Trial Outcomes & Findings for Pembrolizumab and Lenvatinib in Patients With Brain Metastases From Melanoma or Renal Cell Carcinoma (NCT NCT04955743)
NCT ID: NCT04955743
Last Updated: 2026-06-04
Results Overview
Best brain metastasis response rate (BMRR), defined as PR (Partial Response: 30% or greater decrease in sum of diameter \[sum of longest dimension\]) and CR (Complete Response: disappearance of all target lesions) per modified RECIST 1.1. Tumor categories not included in BMRR include SD (Stable Disease: insufficient shrinkage to qualify for PR) and PD (Progressive Disease: 20% or greater increase in sum of diameter relative to the nadir (smallest sum recorded).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
up to 2 years from the start of treatment
Results posted on
2026-06-04
Participant Flow
Participant milestones
| Measure |
Cohort 1: Melanoma
Participants who are melanoma (PD-1/PD-L1-experienced)
Pembrolizumab: 200 mg intravenous (IV) is administered every 3 weeks
Lenvatinib: 20 mg orally (PO) is administered daily
|
Cohort 2: Renal Cell Carcinoma
Participants who are Renal Cell Carcinoma (PD-1/PD-L1 experienced).
Pembrolizumab: 200 mg intravenous (IV) is administered every 3 weeks
Lenvatinib: 20 mg orally (PO) is administered daily
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
2
|
|
Overall Study
COMPLETED
|
16
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab and Lenvatinib in Patients With Brain Metastases From Melanoma or Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Cohort 1: Melanoma
n=16 Participants
Participants who are melanoma (PD-1/PD-L1-experienced)
Pembrolizumab: 200 mg intravenous (IV) is administered every 3 weeks
Lenvatinib: 20 mg orally (PO) is administered daily
|
Cohort 2: Renal Cell Carcinoma
n=2 Participants
Participants who are Renal Cell Carcinoma (PD-1/PD-L1 experienced).
Pembrolizumab: 200 mg intravenous (IV) is administered every 3 weeks
Lenvatinib: 20 mg orally (PO) is administered daily
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 9.6 • n=9 Participants
|
70.1 years
STANDARD_DEVIATION 22.1 • n=27 Participants
|
65.5 years
STANDARD_DEVIATION 10.9 • n=267 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
13 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
18 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
17 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=9 Participants
|
2 participants
n=27 Participants
|
18 participants
n=267 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
11 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
12 Participants
n=267 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
5 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: up to 2 years from the start of treatmentBest brain metastasis response rate (BMRR), defined as PR (Partial Response: 30% or greater decrease in sum of diameter \[sum of longest dimension\]) and CR (Complete Response: disappearance of all target lesions) per modified RECIST 1.1. Tumor categories not included in BMRR include SD (Stable Disease: insufficient shrinkage to qualify for PR) and PD (Progressive Disease: 20% or greater increase in sum of diameter relative to the nadir (smallest sum recorded).
Outcome measures
| Measure |
Cohort 1: Melanoma
n=16 Participants
Participants who are melanoma (PD-1/PD-L1-experienced)
Pembrolizumab: 200 mg intravenous (IV) is administered every 3 weeks
Lenvatinib: 20 mg orally (PO) is administered daily
|
Cohort 2: Renal Cell Carcinoma
n=2 Participants
Participants who are Renal Cell Carcinoma (PD-1/PD-L1 experienced).
Pembrolizumab: 200 mg intravenous (IV) is administered every 3 weeks
Lenvatinib: 20 mg orally (PO) is administered daily
|
|---|---|---|
|
Best Brain Metastasis Response Rate (BMRR)
PR
|
0 Participants
|
0 Participants
|
|
Best Brain Metastasis Response Rate (BMRR)
CR
|
1 Participants
|
1 Participants
|
|
Best Brain Metastasis Response Rate (BMRR)
SD
|
2 Participants
|
1 Participants
|
|
Best Brain Metastasis Response Rate (BMRR)
PD
|
9 Participants
|
0 Participants
|
|
Best Brain Metastasis Response Rate (BMRR)
Not Evaluable
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 2 years from the start of treatmentBest overall objective response rate, defined as Partial Response (Partial Response: 30% or greater decrease in sum of diameter \[sum of longest dimension\]) and CR (Complete Response: disappearance of all target lesions) per modified RECIST 1.1.
Outcome measures
| Measure |
Cohort 1: Melanoma
n=16 Participants
Participants who are melanoma (PD-1/PD-L1-experienced)
Pembrolizumab: 200 mg intravenous (IV) is administered every 3 weeks
Lenvatinib: 20 mg orally (PO) is administered daily
|
Cohort 2: Renal Cell Carcinoma
n=2 Participants
Participants who are Renal Cell Carcinoma (PD-1/PD-L1 experienced).
Pembrolizumab: 200 mg intravenous (IV) is administered every 3 weeks
Lenvatinib: 20 mg orally (PO) is administered daily
|
|---|---|---|
|
Best Overall Objective Response Rate
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: u up to 2 years from the start of treatment or to time of disease progressionPopulation: Patients with measurable disease at baseline who have received at least one treatment dose and have at least one post-baseline efficacy assessment, per RECIST 1.1 guidelines.
PFS, defined as the time from start of study drug administration to the date of the first documentation of disease progression or death from any cause, whichever occurs first.
Outcome measures
| Measure |
Cohort 1: Melanoma
n=16 Participants
Participants who are melanoma (PD-1/PD-L1-experienced)
Pembrolizumab: 200 mg intravenous (IV) is administered every 3 weeks
Lenvatinib: 20 mg orally (PO) is administered daily
|
Cohort 2: Renal Cell Carcinoma
n=2 Participants
Participants who are Renal Cell Carcinoma (PD-1/PD-L1 experienced).
Pembrolizumab: 200 mg intravenous (IV) is administered every 3 weeks
Lenvatinib: 20 mg orally (PO) is administered daily
|
|---|---|---|
|
Progression Free Survival (PFS)
|
2.1 months
Interval 0.0 to 24.0
|
9.6 months
Interval 8.0 to 11.0
|
SECONDARY outcome
Timeframe: up to 2 years from the start of treatment or to time of deathPopulation: Patients with solid tumors and measurable disease at baseline, as defined by RECIST 1.1., censored at 2 years
OS, defined as the time from start of study drug administration to date of death from any cause.
Outcome measures
| Measure |
Cohort 1: Melanoma
n=16 Participants
Participants who are melanoma (PD-1/PD-L1-experienced)
Pembrolizumab: 200 mg intravenous (IV) is administered every 3 weeks
Lenvatinib: 20 mg orally (PO) is administered daily
|
Cohort 2: Renal Cell Carcinoma
n=2 Participants
Participants who are Renal Cell Carcinoma (PD-1/PD-L1 experienced).
Pembrolizumab: 200 mg intravenous (IV) is administered every 3 weeks
Lenvatinib: 20 mg orally (PO) is administered daily
|
|---|---|---|
|
Overall Survival (OS)
|
5.4 months
Interval 1.2 to 24.0
|
17.5 months
Interval 11.0 to 24.0
|
SECONDARY outcome
Timeframe: up to 2 years from the start of treatmentPopulation: Patients who experienced a PR (Partial Response: 30% or greater decrease in sum of diameter \[sum of longest dimension\]) or CR (Complete Response: disappearance of all target lesions) per modified RECIST 1.1.
Duration of brain metastasis response, defined as the time from response to the time of the first documentation of intracranial disease progression.
Outcome measures
| Measure |
Cohort 1: Melanoma
n=4 Participants
Participants who are melanoma (PD-1/PD-L1-experienced)
Pembrolizumab: 200 mg intravenous (IV) is administered every 3 weeks
Lenvatinib: 20 mg orally (PO) is administered daily
|
Cohort 2: Renal Cell Carcinoma
n=2 Participants
Participants who are Renal Cell Carcinoma (PD-1/PD-L1 experienced).
Pembrolizumab: 200 mg intravenous (IV) is administered every 3 weeks
Lenvatinib: 20 mg orally (PO) is administered daily
|
|---|---|---|
|
Duration of Brain Metastasis Response
|
6.9 months
Interval 0.0 to 22.2
|
11.8 months
Interval 2.8 to 20.7
|
Adverse Events
Cohort 1: Melanoma
Serious events: 9 serious events
Other events: 12 other events
Deaths: 7 deaths
Cohort 2: Renal Cell Carcinoma
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort 1: Melanoma
n=16 participants at risk
Participants who are melanoma (PD-1/PD-L1-experienced)
Pembrolizumab: 200 mg intravenous (IV) is administered every 3 weeks
Lenvatinib: 20 mg orally (PO) is administered daily
|
Cohort 2: Renal Cell Carcinoma
n=2 participants at risk
Participants who are Renal Cell Carcinoma (PD-1/PD-L1 experienced).
Pembrolizumab: 200 mg intravenous (IV) is administered every 3 weeks
Lenvatinib: 20 mg orally (PO) is administered daily
|
|---|---|---|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/16 • Up to 26 months
|
50.0%
1/2 • Number of events 1 • Up to 26 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
General disorders and administration site conditions
Bilateral Lower extremity Edema
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
General disorders and administration site conditions
Fever
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
General disorders and administration site conditions
Right Lower Extremity Edema
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Investigations
Blood Bilirubin Increased
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Investigations
Creatinine Increased
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Investigations
Elevated Bilirubin
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Investigations
Increased Bilirubin
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Musculoskeletal and connective tissue disorders
Femur Fracture
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Musculoskeletal and connective tissue disorders
Pain- Back
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Hemorrhage
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Nervous system disorders
Confusion
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Nervous system disorders
Intercranial Hemorrage
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Nervous system disorders
Intracranial Hemorrage
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Nervous system disorders
Memory Impairment
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/16 • Up to 26 months
|
50.0%
1/2 • Number of events 1 • Up to 26 months
|
|
Nervous system disorders
Seizure
|
12.5%
2/16 • Number of events 2 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Nervous system disorders
Weakness-Extremity
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Psychiatric disorders
Delerium
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection-aspiration punumonia
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
Other adverse events
| Measure |
Cohort 1: Melanoma
n=16 participants at risk
Participants who are melanoma (PD-1/PD-L1-experienced)
Pembrolizumab: 200 mg intravenous (IV) is administered every 3 weeks
Lenvatinib: 20 mg orally (PO) is administered daily
|
Cohort 2: Renal Cell Carcinoma
n=2 participants at risk
Participants who are Renal Cell Carcinoma (PD-1/PD-L1 experienced).
Pembrolizumab: 200 mg intravenous (IV) is administered every 3 weeks
Lenvatinib: 20 mg orally (PO) is administered daily
|
|---|---|---|
|
General disorders and administration site conditions
Right Lower Extremity Edema
|
6.2%
1/16 • Number of events 2 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
General disorders and administration site conditions
Sinus Pain (Intermittent)
|
0.00%
0/16 • Up to 26 months
|
50.0%
1/2 • Number of events 1 • Up to 26 months
|
|
General disorders and administration site conditions
Vomitting
|
0.00%
0/16 • Up to 26 months
|
50.0%
1/2 • Number of events 1 • Up to 26 months
|
|
General disorders and administration site conditions
Weight Loss
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Immune system disorders
Arthralgia
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
50.0%
1/2 • Number of events 1 • Up to 26 months
|
|
Infections and infestations
Cough
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Infections and infestations
Covid-19
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Investigations
ALT Elevated
|
6.2%
1/16 • Number of events 2 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Investigations
ALT Increase
|
6.2%
1/16 • Number of events 2 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Investigations
ALT Increased
|
6.2%
1/16 • Number of events 6 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Investigations
ANC Decreased
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Investigations
AST Elevated
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Investigations
AST Increase
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Investigations
AST Increased
|
6.2%
1/16 • Number of events 4 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Investigations
Platelet Count Decreased
|
6.2%
1/16 • Number of events 2 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Investigations
WBC Count Decrease
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Metabolism and nutrition disorders
Anorexia
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
50.0%
1/2 • Number of events 1 • Up to 26 months
|
|
Metabolism and nutrition disorders
Anorexia (Intermittent)
|
0.00%
0/16 • Up to 26 months
|
50.0%
1/2 • Number of events 1 • Up to 26 months
|
|
Metabolism and nutrition disorders
Diabetes
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/16 • Up to 26 months
|
50.0%
1/2 • Number of events 1 • Up to 26 months
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.5%
2/16 • Number of events 3 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness- left knee
|
0.00%
0/16 • Up to 26 months
|
50.0%
1/2 • Number of events 1 • Up to 26 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia (Intermittent)
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Nervous system disorders
Confusion
|
6.2%
1/16 • Number of events 3 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Nervous system disorders
Dysarthria
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
50.0%
1/2 • Number of events 1 • Up to 26 months
|
|
Nervous system disorders
Dysgeusia (Intermittent)
|
0.00%
0/16 • Up to 26 months
|
50.0%
1/2 • Number of events 1 • Up to 26 months
|
|
Nervous system disorders
Headache
|
12.5%
2/16 • Number of events 3 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Nervous system disorders
Headache- Intermittent
|
12.5%
2/16 • Number of events 2 • Up to 26 months
|
50.0%
1/2 • Number of events 2 • Up to 26 months
|
|
Nervous system disorders
Intermittent seizure activity
|
0.00%
0/16 • Up to 26 months
|
50.0%
1/2 • Number of events 1 • Up to 26 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/16 • Up to 26 months
|
50.0%
1/2 • Number of events 1 • Up to 26 months
|
|
Nervous system disorders
Seizure Activity
|
0.00%
0/16 • Up to 26 months
|
50.0%
1/2 • Number of events 1 • Up to 26 months
|
|
Nervous system disorders
Seizure Activity (Intermittent)
|
0.00%
0/16 • Up to 26 months
|
50.0%
1/2 • Number of events 1 • Up to 26 months
|
|
Nervous system disorders
Tremor
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Nervous system disorders
Word Finding dificulty
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Psychiatric disorders
Insomnia (intermittent)
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Renal and urinary disorders
Proteinura
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Renal and urinary disorders
Proteinuria
|
12.5%
2/16 • Number of events 14 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Renal and urinary disorders
Urinary Retention
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Respiratory, thoracic and mediastinal disorders
hoarseness
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Skin and subcutaneous tissue disorders
Calloses bottom of feet bilateral
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythodysethesia syndrome
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
12.5%
2/16 • Number of events 2 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.8%
3/16 • Number of events 3 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Skin and subcutaneous tissue disorders
Skin Infection (Scrotum)
|
0.00%
0/16 • Up to 26 months
|
50.0%
1/2 • Number of events 1 • Up to 26 months
|
|
Skin and subcutaneous tissue disorders
Viral infection- shingles
|
0.00%
0/16 • Up to 26 months
|
50.0%
1/2 • Number of events 1 • Up to 26 months
|
|
Vascular disorders
Hypertension
|
25.0%
4/16 • Number of events 5 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Vascular disorders
Pulmonary Embolism
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
General disorders and administration site conditions
Fall
|
12.5%
2/16 • Number of events 2 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
General disorders and administration site conditions
Fatigue
|
37.5%
6/16 • Number of events 6 • Up to 26 months
|
100.0%
2/2 • Number of events 3 • Up to 26 months
|
|
General disorders and administration site conditions
Oral Pain
|
0.00%
0/16 • Up to 26 months
|
50.0%
1/2 • Number of events 1 • Up to 26 months
|
|
General disorders and administration site conditions
Fatigue (intermittent)
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
50.0%
1/2 • Number of events 1 • Up to 26 months
|
|
General disorders and administration site conditions
Flu Like Symptoms
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
General disorders and administration site conditions
Gait disturbance
|
0.00%
0/16 • Up to 26 months
|
50.0%
1/2 • Number of events 1 • Up to 26 months
|
|
General disorders and administration site conditions
Left Lower Extremity Edema
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
General disorders and administration site conditions
Mucostis
|
0.00%
0/16 • Up to 26 months
|
50.0%
1/2 • Number of events 1 • Up to 26 months
|
|
General disorders and administration site conditions
Oral hemorrhage (mild possible nasal drainage)
|
0.00%
0/16 • Up to 26 months
|
50.0%
1/2 • Number of events 1 • Up to 26 months
|
|
Gastrointestinal disorders
Vomitting
|
18.8%
3/16 • Number of events 3 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
General disorders and administration site conditions
Bilateral Lower extremity Edema
|
0.00%
0/16 • Up to 26 months
|
50.0%
1/2 • Number of events 1 • Up to 26 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/16 • Up to 26 months
|
50.0%
1/2 • Number of events 3 • Up to 26 months
|
|
Endocrine disorders
Hypothyroidism
|
25.0%
4/16 • Number of events 4 • Up to 26 months
|
100.0%
2/2 • Number of events 2 • Up to 26 months
|
|
Eye disorders
Blurred Vision
|
12.5%
2/16 • Number of events 2 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Eye disorders
Eye disorder other- diplopia
|
6.2%
1/16 • Number of events 2 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Eye disorders
Eye Pain
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Eye disorders
Left orbital wound complication with discharge
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Gastrointestinal disorders
Constipation - Intermittent
|
12.5%
2/16 • Number of events 2 • Up to 26 months
|
50.0%
1/2 • Number of events 1 • Up to 26 months
|
|
Gastrointestinal disorders
Diarhea
|
6.2%
1/16 • Number of events 2 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
2/16 • Number of events 5 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Gastrointestinal disorders
Diarrhea - Intermittent
|
25.0%
4/16 • Number of events 5 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Gastrointestinal disorders
GERD
|
12.5%
2/16 • Number of events 2 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
6.2%
1/16 • Number of events 2 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Gastrointestinal disorders
Intermittent Nausea
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Gastrointestinal disorders
Mouth Pain
|
0.00%
0/16 • Up to 26 months
|
50.0%
1/2 • Number of events 2 • Up to 26 months
|
|
Gastrointestinal disorders
Mucositis
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Gastrointestinal disorders
Mucositis (Oral)
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Gastrointestinal disorders
Mucostitis
|
6.2%
1/16 • Number of events 1 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
|
Gastrointestinal disorders
Nausea
|
12.5%
2/16 • Number of events 2 • Up to 26 months
|
0.00%
0/2 • Up to 26 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place