Trial Outcomes & Findings for Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION) (NCT NCT05386550)

Last Updated: 2026-02-19

Results Overview

DFS defined as the time from randomization to the first occurrence of any of the following events: Death from any cause; Objective Disease Recurrence (earlier date of first imaging or biopsy collection confirming event at a DFS assessment): Local or regional relapse which is subsequently confirmed by histopathology unless medically contraindicated or medical risk of biopsy deemed too high: Distant metastases. Confirmation of pathology is recommended in case of solitary metastasis (especially in the lung) after considering potential contraindication and/or medical risk associated with biopsy. DFS time was estimated according to Kaplan-Meier method.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

166 participants

Primary outcome timeframe

Time from randomization to the first occurrence of death from any cause or objective disease recurrence, assessed up to 22.7 months

Results posted on

2026-02-19

Participant Flow

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	81	85
Overall Study Safety Analysis Set (SAF)	82	83
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	81	85

Reasons for withdrawal

Reasons for withdrawal
Measure	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).
Overall Study Death	9	14
Overall Study Lost to Follow-up	0	1
Overall Study Other Reasons	1	3
Overall Study Sponsor Premature Discontinuation Decision	65	66
Overall Study Withdrawal by Subject	6	1

Baseline Characteristics

Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Xevinapant + IMRT n=81 Participants 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 n=85 Participants 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).	Total n=166 Participants Total of all reporting groups
Age, Continuous	69 Years STANDARD_DEVIATION 9.89 • n=4 Participants	69 Years STANDARD_DEVIATION 9.61	69 Years STANDARD_DEVIATION 9.72 • n=4 Participants
Sex: Female, Male Female	18 Participants n=4 Participants	21 Participants	39 Participants n=4 Participants
Sex: Female, Male Male	63 Participants n=4 Participants	64 Participants	127 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity-Hispanic or Latino	10 Participants n=4 Participants	8 Participants	18 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity-Not Hispanic or Latino	61 Participants n=4 Participants	63 Participants	124 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity-Not Reported	9 Participants n=4 Participants	14 Participants	23 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity-Unknown or Not Reported	1 Participants n=4 Participants	0 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Race-American Indian or Alaska Native	0 Participants n=4 Participants	1 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Race-Asian	40 Participants n=4 Participants	45 Participants	85 Participants n=4 Participants
Race/Ethnicity, Customized Race-Black or African American	1 Participants n=4 Participants	0 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Race-More than one race	0 Participants n=4 Participants	1 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Race-Unknown or Not Reported	9 Participants n=4 Participants	14 Participants	23 Participants n=4 Participants
Race/Ethnicity, Customized Race-White	31 Participants n=4 Participants	24 Participants	55 Participants n=4 Participants

PRIMARY outcome

Timeframe: Time from randomization to the first occurrence of death from any cause or objective disease recurrence, assessed up to 22.7 months

Population: Full Analysis Set (FAS) included all participants who were randomized to study treatment.

Outcome measures

Outcome measures
Measure	Xevinapant +IMRT n=81 Participants 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 n=85 Participants 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).
Disease-Free Survival (DFS)	11.10 months Interval 0.03 to 19.32	7.29 months Interval 0.03 to 14.65

SECONDARY outcome

Timeframe: Time from randomization to death from any cause, assessed up to 22.7 months

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

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.

Outcome measures

Outcome measures
Measure	Xevinapant +IMRT n=81 Participants 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 n=85 Participants 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).
Overall Survival (OS)	19.32 months Interval 14.19 to Upper 95% confidence interval (CI) limit could not be calculated and estimated as there were insufficient number of participants with events.	NA months Interval 7.39 to Median and the upper 95% CI limit could not be calculated and estimated as there were insufficient number of participants with events.

SECONDARY outcome

Timeframe: Time from randomization to the start of first subsequent cancer treatment, assessed up to 22.7 months

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

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

Outcome measures

Outcome measures
Measure	Xevinapant +IMRT n=81 Participants 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 n=85 Participants 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).
Time to Subsequent Cancer Treatments	NA months Interval 8.9 to 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.	11.1 months Interval 10.9 to Here "NA" means upper limit of 95% CI could not be calculated and estimated as there were insufficient number of participants with events.

SECONDARY outcome

Timeframe: Time from randomization up to 22.7 months

Population: SAF included all participants, who were administered any dose of any study intervention. One participant who was randomized to the Placebo + IMRT group but was incorrectly administered a dose of Xevinapant was analyzed in the Xevinapant + IMRT group.

Adverse event (AE): any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: events that start with onset or worsening (seriousness or severity) dates occurring within the on-treatment periods. TEAEs included both serious and non-serious TEAEs. Related TEAEs are events with relationship missing or related.

Outcome measures

Outcome measures
Measure	Xevinapant +IMRT n=82 Participants 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 n=83 Participants 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).
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-related TEAEs TEAEs	81 Participants	81 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-related TEAEs Related TEAEs	80 Participants	79 Participants

SECONDARY outcome

Timeframe: Baseline, Day 64 and End of treatment (Day 134)

Population: FAS included all participants who were randomized to study treatment. Here,"Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific categories.

The EORTC QLQ-HN35 is designed to be used together with the core QLQ-C30. The recall period for the items in the module was "the past week". Items hn1 to hn30 were scored on 4 point Likert type categorical scales ("not at all", "a little", "quite a bit", "very much").Items hn31 to hn35 had a "no/yes" response format. The scores were transformed into 0 to 100 scales, with a high score implying a high level of symptoms. Negative changes from baseline indicate deterioration in functioning / global QoL scales and improvement in symptom scales.

Outcome measures

Outcome measures
Measure	Xevinapant +IMRT n=52 Participants 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 n=56 Participants 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).
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN35) Score Pain at Day 64	9.4 score on a scale Interval 1.4 to 17.4	6.0 score on a scale Interval -1.5 to 13.6
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN35) Score Pain at Day 134	-1.1 score on a scale Interval -8.6 to 6.5	-1.2 score on a scale Interval -8.0 to 5.7
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN35) Score Speech at Day 64	2.9 score on a scale Interval -5.3 to 11.1	-3.0 score on a scale Interval -10.7 to 4.7
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN35) Score Speech at Day 134	-2.8 score on a scale Interval -10.9 to 5.3	-3.8 score on a scale Interval -11.2 to 3.6
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN35) Score Swallowing at Day 64	7.6 score on a scale Interval -0.9 to 16.1	3.4 score on a scale Interval -4.6 to 11.4
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN35) Score Swallowing at Day 134	-4.5 score on a scale Interval -12.4 to 3.4	-1.6 score on a scale Interval -8.7 to 5.5

SECONDARY outcome

Timeframe: Baseline, Day 64 and End of treatment (Day 134)

EORTC QLQ-C30 is a 30 item questionnaire composed of 5 multi-item functional subscales (physical, role, cognitive, emotional, and social functioning), 3 multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global health/quality of life (QOL) subscale, and 6 single items assessing other cancer related symptoms (dyspnea, sleep disturbance, appetite, diarrhea, constipation, and the financial impact of cancer). The questionnaire employed twenty-eight 4 point Likert scales with responses from "not at all" to "very much" and two 7 point Likert scales for global health and overall QOL. For functional and global QOL scales, higher scores represented a better level of functioning and all scores were converted to a 0 to 100 scale. For symptom oriented scales, a higher score represented more severe symptoms, and all scores were converted to a 0-100 scale. Negative changes from baseline indicate deterioration in functioning / global QoL scales and improvement in symptom scales.

Outcome measures

Outcome measures
Measure	Xevinapant +IMRT n=54 Participants 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 n=58 Participants 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).
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) Score Fatigue at Day 64	4.9 score on a scale Interval -2.4 to 12.3	0.7 score on a scale Interval -6.2 to 7.5
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) Score Fatigue at Day 134	5.2 score on a scale Interval -3.7 to 14.1	-0.6 score on a scale Interval -8.8 to 7.7
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) Score Physical Functioning at Day 64	-3.4 score on a scale Interval -9.2 to 2.3	-0.2 score on a scale Interval -5.6 to 5.2
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) Score Physical Functioning at Day 134	-3.5 score on a scale Interval -10.2 to 3.2	0.2 score on a scale Interval -6.0 to 6.4
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) Score Global Health Status at Day 64	2.5 score on a scale Interval -4.0 to 9.0	1.0 score on a scale Interval -5.0 to 7.1
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) Score Global Health Status at Day 134	0.9 score on a scale Interval -6.2 to 8.0	3.1 score on a scale Interval -3.3 to 9.5

SECONDARY outcome

Timeframe: Baseline, Day 64 and End of treatment (Day 134)

EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100, where 0 is the worst health you can imagine and 100 is the best health you can imagine.

Outcome measures

Outcome measures
Measure	Xevinapant +IMRT n=50 Participants 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 n=57 Participants 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).
Change From Baseline in EuroQOL 5 Dimension 5 Level Health-Related Quality of Life Measure Visual Analog Scale Score (EQ-5D-5L VAS) At Day 64	-1.8 score on a scale Interval -8.1 to 4.5	1.1 score on a scale Interval -4.7 to 6.9
Change From Baseline in EuroQOL 5 Dimension 5 Level Health-Related Quality of Life Measure Visual Analog Scale Score (EQ-5D-5L VAS) At Day 134	1.1 score on a scale Interval -5.1 to 7.3	2.4 score on a scale Interval -3.3 to 8.0

Adverse Events

Xevinapant + IMRT

Serious events: 19 serious events

Other events: 81 other events

Deaths: 9 deaths

Placebo + IMRT

Serious events: 15 serious events

Other events: 81 other events

Deaths: 14 deaths

Serious adverse events

Other adverse events

Additional Information

Communication Center

Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Phone: +49-6151-72-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Xevinapant + IMRT n=82 participants at risk 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 n=83 participants at risk 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).
Blood and lymphatic system disorders Anaemia	24.4% 20/82 • Number of events 24 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	9.6% 8/83 • Number of events 8 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
Blood and lymphatic system disorders Lymphopenia	15.9% 13/82 • Number of events 17 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	13.3% 11/83 • Number of events 11 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
Gastrointestinal disorders Constipation	13.4% 11/82 • Number of events 13 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	20.5% 17/83 • Number of events 22 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
Gastrointestinal disorders Dry mouth	28.0% 23/82 • Number of events 23 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	32.5% 27/83 • Number of events 30 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
Gastrointestinal disorders Dysphagia	20.7% 17/82 • Number of events 18 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	12.0% 10/83 • Number of events 11 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
Gastrointestinal disorders Nausea	17.1% 14/82 • Number of events 15 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	10.8% 9/83 • Number of events 9 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
Gastrointestinal disorders Odynophagia	7.3% 6/82 • Number of events 8 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	8.4% 7/83 • Number of events 7 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
Gastrointestinal disorders Stomatitis	24.4% 20/82 • Number of events 29 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	21.7% 18/83 • Number of events 19 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
Gastrointestinal disorders Vomiting	7.3% 6/82 • Number of events 7 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	8.4% 7/83 • Number of events 7 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
General disorders Asthenia	13.4% 11/82 • Number of events 13 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	8.4% 7/83 • Number of events 9 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
General disorders Localised oedema	4.9% 4/82 • Number of events 5 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	7.2% 6/83 • Number of events 6 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
General disorders Mucosal inflammation	12.2% 10/82 • Number of events 12 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	13.3% 11/83 • Number of events 12 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
Infections and infestations Pneumonia	4.9% 4/82 • Number of events 4 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	8.4% 7/83 • Number of events 7 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
Injury, poisoning and procedural complications Radiation mucositis	22.0% 18/82 • Number of events 18 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	20.5% 17/83 • Number of events 17 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
Injury, poisoning and procedural complications Radiation skin injury	59.8% 49/82 • Number of events 55 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	47.0% 39/83 • Number of events 39 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
Investigations Alanine aminotransferase increased	15.9% 13/82 • Number of events 16 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	1.2% 1/83 • Number of events 1 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
Investigations Amylase increased	23.2% 19/82 • Number of events 25 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	12.0% 10/83 • Number of events 10 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
Investigations Aspartate aminotransferase increased	12.2% 10/82 • Number of events 16 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	1.2% 1/83 • Number of events 1 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
Investigations Lipase increased	18.3% 15/82 • Number of events 20 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	2.4% 2/83 • Number of events 2 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
Investigations Lymphocyte count decreased	28.0% 23/82 • Number of events 25 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	15.7% 13/83 • Number of events 14 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
Investigations Weight decreased	23.2% 19/82 • Number of events 20 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	14.5% 12/83 • Number of events 15 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
Investigations White blood cell count decreased	11.0% 9/82 • Number of events 14 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	9.6% 8/83 • Number of events 9 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
Metabolism and nutrition disorders Decreased appetite	19.5% 16/82 • Number of events 16 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	20.5% 17/83 • Number of events 17 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
Metabolism and nutrition disorders Hyponatraemia	8.5% 7/82 • Number of events 7 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	4.8% 4/83 • Number of events 4 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
Nervous system disorders Dysgeusia	14.6% 12/82 • Number of events 13 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	14.5% 12/83 • Number of events 12 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
Nervous system disorders Headache	8.5% 7/82 • Number of events 7 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	2.4% 2/83 • Number of events 3 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
Psychiatric disorders Insomnia	6.1% 5/82 • Number of events 5 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	4.8% 4/83 • Number of events 5 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
Respiratory, thoracic and mediastinal disorders Cough	4.9% 4/82 • Number of events 5 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	7.2% 6/83 • Number of events 6 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.1% 5/82 • Number of events 6 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	9.6% 8/83 • Number of events 8 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.
Skin and subcutaneous tissue disorders Rash	13.4% 11/82 • Number of events 14 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.	7.2% 6/83 • Number of events 6 • up to 22.7 months SAF included all participants, who were administered any dose of any study intervention. Participants who were randomized to Placebo + IMRT but who were incorrectly administered any dose of Xevinapant were analyzed in the Xevinapant + IMRT group.