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NCT02567422 · OUTCOME

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

Testing the Addition of M6620 (VX-970, Berzosertib) to Usual Chemotherapy and Radiation for Head and Neck Cancer · Source last updated 2026-07-31

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 6.5 years

What was measured

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.

Groups in this outcome

Dose Level 1

Patients received M6620 (VX-970, berzosertib) 120 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.

Dose Level 2

Patients received M6620 (VX-970, berzosertib) 160 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.

Dose Level 3

Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.

Dose Level 3 Expansion

Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Dose Level 111
Dose Level 26
Dose Level 311
Dose Level 3 Expansion15

Reported measurements

Grade 5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 10Not reportedNot reportedNot reportedNot reported
Dose Level 20Not reportedNot reportedNot reportedNot reported
Dose Level 31Not reportedNot reportedNot reportedNot reported
Dose Level 3 Expansion1Not reportedNot reportedNot reportedNot reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 13Not reportedNot reportedNot reportedNot reported
Dose Level 23Not reportedNot reportedNot reportedNot reported
Dose Level 34Not reportedNot reportedNot reportedNot reported
Dose Level 3 Expansion3Not reportedNot reportedNot reportedNot reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 17Not reportedNot reportedNot reportedNot reported
Dose Level 23Not reportedNot reportedNot reportedNot reported
Dose Level 35Not reportedNot reportedNot reportedNot reported
Dose Level 3 Expansion11Not reportedNot reportedNot reportedNot reported
Grades 1-2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 11Not reportedNot reportedNot reportedNot reported
Dose Level 20Not reportedNot reportedNot reportedNot reported
Dose Level 31Not reportedNot reportedNot reportedNot reported
Dose Level 3 Expansion0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
    title
    Grade 5
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        3
    title
    Grade 4
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        11
    title
    Grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
    title
    Grades 1-2
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      11
    4. group Id
      OG003
      value
      15
    units
    Participants
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.
groups
  1. description
    Patients received M6620 (VX-970, berzosertib) 120 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
    id
    OG000
    title
    Dose Level 1
  2. description
    Patients received M6620 (VX-970, berzosertib) 160 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
    id
    OG001
    title
    Dose Level 2
  3. description
    Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
    id
    OG002
    title
    Dose Level 3
  4. description
    Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
    id
    OG003
    title
    Dose Level 3 Expansion
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 6.5 years
title
Number of Participants Experiencing Grade 3, 4, and 5 Adverse Events
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice