiting
Lancaster Radiation Therapy Center
Lancaster, South Carolina, 29720
Site Public Contact, 800-804-9376
Matthew C. Ward
- Recruiting
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, 48910
Site Public Contact, 313-576-9790, ctoadmin@karmanos.org
Brian K. Yeh
- Recruiting
McLaren Cancer Institute-Lapeer Region
Lapeer, Michigan, 48446
Site Public Contact, 313-576-9790, ctoadmin@karmanos.org
Brian K. Yeh
- Recruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu
Philip E. Schaner
- Recruiting
Sechler Family Cancer Center
Lebanon, Pennsylvania, 17042
Site Public Contact, 717-741-8303, doxenberg@wellspan.org
Amit B. Shah
- Suspended
Los Angeles General Medical Center
Los Angeles, California, 90033
- Suspended
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
- Recruiting
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Site Public Contact, 800-446-5532, Research@carle.com
Sinisa Stanic
- Recruiting
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, 17050
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Yvonne M. Mowery
- Recruiting
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Shelby Lane
- Recruiting
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051
Site Public Contact, 262-257-5100
Musaddiq J. Awan
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Site Public Contact, 414-805-3666
Musaddiq J. Awan
- Recruiting
Zablocki Veterans Administration Medical Center
Milwaukee, Wisconsin, 53295
Site Public Contact, 888-469-6614
Evan Liang
- Recruiting
Atrium Health Union/LCI-Union
Monroe, North Carolina, 28112
Site Public Contact, 980-442-2000
Matthew C. Ward
- Recruiting
UPMC Cancer Center - Monroeville
Monroeville, Pennsylvania, 15146
Site Public Contact, 412-339-5294, Roster@nrgoncology.org
Yvonne M. Mowery
- Recruiting
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, 15146
Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu
Yvonne M. Mowery
- Recruiting
McLaren Cancer Institute-Macomb
Mount Clemens, Michigan, 48043
Site Public Contact, 313-576-9790, ctoadmin@karmanos.org
Brian K. Yeh
- Recruiting
McLaren Cancer Institute-Central Michigan
Mount Pleasant, Michigan, 48858
Site Public Contact, 313-576-9790, ctoadmin@karmanos.org
Brian K. Yeh
- Active, not recruiting
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149
- Recruiting
Sarasota Memorial Hospital-Venice
N. Venice, Florida, 34275
Site Public Contact, 941-261-9000
Kunal Saigal
- Recruiting
Baptist Health Floyd
New Albany, Indiana, 47150
Site Public Contact, 412-339-5294, Roster@nrgoncology.org
William A. Porter
- Recruiting
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, 38652
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Shelby Lane
- Recruiting
UPMC Hillman Cancer Center - New Castle
New Castle, Pennsylvania, 16105
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Yvonne M. Mowery
- Suspended
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, 92663
- Recruiting
Northwestern Medicine Oak Brook
Oak Brook, Illinois, 60523
Site Public Contact, nctnprogram_rhlccc@northwestern.edu
Laila A. Gharzai
- Recruiting
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154
Site Public Contact, 414-805-0505
Musaddiq J. Awan
- Active, not recruiting
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu
Christina Henson
- Recruiting
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462
Site Public Contact, nctnprogram_rhlccc@northwestern.edu
Laila A. Gharzai
- Recruiting
Lake Regional Hospital
Osage Beach, Missouri, 65065
Site Public Contact, 573-302-2768, clinicaltrials@lakeregional.com
Jay W. Carlson
- Recruiting
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, 38655
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Shelby Lane
- Recruiting
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Arizona Center for Cancer Care-Peoria
Peoria, Arizona, 85381
Site Public Contact, 623-773-2873
Steven E. Sckolnik
- Recruiting
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Peru
Peru, Illinois, 61354
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
McLaren Cancer Institute-Northern Michigan
Petoskey, Michigan, 49770
Site Public Contact, 313-576-9790, ctoadmin@karmanos.org
Brian K. Yeh
- Recruiting
Arizona Center for Cancer Care - Phoenix
Phoenix, Arizona, 85027
Site Public Contact, 480-278-8261, penny.labriola@arizonaccc.com
Steven E. Sckolnik
- Recruiting
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, 15215
Site Public Contact, 412-784-4900
Yvonne M. Mowery
- Recruiting
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232
Site Public Contact, 412-647-8073
Yvonne M. Mowery
- Recruiting
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
Site Public Contact, 412-621-2334
Yvonne M. Mowery
- Recruiting
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, 15237
Site Public Contact, 412-367-6454
