Testing the Addition of M6620 (VX-970, Berzosertib) to Usual Chemotherapy and Radiation for Head and Neck Cancer
Public ClinicalTrials.gov record NCT02567422. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I Study of M6620 (VX-970, Berzosertib) in Combination With Cisplatin and XRT in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC; SDC 10060121)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02567422
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 43 participants
Conditions and interventions
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
- Berzosertib Drug
- Cisplatin Drug
- Computed Tomography Procedure
- Laboratory Biomarker Analysis Other
- Magnetic Resonance Imaging Procedure
- Positron Emission Tomography Procedure
- Radiation Therapy Radiation
Drug · Procedure · Other + 1 more
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 16, 2017
- Primary completion
- Dec 30, 2023
- Completion
- May 13, 2027
- Last update posted
- Jul 30, 2026
2017 – 2027
United States locations
- U.S. sites
- 19
- U.S. states
- 13
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | — |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| Smilow Cancer Center/Yale-New Haven Hospital | New Haven | Connecticut | 06510 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| Smilow Cancer Hospital Care Center-Trumbull | Trumbull | Connecticut | 06611 | — |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | — |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | — |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | — |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | — |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | — |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire | 03756 | — |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | — |
| Case Western Reserve University | Cleveland | Ohio | 44106 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | — |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02567422, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 30, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02567422 live on ClinicalTrials.gov.