Trial Outcomes & Findings for Pembrolizumab With Combination Chemotherapy in Treating Participants With Locally Advanced or Metastatic Small Cell/Neuroendocrine Cancers of Urothelium or Prostate (NCT NCT03582475)

Last Updated: 2025-11-12

Results Overview

Durable Response Rate (DRR) defined as the proportion of patients who achieved a confirmed complete or partial response (CR or PR) and maintained that response for at least 6 months.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1

Target enrollment

15 participants

Primary outcome timeframe

At 6 months

Results posted on

2025-11-12

Participant Flow

This trial was opened for accrual with the first enrollment on January 11, 2019. The study closed to accrual on May 5, 2022.

Participant milestones

Participant milestones
Measure	Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1 (Cohort 1). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Docetaxel: Given IV Etoposide: Given IV Pembrolizumab: Given IV	Cohort 2: Small Cell or Neuroendocrine Prostate Cancer Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3, carboplatin IV on day 1, and docetaxel IV on day 1 (Cohort 2). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Treatment Period STARTED	7	8
Treatment Period COMPLETED	7	7
Treatment Period NOT COMPLETED	0	1
Follow-up Period STARTED	7	8
Follow-up Period COMPLETED	7	7
Follow-up Period NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1 (Cohort 1). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Docetaxel: Given IV Etoposide: Given IV Pembrolizumab: Given IV	Cohort 2: Small Cell or Neuroendocrine Prostate Cancer Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3, carboplatin IV on day 1, and docetaxel IV on day 1 (Cohort 2). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Treatment Period Withdrawal by Subject	0	1
Follow-up Period Withdrawal by Subject	0	1

Baseline Characteristics

Pembrolizumab With Combination Chemotherapy in Treating Participants With Locally Advanced or Metastatic Small Cell/Neuroendocrine Cancers of Urothelium or Prostate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer n=7 Participants Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1 (Cohort 1). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Docetaxel: Given IV Etoposide: Given IV Pembrolizumab: Given IV	Cohort 2: Small Cell or Neuroendocrine Prostate Cancer n=8 Participants Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3, carboplatin IV on day 1, and docetaxel IV on day 1 (Cohort 2). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Total n=15 Participants Total of all reporting groups
Age, Customized >50<=60 years	1 Participants n=10 Participants	3 Participants n=10 Participants	4 Participants n=20 Participants
Age, Customized >60<=70 years	3 Participants n=10 Participants	4 Participants n=10 Participants	7 Participants n=20 Participants
Age, Customized >70<=80 years	2 Participants n=10 Participants	1 Participants n=10 Participants	3 Participants n=20 Participants
Age, Customized >80 years	1 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants
Sex: Female, Male Female	1 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants
Sex: Female, Male Male	6 Participants n=10 Participants	8 Participants n=10 Participants	14 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=10 Participants	1 Participants n=10 Participants	2 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=10 Participants	7 Participants n=10 Participants	13 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Asian	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	0 Participants n=10 Participants	1 Participants n=10 Participants	1 Participants n=20 Participants
Race (NIH/OMB) White	7 Participants n=10 Participants	7 Participants n=10 Participants	14 Participants n=20 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Region of Enrollment United States	7 participants n=10 Participants	8 participants n=10 Participants	15 participants n=20 Participants

PRIMARY outcome

Timeframe: At 6 months

Population: one patient withdrew Cohort 2

Durable Response Rate (DRR) defined as the proportion of patients who achieved a confirmed complete or partial response (CR or PR) and maintained that response for at least 6 months.

Outcome measures

Outcome measures
Measure	Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer n=7 Participants Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1 (Cohort 1). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Docetaxel: Given IV Etoposide: Given IV Pembrolizumab: Given IV	Cohort 2: Small Cell or Neuroendocrine Prostate Cancer n=7 Participants Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3, carboplatin IV on day 1, and docetaxel IV on day 1 (Cohort 2). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Durable Response Rate (DRR) (Cohorts 1 and 2)	100 percentage of participants	66.7 percentage of participants

PRIMARY outcome

Timeframe: Up to 3 years

Population: one patient withdrew Cohort 2

Overall Response Rate (ORR) defined as patients by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 exhibited a complete or partial response (CR or PR). CR defined as disappearance of all target lesions. PR defined as \>= 30% decrease in sum of the longest diameter of target lesions. .

Outcome measures

Outcome measures
Measure	Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer n=7 Participants Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1 (Cohort 1). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Docetaxel: Given IV Etoposide: Given IV Pembrolizumab: Given IV	Cohort 2: Small Cell or Neuroendocrine Prostate Cancer n=7 Participants Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3, carboplatin IV on day 1, and docetaxel IV on day 1 (Cohort 2). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Cohorts 1 and 2)	0.43 proportion of participents	0.43 proportion of participents

PRIMARY outcome

Timeframe: From the first documented CR or PR up to 3 years

Population: one patient withdrew Cohort 2

Duration of Response (DOR) defined as the time from the first documented CR or PR until radiograph disease progression or Prostate-Specific Antigen (PSA) progression.

Outcome measures

Outcome measures
Measure	Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer n=7 Participants Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1 (Cohort 1). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Docetaxel: Given IV Etoposide: Given IV Pembrolizumab: Given IV	Cohort 2: Small Cell or Neuroendocrine Prostate Cancer n=7 Participants Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3, carboplatin IV on day 1, and docetaxel IV on day 1 (Cohort 2). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Duration of Response (DOR) Per RECIST 1.1 (Cohorts 1 and 2)	NA Months Median DOR is Not Available (NA) because none of the patients with a confirmed CR or PR had experienced radiographic or PSA progression at data cutoff. Over 50% remained progression-free, so the median could not be estimated.	12.6 Months Interval 3.15 to median, upper and lower bounds of 95% Confidence Interval could not be estimated due to insufficient number of participants with events

PRIMARY outcome

Timeframe: 12 months and 24 months.

Population: Proportion of Participants with Progression Free Survival at 12 and 24 Months was measured using sample size of each cohort and incidence of events to provide confidence intervals.

Progression Free Survival (PFS) defined as the time from the first day of study treatment to first documented disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesion(s).

Outcome measures

Outcome measures
Measure	Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer n=7 Participants Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1 (Cohort 1). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Docetaxel: Given IV Etoposide: Given IV Pembrolizumab: Given IV	Cohort 2: Small Cell or Neuroendocrine Prostate Cancer n=7 Participants Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3, carboplatin IV on day 1, and docetaxel IV on day 1 (Cohort 2). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Proportion of Participants With Progression Free Survival at 12 and 24 Months 12 months	0.86 Proportion of patients Interval 0.63 to 1.0	.43 Proportion of patients Interval 0.18 to 1.0
Proportion of Participants With Progression Free Survival at 12 and 24 Months 24 months	0.86 Proportion of patients Interval 0.63 to 1.0	0.14 Proportion of patients Interval 0.02 to 0.88

PRIMARY outcome

Timeframe: 12 months and 24 months.

Population: one patient withdrew Cohort 2

Overall Survival (OS) defined as the time from the first day of study treatment to the time of death from any cause.

Outcome measures

Outcome measures
Measure	Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer n=7 Participants Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1 (Cohort 1). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Docetaxel: Given IV Etoposide: Given IV Pembrolizumab: Given IV	Cohort 2: Small Cell or Neuroendocrine Prostate Cancer n=7 Participants Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3, carboplatin IV on day 1, and docetaxel IV on day 1 (Cohort 2). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Proportion of Participants With Overall Survival of Cohort 1 and 2 at 12 and 24 Months 12 months	0.86 Proportion of patients Interval 0.63 to 1.0	0.71 Proportion of patients Interval 0.45 to 1.0
Proportion of Participants With Overall Survival of Cohort 1 and 2 at 12 and 24 Months 24 months	0.86 Proportion of patients Interval 0.63 to 1.0	0.57 Proportion of patients Interval 0.3 to 1.0

PRIMARY outcome

Timeframe: 12 months and 24 months.

Population: The Primary outcome of Radiographic PFS (rPFS) with response criteria based off Prostate Cancer Working Group 3 (PCWG3) only applies to Prostate cancer patients enrolled into cohort 2. This criteria does not apply to Bladder cancer patients that enrolled in Cohort 1.

PCWG3 is specifically designed for prostate cancer and incorporates both soft tissue and bone response assessment. RECIST 1.1 is used for evaluating responses in solid tumors, while PCWG3 combines Response evaluation criteria in solid tumors (RECIST)1.1 for soft tissue assessment with specific criteria for bone scans. The PCWG3 response criteria was used to report the portion of participants with rPFS at their 12 and 24 month assessments.

Outcome measures

Outcome measures
Measure	Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1 (Cohort 1). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Docetaxel: Given IV Etoposide: Given IV Pembrolizumab: Given IV	Cohort 2: Small Cell or Neuroendocrine Prostate Cancer n=7 Participants Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3, carboplatin IV on day 1, and docetaxel IV on day 1 (Cohort 2). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Portion of Participants With Radiographic Progression-free Survival (rPFS) by Prostate Cancer Working Group 3 (PCWG3) at 12 and 24 Months (Cohort 2) 12 Months	—	.43 proportion of participants Interval 0.18 to 1.0
Portion of Participants With Radiographic Progression-free Survival (rPFS) by Prostate Cancer Working Group 3 (PCWG3) at 12 and 24 Months (Cohort 2) 24 Months	—	0.14 proportion of participants Interval 0.02 to 0.88

PRIMARY outcome

Timeframe: Up to 3 years

Outcome measures

Outcome measures
Measure	Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer n=7 Participants Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1 (Cohort 1). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Docetaxel: Given IV Etoposide: Given IV Pembrolizumab: Given IV	Cohort 2: Small Cell or Neuroendocrine Prostate Cancer n=7 Participants Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3, carboplatin IV on day 1, and docetaxel IV on day 1 (Cohort 2). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Percentage of Participants With Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (Cohorts 1 and 2) Grade 3 or higher	57 percentage of participants	25 percentage of participants
Percentage of Participants With Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (Cohorts 1 and 2) All Grades	100 percentage of participants	75 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: at 12 months

Population: PD-L1% (defined CPS\>10). combined positive score (CPS). CPS defined as number of PD-L1 staining cells in tumor, lymphocytes, and macrophages divided by total number viable tumor cells x 100.

Outcome measures

Outcome measures
Measure	Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer n=7 Participants Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1 (Cohort 1). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Docetaxel: Given IV Etoposide: Given IV Pembrolizumab: Given IV	Cohort 2: Small Cell or Neuroendocrine Prostate Cancer n=7 Participants Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3, carboplatin IV on day 1, and docetaxel IV on day 1 (Cohort 2). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Percentage of Participants With Programmed Death-ligand 1 (PD-L1) Combined Positive Score (CPS) Greater Than 10, at 12 Months	42.8 Percentage of patients with (CPS) > 10	37.5 Percentage of patients with (CPS) > 10

Adverse Events

Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer

Serious events: 7 serious events

Other events: 7 other events

Deaths: 3 deaths

Cohort 2: Small Cell or Neuroendocrine Prostate Cancer

Serious events: 7 serious events

Other events: 6 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer n=7 participants at risk Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1 (Cohort 1). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Docetaxel: Given IV Etoposide: Given IV Pembrolizumab: Given IV	Cohort 2: Small Cell or Neuroendocrine Prostate Cancer n=8 participants at risk Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3, carboplatin IV on day 1, and docetaxel IV on day 1 (Cohort 2). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Respiratory, thoracic and mediastinal disorders Aspiration pneumonia	0.00% 0/7 • Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.	12.5% 1/8 • Number of events 1 • Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.
Cardiac disorders Artirial Fibrilation	14.3% 1/7 • Number of events 1 • Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.	0.00% 0/8 • Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.
Gastrointestinal disorders Dysphagia	0.00% 0/7 • Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.	12.5% 1/8 • Number of events 1 • Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.
Metabolism and nutrition disorders Electrolyte Toxicity	14.3% 1/7 • Number of events 2 • Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.	0.00% 0/8 • Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.
General disorders Fatigue	14.3% 1/7 • Number of events 2 • Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.	0.00% 0/8 • Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.
Renal and urinary disorders Hydronephrosis	14.3% 1/7 • Number of events 1 • Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.	12.5% 1/8 • Number of events 1 • Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.
Cardiac disorders Myocardial infarction	0.00% 0/7 • Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.	12.5% 1/8 • Number of events 1 • Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.
Renal and urinary disorders Pyelonephritis	14.3% 1/7 • Number of events 1 • Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.	12.5% 1/8 • Number of events 1 • Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.
Nervous system disorders Seizure	0.00% 0/7 • Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.	12.5% 1/8 • Number of events 1 • Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.
Renal and urinary disorders Sepsis due to urinary tract infection	14.3% 1/7 • Number of events 1 • Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.	0.00% 0/8 • Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.
Renal and urinary disorders Urinary tract infection	0.00% 0/7 • Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.	12.5% 1/8 • Number of events 2 • Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.
Renal and urinary disorders Urinary tract obstruction	14.3% 1/7 • Number of events 1 • Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.	0.00% 0/8 • Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.

Other adverse events

Additional Information

Sara Rodriguez

UCLA / Department of Radiology

Phone: 310-794-2877

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place