Trial Outcomes & Findings for M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC) (NCT NCT03631706)
NCT ID: NCT03631706
Last Updated: 2025-04-08
Results Overview
Progression free survival was defined as the time from randomization of study intervention until the first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
304 participants
Primary outcome timeframe
Time from randomization of study drug until the first documentation of PD or death, assessed approximately up to 746 days
Results posted on
2025-04-08
Participant Flow
Participant milestones
| Measure |
M7824
Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
|
Pembrolizumab
Participants received intravenous infusion of Pembrolizumab at a dose of 200 milligrams (mg) once every 3 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
|
|---|---|---|
|
Overall Study
STARTED
|
152
|
152
|
|
Overall Study
Treated
|
151
|
152
|
|
Overall Study
COMPLETED
|
151
|
152
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
M7824
Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
|
Pembrolizumab
Participants received intravenous infusion of Pembrolizumab at a dose of 200 milligrams (mg) once every 3 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
|
|---|---|---|
|
Overall Study
Randomized, not treated
|
1
|
0
|
Baseline Characteristics
M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
M7824
n=152 Participants
Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
|
Pembrolizumab
n=152 Participants
Participants received intravenous infusion of Pembrolizumab at a dose of 200 milligrams (mg) once every 3 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
|
Total
n=304 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 Years
STANDARD_DEVIATION 9.56 • n=99 Participants
|
67 Years
STANDARD_DEVIATION 10.17 • n=107 Participants
|
67 Years
STANDARD_DEVIATION 9.85 • n=206 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=99 Participants
|
116 Participants
n=107 Participants
|
226 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
138 Participants
n=99 Participants
|
138 Participants
n=107 Participants
|
276 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
50 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
105 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
91 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
170 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
7 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Time from randomization of study drug until the first documentation of PD or death, assessed approximately up to 746 daysPopulation: Full analysis set included all participants who were randomized to study intervention.
Progression free survival was defined as the time from randomization of study intervention until the first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Outcome measures
| Measure |
M7824
n=152 Participants
Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
|
Pembrolizumab
n=152 Participants
Participants received intravenous infusion of Pembrolizumab at a dose of 200 milligrams (mg) once every 3 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
|
|---|---|---|
|
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC)
|
7.0 months
Interval 0.0 to 19.4
|
11.1 months
Interval 0.0 to 18.0
|
PRIMARY outcome
Timeframe: Time from randomization of study drug assessed approximately up to 843 daysPopulation: Full analysis set included all participants who were randomized to study intervention.
Overall Survival was defined as the time from randomization of study intervention to the date of death due to any cause. The overall survival was analyzed by using the Kaplan-Meier method.
Outcome measures
| Measure |
M7824
n=152 Participants
Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
|
Pembrolizumab
n=152 Participants
Participants received intravenous infusion of Pembrolizumab at a dose of 200 milligrams (mg) once every 3 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
|
|---|---|---|
|
Overall Survival (OS)
|
21.1 months
Interval 0.2 to 22.1
|
22.1 months
Interval 0.1 to 26.4
|
SECONDARY outcome
Timeframe: Time from first treatment assessed up to approximately 843 daysPopulation: Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs was defined as events with onset date or worsening during the on treatment period. TEAEs included serious AEs and non-serious AEs. Treatment-related TEAEs: reasonably related to the study intervention.
Outcome measures
| Measure |
M7824
n=151 Participants
Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
|
Pembrolizumab
n=152 Participants
Participants received intravenous infusion of Pembrolizumab at a dose of 200 milligrams (mg) once every 3 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Participants with any TEAE
|
150 Participants
|
145 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Participants with any serious TEAE
|
90 Participants
|
61 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Participants with any Treatment Related TEAEs
|
124 Participants
|
105 Participants
|
SECONDARY outcome
Timeframe: Time from randomization of study drug until the first documentation of PD or death, assessed approximately up to 746 daysPopulation: Full analysis set included all participants who were randomized to study intervention.
Percentage of participants with unconfirmed best overall response that is at least one overall assessment of complete response (CR) or partial response (PR) reported here.
Outcome measures
| Measure |
M7824
n=152 Participants
Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
|
Pembrolizumab
n=152 Participants
Participants received intravenous infusion of Pembrolizumab at a dose of 200 milligrams (mg) once every 3 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
|
|---|---|---|
|
Percentage of Participants With Unconfirmed Best Overall Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
|
46.7 percentage of participants
Interval 38.6 to 55.0
|
51.3 percentage of participants
Interval 43.1 to 59.5
|
SECONDARY outcome
Timeframe: From first documented objective response to PD or death due to any cause, assessed approximately up to 746 daysPopulation: Full analysis set included all participants who were randomized to study intervention. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
DOR was defined for participants with objective response, as the time from first documentation of objective response (Complete Response \[CR\] or Partial Response \[PR\]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and assessed by IRC. Results were calculated based on Kaplan-Meier estimates.
Outcome measures
| Measure |
M7824
n=71 Participants
Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
|
Pembrolizumab
n=78 Participants
Participants received intravenous infusion of Pembrolizumab at a dose of 200 milligrams (mg) once every 3 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
|
|---|---|---|
|
Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
|
NA months
Due to small number of events, estimates (Median, lower limit and upper limit) from Kaplan-Meier survival curves could not derive.
|
NA months
Interval 13.5 to
Due to small number of events, estimates (Median and upper limit) from Kaplan-Meier survival curves could not derive.
|
Adverse Events
M7824
Serious events: 90 serious events
Other events: 140 other events
Deaths: 49 deaths
Pembrolizumab
Serious events: 61 serious events
Other events: 135 other events
Deaths: 43 deaths
Serious adverse events
| Measure |
M7824
n=151 participants at risk
Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
|
Pembrolizumab
n=152 participants at risk
Participants received intravenous infusion of Pembrolizumab at a dose of 200 milligrams (mg) once every 3 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
|
|---|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.6%
4/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.3%
2/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Cardiac disorders
Angina pectoris
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Cardiac disorders
Arrhythmia
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Cardiac disorders
Coronary artery disease
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Cardiac disorders
Pericardial effusion
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Endocrine disorders
Adrenocorticotropic hormone deficiency
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.3%
2/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Gastrointestinal disorders
Colitis
|
1.3%
2/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
2/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Gastrointestinal disorders
Duodenitis
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Gastrointestinal disorders
Nausea
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Gastrointestinal disorders
Vomiting
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
General disorders
Asthenia
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
1.3%
2/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
General disorders
Death
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
General disorders
Disease progression
|
4.0%
6/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
4.6%
7/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
General disorders
Fatigue
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
General disorders
General physical health deterioration
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
General disorders
Hyperthermia
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
General disorders
Malaise
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
General disorders
Pyrexia
|
2.0%
3/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
General disorders
Sudden death
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Hepatobiliary disorders
Cholestasis
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Hepatobiliary disorders
Hepatitis
|
1.3%
2/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Immune system disorders
Hypersensitivity
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Infections and infestations
Bacterial sepsis
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Infections and infestations
Bronchitis
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Infections and infestations
COVID-19
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Infections and infestations
Encephalitis
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Infections and infestations
Infection
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Infections and infestations
Influenza
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Infections and infestations
Oral candidiasis
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Infections and infestations
Pneumonia
|
6.0%
9/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
7.9%
12/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Infections and infestations
Pulmonary sepsis
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Infections and infestations
Sepsis
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Infections and infestations
Skin infection
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Injury, poisoning and procedural complications
Fall
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.3%
2/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
1.3%
2/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Injury, poisoning and procedural complications
Radiation necrosis
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Injury, poisoning and procedural complications
Strangulated incisional hernia
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Investigations
Platelet count decreased
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Investigations
Transaminases increased
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Investigations
Troponin increased
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Investigations
Weight decreased
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.3%
2/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.3%
2/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
2.0%
3/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.0%
3/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthom
|
2.0%
3/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
1.3%
2/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
3.3%
5/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Nervous system disorders
Cerebral infarction
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Nervous system disorders
Immune-mediated encephalitis
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Nervous system disorders
Sciatica
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
1.3%
2/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Renal and urinary disorders
Immune-mediated nephritis
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Renal and urinary disorders
Renal failure
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
1.3%
2/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.3%
2/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.0%
6/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
1.3%
2/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.6%
4/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.3%
2/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
2.0%
3/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.3%
2/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.3%
5/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
2.0%
3/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory alkalosis
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
1.3%
2/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Vascular disorders
Aortic aneurysm
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Vascular disorders
Embolism
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
1.3%
2/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Vascular disorders
Hypotension
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Vascular disorders
Orthostatic hypotension
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Vascular disorders
Shock
|
0.00%
0/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.66%
1/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
Other adverse events
| Measure |
M7824
n=151 participants at risk
Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
|
Pembrolizumab
n=152 participants at risk
Participants received intravenous infusion of Pembrolizumab at a dose of 200 milligrams (mg) once every 3 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
30.5%
46/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
11.8%
18/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Endocrine disorders
Hyperthyroidism
|
4.0%
6/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
6.6%
10/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Endocrine disorders
Hypothyroidism
|
11.3%
17/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
15.1%
23/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
3/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
5.3%
8/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Gastrointestinal disorders
Constipation
|
10.6%
16/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
14.5%
22/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.9%
24/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
15.8%
24/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.3%
5/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
7.2%
11/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Gastrointestinal disorders
Nausea
|
12.6%
19/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
13.2%
20/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Gastrointestinal disorders
Vomiting
|
9.3%
14/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
6.6%
10/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
General disorders
Asthenia
|
17.2%
26/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
19.7%
30/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
General disorders
Chest pain
|
5.3%
8/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
3.9%
6/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
General disorders
Fatigue
|
19.9%
30/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
17.1%
26/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
General disorders
Oedema peripheral
|
9.3%
14/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
8.6%
13/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
General disorders
Pyrexia
|
18.5%
28/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
9.9%
15/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Infections and infestations
Pneumonia
|
5.3%
8/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
13.8%
21/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.0%
9/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
1.3%
2/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Infections and infestations
Urinary tract infection
|
7.3%
11/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
2.6%
4/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Investigations
Alanine aminotransferase increased
|
12.6%
19/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
10.5%
16/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Investigations
Amylase increased
|
6.0%
9/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
5.9%
9/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Investigations
Aspartate aminotransferase increased
|
15.2%
23/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
9.2%
14/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Investigations
Blood alkaline phosphatase increased
|
11.9%
18/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
7.2%
11/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Investigations
Blood bilirubin increased
|
6.0%
9/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
2.0%
3/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Investigations
Blood creatinine increased
|
6.0%
9/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
8.6%
13/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
1.3%
2/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
5.3%
8/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Investigations
Gamma-glutamyltransferase increased
|
12.6%
19/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
10.5%
16/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Investigations
Lipase increased
|
7.9%
12/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
4.6%
7/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Investigations
Weight decreased
|
6.6%
10/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
4.6%
7/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.6%
25/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
17.1%
26/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.6%
13/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
6.6%
10/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.0%
9/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
2.0%
3/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.6%
16/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
7.2%
11/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.3%
5/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
5.3%
8/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.6%
4/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
5.3%
8/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.6%
10/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
7.9%
12/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.2%
20/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
13.8%
21/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
8/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
8.6%
13/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.3%
11/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
6.6%
10/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
7.9%
12/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Nervous system disorders
Dizziness
|
7.9%
12/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
5.3%
8/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Nervous system disorders
Headache
|
9.3%
14/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
9.2%
14/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Psychiatric disorders
Insomnia
|
10.6%
16/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
6.6%
10/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.2%
23/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
14.5%
22/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.2%
29/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
11.8%
18/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.9%
15/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
1.3%
2/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
17.9%
27/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
3.9%
6/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.6%
7/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
7.2%
11/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
6.0%
9/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
2.6%
4/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
5.3%
8/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.00%
0/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
34.4%
52/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
27.6%
42/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Rash
|
31.8%
48/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
16.4%
25/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.3%
17/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
3.9%
6/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
5.3%
8/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
3.3%
5/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Vascular disorders
Hypertension
|
2.0%
3/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
6.6%
10/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
|
Vascular disorders
Hypotension
|
7.3%
11/151 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
0.66%
1/152 • Time from first treatment assessed up to approximately 843 days
Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab.
|
Additional Information
Communication Center
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