Skip to content
Triangle logo TriangleGet started
← Full study record

NCT05386550 · OUTCOME

Overall Survival (OS)

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 death from any cause, assessed up to 22.7 months

What was measured

Overall Survival was defined as the time from randomization to the date of death due to any cause. The overall survival was analyzed by using the Kaplan-Meier method.

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 +IMRT19.32Not reported14.19NAUpper 95% confidence interval (CI) limit could not be calculated and estimated as there were insufficient number of participants with events.
Placebo +IMRTNANot reported7.39NAMedian and the upper 95% CI limit 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
        Upper 95% confidence interval (CI) limit could not be calculated and estimated as there were insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        14.19
        upper Limit
        NA
        value
        19.32
      2. comment
        Median and the upper 95% CI limit could not be calculated and estimated as there were insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        7.39
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      81
    2. group Id
      OG001
      value
      85
    units
    Participants
description
Overall Survival was defined as the time from randomization to the date of death due to any cause. The overall survival was analyzed by using the Kaplan-Meier method.
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 death from any cause, assessed up to 22.7 months
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice