Trial Outcomes & Findings for Phase 2 Study of Pembrolizumab in Combination With Gemcitabine and Cisplatin as Neoadjuvant Therapy (NCT NCT02690558)
NCT ID: NCT02690558
Last Updated: 2026-01-28
Results Overview
Pathologic (p) anatomic stage for bladder cancer uses the American Joint Committee on Cancer (AJCC) Tumor/Nodes/Metastasis (TNM) system, which is based on: Size of primary tumor (T) and whether it has grown into nearby areas. Spread to regional lymph nodes (N). Spread (metastasis; M) to other organs of the body. Once the T, N, and M categories have been determined, this information is combined into a prognostic group. Higher numbers mean the cancer is more advanced. Pathologic staging is based on the operative and pathology report from cystectomy at the local site. A pathologic response or downstaging is defined as a reduction in stage to below pathological tumor stage 2 (\<pT2) (pT0-T1N0M0)
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
14 weeks of treatment plus cystectomy within 70 days after treatment
Results posted on
2026-01-28
Participant Flow
Subjects were recruited from two cancer centers between May 2016 and March 2020.
Of the 47 participants screened, 8 were determined to be ineligible and a total of 39 were enrolled.
Participant milestones
| Measure |
Pembrolizumab, Gemcitabine and Cisplatin
There is one arm in this study. Subjects will receive Pembrolizumab 200mg IV on day 1 in combination with cisplatin 35mg/m2 and gemcitabine 1000mg/m2 on day 1 and day 8 every 3 weeks for 4 cycles over 12 weeks.
pembrolizumab, gemcitabine and cisplatin: neoadjuvant administration of pembrolizumab with gemcitabine and cisplatin prior to cystectomy
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2 Study of Pembrolizumab in Combination With Gemcitabine and Cisplatin as Neoadjuvant Therapy
Baseline characteristics by cohort
| Measure |
Pembrolizumab, Gemcitabine and Cisplatin
n=39 Participants
There is one arm in this study. Subjects will receive Pembrolizumab 200mg IV on day 1 in combination with cisplatin 35mg/m2 and gemcitabine 1000mg/m2 on day 1 and day 8 every 3 weeks for 4 cycles over 12 weeks.
pembrolizumab, gemcitabine and cisplatin: neoadjuvant administration of pembrolizumab with gemcitabine and cisplatin prior to cystectomy
|
|---|---|
|
Age, Continuous
|
66 years
n=158 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=158 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=158 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=158 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=158 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=158 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=158 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=158 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=158 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=158 Participants
|
|
Smoking status
Current smoker
|
7 Participants
n=158 Participants
|
|
Smoking status
Former smoker
|
26 Participants
n=158 Participants
|
|
Smoking status
Never smoker
|
6 Participants
n=158 Participants
|
|
Clinical Tumor (T) stage
T2
|
28 Participants
n=158 Participants
|
|
Clinical Tumor (T) stage
T3
|
9 Participants
n=158 Participants
|
|
Clinical Tumor (T) stage
T4a
|
2 Participants
n=158 Participants
|
|
Previous non-muscle invasive bladder cancer
Yes
|
7 Participants
n=158 Participants
|
|
Previous non-muscle invasive bladder cancer
No
|
31 Participants
n=158 Participants
|
|
Previous non-muscle invasive bladder cancer
Unknown
|
1 Participants
n=158 Participants
|
|
Previous Bacillus Calmette-Guérin Therapy
Yes
|
5 Participants
n=158 Participants
|
|
Previous Bacillus Calmette-Guérin Therapy
No
|
34 Participants
n=158 Participants
|
|
Eastern Cooperative Oncology Group performance status (ECOG PS)
0
|
28 Participants
n=158 Participants
|
|
Eastern Cooperative Oncology Group performance status (ECOG PS)
1
|
11 Participants
n=158 Participants
|
|
Histology
Pure urothelial
|
28 Participants
n=158 Participants
|
|
Histology
Urothelial with squamous cell
|
7 Participants
n=158 Participants
|
|
Histology
Urothelial with micropapillary
|
1 Participants
n=158 Participants
|
|
Histology
Urothelial with sarcomatoid
|
1 Participants
n=158 Participants
|
|
Histology
Urothelial with signet ring
|
1 Participants
n=158 Participants
|
|
Histology
Urothelial with glandular and squamous
|
1 Participants
n=158 Participants
|
PRIMARY outcome
Timeframe: 14 weeks of treatment plus cystectomy within 70 days after treatmentPathologic (p) anatomic stage for bladder cancer uses the American Joint Committee on Cancer (AJCC) Tumor/Nodes/Metastasis (TNM) system, which is based on: Size of primary tumor (T) and whether it has grown into nearby areas. Spread to regional lymph nodes (N). Spread (metastasis; M) to other organs of the body. Once the T, N, and M categories have been determined, this information is combined into a prognostic group. Higher numbers mean the cancer is more advanced. Pathologic staging is based on the operative and pathology report from cystectomy at the local site. A pathologic response or downstaging is defined as a reduction in stage to below pathological tumor stage 2 (\<pT2) (pT0-T1N0M0)
Outcome measures
| Measure |
Pembrolizumab, Gemcitabine and Cisplatin
n=39 Participants
There is one arm in this study. Subjects will receive Pembrolizumab 200mg IV on day 1 in combination with cisplatin 35mg/m2 and gemcitabine 1000mg/m2 on day 1 and day 8 every 3 weeks for 4 cycles over 12 weeks.
pembrolizumab, gemcitabine and cisplatin: neoadjuvant administration of pembrolizumab with gemcitabine and cisplatin prior to cystectomy
|
|---|---|
|
Percentage of Subjects That Reach Pathological Downstaging (Response) at the Time of Cystectomy
|
56 percentage of patients with response
Interval 40.0 to 72.0
|
SECONDARY outcome
Timeframe: 14 weeks of treatment plus cystectomy within 70 days of treatmentPathologic (p) anatomic response for bladder cancer uses the American Joint Committee on Cancer (AJCC) TNM staging system, which is based on: Size of primary tumor (T) and whether it has grown into nearby areas. Spread to regional lymph nodes (N). Spread (metastasis) (M) to other organs of the body. Once the T, N, and M categories have been determined, this information is combined into a prognostic group. Higher numbers mean the cancer is more advanced. Pathologic staging is based on the operative and pathology report from cystectomy at the local site. Complete pathologic response (pT0) is defined as pT0 N0 M0.
Outcome measures
| Measure |
Pembrolizumab, Gemcitabine and Cisplatin
n=39 Participants
There is one arm in this study. Subjects will receive Pembrolizumab 200mg IV on day 1 in combination with cisplatin 35mg/m2 and gemcitabine 1000mg/m2 on day 1 and day 8 every 3 weeks for 4 cycles over 12 weeks.
pembrolizumab, gemcitabine and cisplatin: neoadjuvant administration of pembrolizumab with gemcitabine and cisplatin prior to cystectomy
|
|---|---|
|
Percentage of Subjects That Reach Complete Pathologic Response (pT0) at the Time of Cystectomy
|
36 percentage of patients with response
Interval 21.0 to 53.0
|
SECONDARY outcome
Timeframe: 14 weeks of treatment plus 5 years of followupdefined from D1 of neoadjuvant treatment until progression (in those who progress prior to surgery) or until recurrence (post-surgery) or until death as a result of any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 weeks of treatment plus 3 years or until deathOS at 3 years is defined from D1 of treatment until 3 years or death as a result of any cause
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 weeks of treatment plus 30 days for toxicity followupSafety and toxicity will be characterized according to the reported adverse event (AE) profile using NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0, a descriptive terminology. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Outcome measures
| Measure |
Pembrolizumab, Gemcitabine and Cisplatin
n=39 Participants
There is one arm in this study. Subjects will receive Pembrolizumab 200mg IV on day 1 in combination with cisplatin 35mg/m2 and gemcitabine 1000mg/m2 on day 1 and day 8 every 3 weeks for 4 cycles over 12 weeks.
pembrolizumab, gemcitabine and cisplatin: neoadjuvant administration of pembrolizumab with gemcitabine and cisplatin prior to cystectomy
|
|---|---|
|
Number of Participants With Treatment Related Adverse Events.
Grade 1 or higher (Any toxicity)
|
39 Participants
|
|
Number of Participants With Treatment Related Adverse Events.
Grade 3 or higher
|
29 Participants
|
Adverse Events
Pembrolizumab, Gemcitabine and Cisplatin
Serious events: 23 serious events
Other events: 38 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Pembrolizumab, Gemcitabine and Cisplatin
n=39 participants at risk
There is one arm in this study. Subjects will receive Pembrolizumab 200mg IV on day 1 in combination with cisplatin 35mg/m2 and gemcitabine 1000mg/m2 on day 1 and day 8 every 3 weeks for 4 cycles over 12 weeks.
pembrolizumab, gemcitabine and cisplatin: neoadjuvant administration of pembrolizumab with gemcitabine and cisplatin prior to cystectomy
|
|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
15.4%
6/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Gastrointestinal disorders
Constipation
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Investigations
Ejection fraction decreased
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.7%
3/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify- hematochezia
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.1%
2/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Infections and infestations
Infections and infestations - Other, specify pyelonephritis
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
General disorders
Infusion site extravasation
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify neobladder leak
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Infections and infestations
Kidney infection
|
5.1%
2/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify- new cancer
|
20.5%
8/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Investigations
Neutrophil count decreased
|
7.7%
3/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Vascular disorders
Peripheral ischemia
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Investigations
Platelet count decreased
|
12.8%
5/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Infections and infestations
Sepsis
|
5.1%
2/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Infections and infestations
Skin infection
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.1%
2/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Nervous system disorders
Stroke
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Vascular disorders
Thromboembolic event
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Infections and infestations
Wound infection
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
Other adverse events
| Measure |
Pembrolizumab, Gemcitabine and Cisplatin
n=39 participants at risk
There is one arm in this study. Subjects will receive Pembrolizumab 200mg IV on day 1 in combination with cisplatin 35mg/m2 and gemcitabine 1000mg/m2 on day 1 and day 8 every 3 weeks for 4 cycles over 12 weeks.
pembrolizumab, gemcitabine and cisplatin: neoadjuvant administration of pembrolizumab with gemcitabine and cisplatin prior to cystectomy
|
|---|---|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.1%
2/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Eye disorders
Eye disorders - Other, specify
|
5.1%
2/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
General disorders
Fatigue
|
48.7%
19/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
28.2%
11/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.6%
10/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Vascular disorders
Hypotension
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Endocrine disorders
Hypothyroidism
|
5.1%
2/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.1%
2/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
General disorders
Fever
|
12.8%
5/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Gastrointestinal disorders
Flatulence
|
5.1%
2/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
General disorders
Flu like symptoms
|
12.8%
5/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Nervous system disorders
Headache
|
5.1%
2/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Ear and labyrinth disorders
Hearing impaired
|
5.1%
2/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.7%
3/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.3%
4/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
15.4%
6/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Endocrine disorders
Hyperthyroidism
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
12.8%
5/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.3%
4/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.8%
5/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Renal and urinary disorders
Cystitis noninfective
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Psychiatric disorders
Depression
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Gastrointestinal disorders
Diarrhea
|
17.9%
7/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Nervous system disorders
Dizziness
|
17.9%
7/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Eye disorders
Dry eye
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Nervous system disorders
Dysgeusia
|
23.1%
9/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Gastrointestinal disorders
Dyspepsia
|
12.8%
5/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.9%
7/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
General disorders
Edema limbs
|
15.4%
6/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
69.2%
27/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Renal and urinary disorders
Acute kidney injury
|
12.8%
5/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Investigations
Alanine aminotransferase increased
|
10.3%
4/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Investigations
Alkaline phosphatase increased
|
7.7%
3/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Immune system disorders
Allergic reaction
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.8%
5/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Blood and lymphatic system disorders
Anemia
|
69.2%
27/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Metabolism and nutrition disorders
Anorexia
|
5.1%
2/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.8%
5/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Investigations
Aspartate aminotransferase increased
|
10.3%
4/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.3%
4/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Investigations
Cardiac troponin I increased
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Infections and infestations
Catheter related infection
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Cardiac disorders
Chest pain - cardiac
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
General disorders
Chills
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Gastrointestinal disorders
Constipation
|
28.2%
11/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.8%
5/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Investigations
Creatinine increased
|
28.2%
11/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
General disorders
Infusion site extravasation
|
7.7%
3/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Psychiatric disorders
Insomnia
|
5.1%
2/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Investigations
Investigations - Other, specify
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
General disorders
Localized edema
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Investigations
Lymphocyte count decreased
|
23.1%
9/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Nervous system disorders
Memory impairment
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Gastrointestinal disorders
Mucositis oral
|
10.3%
4/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
3/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Gastrointestinal disorders
Nausea
|
48.7%
19/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Investigations
Neutrophil count decreased
|
59.0%
23/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
General disorders
Non-cardiac chest pain
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
General disorders
Pain
|
5.1%
2/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Cardiac disorders
Palpitations
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Infections and infestations
Papulopustular rash
|
5.1%
2/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.1%
2/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.8%
5/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Vascular disorders
Phlebitis
|
7.7%
3/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Investigations
Platelet count decreased
|
66.7%
26/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Renal and urinary disorders
Proteinuria
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.4%
6/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Infections and infestations
Rash pustular
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Gastrointestinal disorders
Rectal pain
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Infections and infestations
Skin infection
|
5.1%
2/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Vascular disorders
Superficial thrombophlebitis
|
12.8%
5/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Nervous system disorders
Syncope
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Vascular disorders
Thromboembolic event
|
12.8%
5/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Ear and labyrinth disorders
Tinnitus
|
20.5%
8/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Infections and infestations
Upper respiratory infection
|
7.7%
3/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Renal and urinary disorders
Urinary frequency
|
7.7%
3/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Infections and infestations
Urinary tract infection
|
12.8%
5/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Injury, poisoning and procedural complications
Urostomy obstruction
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Vascular disorders
Vascular disorders - Other, specify
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Gastrointestinal disorders
Vomiting
|
17.9%
7/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Investigations
Weight loss
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Investigations
White blood cell decreased
|
66.7%
26/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
|
Injury, poisoning and procedural complications
Wound complication
|
2.6%
1/39 • 14 weeks of treatment plus cystectomy within 70 days after treatment plus 30 days for toxicity follow up (a total of approximately 28 weeks)
|
Additional Information
Robin V. Johnson
University of North Carolina Lineberger Comprehensive Cancer Center
Phone: 919-966-1125
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place