Adding BMX-001, a drug that protects normal tissue from radiation damage, to standard chemoradiation for head and neck cancer
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
Run by NRG Oncology · NCT06532279 · Data updated 2026-11-12
This trial tests whether giving BMX-001 along with usual mouth-care reduces severe mouth sores in people getting cisplatin-based chemoradiation for HPV-related and other head and neck cancers.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 98 (estimated) |
| Sponsor | NRG Oncology Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 153 sites (Gilbert, Arizona and 152 other locations) |
| Status | Recruiting |
| Started | June 23, 2025 |
| Main results expected | January 1, 2027 |
| Study ends | January 1, 2032 |
| Registry record updated | August 17, 2026 |
| Trial ID | NCT06532279 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with pathologically confirmed squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharynx, or oral cavity who are planned for definitive cisplatin-based concurrent chemoradiation and meet the trial's radiation dose-volume and HPV/p16 documentation requirements.
✕Probably not a fit
Patients treated in the adjuvant (postoperative) setting, those not receiving concurrent cisplatin, or those whose radiation fields do not expose the required oral subsites to ≥50 Gy are not eligible and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized phase II trial compares BMX-001 versus placebo added to standard symptom management during definitive cisplatin-based chemoradiation for head and neck squamous cell carcinomas. Patients are randomized to receive either BMX-001 or placebo alongside usual mouth rinses and pain control, with treatment delivered at participating Arizona cancer centers. The primary endpoint is the incidence of severe oral mucositis (≥ grade 3 WHO) from the start of radiation through four weeks after treatment, with additional assessments to 12 weeks; secondary endpoints include mucositis duration, patient-reported mouth-related symptoms (OMWQ-HN), xerostomia, radiation dermatitis, and toxicity measures. Exploratory endpoints include progression-free and overall survival and collection of blood samples for future translational research.
Why it matters
Potential benefit: If successful, BMX-001 could reduce how often and how long patients experience severe mouth sores and related pain during and after chemoradiation.
How similar studies have gone: Antioxidant mimetics and radioprotectors like MnSOD analogs have shown promise in preclinical models and early-phase work, but randomized phase II evidence in head and neck chemoradiation is still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * 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.
Where it's running
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Arizona Center for Cancer Care - Gilbert
Gilbert, Arizona, United States Recruiting -
Arizona Center for Cancer Care-Peoria
Peoria, Arizona, United States Recruiting -
Arizona Center for Cancer Care - Phoenix
Phoenix, Arizona, United States Recruiting -
Arizona Center for Cancer Care - Scottsdale
Scottsdale, Arizona, United States Recruiting -
Arizona Center for Cancer Care-Surprise
Surprise, Arizona, United States Recruiting -
Arizona Center for Cancer Care
Tempe, Arizona, United States Recruiting
Show 44 more locations
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NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States Recruiting -
UC San Diego Health System - Encinitas
Encinitas, California, United States Recruiting -
UC San Diego Moores Cancer Center
La Jolla, California, United States Recruiting -
UC San Diego Medical Center - Hillcrest
San Diego, California, United States Recruiting -
Shaw Cancer Center
Edwards, Colorado, United States Recruiting -
George Washington University Medical Center
Washington D.C., District of Columbia, United States Recruiting -
Sarasota Memorial Hospital-Venice
N. Venice, Florida, United States Recruiting -
Moffitt Cancer Center at SouthShore
Ruskin, Florida, United States Recruiting -
Florida Cancer Specialists - Sarasota
Sarasota, Florida, United States Recruiting -
Florida Cancer Specialists - Sarasota Downtown
Sarasota, Florida, United States Recruiting -
Sarasota Memorial Hospital
Sarasota, Florida, United States Recruiting -
Sarasota Memorial Health Care Center at University Parkway
Sarasota, Florida, United States Recruiting -
Moffitt Cancer Center-International Plaza
Tampa, Florida, United States Recruiting -
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, United States Recruiting -
Moffitt Cancer Center
Tampa, Florida, United States Recruiting -
Florida Cancer Specialists - Venice Pinebrook
Venice, Florida, United States Recruiting -
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, United States Recruiting -
OSF Saint Joseph Medical Center
Bloomington, Illinois, United States Recruiting -
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States Recruiting -
Illinois CancerCare-Canton
Canton, Illinois, United States Recruiting -
Northwestern University
Chicago, Illinois, United States Recruiting -
Carle at The Riverfront
Danville, Illinois, United States Recruiting -
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States Recruiting -
Carle Physician Group-Effingham
Effingham, Illinois, United States Recruiting -
Illinois CancerCare-Eureka
Eureka, Illinois, United States Recruiting -
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States Recruiting -
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States Recruiting -
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States Recruiting -
Illinois CancerCare-Macomb
Macomb, Illinois, United States Recruiting -
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States Recruiting -
Northwestern Medicine Oak Brook
Oak Brook, Illinois, United States Recruiting -
Northwestern Medicine Orland Park
Orland Park, Illinois, United States Recruiting -
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States Recruiting -
Illinois CancerCare-Pekin
Pekin, Illinois, United States Recruiting -
Illinois CancerCare-Peoria
Peoria, Illinois, United States Recruiting -
OSF Saint Francis Medical Center
Peoria, Illinois, United States Recruiting -
Illinois CancerCare-Peru
Peru, Illinois, United States Recruiting -
Illinois CancerCare-Princeton
Princeton, Illinois, United States Recruiting -
Carle Cancer Center
Urbana, Illinois, United States Recruiting -
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States Recruiting -
Illinois CancerCare - Washington
Washington, Illinois, United States Recruiting -
Baptist Health Floyd
New Albany, Indiana, United States Recruiting -
McFarland Clinic - Ames
Ames, Iowa, United States Recruiting -
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, United States Recruiting
+103 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: David M Brizel — NRG Oncology
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Studying how well head and neck cancer patients follow swallowing exercises after radiation
This study looks at how well people with head and neck cancer stick to their swallowing exercises after radiation treatment and what factors might help or hinder them.
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Comparing two imaging techniques for assessing blood vessel effects in head and neck cancer patients receiving radiation therapy
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Camonsertib added to precise radiation therapy for recurrent head and neck cancer
This early-phase study tests whether the cancer drug camonsertib, given with targeted SBRT radiation, is safe and tolerable for people with recurrent or unresectable head and neck squamous cell carcinoma.
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Cemiplimab with or without CDX-1140 given before surgery for stage III-IV head and neck cancer
This trial tests whether adding the immune stimulant CDX-1140 to cemiplimab before surgery helps shrink tumors in people with resectable stage III-IV head and neck squamous cell carcinoma.
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Combining Ipatasertib with Chemotherapy and Radiation for Head and Neck Cancer
This study is testing if adding a new drug called ipatasertib to chemotherapy and radiation can help people with advanced head and neck cancer feel better and improve their treatment results.
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Adding chemotherapy or chemo-immunotherapy to standard salvage surgery for advanced head and neck cancer
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.