OncoMatch/Clinical Trials/NCT06532279
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
Is NCT06532279 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Cisplatin and MnSOD Mimetic BMX-001 for clinical stage i hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8.
Treatment: Cisplatin · MnSOD Mimetic BMX-001 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: CDKN2A p16 overexpression
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.
Required: HPV HPV status documented
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.
Disease stage
Excluded: Stage TX, UNKNOWN PRIMARY
No patients with T0/Tx/unknown primary disease. No definitive clinical or radiologic evidence of metastatic (M1) disease related to current diagnosis.
Performance status
ZUBROD 0–2
Prior therapy
Cannot have received: radiation therapy
Exception: if would result in overlap of radiation treatment fields with planned treatment for study cancer
No prior radiotherapy that would result in overlap of radiation treatment fields with planned treatment for study cancer
Cannot have received: induction chemotherapy
No prior induction chemotherapy treatment.
Cannot have received: gross total excision of both primary and nodal disease
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.
Lab requirements
Blood counts
Absolute neutrophil count (ANC) >= 1,500 cells/mm^3; Platelets >= 100,000 cells/mm^3; Hemoglobin >= 9.0 g/dl (transfusion/intervention to achieve Hgb >= 10.0 g/dl is acceptable)
Kidney function
Adequate renal function defined as creatinine clearance (CrCL) > 50 mL/min by the Cockcroft-Gault formula.
Liver function
Total bilirubin <= 2 x institutional upper limit of normal (ULN) (not applicable to patients with known Gilbert's syndrome); AST and ALT <= 3 x institutional ULN
Potassium ≥ institutional lower limit of normal (LLN) and magnesium ≥ institutional LLN. ANC >= 1,500 cells/mm^3. Platelets >= 100,000 cells/mm^3. Hemoglobin >= 9.0 g/dl. 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). AST and ALT <= 3 x institutional ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Arizona Center for Cancer Care - Gilbert · Gilbert, Arizona
- Arizona Center for Cancer Care-Peoria · Peoria, Arizona
- Arizona Center for Cancer Care - Phoenix · Phoenix, Arizona
- Arizona Center for Cancer Care - Scottsdale · Scottsdale, Arizona
- Arizona Center for Cancer Care-Surprise · Surprise, Arizona
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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