Yvonne M. Mowery
- Recruiting
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, 15243
Site Public Contact, 412-502-3920
Yvonne M. Mowery
- Recruiting
McLaren-Port Huron
Port Huron, Michigan, 48060
Site Public Contact, 313-576-9790, ctoadmin@karmanos.org
Brian K. Yeh
- Recruiting
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Renown Regional Medical Center
Reno, Nevada, 89502
Site Public Contact, 702-384-0013, research@sncrf.org
Abhinand V. Peddada
- Recruiting
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, 54501
Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org
Andrew J. Huang
- Recruiting
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
Site Public Contact, ctoclinops@vcu.edu
Erin R. Alesi
- Recruiting
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Site Public Contact, 804-628-6430, CTOclinops@vcu.edu
Erin R. Alesi
- Recruiting
Rock Hill Radiation Therapy Center
Rock Hill, South Carolina, 29730
Site Public Contact, 800-804-9376
Matthew C. Ward
- Recruiting
Levine Cancer Institute-Rock Hill
Rock Hill, South Carolina, 29732
Site Public Contact, 800-804-9376
Matthew C. Ward
- Recruiting
Moffitt Cancer Center at SouthShore
Ruskin, Florida, 33570
Site Public Contact, 800-679-0775, ClinicalTrials@moffitt.org
Niema B. Razavian
- Recruiting
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, 05819
Site Public Contact, 800-639-6918, cancer.research.nurse@hitchcock.org
Philip E. Schaner
- Recruiting
Salina Regional Health Center
Salina, Kansas, 67401
Site Public Contact, 785-452-7038, mleepers@srhc.com
Christopher Lominska
- Recruiting
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103
Site Public Contact, rhabbaba@health.ucsd.edu
Karen M. Yun
- Recruiting
Florida Cancer Specialists - Sarasota
Sarasota, Florida, 34232
Site Public Contact, 412-339-5294, Roster@nrgoncology.org
Kunal Saigal
- Recruiting
Florida Cancer Specialists - Sarasota Downtown
Sarasota, Florida, 34239
Site Public Contact, 239-274-9930, ClinicalTrials@FLCancer.com
Kunal Saigal
- Recruiting
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Site Public Contact, 941-917-2225
Kunal Saigal
- Recruiting
Sarasota Memorial Health Care Center at University Parkway
Sarasota, Florida, 34243
Site Public Contact, 941-917-6519
Kunal Saigal
- Recruiting
Arizona Center for Cancer Care - Scottsdale
Scottsdale, Arizona, 85258
Site Public Contact, 480-278-8261, penny.labriola@arizonaccc.com
Steven E. Sckolnik
- Recruiting
Atrium Health Cleveland/LCI-Cleveland
Shelby, North Carolina, 28150
Site Public Contact, 800-804-9376
Matthew C. Ward
- Recruiting
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Shelby Lane
- Recruiting
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481
Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org
Andrew J. Huang
- Recruiting
Arizona Center for Cancer Care-Surprise
Surprise, Arizona, 85374
Site Public Contact, 412-339-5294, Roster@nrgoncology.org
Steven E. Sckolnik
- Recruiting
Moffitt Cancer Center-International Plaza
Tampa, Florida, 33607
Site Public Contact, 800-679-0775, ClinicalTrials@moffitt.org
Niema B. Razavian
- Recruiting
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, 33612
Site Public Contact, 800-679-0775, ClinicalTrials@moffitt.org
Niema B. Razavian
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Site Public Contact, 800-679-0775, ClinicalTrials@moffitt.org
Niema B. Razavian
- Recruiting
Arizona Center for Cancer Care
Tempe, Arizona, 85284
Site Public Contact, 480-278-8261, penny.labriola@arizonaccc.com
Steven E. Sckolnik
- Recruiting
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
Site Public Contact, 718-379-6866, eskwak@montefiore.org
Rafi Kabarriti
- Recruiting
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
Site Public Contact, 718-379-6866, eskwak@montefiore.org
Rafi Kabarriti
- Recruiting
Carle Cancer Center
Urbana, Illinois, 61801
Site Public Contact, 800-446-5532, Research@carle.com
Sinisa Stanic
- Recruiting
Florida Cancer Specialists - Venice Pinebrook
Venice, Florida, 34275
Site Public Contact, 239-274-9930, ClinicalTrials@FLCancer.com
Kunal Saigal
- Recruiting
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Laila A. Gharzai
- Recruiting
Illinois CancerCare - Washington
Washington, Illinois, 61571
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
George Washington University Medical Center
Washington D.C., District of Columbia, 20037
Site Public Contact, 202-741-2210
Sharad Goyal
- Recruiting
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, 50263
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Active, not recruiting
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188
- Recruiting
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401
Site Public Contact, 877-405-6866
Andrew J. Huang
- Recruiting
