Skip to content
Triangle logo TriangleGet started
← Study library

NCT02567422 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2026-07-31

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Number of Participants Experiencing Grade 3, 4, and 5 Adverse Events

→

outcome · POSTED

Number of Participants Experiencing a Dose Limiting Toxicities

→

outcome · POSTED

Establish the Recommended Phase 2 Dose (RP2D)

→

outcome · POSTED

Pharmacokinetic Characteristics of Berzosertib

→

outcome · POSTED

Potential Drug-drug Interaction

→

outcome · POSTED

Number of Participants Experiencing a Response

→

outcome · POSTED

Number of Participants Experiencing a Metabolic Response

→

outcome · POSTED

Expression of Tissue-based Biomarkers as Markers of Deoxyribonucleic Acid Damage and Predictors of Clinical Outcome

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
Inclusion Criteria: * Patients must have histologically or cytologically confirmed head and neck squamous cell cancer (HNSCC) including paranasal sinus cancers but excluding nasopharyngeal carcinomas * Clinical staged III or IV HNSCC, according to American Joint Committee on Cancer (AJCC) 7th Edition, that is not amenable to surgical resection * Carcinoma of the neck of unknown primary site origin (regardless of HPV/p16 status) is eligible * Age \>= 18 years; because no dosing or adverse event data are currently available on the use of M6620 (VX-970, berzosertib) in combination with cisplatin in patients \< 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%) * Life expectancy of greater than 3 months * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 20 mm (\>= 2 cm) with conventional techniques or as \>= 10 mm (\>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam * Leukocytes \>= 3,000/mcL * Absolute neutrophil count \>= 1,500/mcL * Platelets \>= 100,000/mcL * Total bilirubin within normal institutional limits * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal * Creatinine within normal institutional limits OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal * The effects of M6620 (VX-970, berzosertib) on the developing human fetus are unknown; for this reason and because DNA-damage response (DDR) inhibitors as well as other therapeutic agents used in this trial may have teratogenic potential, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 months after completion of M6620 (VX-970, berzosertib) administration * Ability to understand and the willingness to sign a written informed consent document * Women of childbearing potential who are sexually active should be willing and able to use medically acceptable forms of contraception throughout the treatment phase of the trial and for up to 6 months following the last administration of study treatment; men who are sexually active must be willing and able to use medically acceptable forms of contraception throughout the treatment phase of the trial and for 6 months after completion of M6620 (VX-970, berzosertib) administration Exclusion Criteria: * Patients with nasopharyngeal carcinoma, skin squamous cell carcinoma (SCC), and salivary gland carcinomas are not eligible * Patients who are receiving adjuvant chemoradiation after surgical resection of the primary site of disease * Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier * Patients who are receiving any other investigational agents * Patients on tacrolimus or any other immunosuppressants with significant interaction with cisplatin * Patient who requires live vaccine administration * Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events * History of allergic reactions attributed to compounds of similar chemical or biologic composition to M6620 (VX-970, berzosertib) or cisplatin * Prior systemic chemotherapy for the current cancer (prior chemotherapy for a different cancer is allowed) * Prior receipt of radiotherapy that would result in overlap of the new and old radiation therapy fields * Uncontrolled intercurrent illness including, but not limited to: * Ongoing or active infection requiring intravenous antibiotics at the time of treatment initiation * Symptomatic congestive heart failure (requiring hospital stay within the last 6 months) * Myocardial infarction within the last 6 months * Unstable angina pectoris, cardiac arrhythmia * Psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study because M6620 (VX-970, berzosertib) as a DNA-damage response (DDR) inhibitor may have the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with M6620 (VX-970, berzosertib), breastfeeding should be discontinued if the mother is treated with M6620 (VX-970, berzosertib); these potential risks may also apply to other agents used in this study * Human immunodeficiency virus (HIV)-positive patients with well-controlled disease, as determined by CD4 count and viral load, who are on antiretroviral therapy that does not contain a strong inducer or inhibitor of CYP3A4 are allowed on trial; HIV-positive patients on combination antiretroviral therapy with strong inducers or inhibitors of CYP3A4 are ineligible because of the potential for pharmacokinetic interactions; patients with poorly controlled HIV are not eligible due to the increased risk of lethal infections when treated with marrow-suppressive therapy * Definitive clinical or radiographic evidence of distant metastasis or adenopathy below the clavicles * M6620 (VX-970, berzosertib) is primarily metabolized by CYP3A4; therefore, concomitant administration with strong inhibitors or inducers of CYP3A4 should be avoided; because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference for a list of drugs to avoid or minimize use of; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive berzosertib IV over 60 minutes on day -7 and then weekly on day 2 and cisplatin IV over 30-60 minutes weekly on day 1. Patients also undergo radiation therapy once daily, 5 days a week. Treatment continues for up to 7 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT, PET/CT, or MRI throughout the study.
