Trial Outcomes & Findings for Pembrolizumab in Treating Patients With Bladder Cancer Undergoing Radical Cystectomy (NCT NCT03319745)
NCT ID: NCT03319745
Last Updated: 2024-06-25
Results Overview
The primary endpoint is a joint endpoint classifying patients as having a toxicity of concern (TOX), defined as the presence of any of these: 1) any 30-day grade 3 or higher surgical complication at least possibly related to the treatment, 2) any toxicity at least possibly related to the treatment that prevents surgery, or 3) death between the start of the study and the 30-day post-surgical assessment as long as it is at least possibly related to pembrolizumab or surgery.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
Results posted on
2024-06-25
Participant Flow
23 participants consented, 6 screen failed. 18 participants were found eligible to receive study treatment. 16 out of the 18 were able to undergo surgery.
Participant milestones
| Measure |
Pembrolizumab
Participants receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. About 4 weeks after treatment, participants then undergo radical cystectomy per standard of care.
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|---|---|
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Overall Study
STARTED
|
18
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Overall Study
COMPLETED
|
16
|
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Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Pembrolizumab
Participants receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. About 4 weeks after treatment, participants then undergo radical cystectomy per standard of care.
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|---|---|
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Overall Study
Death
|
1
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Overall Study
Toxicity Precluding Surgery
|
1
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Baseline Characteristics
Pembrolizumab in Treating Patients With Bladder Cancer Undergoing Radical Cystectomy
Baseline characteristics by cohort
| Measure |
Pembrolizumab
n=18 Participants
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. About 4 weeks after treatment, patients then undergo radical cystectomy per standard of care.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 monthsThe primary endpoint is a joint endpoint classifying patients as having a toxicity of concern (TOX), defined as the presence of any of these: 1) any 30-day grade 3 or higher surgical complication at least possibly related to the treatment, 2) any toxicity at least possibly related to the treatment that prevents surgery, or 3) death between the start of the study and the 30-day post-surgical assessment as long as it is at least possibly related to pembrolizumab or surgery.
Outcome measures
| Measure |
Pembrolizumab
n=18 Participants
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. About 4 weeks after treatment, patients then undergo radical cystectomy per standard of care.
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|---|---|
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Toxicity for Safety Monitoring (TOX)
|
15 percentage of participants
Interval 3.0 to 33.0
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SECONDARY outcome
Timeframe: Efficacy endpoint will be measured at time of surgeryPopulation: Only 16 participants were included in the analysis of this outcome as 2 of the 18 participants were unable to undergo surgery; therefore, we did not have their surgical specimens.
To explore anti-cancer immunological activity by evaluating surgical specimens for evidence of post-treatment and residual tumor compared to pre-treatment biopsy samples. The main mechanism for doing so will be via histopathologic review of the radical cystectomy specimen. MIBC participants are defined as responders if they achieve a pT1 stage or less. In the case of NMIBC a pT0 status will be used to identify complete response.
Outcome measures
| Measure |
Pembrolizumab
n=16 Participants
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. About 4 weeks after treatment, patients then undergo radical cystectomy per standard of care.
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|---|---|
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Efficacy Endpoint
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5 Participants
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Adverse Events
Pembrolizumab
Serious events: 9 serious events
Other events: 17 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Pembrolizumab
n=18 participants at risk
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. About 4 weeks after treatment, patients then undergo radical cystectomy per standard of care.
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|---|---|
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Infections and infestations
Sepsis
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Cardiac disorders
Myocarditis
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
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|
Vascular disorders
Thromboemolic Event
|
16.7%
3/18 • Number of events 3 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
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|
Musculoskeletal and connective tissue disorders
Myositis
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Gastrointestinal disorders
Small Intestinal Leak
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Renal and urinary disorders
Acute Pyelonephritis
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
11.1%
2/18 • Number of events 2 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Infections and infestations
Enterocolitis Infectious
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
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|
Infections and infestations
Pelvic Infection
|
11.1%
2/18 • Number of events 2 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Renal and urinary disorders
UTI
|
11.1%
2/18 • Number of events 2 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Renal and urinary disorders
Ureteric Anastomotic Leak
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection
|
11.1%
2/18 • Number of events 2 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Gastrointestinal disorders
Anorexia
|
11.1%
2/18 • Number of events 2 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
2/18 • Number of events 2 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
Other adverse events
| Measure |
Pembrolizumab
n=18 participants at risk
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. About 4 weeks after treatment, patients then undergo radical cystectomy per standard of care.
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|---|---|
|
Renal and urinary disorders
UTI
|
16.7%
3/18 • Number of events 3 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
3/18 • Number of events 3 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Investigations
ALK Increased
|
11.1%
2/18 • Number of events 2 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Blood and lymphatic system disorders
Anemia
|
77.8%
14/18 • Number of events 14 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
General disorders
Fatigue
|
50.0%
9/18 • Number of events 9 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Investigations
Hyponatremia
|
38.9%
7/18 • Number of events 7 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Renal and urinary disorders
Creatinine Increased
|
22.2%
4/18 • Number of events 4 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Investigations
Hypokalemia
|
16.7%
3/18 • Number of events 3 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Investigations
ALT Increased
|
16.7%
3/18 • Number of events 3 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
3/18 • Number of events 3 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
16.7%
3/18 • Number of events 3 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.1%
2/18 • Number of events 2 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Gastrointestinal disorders
Ileus
|
11.1%
2/18 • Number of events 2 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Investigations
Lipase Increased
|
11.1%
2/18 • Number of events 2 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Cardiac disorders
Tachicardia
|
11.1%
2/18 • Number of events 2 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Blood and lymphatic system disorders
Platelet Count Decreased
|
11.1%
2/18 • Number of events 2 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Investigations
AST Increased
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Gastrointestinal disorders
Bloating
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
General disorders
Chills
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Nervous system disorders
Confusion
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Skin and subcutaneous tissue disorders
Dematitis
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Blood and lymphatic system disorders
WBC Decreased
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Nervous system disorders
Neuropathy
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Nervous system disorders
Anxiety
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Nervous system disorders
Weakness
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Investigations
Hyperuricemia
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Investigations
Hypermagnesemia
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Investigations
Hyperkalemia
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Renal and urinary disorders
Hematuria
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Renal and urinary disorders
Urinary Retention
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
General disorders
Hot Flashes
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Infections and infestations
Stoma Infection
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
|
Blood and lymphatic system disorders
Edema Limbs
|
5.6%
1/18 • Number of events 1 • From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
From the time of initiation of pembrolizumab through 30 days after surgery, all adverse events must be reported by the investigator. Additionally, all adverse events meeting serious criteria, from time of treatment initiation through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anti cancer therapy should be reported by the investigator.
|
Additional Information
Dr. Neema Navai
The University of Texas MD Anderson Cancer Center
Phone: (713) 792-3250
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place