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ACTIVE NOT RECRUITING Phase 1

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

NCT02567422 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • PROCEDURE Computed Tomography
  • DRUG Cisplatin
  • PROCEDURE Magnetic Resonance Imaging
  • OTHER Laboratory Biomarker Analysis
  • DRUG Berzosertib

Study Locations (19)

Connecticut

  • Smilow Cancer Center/Yale-New Haven Hospital — New Haven
  • Yale University — New Haven
  • Smilow Cancer Hospital Care Center-Trumbull — Trumbull

California

  • City of Hope Comprehensive Cancer Center — Duarte
  • University of California Davis Comprehensive Cancer Center — Sacramento

Georgia

  • Emory University Hospital Midtown — Atlanta
  • Emory University Hospital/Winship Cancer Institute — Atlanta

Maryland

  • University of Maryland/Greenebaum Cancer Center — Baltimore
  • Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore

Ohio

  • Case Western Reserve University — Cleveland
  • Ohio State University Comprehensive Cancer Center — Columbus

Iowa

  • University of Iowa/Holden Comprehensive Cancer Center — Iowa City

Kentucky

  • University of Kentucky/Markey Cancer Center — Lexington

Michigan

  • Wayne State University/Karmanos Cancer Institute — Detroit

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2017-04-17
Est. Completion 2026-05-14
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02567422

The ClinicalTrials.gov registry entry for NCT02567422 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions — of which Computed Tomography is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02567422 reports 19 study locations spanning 13 distinct geographic areas — top geographies include Connecticut, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02567422 about?

NCT02567422 is a clinical study titled "Testing the Addition of M6620 (VX-970, Berzosertib) to Usual Chemotherapy and Radiation for Head and Neck Cancer". 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 ma...

What is the current status of trial NCT02567422?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2017-04-17. Estimated completion is 2026-05-14.

What conditions does trial NCT02567422 study?

This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma, Head and Neck Carcinoma of Unknown Primary, Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7, Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02567422?

The interventions under investigation include: Computed Tomography (PROCEDURE), Cisplatin (DRUG), Magnetic Resonance Imaging (PROCEDURE), Laboratory Biomarker Analysis (OTHER), Berzosertib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02567422?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02567422 being conducted?

This trial has 19 study locations across California, Connecticut, Georgia, Iowa, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial