Trial Outcomes & Findings for Interleukin-2 and Pembrolizumab for Metastatic Kidney Cancer (NCT NCT02964078)

NCT ID: NCT02964078

Last Updated: 2026-04-02

Results Overview

Overall Response According to Immune-related response criteria (irRC). Overall response rate ORR is defined with confirmation of the response status Complete Response (CR) or Partial Response (PR) among the combination treatment population patients; the binomial estimate and its one-sided 95% confidence interval will be reported. CR: Disappearance of all lesions in two consecutive observation not less than 4 weeks apart. PR: ≥50% decrease in tumor burden compared with baseline in two observations at least 4 weeks apart.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

Up to 24 months

Results posted on

2026-04-02

Participant Flow

Participant milestones

Participant milestones
Measure
Pembrolizumab and Interleukin-2
Outpatient Intravenous (IV) infusion of Pembrolizumab and Inpatient IV infusion of Interleukin-2.
Overall Study
STARTED
27
Overall Study
COMPLETED
27
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Interleukin-2 and Pembrolizumab for Metastatic Kidney Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Pembrolizumab and Interleukin-2
n=27 Participants
Outpatient Intravenous (IV) infusion of Pembrolizumab and Inpatient IV infusion of Interleukin-2.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
17 Participants
n=5 Participants
Age, Categorical
>=65 years
10 Participants
n=5 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
Sex: Female, Male
Male
22 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
25 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
25 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
Region of Enrollment
United States
27 participants
n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 months

Overall Response According to Immune-related response criteria (irRC). Overall response rate ORR is defined with confirmation of the response status Complete Response (CR) or Partial Response (PR) among the combination treatment population patients; the binomial estimate and its one-sided 95% confidence interval will be reported. CR: Disappearance of all lesions in two consecutive observation not less than 4 weeks apart. PR: ≥50% decrease in tumor burden compared with baseline in two observations at least 4 weeks apart.

Outcome measures

Outcome measures
Measure
Pembrolizumab and Interleukin-2
n=27 Participants
Outpatient Intravenous (IV) infusion of Pembrolizumab and Inpatient IV infusion of Interleukin-2.
Overall Response Rate (ORR)
70.4 percentage of participants
Interval 54.6 to 100.0

SECONDARY outcome

Timeframe: Up to 24 months

Analysis: Overall Survival (OS) of ITT patients using Kaplan-Meier estimate, counting from the eligible date to death from any cause, or censored on end of known follow up, either within this study or in the Prometheus Laboratories sponsored PROCLAIM registry (PROCLAIM Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy, NCT01415167).

Outcome measures

Outcome measures
Measure
Pembrolizumab and Interleukin-2
n=27 Participants
Outpatient Intravenous (IV) infusion of Pembrolizumab and Inpatient IV infusion of Interleukin-2.
Overall Survival (OS) of Intent to Treat (ITT) Population
1 proportion of participants
Interval 0.871 to 1.0

SECONDARY outcome

Timeframe: Up to 24 months

Progression-free survival (PFS) of ITT patients using Kaplan Meier estimate, from the confirmed eligible date to the first occurrence of disease progression or death, from any cause, or lost to follow up, whichever is earliest; or censored at last follow-up during study. Progressive Disease (PD): At least 25% increase in tumor burden compared with nadir (at any single time point) in two consecutive observations at least 4 weeks apart.

Outcome measures

Outcome measures
Measure
Pembrolizumab and Interleukin-2
n=27 Participants
Outpatient Intravenous (IV) infusion of Pembrolizumab and Inpatient IV infusion of Interleukin-2.
Progression Free Survival (PFS)
.630 proportion of participants
Interval 0.421 to 0.781

