Trial Outcomes & Findings for Perioperative Lenvatinib With Pembrolizumab in Patients With Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma (NCT NCT04393350)
NCT ID: NCT04393350
Last Updated: 2026-04-20
Results Overview
Will assess the proportion of patients with a reduction in overall tumor burden from baseline after 12 weeks of treatment with neoadjuvant lenvatinib and pembrolizumab.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Baseline until end of Cycle 1 (4 Cycles (12 weeks)
Results posted on
2026-04-20
Participant Flow
Participant milestones
| Measure |
Treatment (Lenvatinib, Pembrolizumab)
Patients receive lenvatinib PO QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatments repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Lenvatinib: Given PO
Lenvatinib Mesylate: Given PO
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Lenvatinib, Pembrolizumab)
Patients receive lenvatinib PO QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatments repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Lenvatinib: Given PO
Lenvatinib Mesylate: Given PO
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Perioperative Lenvatinib With Pembrolizumab in Patients With Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Treatment (Lenvatinib, Pembrolizumab)
n=18 Participants
Patients receive lenvatinib PO QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatments repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Lenvatinib: Given PO
Lenvatinib Mesylate: Given PO
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=129 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=129 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=129 Participants
|
|
Age, Continuous
|
64.5 Years
STANDARD_DEVIATION 12.6 • n=129 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=129 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=129 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=129 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=129 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=129 Participants
|
PRIMARY outcome
Timeframe: Baseline until end of Cycle 1 (4 Cycles (12 weeks)Will assess the proportion of patients with a reduction in overall tumor burden from baseline after 12 weeks of treatment with neoadjuvant lenvatinib and pembrolizumab.
Outcome measures
| Measure |
Treatment (Lenvatinib, Pembrolizumab)
n=17 Participants
Patients receive lenvatinib PO QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatments repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Lenvatinib: Given PO
Lenvatinib Mesylate: Given PO
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Objective Response Rate (Complete and Partial Responses)
Complete response
|
0 Proportion of participants
Interval 0.0 to 0.0
|
|
Objective Response Rate (Complete and Partial Responses)
Partial Response
|
.176 Proportion of participants
Interval 0.0 to 0.358
|
|
Objective Response Rate (Complete and Partial Responses)
Stable Disease
|
.824 Proportion of participants
Interval 0.641 to 0.999
|
|
Objective Response Rate (Complete and Partial Responses)
Progression
|
0 Proportion of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: From treatment phase up to 14 day post treatmentAdverse events will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The safety profile of the treatment will be documented and summarized by summary statistics as frequency and percentage for each AE.
Outcome measures
| Measure |
Treatment (Lenvatinib, Pembrolizumab)
n=18 Participants
Patients receive lenvatinib PO QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatments repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Lenvatinib: Given PO
Lenvatinib Mesylate: Given PO
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Incidence of Adverse Events (AEs)
Fatigue, any grade
|
15 participants
|
|
Incidence of Adverse Events (AEs)
Fatigue, ≥Grade 3
|
0 participants
|
|
Incidence of Adverse Events (AEs)
Hypertension, Any Grade
|
10 participants
|
|
Incidence of Adverse Events (AEs)
Hypertension, ≥Grade 3
|
7 participants
|
|
Incidence of Adverse Events (AEs)
Hypothyroidism, Any Grade
|
10 participants
|
|
Incidence of Adverse Events (AEs)
Hypothyroidism, ≥Grade 3
|
0 participants
|
|
Incidence of Adverse Events (AEs)
Palmar-Plantar Erythrodysesthesia Syndrome, Any Grade
|
9 participants
|
|
Incidence of Adverse Events (AEs)
Palmar-Plantar Erythrodysesthesia Syndrome, ≥Grade 3
|
0 participants
|
|
Incidence of Adverse Events (AEs)
Diarrhea, Any Grade
|
8 participants
|
|
Incidence of Adverse Events (AEs)
Diarrhea, ≥Grade 3
|
0 participants
|
|
Incidence of Adverse Events (AEs)
Anorexia, Any Grade
|
7 participants
|
|
Incidence of Adverse Events (AEs)
Anorexia, ≥Grade 3
|
0 participants
|
|
Incidence of Adverse Events (AEs)
Mucositis Oral, Any Grade
|
7 participants
|
|
Incidence of Adverse Events (AEs)
Mucositis Oral, ≥Grade 3
|
0 participants
|
|
Incidence of Adverse Events (AEs)
Nausea, Any Grade
|
7 participants
|
|
Incidence of Adverse Events (AEs)
Nausea, ≥Grade 3
|
2 participants
|
|
Incidence of Adverse Events (AEs)
Proteinuria, Any Grade
|
7 participants
|
|
Incidence of Adverse Events (AEs)
Proteinuria, ≥Grade 3
|
2 participants
|
SECONDARY outcome
Timeframe: 1 and 3 yearsOS will be estimated with the Kaplan-Meier method. The OS of each patient group at specific time points such as 6 months, 1 year, 3 years, etc. and will be also estimated alone with 95% confidence interval (CI).