    intervention Names
    1. Drug: Berzosertib
    2. Drug: Cisplatin
    3. Procedure: Computed Tomography
    4. Other: Laboratory Biomarker Analysis
    5. Procedure: Magnetic Resonance Imaging
    6. Procedure: Positron Emission Tomography
    7. Radiation: Radiation Therapy
    label
    Treatment (berzosertib, cisplatin, radiation therapy)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (berzosertib, cisplatin, radiation therapy)
    description
    Given IV
    name
    Berzosertib
    other Names
    1. 2-Pyrazinamine, 3-(3-(4-((Methylamino)methyl)phenyl)-5-isoxazolyl)-5-(4-((1-methylethyl)sulfonyl)phenyl)-
    2. M 6620
    3. M6620
    4. VX 970
    5. VX-970
    6. VX970
    type
    DRUG
  2. arm Group Labels
    1. Treatment (berzosertib, cisplatin, radiation therapy)
    description
    Given IV
    name
    Cisplatin
    other Names
    1. Abiplatin
    2. Blastolem
    3. Briplatin
    4. CDDP
    5. Cis-diammine-dichloroplatinum
    6. Cis-diamminedichloridoplatinum
    7. Cis-diamminedichloro Platinum (II)
    8. Cis-diamminedichloroplatinum
    9. Cis-dichloroammine Platinum (II)
    10. Cis-platinous Diamine Dichloride
    11. Cis-platinum
    12. Cis-platinum II
    type
    DRUG
  3. arm Group Labels
    1. Treatment (berzosertib, cisplatin, radiation therapy)
    description
    Undergo CT or PET/CT
    name
    Computed Tomography
    other Names
    1. CAT
    2. CAT Scan
    3. Computed Axial Tomography
    4. Computerized Axial Tomography
    5. Computerized axial tomography (procedure)
    6. Computerized Tomography
    7. Computerized Tomography (CT) scan
    8. CT
    9. CT Scan
    10. Diagnostic CAT Scan
    11. Diagnostic CAT Scan Service Type
    12. tomography
    type
    PROCEDURE
  4. arm Group Labels
    1. Treatment (berzosertib, cisplatin, radiation therapy)
    description
    Correlative studies
    name
    Laboratory Biomarker Analysis
    type
    OTHER
  5. arm Group Labels
    1. Treatment (berzosertib, cisplatin, radiation therapy)
    description
    Undergo MRI
    name
    Magnetic Resonance Imaging
    other Names
    1. Magnetic Resonance
    2. Magnetic Resonance Imaging (MRI)
    3. Magnetic resonance imaging (procedure)
    4. Magnetic Resonance Imaging Scan
    5. Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    6. MR
    7. MR Imaging
    8. MRI
    9. MRI Scan
    10. MRIs
    11. NMR Imaging
    12. NMRI
    type
    PROCEDURE
  6. arm Group Labels
    1. Treatment (berzosertib, cisplatin, radiation therapy)
    description
    Undergo PET/CT
    name
    Positron Emission Tomography
    other Names
    1. Medical Imaging, Positron Emission Tomography
    2. PET
    3. PET Scan
    4. Positron emission tomography (procedure)
    5. Positron Emission Tomography Scan
    6. Positron-Emission Tomography
    7. PT
    type
    PROCEDURE
  7. arm Group Labels
    1. Treatment (berzosertib, cisplatin, radiation therapy)
    description
    Undergo radiation therapy
    name
    Radiation Therapy
    other Names
    1. Cancer Radiotherapy
    2. Energy Type
    3. ENERGY_TYPE
    4. Irradiate
    5. Irradiated
    6. Irradiation
    7. Radiation
    8. Radiation Therapy, NOS
    9. Radiotherapeutics
    10. Radiotherapy
    11. RT
    12. Therapy, Radiation
    type
    RADIATION
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
43
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    According to the Cancer Therapy Evaluation Program National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v. 5). The highest grade experienced by the participant will be reported.
    measure
    Number of Participants Experiencing Grade 3, 4, and 5 Adverse Events
    time Frame
    Up to 6.5 years
  2. description
    Dose limiting toxicities are protocol-specific adverse events considered at least possibly related to the study intervention. Graded according to NCI CTCAE v5.
    measure
    Number of Participants Experiencing a Dose Limiting Toxicities
    time Frame
    Up to 3 weeks after completion of radiation therapy
  3. description
    Defined as the highest doses of cisplatin and berzosertib safely combined with radiation.
    measure
    Establish the Recommended Phase 2 Dose (RP2D)
    time Frame
    Up to 7 weeks
secondary Outcomes
  1. description
    The maximum concentration ratio between Day -7 collections to Day 2 collections. Collection time points are baseline, 30 and 55 minutes after the start of M6620 infusion, 5, 15, 30 minutes, 1, 2, 4, 23 (Day 3), 48 (Day 4), and 72 hours (Day 5) after the end of M6620 infusion given on Day 2.
    measure
    Pharmacokinetic Characteristics of Berzosertib
    time Frame
    Up to Day 5
  2. description
    The maximum concentration of M6620 in the blood when aprepitant is also given.
    measure
    Potential Drug-drug Interaction
    time Frame
    Up to Day 5
  3. description
    Evaluated by Response Evaluation Criteria in Solid Tumors 1.1. Response is defined as complete response (disappearance of all target and non-target lesions) or partial response (at least a 30% decrease in the sum of diameters of target lesions from baseline).
    measure
    Number of Participants Experiencing a Response
    time Frame
    Up to 6.5 years
  4. description
    Assessed by fluorodeoxyglucose-positron emission tomography (FDG PET) and measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Metabolic response are participants demonstrating a complete response (disappearance of all target and non-target lesions) or a partial response (at least a 30% decrease in the sum of diameters of target lesions from baseline).
    measure
    Number of Participants Experiencing a Metabolic Response
    time Frame
    At week 12 after completing intervention
  5. description
    Kaplan-Meier curves for Progression Free Survival (PFS), defined as time to disease progression, and Overall Survival (OS), defined as time until death or off study, were used to evaluate if the gene expression profiles of ERCC1 and XRCC1, and TP53 correlated to these outcomes.
    measure
    Expression of Tissue-based Biomarkers as Markers of Deoxyribonucleic Acid Damage and Predictors of Clinical Outcome
    time Frame
    Up to 6.5 years
Full study description
brief 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.
detailed Description
PRIMARY OBJECTIVES: I. Assess the safety and tolerability of M6620 (VX-970, berzosertib) when administered along with weekly cisplatin and radiation therapy (XRT) in patients with locoregionally advanced head and neck squamous cell carcinoma (HNSCC). II. Establish the recommended phase 2 dose (RP2D) of the combination. SECONDARY OBJECTIVES: I. Characterize the pharmacokinetic (PK) profile of M6620 (VX-970, berzosertib). II. Assess for potential drug-drug interaction between M6620 (VX-970, berzosertib) and aprepitant. III. To observe and record anti-tumor activity. IV. To assess the rate of complete metabolic response (CMR) at 12 weeks post completion of chemoradiation using 18 fluorodeoxyglucose (FDG) positron emission tomography (PET) scans. V. To collect archival tumor material for retrospective analysis of association between tissue-based biomarkers and clinical outcome. OUTLINE: This is a dose-escalation study of berzosertib. Patients receive berzosertib intravenously (IV) over 60 minutes on day -7 and then weekly on day 2 and cisplatin IV over 30-60 minutes weekly on day 1. Patients also undergo radiation therapy once daily, 5 days a week. Treatment continues for up to 7 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo computed tomography (CT), PET/CT, or magnetic resonance imaging (MRI) throughout the study. After completion of study treatment, patients are followed up for 30 days, every 2 weeks for 3 months, and then every 3 months for 2 years.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-add719ff79de38d6b7d1
      requested nct id
      NCT02567422
      primary nct id
      NCT02567422
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      fd31a95088dd8ee475e2862bffd724180f0c754cf3f0e892cba5b448df424980
      payload sha256
      87531db8fb732a022d901e9183ba5ad8be8b256ef1600c744fbf2c7ee8678c1a
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-add719ff79de38d6b7d1
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT02567422
      occurrences
      1. context exact
        NCT02567422
        end
        11
        exact text
        NCT02567422
        start
        0
      offset unit
      unicode_code_points
      query cond
      Laryngeal Cancer
      query disease state id
      ds-laryngeal-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-laryngeal-cancer-000.json
      source file sha256
      fd31a95088dd8ee475e2862bffd724180f0c754cf3f0e892cba5b448df424980
      source json pointer
      /studies/95/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      bd3f3e6e90d26919f2c88705b1fe225ddaf28196d4904304ab55939706dc61cd
    2. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-b54c508ac2fb4b7b6a09
      requested nct id
      NCT02567422
      primary nct id
      NCT02567422
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      cd92c144c33b33e75a38086ce6cbd6e62d34b7ba84c72dacac16e6781439e40e
      payload sha256
      e7ca228d3a30769e93b6b913baaca80a6083c35d67639431e87061a3802d1221
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-b54c508ac2fb4b7b6a09
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT02567422
      occurrences
      1. context exact
        NCT02567422
        end
        11
        exact text
        NCT02567422
        start
        0
      offset unit
      unicode_code_points
      query cond
      Hypopharyngeal Cancer
      query disease state id
      ds-hypopharyngeal-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-hypopharyngeal-cancer-000.json
      source file sha256
      cd92c144c33b33e75a38086ce6cbd6e62d34b7ba84c72dacac16e6781439e40e
      source json pointer
      /studies/73/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      bd3f3e6e90d26919f2c88705b1fe225ddaf28196d4904304ab55939706dc61cd

    Preserved source evidence · Not medical advice