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, 33544
Site Public Contact, 800-679-0775, ClinicalTrials@moffitt.org
Niema B. Razavian
- Recruiting
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095
Site Public Contact, 414-805-0505
Musaddiq J. Awan
- Recruiting
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069
Site Public Contact, 513-584-7698, cancer@uchealth.com
Sara Medek
- Recruiting
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Christopher Lominska
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Site Public Contact, 336-713-6771
Ryan T. Hughes
- Recruiting
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494
Site Public Contact, 715-422-7718
Andrew J. Huang
- Recruiting
WellSpan Health-York Cancer Center
York, Pennsylvania, 17403
Site Public Contact, 877-441-7957
Amit B. Shah
About this study
Official title: A Randomized, Masked, Placebo Controlled, Phase II Trial Of Concurrent Chemoradiation With BMX-001 In Patients With Head And Neck Squamous Cell Carcinoma Receiving Concurrent Chemoradiation
This phase II trial compares the effectiveness of adding BMX-001 to usual symptom management versus usual symptom management alone for reducing oral mucositis in patients who are receiving chemoradiation for head and neck cancer. Oral mucositis (inflammation and mouth sores) is a common side effect of chemoradiation that can cause pain and difficulty swallowing. Usual management of these side effects typically consists of using mouth rinses and pain medications during treatment and for several weeks after completion of treatment. BMX-001 neutralizes harmful substances in the body, preventing damage to macromolecules such as DNA and minimizes free radical-related toxicity in normal tissues. Adding BMX-001 to usual symptom management may be more effective than usual symptom management alone at reducing oral mucositis in patients receiving chemoradiation for head and neck cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To compare the incidence of severe oral mucositis (SOM) between manganese superoxide dismutase (MnSOD) mimetic BMX-001 (BMX-001) and placebo, defined as >= grade 3 per World Health Organization (WHO) criteria from the start of radiation through 4 weeks after completion of study treatment, with additional assessments at 6, 8 and 12 weeks after completion of study treatment.
SECONDARY OBJECTIVES:
- To compare the duration of SOM in the BMX-001 arm versus (vs.) placebo arm. II. To assess the difference between arms in the Oral Mucositis Weekly Questionnaire-Head and Neck (OMWQ-HN) change score from baseline to 4 weeks after the end of chemoradiation.
III. To describe the incidence and severity of xerostomia and radiation dermatitis, as measured by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0, in both arms.
IV. To compare the duration of radiation dermatitis in the BMX-001 arm vs. placebo arm.
- To describe toxicity, as measured by CTCAE v5.0 and Patient Reported Outcome (PRO)-CTCAE, in both arms.
EXPLORATORY OBJECTIVES:
- To assess the between arm difference in progression-free survival (PFS). II. To assess the between arm difference in overall survival (OS). III. Data demonstrating improvement in pain, as measured by reduction in narcotic use between BMX-001 versus usual care.
IV. Collect serum and plasma for future translational research analyses.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients receive cisplatin once weekly (QW) or once every 3 weeks (Q3W) and undergo image-guided intensity-modulated radiation therapy once daily (QD) 5 days per week for 7 weeks per standard of care (SOC). In addition to usual symptom management, patients receive placebo subcutaneously (SC) as early as 96 hours and no later than one hour prior to their first dose of radiation therapy, and as early as 96 hours and no later than 48 hours prior to first dose of cisplatin. Patients then receive placebo SC twice a week (BIW) for 8 weeks (16 doses). Patients also undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) on study and may optionally undergo collection of blood, serum, and/or plasma throughout the study.
ARM 2: Patients receive cisplatin QW or Q3W and undergo image-guided intensity-modulated radiation therapy QD 5 days per week for 7 weeks per SOC. In addition to usual symptom management, patients receive BMX-001 SC as early as 96 hours and no later than one hour prior to their first dose of radiation therapy, and as early as 96 hours and no later than 48 hours prior to first dose of cisplatin. Patients then receive BMX-001 SC BIW for 8 weeks (16 doses). Patients also undergo CT and/or MRI on study and may optionally undergo collection of blood, serum, and/or plasma throughout the study.
After completion of study treatment, patients are followed up at 1, 2, 3, 6, 12, and 24 months.
- 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
- Being tested
- Best Practice, Biospecimen Collection, Cisplatin, Computed Tomography, Image Guided Radiation Therapy
- Medical subject headings
- Oropharyngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck, Hypopharyngeal Neoplasms, Nasopharyngeal Carcinoma, Carcinoma, Laryngeal Neoplasms, Mouth Neoplasms, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive usual symptom management
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood, serum, and/or plasma samples
CisplatinDrug
Also called Abiplatin, Blastolem, Briplatin, CDDP
Given cisplatin
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Image Guided Radiation TherapyRadiation
Also called IGRT, Image Guided Radiotherapy, image-guided radiation therapy, Image-Guided Radiotherapy
Undergo image-guided radiation therapy
Intensity-Modulated Radiation TherapyRadiation
Also called IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy
Undergo intensity-modulated radiation therapy
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
MnSOD Mimetic BMX-001Drug
Also called BMX-001, Manganese (III) ortho N-Butoxyethylpyridylporphyrin, Manganese Butoxyethyl Pyridyl Porphyrin, Mitochondrial Manganese Superoxide Dismutatse Mimetic BMX-001
Given SC
Placebo AdministrationDrug
Given SC
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (placebo) | Placebo comparator | Patients receive cisplatin QW or Q3W and undergo image-guided intensity-modulated radiation therapy QD 5 days per week for 7 weeks per SOC. In addition to usual symptom management, patients receive placebo SC as early as 96 hours and no later than one hour prior to their first dose of radiation therapy, and as early as 96 hours and no later than 48 hours prior to first dose of cisplatin. Patients then receive placebo SC BIW for 8 weeks (16 doses). Patients also undergo CT and/or MRI on study and may optionally undergo collection of blood, serum, and/or plasma throughout the study. Receives: Other: Best Practice; Procedure: Biospecimen Collection; Drug: Cisplatin; Procedure: Computed Tomography; Radiation: Image Guided Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy; Procedure: Magnetic Resonance Imaging; Drug: Placebo Administration; Other: Questionnaire Administration |
| Arm 2 (BMX-001) | Experimental | Patients receive cisplatin QW or Q3W and undergo image-guided intensity-modulated radiation therapy QD 5 days per week for 7 weeks per SOC. In addition to usual symptom management, patients receive BMX-001 SC as early as 96 hours and no later than one hour prior to their first dose of radiation therapy, and as early as 96 hours and no later than 48 hours prior to first dose of cisplatin. Patients then receive BMX-001 SC BIW for 8 weeks (16 doses). Patients also undergo CT and/or MRI on study and may optionally undergo collection of blood, serum, and/or plasma throughout the study. Receives: Other: Best Practice; Procedure: Biospecimen Collection; Drug: Cisplatin; Procedure: Computed Tomography; Radiation: Image Guided Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy; Procedure: Magnetic Resonance Imaging; Drug: MnSOD Mimetic BMX-001; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe oral mucositis (SOM)
Proportion of patients with reported SOM >= grade 3 per World Health Organization criteria.
Measured: From start of radiation through 4 weeks after completion of study treatment
Secondary outcomes (5)
Duration of SOM
Defined from first determination of >= grade 3 oral mucositis (OM) to the first instance of non-SOM (=< grade 2), without subsequent instance of >= grade 3 within the following 4 weeks.
Measured: Up to 12 weeks after completion of chemoradiation
Time to SOM
Defined from date of randomization to date of first determination of >= grade 3 OM.
Measured: Up to 12 weeks after completion of chemoradiation
Incidence and duration of xerostomia and radiation dermatitis
The proportion of patients with any grade and grade ≥ 3 xerostomia and radiation dermatitis, separately. Duration is measured from the first determination of radiation dermatitis or xerostomia, separately, (grade ≥ 1 as measured by Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5.0) to the first report of none (grade 0).
Measured: Up to 12 weeks after completion of chemoradiation
Incidence of toxicity
Adverse events (AEs) will be graded by the physician-reported CTCAE v5.0 and also measured using the Patient Reported Outcome-CTCAE. Counts of all AEs by grade will be provided by treatment arm.
Measured: Up to 24 months after completion of chemoradiation
Patient reported oral mucositis
Will be measured by the Oral Mucositis Weekly Questionnaire (OMWQ). Decline within patients is defined using a minimally important difference of 7.
Measured: Up to 24 months after completion of chemoradiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start23 Jun 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Studies of the same condition, open and under way.
- More trials run by NRG OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NRG Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David M Brizel, Principal investigator, NRG Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532279
- Sponsor's protocol ID
- NRG-CC013
- Other IDs
- NCI-2024-03906, NRG-CC013, NRG-CC013, NRG-CC013, UG1CA189867
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.