Trials / Recruiting

RecruitingNCT06532279

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 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

Status: Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 98 (estimated)

Sponsor: NRG Oncology · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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. 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.

Detailed description

PRIMARY OBJECTIVE: I. 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: I. 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. V. To describe toxicity, as measured by CTCAE v5.0 and Patient Reported Outcome (PRO)-CTCAE, in both arms. EXPLORATORY OBJECTIVES: I. 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

Interventions

Type	Name	Description
OTHER	Best Practice	Receive usual symptom management
PROCEDURE	Biospecimen Collection	Undergo collection of blood, serum, and/or plasma samples
DRUG	Cisplatin	Given cisplatin
PROCEDURE	Computed Tomography	Undergo CT
RADIATION	Image Guided Radiation Therapy	Undergo image-guided radiation therapy
RADIATION	Intensity-Modulated Radiation Therapy	Undergo intensity-modulated radiation therapy
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
DRUG	MnSOD Mimetic BMX-001	Given SC
DRUG	Placebo Administration	Given SC
OTHER	Questionnaire Administration	Ancillary studies

Timeline

Start date: 2024-12-16
Primary completion: 2027-01-01
Completion: 2027-01-01
First posted: 2024-08-01
Last updated: 2026-04-03

Locations

149 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT06532279. Inclusion in this directory is not an endorsement.