Trial Outcomes & Findings for A Study of Pembrolizumab in Combination With Cisplatin and Pemetrexed in Advanced Malignant Pleural Mesothelioma (MPM) (MK-3475-A17) (NCT NCT04153565)
NCT ID: NCT04153565
Last Updated: 2025-07-17
Results Overview
DLTs were assessed during Cycle 1 (21 days) and defined as any of the following, if considered by investigator to be related to any of the study interventions: Grade 4 hematologic toxicities, except neutropenia and febrile neutropenia; Grade 4 neutropenia lasting \>7 days despite appropriate supportive treatment; Grade 4 febrile neutropenia only if the event considered as clinically significant by investigator and sponsor; any Grade 4 non-hematologic toxicity (except laboratory test abnormal including transient electrolyte abnormalities); any Grade 3 non-hematologic toxicity lasting \>72 hours despite appropriate supportive treatment (not laboratory); and any Grade 4 laboratory test value abnormality; any Grade 3 laboratory test value abnormality lasting \>7 days; delay in start of second course of more than 2 weeks (more than 35 days after the first dose) due to toxicity related to study procedures; any Grade 5 toxicity.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
19 participants
Primary outcome timeframe
Up to 3 weeks (through Cycle 1 [21 days])
Results posted on
2025-07-17
Participant Flow
Participant milestones
| Measure |
Pembrolizumab + Pemetrexed + Cisplatin
Participants received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with pemetrexed 500 mg/m\^2 IV and cisplatin 75 mg/m\^2 IV for 4-6 cycles, followed by pembrolizumab 200 mg/m\^2 IV monotherapy Q3W for up to 35 cycles from the first dose of the study treatment (approximately 2 years). Each cycle was 21 days.
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|---|---|
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Overall Study
STARTED
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19
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Overall Study
COMPLETED
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6
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Overall Study
NOT COMPLETED
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13
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Reasons for withdrawal
| Measure |
Pembrolizumab + Pemetrexed + Cisplatin
Participants received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with pemetrexed 500 mg/m\^2 IV and cisplatin 75 mg/m\^2 IV for 4-6 cycles, followed by pembrolizumab 200 mg/m\^2 IV monotherapy Q3W for up to 35 cycles from the first dose of the study treatment (approximately 2 years). Each cycle was 21 days.
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Overall Study
Death
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13
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Baseline Characteristics
A Study of Pembrolizumab in Combination With Cisplatin and Pemetrexed in Advanced Malignant Pleural Mesothelioma (MPM) (MK-3475-A17)
Baseline characteristics by cohort
| Measure |
Pembrolizumab + Pemetrexed + Cisplatin
n=19 Participants
Participants received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with pemetrexed 500 mg/m\^2 IV and cisplatin 75 mg/m\^2 IV for 4-6 cycles, followed by pembrolizumab 200 mg/m\^2 IV monotherapy Q3W for up to 35 cycles from the first dose of the study treatment (approximately 2 years). Each cycle was 21 days.
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Age, Continuous
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67.8 Years
STANDARD_DEVIATION 7.6 • n=5 Participants
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Sex: Female, Male
Female
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4 Participants
n=5 Participants
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Sex: Female, Male
Male
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15 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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19 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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19 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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0 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Up to 3 weeks (through Cycle 1 [21 days])Population: All participants who received at least 1 dose of study intervention and who met the criteria for DLT evaluability by finishing Cycle 1 without a DLT or having experienced a DLT
DLTs were assessed during Cycle 1 (21 days) and defined as any of the following, if considered by investigator to be related to any of the study interventions: Grade 4 hematologic toxicities, except neutropenia and febrile neutropenia; Grade 4 neutropenia lasting \>7 days despite appropriate supportive treatment; Grade 4 febrile neutropenia only if the event considered as clinically significant by investigator and sponsor; any Grade 4 non-hematologic toxicity (except laboratory test abnormal including transient electrolyte abnormalities); any Grade 3 non-hematologic toxicity lasting \>72 hours despite appropriate supportive treatment (not laboratory); and any Grade 4 laboratory test value abnormality; any Grade 3 laboratory test value abnormality lasting \>7 days; delay in start of second course of more than 2 weeks (more than 35 days after the first dose) due to toxicity related to study procedures; any Grade 5 toxicity.
Outcome measures
| Measure |
Pembrolizumab + Pemetrexed + Cisplatin
n=18 Participants
Participants received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with pemetrexed 500 mg/m\^2 IV and cisplatin 75 mg/m\^2 IV for 4-6 cycles, followed by pembrolizumab 200 mg/m\^2 IV monotherapy Q3W for up to 35 cycles from the first dose of the study treatment (approximately 2 years). Each cycle was 21 days.
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Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) During Cycle 1, Per Common Terminology Criteria for Adverse Events (AEs), Version 5.0 (CTCAE)
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2 Participants
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PRIMARY outcome
Timeframe: Up to approximately 34 monthsPopulation: All participants who received at least 1 dose of study intervention
An AE was defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE.
Outcome measures
| Measure |
Pembrolizumab + Pemetrexed + Cisplatin
n=19 Participants
Participants received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with pemetrexed 500 mg/m\^2 IV and cisplatin 75 mg/m\^2 IV for 4-6 cycles, followed by pembrolizumab 200 mg/m\^2 IV monotherapy Q3W for up to 35 cycles from the first dose of the study treatment (approximately 2 years). Each cycle was 21 days.
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Number of Participants With One or More Adverse Events (AEs)
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19 Participants
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PRIMARY outcome
Timeframe: Up to approximately 2 yearsPopulation: All participants who received at least 1 dose of study intervention
An AE was defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE.
Outcome measures
| Measure |
Pembrolizumab + Pemetrexed + Cisplatin
n=19 Participants
Participants received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with pemetrexed 500 mg/m\^2 IV and cisplatin 75 mg/m\^2 IV for 4-6 cycles, followed by pembrolizumab 200 mg/m\^2 IV monotherapy Q3W for up to 35 cycles from the first dose of the study treatment (approximately 2 years). Each cycle was 21 days.
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Number of Participants Discontinuing Study Treatment Due to an AE
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6 Participants
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SECONDARY outcome
Timeframe: Up to approximately 31 monthsPopulation: All participants who received at least 1 dose of study intervention
ORR was defined as the percentage of participants who have a Complete Response (CR: disappearance of target and non-target lesions and normalization of tumor markers) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions). ORR was based on modified Response Evaluation Criteria In Solid Tumors (RECIST) for Malignant Pleural Mesothelioma (MPM) as assessed by investigator.
Outcome measures
| Measure |
Pembrolizumab + Pemetrexed + Cisplatin
n=19 Participants
Participants received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with pemetrexed 500 mg/m\^2 IV and cisplatin 75 mg/m\^2 IV for 4-6 cycles, followed by pembrolizumab 200 mg/m\^2 IV monotherapy Q3W for up to 35 cycles from the first dose of the study treatment (approximately 2 years). Each cycle was 21 days.
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Objective Response Rate (ORR)
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73.7 Percentage of participants
Interval 48.8 to 90.9
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SECONDARY outcome
Timeframe: Up to approximately 31 monthsPopulation: All participants who received at least 1 dose of study intervention
DCR was defined as the percentage of participants who had a Complete Response (CR: disappearance of target and non-target lesions and normalization of tumor markers) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.\]) DCR was based on modified RECIST for MPM as assessed by investigator.
Outcome measures
| Measure |
Pembrolizumab + Pemetrexed + Cisplatin
n=19 Participants
Participants received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with pemetrexed 500 mg/m\^2 IV and cisplatin 75 mg/m\^2 IV for 4-6 cycles, followed by pembrolizumab 200 mg/m\^2 IV monotherapy Q3W for up to 35 cycles from the first dose of the study treatment (approximately 2 years). Each cycle was 21 days.
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Disease Control Rate (DCR)
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94.7 Percentage of participants
Interval 74.0 to 99.9
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SECONDARY outcome
Timeframe: Up to approximately 31 monthsPopulation: All participants who received at least 1 dose of study intervention and demonstrated a confirmed response (CR or PR)
For participants who demonstrate a confirmed complete response (CR: disappearance of target and non-target lesions and normalization of tumor markers) or confirmed Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions), DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR was based on modified RECIST for MPM as assessed by investigator.
Outcome measures
| Measure |
Pembrolizumab + Pemetrexed + Cisplatin
n=14 Participants
Participants received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with pemetrexed 500 mg/m\^2 IV and cisplatin 75 mg/m\^2 IV for 4-6 cycles, followed by pembrolizumab 200 mg/m\^2 IV monotherapy Q3W for up to 35 cycles from the first dose of the study treatment (approximately 2 years). Each cycle was 21 days.
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Duration of Response (DOR)
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16.8 Months
Interval 3.0 to
NA=DOR upper limit not reached at time of data cutoff due to insufficient number of responding participants with relapse
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Adverse Events
Pembrolizumab + Pemetrexed + Cisplatin
Serious events: 7 serious events
Other events: 19 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Pembrolizumab + Pemetrexed + Cisplatin
n=19 participants at risk
Participants received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with pemetrexed 500 mg/m\^2 IV and cisplatin 75 mg/m\^2 IV for 4-6 cycles, followed by pembrolizumab 200 mg/m\^2 IV monotherapy Q3W for up to 35 cycles from the first dose of the study treatment (approximately 2 years). Each cycle was 21 days.
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Blood and lymphatic system disorders
Febrile neutropenia
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5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
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Eye disorders
Uveitis
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5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
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General disorders
Pyrexia
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5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
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Infections and infestations
COVID-19
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5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
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Nervous system disorders
Facial paralysis
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5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
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Respiratory, thoracic and mediastinal disorders
Pneumonitis
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10.5%
2/19 • Number of events 2 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
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Infections and infestations
Pneumonia bacterial
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10.5%
2/19 • Number of events 2 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
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Other adverse events
| Measure |
Pembrolizumab + Pemetrexed + Cisplatin
n=19 participants at risk
Participants received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with pemetrexed 500 mg/m\^2 IV and cisplatin 75 mg/m\^2 IV for 4-6 cycles, followed by pembrolizumab 200 mg/m\^2 IV monotherapy Q3W for up to 35 cycles from the first dose of the study treatment (approximately 2 years). Each cycle was 21 days.
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|---|---|
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Blood and lymphatic system disorders
Anaemia
|
57.9%
11/19 • Number of events 11 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
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Blood and lymphatic system disorders
Febrile neutropenia
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5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
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Blood and lymphatic system disorders
Lymphopenia
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5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
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Blood and lymphatic system disorders
Neutropenia
|
31.6%
6/19 • Number of events 13 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
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|
Cardiac disorders
Atrial fibrillation
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Ear and labyrinth disorders
Vertigo
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Endocrine disorders
Hypothyroidism
|
10.5%
2/19 • Number of events 2 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Constipation
|
68.4%
13/19 • Number of events 15 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
52.6%
10/19 • Number of events 12 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Lip dry
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
84.2%
16/19 • Number of events 21 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Stomatitis
|
10.5%
2/19 • Number of events 2 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
10.5%
2/19 • Number of events 2 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Malaise
|
47.4%
9/19 • Number of events 11 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Oedema peripheral
|
10.5%
2/19 • Number of events 2 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Pyrexia
|
21.1%
4/19 • Number of events 5 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Immune system disorders
Hypersensitivity
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Gingivitis
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Herpes zoster
|
10.5%
2/19 • Number of events 2 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Amylase increased
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood creatinine increased
|
10.5%
2/19 • Number of events 2 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
C-reactive protein increased
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Creatinine renal clearance decreased
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Lipase increased
|
10.5%
2/19 • Number of events 4 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Lymphocyte count decreased
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Neutrophil count decreased
|
21.1%
4/19 • Number of events 10 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Weight decreased
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
White blood cell count decreased
|
36.8%
7/19 • Number of events 12 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
26.3%
5/19 • Number of events 5 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.5%
2/19 • Number of events 2 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
21.1%
4/19 • Number of events 8 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.8%
3/19 • Number of events 3 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
10.5%
2/19 • Number of events 3 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.8%
3/19 • Number of events 3 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
10.5%
2/19 • Number of events 2 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Cognitive disorder
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Dysgeusia
|
36.8%
7/19 • Number of events 10 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Neuropathy peripheral
|
10.5%
2/19 • Number of events 2 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Tremor
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Psychiatric disorders
Delirium
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Psychiatric disorders
Insomnia
|
21.1%
4/19 • Number of events 4 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Renal impairment
|
15.8%
3/19 • Number of events 3 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
26.3%
5/19 • Number of events 11 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
15.8%
3/19 • Number of events 3 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
26.3%
5/19 • Number of events 5 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
10.5%
2/19 • Number of events 3 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
31.6%
6/19 • Number of events 9 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Hypertension
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Vascular pain
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Pharyngitis
|
5.3%
1/19 • Number of events 1 • Up to approximately 34 months
All-cause mortality table includes all allocated participants. Serious and other AEs include all participants who received at least 1 dose of study intervention. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp& Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER