Trial Outcomes & Findings for Phase II Study of Pembrolizumab and Lenvatinib in Advanced Well-differentiated Neuroendocrine Tumors (NCT NCT03290079)

Last Updated: 2025-12-22

Results Overview

Response Evaluation Criteria in Solid Tumors (RECIST) based response rate. Complete Response (CR): Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \<10 mm in short axis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest). The SLD must also demonstrate an absolute increase of at least 5mm. (Two lesions increasing from 2 mm to 3 mm, for example, does not qualify). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Up to 12 months

Results posted on

2025-12-22

Participant Flow

Participant milestones

Participant milestones
Measure	Pembrolizumab & Lenvatinib Treatment Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks, in addition to 20 mg Lenvatinib by mouth every day of each 3 week cycle. Estimated average length of treatment per participant: 4 months. Pembrolizumab: 200 mg Pembrolizumab by IV on Day 1 of each 3 week cycle. Lenvatinib: 20 mg Lenvatinib by mouth every day of each 3 week cycle
Overall Study STARTED	20
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Pembrolizumab & Lenvatinib Treatment Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks, in addition to 20 mg Lenvatinib by mouth every day of each 3 week cycle. Estimated average length of treatment per participant: 4 months. Pembrolizumab: 200 mg Pembrolizumab by IV on Day 1 of each 3 week cycle. Lenvatinib: 20 mg Lenvatinib by mouth every day of each 3 week cycle
Overall Study Death	2

Baseline Characteristics

Phase II Study of Pembrolizumab and Lenvatinib in Advanced Well-differentiated Neuroendocrine Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab & Lenvatinib Treatment n=20 Participants Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks, in addition to 20 mg Lenvatinib by mouth every day of each 3 week cycle. Estimated average length of treatment per participant: 4 months. Pembrolizumab: 200 mg Pembrolizumab by IV on Day 1 of each 3 week cycle. Lenvatinib: 20 mg Lenvatinib by mouth every day of each 3 week cycle
Age, Categorical <=18 years	0 Participants n=18 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=18 Participants
Age, Categorical >=65 years	11 Participants n=18 Participants
Sex: Female, Male Female	8 Participants n=18 Participants
Sex: Female, Male Male	12 Participants n=18 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=18 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=18 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=18 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=18 Participants
Race (NIH/OMB) Asian	0 Participants n=18 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=18 Participants
Race (NIH/OMB) Black or African American	1 Participants n=18 Participants
Race (NIH/OMB) White	18 Participants n=18 Participants
Race (NIH/OMB) More than one race	0 Participants n=18 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=18 Participants
Region of Enrollment United States	20 participants n=18 Participants

PRIMARY outcome

Timeframe: Up to 12 months

Population: Evaluable participants

Outcome measures

Outcome measures
Measure	Pembrolizumab & Lenvatinib Treatment n=18 Participants Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks, in addition to 20 mg Lenvatinib by mouth every day of each 3 week cycle. Estimated average length of treatment per participant: 4 months. Pembrolizumab: 200 mg Pembrolizumab by IV on Day 1 of each 3 week cycle. Lenvatinib: 20 mg Lenvatinib by mouth every day of each 3 week cycle
Objective Radiographic Response Rate (ORR)	.1 proportion of participants Interval 0.03 to 0.3

SECONDARY outcome

Timeframe: Up to 12 months

Population: Evaluable participants

DOR, defined as the time from first documented evidence of Complete Response (CR) or Partial Response (PR) until disease progression or death due to any cause, whichever occurs first.

Outcome measures

Outcome measures
Measure	Pembrolizumab & Lenvatinib Treatment n=18 Participants Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks, in addition to 20 mg Lenvatinib by mouth every day of each 3 week cycle. Estimated average length of treatment per participant: 4 months. Pembrolizumab: 200 mg Pembrolizumab by IV on Day 1 of each 3 week cycle. Lenvatinib: 20 mg Lenvatinib by mouth every day of each 3 week cycle
Duration of Response (DOR)	6.5 months Interval 4.8 to 7.4

SECONDARY outcome

Timeframe: Up to 12 months

PFS, defined as the time from initial treatment to the first documented disease progression according to RECIST 1.1, or death due to any cause, whichever occurs first.

Outcome measures

Outcome measures
Measure	Pembrolizumab & Lenvatinib Treatment n=20 Participants Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks, in addition to 20 mg Lenvatinib by mouth every day of each 3 week cycle. Estimated average length of treatment per participant: 4 months. Pembrolizumab: 200 mg Pembrolizumab by IV on Day 1 of each 3 week cycle. Lenvatinib: 20 mg Lenvatinib by mouth every day of each 3 week cycle
Progression Free Survival (PFS)	8 months Interval 5.8 to 10.2

SECONDARY outcome

Timeframe: At 12 months

OS defined as the time from initial treatment until death from any cause.

Outcome measures

Outcome measures
Measure	Pembrolizumab & Lenvatinib Treatment n=20 Participants Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks, in addition to 20 mg Lenvatinib by mouth every day of each 3 week cycle. Estimated average length of treatment per participant: 4 months. Pembrolizumab: 200 mg Pembrolizumab by IV on Day 1 of each 3 week cycle. Lenvatinib: 20 mg Lenvatinib by mouth every day of each 3 week cycle
Overall Survival (OS)	70 percentage of participants Interval 48.1 to 84.4

Adverse Events

Pembrolizumab & Lenvatinib Treatment

Serious events: 12 serious events

Other events: 20 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Pembrolizumab & Lenvatinib Treatment n=20 participants at risk Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks, in addition to 20 mg Lenvatinib by mouth every day of each 3 week cycle. Estimated average length of treatment per participant: 4 months. Pembrolizumab: 200 mg Pembrolizumab by IV on Day 1 of each 3 week cycle. Lenvatinib: 20 mg Lenvatinib by mouth every day of each 3 week cycle
Infections and infestations Kidney Infection	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Gastrointestinal disorders Abdominal Pain	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Gastrointestinal disorders Constipation	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Investigations Alanine aminotransferase increased	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Investigations Aspartate aminotransferase increased	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
General disorders Disease Progression	15.0% 3/20 • Number of events 3 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
General disorders Fever	10.0% 2/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Infections and infestations Infections and infestations - Other	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Vascular disorders Hypotension	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Infections and infestations Urinary tract infection	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
General disorders Death, NOS	10.0% 2/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Cardiac disorders Atrioventricular block complete	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Cardiac disorders Pericardial effusion	10.0% 2/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Cardiac disorders Sinus tachycardia	10.0% 2/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
General disorders Hip pain	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Metabolism and nutrition disorders Hypoglycemia	5.0% 1/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Nervous system disorders Headache	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Metabolism and nutrition disorders Dehydration	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Vascular disorders Hypertension	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.

Other adverse events

Other adverse events
Measure	Pembrolizumab & Lenvatinib Treatment n=20 participants at risk Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks, in addition to 20 mg Lenvatinib by mouth every day of each 3 week cycle. Estimated average length of treatment per participant: 4 months. Pembrolizumab: 200 mg Pembrolizumab by IV on Day 1 of each 3 week cycle. Lenvatinib: 20 mg Lenvatinib by mouth every day of each 3 week cycle
Gastrointestinal disorders Abdominal Pain	55.0% 11/20 • Number of events 18 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Gastrointestinal disorders Diarrhea	55.0% 11/20 • Number of events 15 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Gastrointestinal disorders Constipation	35.0% 7/20 • Number of events 10 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Gastrointestinal disorders Nausea	15.0% 3/20 • Number of events 3 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Gastrointestinal disorders Vomiting	20.0% 4/20 • Number of events 4 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Gastrointestinal disorders Mucositis oral	20.0% 4/20 • Number of events 6 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Gastrointestinal disorders Gastrointestinal disorders - Other	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Gastrointestinal disorders Belching	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Gastrointestinal disorders Bloating	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Gastrointestinal disorders Dry mouth	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Gastrointestinal disorders Dyspepsia	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Gastrointestinal disorders Gastritis	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Gastrointestinal disorders Gastroesophageal reflux disease	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Gastrointestinal disorders Gastrointestinal pain	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Gastrointestinal disorders Hemorrhoids	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Gastrointestinal disorders Lip pain	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Gastrointestinal disorders Oral hemorrhage	5.0% 1/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Gastrointestinal disorders Oral pain	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Gastrointestinal disorders Rectal hemorrhage	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Gastrointestinal disorders Toothache	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
General disorders Fatigue	60.0% 12/20 • Number of events 24 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
General disorders Fever	25.0% 5/20 • Number of events 6 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
General disorders Pain	25.0% 5/20 • Number of events 6 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
General disorders Edema limbs	15.0% 3/20 • Number of events 3 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
General disorders Non-cardiac chest pain	10.0% 2/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
General disorders Chills	10.0% 2/20 • Number of events 4 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
General disorders Flu like symptoms	10.0% 2/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
General disorders Facial pain	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
General disorders General disorders and administration site conditions - Other	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Nervous system disorders Headache	45.0% 9/20 • Number of events 13 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Nervous system disorders Dizziness	15.0% 3/20 • Number of events 4 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Nervous system disorders Dysgeusia	15.0% 3/20 • Number of events 4 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Nervous system disorders Lethargy	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Nervous system disorders Paresthesia	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Nervous system disorders Presyncope	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Vascular disorders Hypertension	75.0% 15/20 • Number of events 27 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Vascular disorders Hypotension	25.0% 5/20 • Number of events 6 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Vascular disorders Flushing	10.0% 2/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Musculoskeletal and connective tissue disorders Back pain	35.0% 7/20 • Number of events 11 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Musculoskeletal and connective tissue disorders Arthralgia	30.0% 6/20 • Number of events 7 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Musculoskeletal and connective tissue disorders Flank pain	15.0% 3/20 • Number of events 3 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	10.0% 2/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Musculoskeletal and connective tissue disorders Myalgia	10.0% 2/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Musculoskeletal and connective tissue disorders Bone pain	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Musculoskeletal and connective tissue disorders Muscle cramp	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Cardiac disorders Sinus tachycardia	30.0% 6/20 • Number of events 9 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Cardiac disorders Pericardial effusion	15.0% 3/20 • Number of events 3 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Cardiac disorders Sinus bradycardia	15.0% 3/20 • Number of events 3 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Cardiac disorders Palpitations	10.0% 2/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Cardiac disorders Atrioventricular block complete	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Cardiac disorders Atrioventricular block first degree	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Cardiac disorders Cardiac disorders - Other	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Cardiac disorders Myocarditis	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Investigations Weight loss	40.0% 8/20 • Number of events 12 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Investigations Alanine aminotransferase increased	10.0% 2/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Investigations Aspartate aminotransferase increased	10.0% 2/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Investigations Thyroid stimulating hormone increased	15.0% 3/20 • Number of events 3 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Investigations Electrocardiogram T wave abnormal	10.0% 2/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Investigations Alkaline phosphatase increased	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Investigations Blood bilirubin increased	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Investigations Electrocardiogram QT corrected interval prolonged	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Investigations Investigations - Other	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 4/20 • Number of events 5 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	25.0% 5/20 • Number of events 7 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Respiratory, thoracic and mediastinal disorders Epistaxis	10.0% 2/20 • Number of events 3 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	10.0% 2/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Respiratory, thoracic and mediastinal disorders Hoarseness	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Respiratory, thoracic and mediastinal disorders Sore throat	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	30.0% 6/20 • Number of events 12 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	25.0% 5/20 • Number of events 6 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Skin and subcutaneous tissue disorders Pruritus	10.0% 2/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Skin and subcutaneous tissue disorders Pain of skin	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Renal and urinary disorders Proteinuria	40.0% 8/20 • Number of events 12 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Renal and urinary disorders Hematuria	5.0% 1/20 • Number of events 3 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Renal and urinary disorders Urinary frequency	10.0% 2/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Renal and urinary disorders Urinary incontinence	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Endocrine disorders Hypothyroidism	30.0% 6/20 • Number of events 6 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Endocrine disorders Endocrine disorders - Other	10.0% 2/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Endocrine disorders Hyperthyroidism	10.0% 2/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Infections and infestations Urinary tract infection	10.0% 2/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Infections and infestations Infections and infestations - Other	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Infections and infestations Kidney infection	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Infections and infestations Otitis externa	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Infections and infestations Papulopustular rash	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Infections and infestations Prostate infection	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Infections and infestations Upper respiratory infection	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Metabolism and nutrition disorders Anorexia	15.0% 3/20 • Number of events 5 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Metabolism and nutrition disorders Hyperglycemia	10.0% 2/20 • Number of events 4 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Metabolism and nutrition disorders Dehydration	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Metabolism and nutrition disorders Hyperkalemia	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Metabolism and nutrition disorders Hypoglycemia	5.0% 1/20 • Number of events 4 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Metabolism and nutrition disorders Hypokalemia	5.0% 1/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Psychiatric disorders Anxiety	15.0% 3/20 • Number of events 4 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Psychiatric disorders Confusion	10.0% 2/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Psychiatric disorders Depression	10.0% 2/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Psychiatric disorders Insomnia	10.0% 2/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Injury, poisoning and procedural complications Fall	10.0% 2/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Injury, poisoning and procedural complications Bruising	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Injury, poisoning and procedural complications Fracture	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Injury, poisoning and procedural complications Wound complication	5.0% 1/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Eye disorders Eye disorders - Other	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Eye disorders Eye pain	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Eye disorders Watering eyes	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Reproductive system and breast disorders Irregular menstruation	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Reproductive system and breast disorders Reproductive system and breast disorders - Other	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Blood and lymphatic system disorders Eosinophilia	10.0% 2/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Blood and lymphatic system disorders Lymph node pain	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Ear and labyrinth disorders Ear and labyrinth disorders - Other	5.0% 1/20 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.
Ear and labyrinth disorders Vertigo	5.0% 1/20 • Number of events 2 • Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.

Additional Information

Jonathan Strosberg, MD

Moffitt Cancer Center

Phone: 813-745-5553

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place