Trial Outcomes & Findings for Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX) (NCT NCT06056310)

Last Updated: 2025-09-29

Results Overview

DLT-like events defined as any of the following treatment-related adverse events (AEs) or lab abnormalities occurring during the 5-week DLT-like assessment period and assessed as related to the study intervention: Grade 4 asymptomatic neutropenia more than (\>) 7 days; Grade 2-3 febrile neutropenia; Grade 4 thrombocytopenia without bleeding more than and equal to (\>=) 5 days or Grade 2-3 with bleeding or requiring transfusion; Grade 2-3 nonhematologic toxicity (e.g., renal impairment based on eGFR, Grade 4 skin toxicity/mucositis interfering with treatment); less than (\<) 60% planned cumulative dose of xevinapant or cisplatin due to AE; \>2-week Radiation therapy (RT) delay due to AE; Grade \>=2 ototoxicity worsening \>=2 grades from baseline and considered treatment-limiting; Hy's Law DILI; Grade \>=3 lab abnormalities; any life-threatening or Grade 5 toxicity.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

18 participants

Primary outcome timeframe

Time from the first dose of study intervention day upto 35 days (5 weeks)

Results posted on

2025-09-29

Participant Flow

Participant milestones

Participant milestones
Measure	Sequence 1 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. The first three cycles are given in combination with Cisplatin at dose of 40 milligrams per square meter (mg/m2) once daily on Cycle 1 Day 2 (C1D2, C1D9, C1D16, C2D2, C2D9, C2D16, and C3D2) With 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 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).
Overall Study STARTED	18
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Sequence 1 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. The first three cycles are given in combination with Cisplatin at dose of 40 milligrams per square meter (mg/m2) once daily on Cycle 1 Day 2 (C1D2, C1D9, C1D16, C2D2, C2D9, C2D16, and C3D2) With 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 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).
Overall Study Other Reasons	2
Overall Study Sponsor Request	16

Baseline Characteristics

Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sequence 1 n=18 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. The first three cycles are given in combination with Cisplatin at dose of 40 milligrams per square meter (mg/m2) once daily on Cycle 1 Day 2 (C1D2, C1D9, C1D16, C2D2, C2D9, C2D16, and C3D2) With 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 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).
Age, Continuous	60 Years STANDARD_DEVIATION 12.19 • n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	15 Participants n=99 Participants
Race/Ethnicity, Customized Ethnicity-Hispanic or Latino	1 Participants n=99 Participants
Race/Ethnicity, Customized Ethnicity-Not Hispanic or Latino	17 Participants n=99 Participants
Race/Ethnicity, Customized Race-Asian	11 Participants n=99 Participants
Race/Ethnicity, Customized Race-Black or African American	1 Participants n=99 Participants
Race/Ethnicity, Customized Race-White	6 Participants n=99 Participants

PRIMARY outcome

Timeframe: Time from the first dose of study intervention day upto 35 days (5 weeks)

Population: DLT analysis set: all participants who received any study dose, met at least 1 of criteria: Had at least one DLT like event confirmed by SMC during DLT like assessment period or for whom ICE strategy led to DLT event, regardless of administered number of doses; Received at least 60% planned cumulative dose of xevinapant, cisplatin, regardless of completion in assessment period.

Outcome measures

Outcome measures
Measure	Sequence 1 n=18 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. The first three cycles are given in combination with Cisplatin at dose of 40 milligrams per square meter (mg/m2) once daily on Cycle 1 Day 2 (C1D2, C1D9, C1D16, C2D2, C2D9, C2D16, and C3D2) With 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 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).
Number of Participants With Dose Limiting Toxicity (DLT)-Like Events	0 Participants

SECONDARY outcome

Timeframe: Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)

Population: Safety analysis set (SAS) included all participants who were administered any dose of any study intervention.

AEs were defined as 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. TEAEs were defined as AEs emerging or worsening after start of treatment until 30 days after end of treatment. Adverse events were coded according to the latest available version of the Medical Dictionary for Regulatory Activities (MedDRA). Treatment-Related TEAEs was defined as any AE considered as related to study treatment.

