Trial Outcomes & Findings for Pembrolizumab and Lenvatinib in Advanced/Metastatic Neuroendocrine Prostate Cancer (NCT NCT04848337)
NCT ID: NCT04848337
Last Updated: 2026-05-11
Results Overview
rPFS is defined as the date of treatment intiation to date of radiologic progression of soft tissue lesions per RECIST 1.1 or death whichever occurs first.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
6 months, with a 1-week window
Results posted on
2026-05-11
Participant Flow
Participant milestones
| Measure |
Study Treatment Arm
Lenvatinib 20 mg Orally Day1-21 with Pembrolizumab 200 mg Intravenously (IV) over 30 minutes Day 1. Each cycle = 21 days
Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
Lenvatinib: Lenvatinib 20 mg orally daily.
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Study Treatment Arm
Lenvatinib 20 mg Orally Day1-21 with Pembrolizumab 200 mg Intravenously (IV) over 30 minutes Day 1. Each cycle = 21 days
Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
Lenvatinib: Lenvatinib 20 mg orally daily.
|
|---|---|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Death
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Symptomatic Deterioration
|
2
|
|
Overall Study
Travel limitations due to natural disaster
|
1
|
Baseline Characteristics
Pembrolizumab and Lenvatinib in Advanced/Metastatic Neuroendocrine Prostate Cancer
Baseline characteristics by cohort
| Measure |
Study Treatment Arm
n=45 Participants
Lenvatinib 20 mg Orally Day1-21 with Pembrolizumab 200 mg Intravenously (IV) over 30 minutes Day 1. Each cycle = 21 days
Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
Lenvatinib: Lenvatinib 20 mg orally daily.
|
|---|---|
|
Age, Customized
|
69 years
n=44 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=44 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=44 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=44 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=44 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=44 Participants
|
PRIMARY outcome
Timeframe: 6 months, with a 1-week windowrPFS is defined as the date of treatment intiation to date of radiologic progression of soft tissue lesions per RECIST 1.1 or death whichever occurs first.
Outcome measures
| Measure |
Study Treatment Arm
n=45 Participants
Lenvatinib 20 mg Orally Day1-21 with Pembrolizumab 200 mg Intravenously (IV) over 30 minutes Day 1. Each cycle = 21 days
Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
Lenvatinib: Lenvatinib 20 mg orally daily.
|
|---|---|
|
Radiologic Progression Free Survival (rPFS)
|
4.0 months
Interval 3.4 to 6.2
|
SECONDARY outcome
Timeframe: 2 yearsFrequency and severity of adverse events as measured by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsOverall survival (OS) will be measured from date of registration to date of death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsORR will be the proportion of patients achieving either a complete response or a partial response
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsDOR will be measured from the start date of the best response achieved until the date of relapse
Outcome measures
Outcome data not reported
Adverse Events
Study Treatment Arm
Serious events: 39 serious events
Other events: 45 other events
Deaths: 39 deaths
Serious adverse events
| Measure |
Study Treatment Arm
n=45 participants at risk
Lenvatinib 20 mg Orally Day1-21 with Pembrolizumab 200 mg Intravenously (IV) over 30 minutes Day 1. Each cycle = 21 days
Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
Lenvatinib: Lenvatinib 20 mg orally daily.
|
|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
11.1%
5/45 • Number of events 5 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
|
Investigations
Creatinine increased
|
2.2%
1/45 • Number of events 1 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
3/45 • Number of events 3 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.2%
1/45 • Number of events 1 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
|
General disorders
Fatigue
|
28.9%
13/45 • Number of events 13 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
|
Cardiac disorders
Hypertension
|
22.2%
10/45 • Number of events 10 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
|
Gastrointestinal disorders
Mucositis oral
|
4.4%
2/45 • Number of events 2 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
|
Endocrine disorders
Adrenal insufficiency
|
4.4%
2/45 • Number of events 2 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
|
Investigations
Aspartate aminotransferase increased
|
4.4%
2/45 • Number of events 2 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
Other adverse events
| Measure |
Study Treatment Arm
n=45 participants at risk
Lenvatinib 20 mg Orally Day1-21 with Pembrolizumab 200 mg Intravenously (IV) over 30 minutes Day 1. Each cycle = 21 days
Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
Lenvatinib: Lenvatinib 20 mg orally daily.
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
22.2%
10/45 • Number of events 10 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
|
Investigations
Aspartate aminotransferase increased
|
22.2%
10/45 • Number of events 10 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
26.7%
12/45 • Number of events 12 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
|
Metabolism and nutrition disorders
Anorexia
|
60.0%
27/45 • Number of events 27 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
|
Infections and infestations
Creatinine increased
|
13.3%
6/45 • Number of events 6 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.9%
4/45 • Number of events 4 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
|
Gastrointestinal disorders
Diarrhea
|
57.8%
26/45 • Number of events 26 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
|
Nervous system disorders
Dizziness
|
28.9%
13/45 • Number of events 13 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
|
Metabolism and nutrition disorders
Dysguesia
|
13.3%
6/45 • Number of events 6 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
24.4%
11/45 • Number of events 11 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
4.4%
2/45 • Number of events 2 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
|
General disorders
Fatigue
|
91.1%
41/45 • Number of events 41 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
|
Cardiac disorders
Hypertension
|
24.4%
11/45 • Number of events 11 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
|
Endocrine disorders
Hypothyroidism
|
35.6%
16/45 • Number of events 16 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
|
Gastrointestinal disorders
Mucositis oral
|
20.0%
9/45 • Number of events 9 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
|
Gastrointestinal disorders
Nausea
|
62.2%
28/45 • Number of events 28 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
|
Renal and urinary disorders
Proteinuria
|
11.1%
5/45 • Number of events 5 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
24.4%
11/45 • Number of events 11 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia
|
11.1%
5/45 • Number of events 5 • Adverse Events were captured from the time of informed consent until 30 days after discontinuation of study drug. Information is still being collected; however, below data of treatment related adverse events were collected over the first 50 months of the study.
|
Additional Information
University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin
University of Michigan Rogel Cancer Center
Phone: 734-936-9499
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place