Testing the Addition of M6620 (VX-970, Berzosertib) to Usual Chemotherapy and Radiation for Head and Neck Cancer

Summary

This phase I trial studies the side effects and best dose of berzosertib (M6620) when given together with cisplatin and radiation therapy in treating patients with head and neck squamous cell carcinoma that has spread from where it started to nearby tissue or lymph nodes (locally advanced). M6620 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving M6620 together with cisplatin and radiation therapy may work better in treating patients with locally advanced head and neck squamous cell carcinoma.

Conditions

• Head and Neck Carcinoma of Unknown Primary
• Head and Neck Squamous Cell Carcinoma
• Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7
• Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7
• Stage III Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
• Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7
• Stage III Sinonasal Squamous Cell Carcinoma AJCC v6 and v7
• Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7
• Stage IV Laryngeal Squamous Cell Carcinoma AJCC v7
• Stage IV Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
• Stage IV Oropharyngeal Squamous Cell Carcinoma AJCC v7
• Stage IV Sinonasal Squamous Cell Carcinoma AJCC v7

Interventions

DRUG

Berzosertib

Given IV

DRUG

Cisplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

RADIATION

Radiation Therapy

Undergo radiation therapy

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Taofeek K Owonikoko · JHU Sidney Kimmel Comprehensive Cancer Center LAO

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-17

Primary Completion

2023-12-31

Completion

2026-05-14

FDA Drug

Yes

Countries

• United States

Study Locations