Outcome measures

Outcome measures
Measure	Sequence 1 n=18 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. The first three cycles are given in combination with Cisplatin at dose of 40 milligrams per square meter (mg/m2) once daily on Cycle 1 Day 2 (C1D2, C1D9, C1D16, C2D2, C2D9, C2D16, and C3D2) With 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 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).
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs TEAEs	18 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs Treatment Related TEAEs	18 Participants

SECONDARY outcome

Timeframe: At Cycle1 Day 4 (C1D4), C1D11, C1D18, C2D1, C2D4, C2D11, C2D18, C3D1, C3D4, C4D1, C5D1, C6D1 and End of treatment (Day 134) (each cycle is of 3 weeks)

Population: SAS included all participants who were administered any dose of any study intervention. Here" overall number of participants analyzed signified" participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.

eGFR creatinine was evaluated using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. Absolute values in eGFR was presented. Here, mL/min/1.73 m\^2 is defined as milliliters per minute per 1.73 square meters.

Outcome measures

Outcome measures
Measure	Sequence 1 n=17 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. The first three cycles are given in combination with Cisplatin at dose of 40 milligrams per square meter (mg/m2) once daily on Cycle 1 Day 2 (C1D2, C1D9, C1D16, C2D2, C2D9, C2D16, and C3D2) With 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 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).
Absolute Estimated Glomerular Filtration Rate (eGFR) Values C1D4	83.2080 mL/min/1.73 m^2 Standard Deviation 17.72417
Absolute Estimated Glomerular Filtration Rate (eGFR) Values C3D1	87.1169 mL/min/1.73 m^2 Standard Deviation 12.80356
Absolute Estimated Glomerular Filtration Rate (eGFR) Values C3D4	82.8900 mL/min/1.73 m^2 Standard Deviation 17.87483
Absolute Estimated Glomerular Filtration Rate (eGFR) Values C1D11	83.3678 mL/min/1.73 m^2 Standard Deviation 15.16465
Absolute Estimated Glomerular Filtration Rate (eGFR) Values C1D18	85.0461 mL/min/1.73 m^2 Standard Deviation 15.67478
Absolute Estimated Glomerular Filtration Rate (eGFR) Values C2D1	93.4136 mL/min/1.73 m^2 Standard Deviation 14.57590
Absolute Estimated Glomerular Filtration Rate (eGFR) Values C2D4	83.4911 mL/min/1.73 m^2 Standard Deviation 14.94634
Absolute Estimated Glomerular Filtration Rate (eGFR) Values C2D11	81.6135 mL/min/1.73 m^2 Standard Deviation 17.53286
Absolute Estimated Glomerular Filtration Rate (eGFR) Values C2D18	85.1155 mL/min/1.73 m^2 Standard Deviation 16.14240
Absolute Estimated Glomerular Filtration Rate (eGFR) Values C4D1	90.0343 mL/min/1.73 m^2 Standard Deviation 15.56475
Absolute Estimated Glomerular Filtration Rate (eGFR) Values C5D1	90.0000 mL/min/1.73 m^2 Standard Deviation 13.74773
Absolute Estimated Glomerular Filtration Rate (eGFR) Values C6D1	69.5000 mL/min/1.73 m^2 Standard Deviation 14.84924
Absolute Estimated Glomerular Filtration Rate (eGFR) Values End of treatment	87.1937 mL/min/1.73 m^2 Standard Deviation 18.00761

SECONDARY outcome

Timeframe: Baseline, C1D4, C1D11, C1D18, C2D1, C2D4, C2D11, C2D18, C3D1, C3D4, C4D1, C5D1, C6D1 and End of treatment (Day 134) (each cycle is of 3 weeks)

Population: SAS included all participants who were administered any dose of any study intervention. Here "number analyzed" signifies participants who were evaluable at specified timepoints.

eGFR creatinine was evaluated using CKD-EPI formula. Absolute change from baseline in eGFR was presented.

Outcome measures

Outcome measures
Measure	Sequence 1 n=18 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. The first three cycles are given in combination with Cisplatin at dose of 40 milligrams per square meter (mg/m2) once daily on Cycle 1 Day 2 (C1D2, C1D9, C1D16, C2D2, C2D9, C2D16, and C3D2) With 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 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).
Absolute Change From Baseline in eGFR C2D18	-4.7388 mL/min/1.73 m^2 Standard Deviation 12.75881
Absolute Change From Baseline in eGFR C3D1	-2.9103 mL/min/1.73 m^2 Standard Deviation 14.80991
Absolute Change From Baseline in eGFR C3D4	-6.7050 mL/min/1.73 m^2 Standard Deviation 14.90582
Absolute Change From Baseline in eGFR Baseline	89.6908 mL/min/1.73 m^2 Standard Deviation 13.35296
Absolute Change From Baseline in eGFR C1D4	-7.1908 mL/min/1.73 m^2 Standard Deviation 10.69578
Absolute Change From Baseline in eGFR C1D11	-8.2532 mL/min/1.73 m^2 Standard Deviation 17.46117
Absolute Change From Baseline in eGFR C1D18	-5.8696 mL/min/1.73 m^2 Standard Deviation 6.03911
Absolute Change From Baseline in eGFR C2D1	2.3052 mL/min/1.73 m^2 Standard Deviation 10.00664
Absolute Change From Baseline in eGFR C2D4	-6.3632 mL/min/1.73 m^2 Standard Deviation 13.50060
Absolute Change From Baseline in eGFR C2D11	-9.3021 mL/min/1.73 m^2 Standard Deviation 16.44543
Absolute Change From Baseline in eGFR C4D1	-3.3451 mL/min/1.73 m^2 Standard Deviation 25.03351
Absolute Change From Baseline in eGFR C5D1	-5.3312 mL/min/1.73 m^2 Standard Deviation 12.52264
Absolute Change From Baseline in eGFR C6D1	-26.5000 mL/min/1.73 m^2 Standard Deviation 7.77817
Absolute Change From Baseline in eGFR End of treatment	-2.4789 mL/min/1.73 m^2 Standard Deviation 16.82505

SECONDARY outcome

Timeframe: Up to approximately 6 months

Population: FAS included all participants who were administered any dose of any study intervention. As pre-specified in statistical analysis plan (SAP), efficacy analysis was not conducted in this study (samples were not processed) and therefore data could not be analyzed and reported in this outcome measure.

OR is defined as the number of participants who have a best overall response of complete response (CR) or partial response (PR) CR: Disappearance of target and non-target lesions and normalization of tumor markers. PR: At least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non target lesions must be non-progressive disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from randomization to the first documented disease progression, or death due to any cause, whichever occurs first (up to approximately 6 months)

Population: Full Analysis Set included all participants who were randomized to study treatment. As pre-specified in SAP, efficacy analysis was not conducted in this study (samples were not processed) and therefore data could not be analyzed and reported in this outcome measure.

PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on Blinded Independent Central Review (BICR), or death due to any cause, whichever occurs first. According to RECIST 1.1, progressive disease (PD) was defined as a 20% relative increase in the sum of diameters (SOD) of target lesions, taking as reference the nadir SOD and an absolute increase of \>5 millimeter (mm) in the SOD, or the appearance of new lesions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from date of the first treatment until date of the first occurrence of progression at the site of the primary tumor or the locoregional lymph nodes or End of Study, assessed approximately up to 6 months

LRC is defined as the time from date of the first treatment until date of the first occurrence of progression at the site of the primary tumor or the locoregional lymph nodes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from date of the first treatment administration until the start date of the first subsequent systemic cancer treatment for SCCHN or End of study, assessed up to approximately 6 months

Time to subsequent systematic cancer treatments was defined as time from date of the first treatment administration until the start date of the first subsequent systemic cancer treatment for squamous cell carcinoma of the head and neck (SCCHN).

Outcome measures

Outcome data not reported

Adverse Events

Sequence 1

Serious events: 5 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sequence 1 n=18 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. The first three cycles are given in combination with Cisplatin at dose of 40 milligrams per square meter (mg/m2) once daily on Cycle 1 Day 2 (C1D2, C1D9, C1D16, C2D2, C2D9, C2D16, and C3D2) With 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 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).
Cardiac disorders Cardiac failure chronic	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Gastrointestinal disorders Nausea	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Gastrointestinal disorders Vomiting	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Infections and infestations Bronchitis	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Infections and infestations Pneumonia	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Investigations Weight decreased	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Metabolism and nutrition disorders Decreased appetite	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Musculoskeletal and connective tissue disorders Back pain	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Musculoskeletal and connective tissue disorders Muscular weakness	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Nervous system disorders Paraesthesia	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)

Other adverse events

Other adverse events
Measure	Sequence 1 n=18 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. The first three cycles are given in combination with Cisplatin at dose of 40 milligrams per square meter (mg/m2) once daily on Cycle 1 Day 2 (C1D2, C1D9, C1D16, C2D2, C2D9, C2D16, and C3D2) With 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 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).
Blood and lymphatic system disorders Anaemia	27.8% 5/18 • Number of events 7 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Blood and lymphatic system disorders Leukopenia	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Blood and lymphatic system disorders Neutropenia	16.7% 3/18 • Number of events 3 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Blood and lymphatic system disorders Thrombocytopenia	22.2% 4/18 • Number of events 5 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Cardiac disorders Cardiac failure chronic	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Ear and labyrinth disorders Ear pain	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Ear and labyrinth disorders Tinnitus	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Eye disorders Central serous chorioretinopathy	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Gastrointestinal disorders Abdominal pain	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Gastrointestinal disorders Aphthous ulcer	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Gastrointestinal disorders Constipation	44.4% 8/18 • Number of events 9 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Gastrointestinal disorders Diarrhoea	22.2% 4/18 • Number of events 5 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Gastrointestinal disorders Dry mouth	11.1% 2/18 • Number of events 2 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Gastrointestinal disorders Dyspepsia	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Gastrointestinal disorders Dysphagia	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Gastrointestinal disorders Gastrooesophageal reflux disease	11.1% 2/18 • Number of events 2 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Gastrointestinal disorders Haemorrhoids	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Gastrointestinal disorders Nausea	38.9% 7/18 • Number of events 7 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Gastrointestinal disorders Odynophagia	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Gastrointestinal disorders Oral pain	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Gastrointestinal disorders Stomatitis	16.7% 3/18 • Number of events 3 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Gastrointestinal disorders Vomiting	11.1% 2/18 • Number of events 2 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
General disorders Asthenia	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
General disorders Face oedema	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
General disorders Fatigue	11.1% 2/18 • Number of events 2 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
General disorders Localised oedema	5.6% 1/18 • Number of events 2 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
General disorders Mucosal inflammation	16.7% 3/18 • Number of events 4 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
General disorders Oedema peripheral	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
General disorders Pain	11.1% 2/18 • Number of events 2 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
General disorders Pyrexia	16.7% 3/18 • Number of events 3 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Infections and infestations Candida infection	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Infections and infestations Gingivitis	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Infections and infestations Nasopharyngitis	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Infections and infestations Oral candidiasis	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Infections and infestations Pneumonia	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Infections and infestations Tongue fungal infection	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Infections and infestations Urinary tract infection	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Injury, poisoning and procedural complications Radiation skin injury	16.7% 3/18 • Number of events 3 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Investigations Alanine aminotransferase increased	27.8% 5/18 • Number of events 6 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Investigations Amylase increased	22.2% 4/18 • Number of events 5 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Investigations Aspartate aminotransferase increased	16.7% 3/18 • Number of events 3 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Investigations Blood creatinine increased	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Investigations Electrocardiogram QT prolonged	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Investigations Lipase increased	16.7% 3/18 • Number of events 3 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Investigations Lymphocyte count decreased	27.8% 5/18 • Number of events 5 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Investigations Neutrophil count decreased	11.1% 2/18 • Number of events 2 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Investigations Platelet count decreased	11.1% 2/18 • Number of events 4 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Investigations Weight decreased	33.3% 6/18 • Number of events 6 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Investigations White blood cell count decreased	16.7% 3/18 • Number of events 5 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Metabolism and nutrition disorders Decreased appetite	22.2% 4/18 • Number of events 4 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Metabolism and nutrition disorders Hypercalcaemia	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Metabolism and nutrition disorders Hyperglycaemia	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Metabolism and nutrition disorders Hyperkalaemia	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Metabolism and nutrition disorders Hypokalaemia	16.7% 3/18 • Number of events 8 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Metabolism and nutrition disorders Hypomagnesaemia	16.7% 3/18 • Number of events 6 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Metabolism and nutrition disorders Hypophosphataemia	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Musculoskeletal and connective tissue disorders Back pain	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Nervous system disorders Dizziness	11.1% 2/18 • Number of events 2 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Nervous system disorders Dysgeusia	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Nervous system disorders Headache	11.1% 2/18 • Number of events 2 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Nervous system disorders Hypogeusia	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Nervous system disorders Neuropathy peripheral	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Nervous system disorders Taste disorder	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Psychiatric disorders Confusional state	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Psychiatric disorders Insomnia	11.1% 2/18 • Number of events 2 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Renal and urinary disorders Chronic kidney disease	11.1% 2/18 • Number of events 3 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Renal and urinary disorders Nephropathy toxic	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Respiratory, thoracic and mediastinal disorders Dysphonia	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Respiratory, thoracic and mediastinal disorders Hypoxia	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	33.3% 6/18 • Number of events 11 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Respiratory, thoracic and mediastinal disorders Productive cough	16.7% 3/18 • Number of events 3 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Skin and subcutaneous tissue disorders Erythema	11.1% 2/18 • Number of events 2 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Skin and subcutaneous tissue disorders Rash	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Skin and subcutaneous tissue disorders Rash maculo-papular	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Skin and subcutaneous tissue disorders Urticaria	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Vascular disorders Hypertension	5.6% 1/18 • Number of events 1 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)
Vascular disorders Hypotension	11.1% 2/18 • Number of events 2 • Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)

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