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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 2, 2025

Primary Completion Date

January 1, 2027

Study Completion Date

January 1, 2027

Conditions

Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Head and Neck Squamous Cell CarcinomaHypopharyngeal Squamous Cell CarcinomaLaryngeal Squamous Cell CarcinomaNasopharyngeal Squamous Cell CarcinomaOral Cavity Squamous Cell CarcinomaOropharyngeal Squamous Cell CarcinomaStage 0 Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8Stage 0 Hypopharyngeal Carcinoma AJCC v8Stage 0 Nasopharyngeal Carcinoma AJCC v8Stage 0 Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage I Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8Stage I Hypopharyngeal Carcinoma AJCC v8Stage I Laryngeal Cancer AJCC v8Stage I Lip and Oral Cavity Cancer AJCC v8Stage I Nasopharyngeal Carcinoma AJCC v8Stage I Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage II Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8Stage II Hypopharyngeal Carcinoma AJCC v8Stage II Laryngeal Cancer AJCC v8Stage II Lip and Oral Cavity Cancer AJCC v8Stage II Nasopharyngeal Carcinoma AJCC v8Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8Stage III Hypopharyngeal Carcinoma AJCC v8Stage III Laryngeal Cancer AJCC v8Stage III Lip and Oral Cavity Cancer AJCC v8Stage III Nasopharyngeal Carcinoma AJCC v8Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IVA Hypopharyngeal Carcinoma AJCC v8Stage IVA Laryngeal Cancer AJCC v8Stage IVA Lip and Oral Cavity Cancer AJCC v8Stage IVA Nasopharyngeal Carcinoma AJCC v8Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IVB Hypopharyngeal Carcinoma AJCC v8Stage IVB Laryngeal Cancer AJCC v8Stage IVB Lip and Oral Cavity Cancer AJCC v8Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stomatitis

Interventions

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

Trial Locations (55)

15146

RECRUITING

UPMC Cancer Center - Monroeville, Monroeville

RECRUITING

UPMC Hillman Cancer Center - Monroeville, Monroeville

15215

RECRUITING

UPMC-Saint Margaret, Pittsburgh

15232

RECRUITING

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh

RECRUITING

UPMC-Shadyside Hospital, Pittsburgh

15237

RECRUITING

UPMC-Passavant Hospital, Pittsburgh

16505

RECRUITING

UPMC Hillman Cancer Center Erie, Erie

17050

RECRUITING

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion, Mechanicsburg

17109

RECRUITING

UPMC Pinnacle Cancer Center/Community Osteopathic Campus, Harrisburg

21204

RECRUITING

Greater Baltimore Medical Center, Baltimore

28054

RECRUITING

CaroMont Regional Medical Center, Gastonia

44304

RECRUITING

Summa Health System - Akron Campus, Akron

45069

RECRUITING

University of Cincinnati Cancer Center-West Chester, West Chester

45219

RECRUITING

University of Cincinnati Cancer Center-UC Medical Center, Cincinnati

48201

RECRUITING

Wayne State University/Karmanos Cancer Institute, Detroit

48334

RECRUITING

Weisberg Cancer Treatment Center, Farmington Hills

48706

RECRUITING

McLaren Cancer Institute-Bay City, Bay City

48858

RECRUITING

McLaren Cancer Institute-Central Michigan, Mount Pleasant

50010

RECRUITING

McFarland Clinic - Ames, Ames

52403

RECRUITING

Mercy Hospital, Cedar Rapids

RECRUITING

Oncology Associates at Mercy Medical Center, Cedar Rapids

53066

RECRUITING

ProHealth Oconomowoc Memorial Hospital, Oconomowoc

53149

RECRUITING

ProHealth D N Greenwald Center, Mukwonago

53188

RECRUITING

UW Cancer Center at ProHealth Care, Waukesha

54401

RECRUITING

Aspirus Regional Cancer Center, Wausau

54806

RECRUITING

Northwest Wisconsin Cancer Center, Ashland

55805

RECRUITING

Miller-Dwan Hospital, Duluth

60115

RECRUITING

Northwestern Medicine Cancer Center Kishwaukee, DeKalb

60134

RECRUITING

Northwestern Medicine Cancer Center Delnor, Geneva

60462

RECRUITING

Northwestern Medicine Orland Park, Orland Park

60555

RECRUITING

Northwestern Medicine Cancer Center Warrenville, Warrenville

60611

RECRUITING

Northwestern University, Chicago

61350

RECRUITING

Illinois CancerCare-Ottawa Clinic, Ottawa

61354

RECRUITING

Illinois CancerCare-Peru, Peru

61356

RECRUITING

Illinois CancerCare-Princeton, Princeton

61401

RECRUITING

Illinois CancerCare-Galesburg, Galesburg

61443

RECRUITING

Illinois CancerCare-Kewanee Clinic, Kewanee

61455

RECRUITING

Illinois CancerCare-Macomb, Macomb

61520

RECRUITING

Illinois CancerCare-Canton, Canton

61530

RECRUITING

Illinois CancerCare-Eureka, Eureka

61554

RECRUITING

Illinois CancerCare-Pekin, Pekin

61571

RECRUITING

Illinois CancerCare - Washington, Washington

61615

RECRUITING

Illinois CancerCare-Peoria, Peoria

61637

RECRUITING

OSF Saint Francis Medical Center, Peoria

61701

RECRUITING

OSF Saint Joseph Medical Center, Bloomington

61704

RECRUITING

Illinois CancerCare-Bloomington, Bloomington

63703

RECRUITING

Saint Francis Medical Center, Cape Girardeau

73104

RECRUITING

University of Oklahoma Health Sciences Center, Oklahoma City

85027

RECRUITING

Arizona Center for Cancer Care - Phoenix, Phoenix

85258

RECRUITING

Arizona Center for Cancer Care - Scottsdale, Scottsdale

85381

RECRUITING

Arizona Center for Cancer Care-Peoria, Peoria

90033

RECRUITING

Los Angeles General Medical Center, Los Angeles

RECRUITING

USC / Norris Comprehensive Cancer Center, Los Angeles

90621

RECRUITING

Keck Medicine of USC Buena Park, Buena Park

92663

RECRUITING

USC Norris Oncology/Hematology-Newport Beach, Newport Beach