Outcome measures
| Measure |
Treatment (Lenvatinib, Pembrolizumab)
n=18 Participants
Patients receive lenvatinib PO QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatments repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Lenvatinib: Given PO
Lenvatinib Mesylate: Given PO
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Overall Survival (OS)
1-year OS rate
|
0.933 Proportion of participants
Interval 0.824 to 0.999
|
|
Overall Survival (OS)
3-year OS rate
|
0.933 Proportion of participants
Interval 0.824 to 0.999
|
SECONDARY outcome
Timeframe: 1 & 3 yearsDFS will be estimated with the Kaplan-Meier method. The DFS of each patient group at specific time points such as 6 months, 1 year, 3 years, etc. and will be also estimated alone with 95% CI.
Outcome measures
| Measure |
Treatment (Lenvatinib, Pembrolizumab)
n=18 Participants
Patients receive lenvatinib PO QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatments repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Lenvatinib: Given PO
Lenvatinib Mesylate: Given PO
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Disease Free Survival (DFS)
1-year DFS rate
|
0.933 Proportion of participants
Interval 0.824 to 0.999
|
|
Disease Free Survival (DFS)
3-year DFS rate
|
0.778 Proportion of participants
Interval 0.48 to 0.999
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 4 years after study startPaired t-test or Wilcoxon singed-rank test will be used to compare the biomarkers change before, during, and after treatment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 4 years after study startQOL will be assessed using the Functional Assessment of Cancer Therapy-Kidney Specific Index-19 (FKSI-19) questionnaire. Summary statistics will be applied to all items in the measurements for quality of life. The KSI-19 is an experimental end point. The minimum and maximum values and whether higher scores mean a better or worse outcome will be determined once data is collected. Scores (0=worst, 76=best)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 4 years after study startWill be assessed using the using the Fried Frailty score. Summary statistics will be applied to all items in the measurements for frailty. The Fried Frailty Score is an experimental end point. The minimum and maximum values and whether higher scores mean a better or worse outcome will be determined once data is collected.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 4 years after study startWill assess pre-and post-treatment imaging via SliceOmatic version (V) 5.0 by TomoVision program. Summary statistics will be applied to all items in the measurements for degree of sarcopenia.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Lenvatinib, Pembrolizumab)
Serious events: 2 serious events
Other events: 18 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment (Lenvatinib, Pembrolizumab)
n=18 participants at risk
Patients receive lenvatinib PO QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatments repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Lenvatinib: Given PO
Lenvatinib Mesylate: Given PO
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Vascular disorders
Thromboembolic event
|
5.6%
1/18 • Number of events 1 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Investigations
CPK Increased (Autoimmune Rhabdomyolysis)
|
5.6%
1/18 • Number of events 1 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
Other adverse events
| Measure |
Treatment (Lenvatinib, Pembrolizumab)
n=18 participants at risk
Patients receive lenvatinib PO QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatments repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Lenvatinib: Given PO
Lenvatinib Mesylate: Given PO
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Gastrointestinal disorders
anal pain
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
3/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
38.9%
7/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Psychiatric disorders
Anxiety
|
11.1%
2/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
38.9%
7/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
16.7%
3/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
22.2%
4/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Immune system disorders
Autoimmune disorder
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
6/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Gastrointestinal disorders
Bloating
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Investigations
Blood bilirubin increased
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Eye disorders
Blurred vision
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Blood and lymphatic system disorders
capillary bleeding in the scrotum
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Investigations
Cardiac troponin I increased
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
General disorders
Chills
|
11.1%
2/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Renal and urinary disorders
Chronic kidney disease
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Nervous system disorders
Cognitive disturbance
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Nervous system disorders
Concentration impairment
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
33.3%
6/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
44.4%
8/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Infections and infestations
COVID-19
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Investigations
CPK increased
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Investigations
Creatinine increased
|
22.2%
4/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Renal and urinary disorders
Cystitis noninfective
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Gastrointestinal disorders
Dark, tar-like stools
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Psychiatric disorders
Delirium
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Gastrointestinal disorders
Dental caries
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Psychiatric disorders
Depression
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
44.4%
8/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Gastrointestinal disorders
Diverticulosis
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Nervous system disorders
Dizziness
|
11.1%
2/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Nervous system disorders
Dysgeusia
|
11.1%
2/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
27.8%
5/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Renal and urinary disorders
Dysuria
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
General disorders
Edema limbs
|
16.7%
3/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
General disorders
Fatigue
|
83.3%
15/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
General disorders
Fever
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Gastrointestinal disorders
Flatulence
|
11.1%
2/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Gastrointestinal disorders
Gingival pain
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Nervous system disorders
Headache
|
38.9%
7/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Ear and labyrinth disorders
Hearing impaired
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Renal and urinary disorders
Hematuria
|
16.7%
3/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Gastrointestinal disorders
Hemorrhoids
|
11.1%
2/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
22.2%
4/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Vascular disorders
Hot flashes
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.1%
2/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Vascular disorders
Hypertension
|
61.1%
11/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Endocrine disorders
Hyperthyroidism
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.1%
2/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
2/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Endocrine disorders
Hypothyroidism
|
55.6%
10/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Infections and infestations
Other - C. difficile infection
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Psychiatric disorders
Insomnia
|
16.7%
3/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
General disorders
Irritability
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Blood and lymphatic system disorders
Leukocytosis
|
11.1%
2/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Investigations
Lipase increased
|
27.8%
5/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Immune system disorders
Other - Lower back pain
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Nervous system disorders
Memory impairment
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Gastrointestinal disorders
Mucositis oral
|
38.9%
7/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramps/Muscle Spasms
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
3/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Infections and infestations
Nail infection
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.1%
2/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
50.0%
9/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Eye disorders
Night blindness
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Renal and urinary disorders
Nocturia
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
General disorders
Non-cardiac chest pain
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Gastrointestinal disorders
Oral dysesthesia
|
11.1%
2/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Blood and lymphatic system disorders
Oral hemorrhage
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Gastrointestinal disorders
Oral pain
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnea
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
General disorders
Pain
|
11.1%
2/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
50.0%
9/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Immune system disorders
Pembro reaction: Lower back and abdominal pain
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
11.1%
2/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Renal and urinary disorders
Proteinuria
|
38.9%
7/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
11.1%
2/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo - papular
|
22.2%
4/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Gastrointestinal disorders
Rectal hemorrhage (hemorrhoids)
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Gastrointestinal disorders
Rectal pain
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify (Med Hx of nocturia,
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Nervous system disorders
Restless Leg Syndrome
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Investigations
Serum amylase increased
|
11.1%
2/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Infections and infestations
Sinusitis
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Infections and infestations
Skin infection
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
11.1%
2/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Gastrointestinal disorders
Stomach pain
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Eye disorders
subconjunctival hemorrhage
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Cardiac disorders
Supraventricular tachycardia
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Vascular disorders
Thromboembolic event
|
16.7%
3/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Infections and infestations
Tooth infection
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Nervous system disorders
Tremor
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Investigations
Weight gain
|
16.7%
3/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Infections and infestations
Upper respiratory infection
|
16.7%
3/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Renal and urinary disorders
Urinary hesitancy
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Renal and urinary disorders
Urinary incontinence
|
11.1%
2/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Ear and labyrinth disorders
Vestibular disorder
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
3/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Investigations
Weight loss
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Injury, poisoning and procedural complications
Wound complication
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Psychiatric disorders
Agitation
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Investigations
Alanine amino transferase increased
|
22.2%
4/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Immune system disorders
Allergic reaction
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.6%
1/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
|
Nervous system disorders
Amnesia
|
11.1%
2/18 • All-Cause Mortality was assessed through 4 years; adverse events were assessed through 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place