NCT05172245 - Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 19, 2022

Primary Completion Date

June 1, 2026

Study Completion Date

June 1, 2026

Conditions

Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Head and Neck Carcinoma of Unknown PrimaryLocally Advanced Head and Neck Squamous Cell CarcinomaLocally Advanced Hypopharyngeal Squamous Cell CarcinomaLocally Advanced Laryngeal Squamous Cell CarcinomaLocally Advanced Nasal Cavity Squamous Cell CarcinomaLocally Advanced Oral Cavity Squamous Cell CarcinomaLocally Advanced Oropharyngeal Squamous Cell CarcinomaLocally Advanced Paranasal Sinus Squamous Cell CarcinomaLocally Advanced Sinonasal Squamous Cell CarcinomaMaxillary Sinus Squamous Cell CarcinomaStage III Hypopharyngeal Carcinoma AJCC v8Stage III Laryngeal Cancer AJCC v8Stage III Lip and Oral Cavity Cancer AJCC v8Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage III Sinonasal Cancer AJCC v8Stage IVA Hypopharyngeal Carcinoma AJCC v8Stage IVA Laryngeal Cancer AJCC v8Stage IVA Lip and Oral Cavity Cancer AJCC v8Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IVA Sinonasal Cancer 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 v8Stage IVB Sinonasal Cancer AJCC v8

Interventions

PROCEDURE

Biopsy Procedure

Undergo tumor biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Cisplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

DRUG

Ipatasertib

Given PO

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

RADIATION

Radiation Therapy

Undergo radiation therapy

Trial Locations (18)

10461

RECRUITING

Montefiore Medical Center-Einstein Campus, The Bronx

10467

RECRUITING

Montefiore Medical Center - Moses Campus, The Bronx

21201

RECRUITING

University of Maryland/Greenebaum Cancer Center, Baltimore

22908

RECRUITING

University of Virginia Cancer Center, Charlottesville

23298

RECRUITING

VCU Massey Comprehensive Cancer Center, Richmond

28025

SUSPENDED

Atrium Health Cabarrus/LCI-Concord, Concord

28203

ACTIVE_NOT_RECRUITING

Carolinas Medical Center/Levine Cancer Institute, Charlotte

33612

RECRUITING

Moffitt Cancer Center, Tampa

40536

RECRUITING

University of Kentucky/Markey Cancer Center, Lexington

45069

RECRUITING

University of Cincinnati Cancer Center-West Chester, West Chester

45219

RECRUITING

University of Cincinnati Cancer Center-UC Medical Center, Cincinnati

60611

RECRUITING

Northwestern University, Chicago

66160

RECRUITING

University of Kansas Cancer Center, Kansas City

66205

RECRUITING

University of Kansas Clinical Research Center, Fairway

RECRUITING

University of Kansas Hospital-Westwood Cancer Center, Westwood

08903

RECRUITING

Rutgers Cancer Institute of New Jersey, New Brunswick

07101

RECRUITING

Rutgers New Jersey Medical School, Newark

M5G 2M9

RECRUITING

University Health Network-Princess Margaret Hospital, Toronto

All Listed Sponsors

lead

National Cancer Institute (NCI)

NIH