Trial Outcomes & Findings for MK-3475/BCG in High Risk Superficial Bladder Cancer (NCT NCT02324582)
NCT ID: NCT02324582
Last Updated: 2024-09-03
Results Overview
Grade and quantity of treatment related adverse events. Due to the small sampling of subjects, no statistical analysis will be performed. Descriptive statistics in the form of counts calculated as percentages will be reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
change from baseline to 23 weeks
Results posted on
2024-09-03
Participant Flow
Enrollment for the study was open between 02 June 2015 through 10Oct 2019 in 2 urologic outpatient clinics.
Participant milestones
| Measure |
Intravenous MK-3475-100 mg/ Intravesical BCG
3 subjects will be treated at a dose of 100 mg MK-3475 at 100 mg every 3 weeks (Q3W) intravenously (IV) for 6 doses and 1 vial intravesicular BCG suspended in 50 ml preservative-free saline once per week of 6 weekly doses
Intravenous MK-3475/ Intravesical BCG: 6 cycles (each cycle is 21 days) of pembrolizumab will be given over 9 weeks in combination with BCG. BCG treatment will begin on Day 1 of cycle 3 of pembrolizumab.
|
Intravenous MK-3475-200 mg/ Intravesical BCG
Up to 12 Subjects will be treated at a dose of 200 mg MK-3475 at 100 mg every 3 weeks (Q3W) intravenously (IV) for 6 doses and 1 vial intravesicular BCG suspended in 50 ml preservative-free saline once per week of 6 weekly doses
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
15
|
|
Overall Study
COMPLETED
|
3
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
Reasons for withdrawal
| Measure |
Intravenous MK-3475-100 mg/ Intravesical BCG
3 subjects will be treated at a dose of 100 mg MK-3475 at 100 mg every 3 weeks (Q3W) intravenously (IV) for 6 doses and 1 vial intravesicular BCG suspended in 50 ml preservative-free saline once per week of 6 weekly doses
Intravenous MK-3475/ Intravesical BCG: 6 cycles (each cycle is 21 days) of pembrolizumab will be given over 9 weeks in combination with BCG. BCG treatment will begin on Day 1 of cycle 3 of pembrolizumab.
|
Intravenous MK-3475-200 mg/ Intravesical BCG
Up to 12 Subjects will be treated at a dose of 200 mg MK-3475 at 100 mg every 3 weeks (Q3W) intravenously (IV) for 6 doses and 1 vial intravesicular BCG suspended in 50 ml preservative-free saline once per week of 6 weekly doses
|
|---|---|---|
|
Overall Study
Screen Failures
|
0
|
5
|
Baseline Characteristics
MK-3475/BCG in High Risk Superficial Bladder Cancer
Baseline characteristics by cohort
| Measure |
Intravenous MK-3475-100 mg/ Intravesical BCG
n=3 Participants
3 subjects will be treated at a dose of 100 mg MK-3475 every 3 weeks (Q3W) intravenously (IV) for 6 doses and 1 vial (50 mg) intravesicular BCG suspended in 50 ml preservative-free saline once per week of 6 weekly doses
Intravenous MK-3475/ Intravesical BCG: 6 cycles (each cycle is 21 days) of pembrolizumab will be given over 19 weeks in combination with BCG. 6 cycles of BCG treatment will begin on Day 1 of cycle 3 of pembrolizumab.
|
Intravenous MK-3475-200 mg/ Intravesical BCG
n=10 Participants
Up to 12 subjects will be treated at a dose of 200 mg MK-3475 every 3 weeks (Q3W) intravenously (IV) for 6 doses and 1 vial (50 mg) intravesicular BCG suspended in 50 ml preservative-free saline once per week of 6 weekly doses
Intravenous MK-3475/ Intravesical BCG: 6 cycles (each cycle is 21 days) of pembrolizumab will be given over 19 weeks in combination with BCG. 6 cycles of BCG treatment will begin on Day 1 of cycle 3 of pembrolizumab.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
68 years
n=5 Participants
|
70 years
n=7 Participants
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
10 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Absence of tumor in the bladder following restaging resection.
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: change from baseline to 23 weeksPopulation: Thirteen patients were dosed (3 with 100mg MK3475 and 10 with 200 mg MK-3475) with a combination of MK-3475 (pembrolizumab) and BCG. All patients were evaluated for Grade 3 and higher adverse events considered related or possibly related to the addition of pembrolizumab to the treatment regimen. Due to the small sampling of subjects, no statistical analysis will be performed. Descriptive statistics in the form of counts calculated as percentages will be reported.
Grade and quantity of treatment related adverse events. Due to the small sampling of subjects, no statistical analysis will be performed. Descriptive statistics in the form of counts calculated as percentages will be reported.
Outcome measures
| Measure |
Intravenous MK-3475-100 mg/ Intravesical BCG
n=3 Participants
3 subjects will be treated at a dose of 100 mg MK-3475 at 100 mg every 3 weeks (Q3W) intravenously (IV) for 6 doses and 1 vial intravesicular BCG suspended in 50 ml preservative-free saline once per week of 6 weekly doses
Intravenous MK-3475/ Intravesical BCG: 6 cycles (each cycle is 21 days) of pembrolizumab will be given over 19 weeks in combination with BCG. BCG treatment will begin on Day 1 of cycle 3 of pembrolizumab.
|
Intravenous MK-3475-200 mg/ Intravesical BCG
n=10 Participants
Up to 12 Subjects will be treated at a dose of 200 mg MK-3475 at 100 mg every 3 weeks (Q3W) intravenously (IV) for 6 doses and 1 vial intravesicular BCG suspended in 50 ml preservative-free saline once per week of 6 weekly doses
|
|---|---|---|
|
Number of Participants With Grade 3, 4, and 5 Treatment Related Adverse Events
Number of Subjects with Grade 3, 4, or 5 treatment related adverse event(s)
|
0 Participants
|
4 Participants
|
|
Number of Participants With Grade 3, 4, and 5 Treatment Related Adverse Events
Number of Subjects without a Grade 3, 4, or 5treatment related adverse event(s)
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 19 weeksPopulation: Subjects presenting at Week 19 for cystoscopy with a bladder free of tumors or local or metastatic spread would be considered a complete response. Suspicious lesions would be biopsied and sent for confirmation of pathology.
Complete response rate per cystoscopy assessment of the bladder at 19 weeks from start of treatment with MK-3475 (pembrolizumab) at week 1.Subjects presenting at Week 19 with a bladder free of tumors upon cystoscopy and without local or metastatic spread were considered a complete response.. Suspicious lesions would be biopsied and sent for confirmation of pathology. Due to the small sampling of subjects, no statistical analysis will be performed. Descriptive statistics in the form of counts calculated as percentages will be reported.
Outcome measures
| Measure |
Intravenous MK-3475-100 mg/ Intravesical BCG
n=3 Participants
3 subjects will be treated at a dose of 100 mg MK-3475 at 100 mg every 3 weeks (Q3W) intravenously (IV) for 6 doses and 1 vial intravesicular BCG suspended in 50 ml preservative-free saline once per week of 6 weekly doses
Intravenous MK-3475/ Intravesical BCG: 6 cycles (each cycle is 21 days) of pembrolizumab will be given over 19 weeks in combination with BCG. BCG treatment will begin on Day 1 of cycle 3 of pembrolizumab.
|
Intravenous MK-3475-200 mg/ Intravesical BCG
n=9 Participants
Up to 12 Subjects will be treated at a dose of 200 mg MK-3475 at 100 mg every 3 weeks (Q3W) intravenously (IV) for 6 doses and 1 vial intravesicular BCG suspended in 50 ml preservative-free saline once per week of 6 weekly doses
|
|---|---|---|
|
Number of Participants Without Bladder Tumors Upon Cystoscopy Following Treatment.
|
2 Participants
|
6 Participants
|
Adverse Events
Intravenous MK-3475-100 mg/ Intravesical BCG
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Intravenous MK-3475-200 mg/ Intravesical BCG
Serious events: 6 serious events
Other events: 10 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Intravenous MK-3475-100 mg/ Intravesical BCG
n=3 participants at risk
3 subjects will be treated at a dose of 100 mg MK-3475 at 100 mg every 3 weeks (Q3W) intravenously (IV) for 6 doses and 1 vial (50mg) intravesicular BCG suspended in 50 ml preservative-free saline once per week of 6 weekly doses
|
Intravenous MK-3475-200 mg/ Intravesical BCG
n=10 participants at risk
Up to 12 subjects will be treated at a dose of 200 mg MK-3475 at 100 mg every 3 weeks (Q3W) intravenously (IV) for 6 doses and 1 vial (50 mg) intravesicular BCG suspended in 50 ml preservative-free saline once per week of 6 weekly doses
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
arthritis
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Endocrine disorders
adrenal Insufficiency
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Vascular disorders
thrombormbolic event
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Cardiac disorders
cardiomyopathy
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Nervous system disorders
neuropathy
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Endocrine disorders
hyperthyroidism
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
General disorders
injection site reaction
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 2 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
General disorders
pain-extremity
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Metabolism and nutrition disorders
hypokalemia
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Renal and urinary disorders
intra-operative hematuria
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Cardiac disorders
cardiac arrest
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
Other adverse events
| Measure |
Intravenous MK-3475-100 mg/ Intravesical BCG
n=3 participants at risk
3 subjects will be treated at a dose of 100 mg MK-3475 at 100 mg every 3 weeks (Q3W) intravenously (IV) for 6 doses and 1 vial (50mg) intravesicular BCG suspended in 50 ml preservative-free saline once per week of 6 weekly doses
|
Intravenous MK-3475-200 mg/ Intravesical BCG
n=10 participants at risk
Up to 12 subjects will be treated at a dose of 200 mg MK-3475 at 100 mg every 3 weeks (Q3W) intravenously (IV) for 6 doses and 1 vial (50 mg) intravesicular BCG suspended in 50 ml preservative-free saline once per week of 6 weekly doses
|
|---|---|---|
|
Investigations
elevated Blood Urea Nitrogen (BUN)
|
33.3%
1/3 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
20.0%
2/10 • Number of events 2 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
General disorders
allergic rhinitis
|
33.3%
1/3 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Blood and lymphatic system disorders
anemia
|
33.3%
1/3 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
0.00%
0/10 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Metabolism and nutrition disorders
anorexia
|
33.3%
1/3 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Nervous system disorders
anxiety
|
33.3%
1/3 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
0.00%
0/10 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
33.3%
1/3 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Musculoskeletal and connective tissue disorders
arthritis
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Investigations
elevated AST
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Endocrine disorders
thyroiditis
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
General disorders
non-cardiac chest pain
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
General disorders
chills
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
30.0%
3/10 • Number of events 3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Renal and urinary disorders
cystitis non-infective
|
66.7%
2/3 • Number of events 3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
60.0%
6/10 • Number of events 11 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
General disorders
darkening of hair
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
20.0%
2/10 • Number of events 2 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Nervous system disorders
dizziness
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Gastrointestinal disorders
dyspepsia
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Ear and labyrinth disorders
cerumen impaction
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
General disorders
edema-limb
|
33.3%
1/3 • Number of events 2 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
20.0%
2/10 • Number of events 2 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
General disorders
fatigue
|
33.3%
1/3 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
80.0%
8/10 • Number of events 10 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
General disorders
fever
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
20.0%
2/10 • Number of events 2 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
General disorders
flu like symptoms
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
30.0%
3/10 • Number of events 5 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Musculoskeletal and connective tissue disorders
generalized muscle weakness
|
33.3%
1/3 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Nervous system disorders
headache
|
33.3%
1/3 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Renal and urinary disorders
hematuria
|
33.3%
1/3 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
30.0%
3/10 • Number of events 5 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Hepatobiliary disorders
jaundice
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
General disorders
hypersomnia
|
33.3%
1/3 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
0.00%
0/10 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Metabolism and nutrition disorders
hypokalemia
|
33.3%
1/3 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
20.0%
2/10 • Number of events 2 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Endocrine disorders
hypothyroidism
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
30.0%
3/10 • Number of events 3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Infections and infestations
urinary tract infection
|
33.3%
1/3 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
0.00%
0/10 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
General disorders
injection site reaction
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
General disorders
insomnia
|
66.7%
2/3 • Number of events 2 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
30.0%
3/10 • Number of events 3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Metabolism and nutrition disorders
increased protein in urine
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
66.7%
2/3 • Number of events 3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Gastrointestinal disorders
nausea
|
33.3%
1/3 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
30.0%
3/10 • Number of events 3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Nervous system disorders
neuralgia
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Nervous system disorders
axonal neuropathy
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Eye disorders
ocular redness
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Infections and infestations
otitis externa
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Gastrointestinal disorders
toothache
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Musculoskeletal and connective tissue disorders
flank pain
|
33.3%
1/3 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
0.00%
0/10 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
33.3%
1/3 • Number of events 2 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Gastrointestinal disorders
intestinal pain
|
66.7%
2/3 • Number of events 2 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
0.00%
0/10 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
33.3%
1/3 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
0.00%
0/10 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Reproductive system and breast disorders
prostatic pain
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Infections and infestations
sinusitis
|
33.3%
1/3 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
0.00%
0/10 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Nervous system disorders
paresthesia
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
pruritus
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
rash acneiform
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
30.0%
3/10 • Number of events 3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Renal and urinary disorders
urinary retention
|
33.3%
1/3 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
0.00%
0/10 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
20.0%
2/10 • Number of events 2 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Investigations
weight loss
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
|
Investigations
Elevated leukocytes in urine
|
0.00%
0/3 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
10.0%
1/10 • Number of events 1 • Each subject had adverse events collected from the time of consent through 30 days post-treatment completion with MK-3475/pembrolizumab. This was up to 23 weeks from the time of first treatment with MK-3475/pembrolizumab.
|
Additional Information
Dr. Krishna Rao
Southern Illinois University School of Medicine
Phone: 217-545-7969
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place