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NCT05386550 · OUTCOME

Time to Subsequent Cancer Treatments

Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION) · Source last updated 2026-02-19

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Time from randomization to the start of first subsequent cancer treatment, assessed up to 22.7 months

What was measured

Time to subsequent cancer treatments was defined as the time from randomization to the start for the first new anticancer treatment.

Analysis population: FAS included all participants who were randomized to study treatment.

Groups in this outcome

Xevinapant +IMRT

Participants received 3 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).

Placebo +IMRT

Participants received 3 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14 per 3-week cycle in combination with with 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).

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

Analysis denominator · Participants

GroupSource count
Xevinapant +IMRT81
Placebo +IMRT85

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Xevinapant +IMRTNANot reported8.9NAHere "NA" means median and upper limit of 95% CI could not be calculated and estimated as there were insufficient number of participants with events.
Placebo +IMRT11.1Not reported10.9NAHere "NA" means upper limit of 95% CI could not be calculated and estimated as there were insufficient number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Here "NA" means median and upper limit of 95% CI could not be calculated and estimated as there were insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        8.9
        upper Limit
        NA
        value
        NA
      2. comment
        Here "NA" means upper limit of 95% CI could not be calculated and estimated as there were insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        10.9
        upper Limit
        NA
        value
        11.1
denoms
  1. counts
    1. group Id
      OG000
      value
      81
    2. group Id
      OG001
      value
      85
    units
    Participants
description
Time to subsequent cancer treatments was defined as the time from randomization to the start for the first new anticancer treatment.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 3 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).
    id
    OG000
    title
    Xevinapant +IMRT
  2. description
    Participants received 3 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14 per 3-week cycle in combination with with 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).
    id
    OG001
    title
    Placebo +IMRT
param Type
MEDIAN
population Description
FAS included all participants who were randomized to study treatment.
reporting Status
POSTED
time Frame
Time from randomization to the start of first subsequent cancer treatment, assessed up to 22.7 months
title
Time to Subsequent Cancer Treatments
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice