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

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.