Adverse Events

Pembrolizumab and Interleukin-2

Serious events: 17 serious events
Other events: 25 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Pembrolizumab and Interleukin-2
n=27 participants at risk
Outpatient Intravenous (IV) infusion of Pembrolizumab and Inpatient IV infusion of Interleukin-2.
Cardiac disorders
Atrial fibrilation
11.1%
3/27 • Number of events 3 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Cardiac disorders
Atrial flutter
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Cardiac disorders
Supraventricular tachycardia
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Cardiac disorders
Ventricular tachycardia
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Gastrointestinal disorders
Nausea
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Gastrointestinal disorders
Vomiting
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
General disorders
Flu like symptoms
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
General disorders
Infusion related reaction
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Investigations
Creatinine increased
11.1%
3/27 • Number of events 3 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Metabolism and nutrition disorders
Hypocalcemia
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Metabolism and nutrition disorders
Hyponatremia
14.8%
4/27 • Number of events 8 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
11.1%
3/27 • Number of events 4 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Nervous system disorders
Edema cerebral
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Nervous system disorders
Headache
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Nervous system disorders
Intracranial hemorrhage
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Nervous system disorders
Nervous system disorders - Other
7.4%
2/27 • Number of events 4 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Renal and urinary disorders
Acute kidney injury
22.2%
6/27 • Number of events 6 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Renal and urinary disorders
Renal and urinary disorders - Other
29.6%
8/27 • Number of events 8 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Respiratory, thoracic and mediastinal disorders
Dyspnea
11.1%
3/27 • Number of events 3 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Vascular disorders
Capillary leak syndrome
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Vascular disorders
Hypotension
25.9%
7/27 • Number of events 12 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Investigations
Blood bilirubin increased
11.1%
3/27 • Number of events 4 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Investigations
Alanine aminotransferase increased
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Investigations
Aspartate aminotransferase increased
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Blood and lymphatic system disorders
Anemia
3.7%
1/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Investigations
Lymphocyte count decreased
25.9%
7/27 • Number of events 19 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Metabolism and nutrition disorders
Hypophosphatemia
29.6%
8/27 • Number of events 14 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Vascular disorders
Hypertension
11.1%
3/27 • Number of events 6 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Vascular disorders
Vascular disorders - Other
7.4%
2/27 • Number of events 3 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Blood and lymphatic system disorders
Leukocytosis
18.5%
5/27 • Number of events 10 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Investigations
Electrocardiogram QT corrected interval prolonged
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Metabolism and nutrition disorders
Hypermagnesemia
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Metabolism and nutrition disorders
Hypoalbuminemia
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
General disorders
Fatigue
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Metabolism and nutrition disorders
Hypokalemia
7.4%
2/27 • Number of events 3 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Musculoskeletal and connective tissue disorders
Arthralgia
11.1%
3/27 • Number of events 4 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Respiratory, thoracic and mediastinal disorders
Hypoxia
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Gastrointestinal disorders
Abdominal Pain
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
General disorders
Pain
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Metabolism and nutrition disorders
Hyperglycemia
3.7%
1/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Metabolism and nutrition disorders
Dehydration
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Nervous system disorders
Nystagmus
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Metabolism and nutrition disorders
Hyperuricemia
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment

Other adverse events

Other adverse events
Measure
Pembrolizumab and Interleukin-2
n=27 participants at risk
Outpatient Intravenous (IV) infusion of Pembrolizumab and Inpatient IV infusion of Interleukin-2.
Investigations
Creatinine increased
25.9%
7/27 • Number of events 12 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Investigations
Lymphocyte count decreased
25.9%
7/27 • Number of events 19 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Investigations
Blood bilirubin increased
18.5%
5/27 • Number of events 6 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Investigations
Urine output decreased
11.1%
3/27 • Number of events 4 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Investigations
Alanine aminotransferase increased
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Investigations
Electrocardiogram QT corrected interval prolonged
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Investigations
Investigations - Other
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Investigations
Aspartate aminotransferase increased
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Investigations
Weight gain
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Metabolism and nutrition disorders
Hypophosphatemia
29.6%
8/27 • Number of events 14 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Metabolism and nutrition disorders
Hyponatremia
18.5%
5/27 • Number of events 9 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Metabolism and nutrition disorders
Hypokalemia
7.4%
2/27 • Number of events 3 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Metabolism and nutrition disorders
Anorexia
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Metabolism and nutrition disorders
Dehydration
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Metabolism and nutrition disorders
Hyperglycemia
3.7%
1/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Metabolism and nutrition disorders
Hypermagnesemia
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Metabolism and nutrition disorders
Hyperuricemia
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Metabolism and nutrition disorders
Hyperalbuminemia
3.7%
1/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Metabolism and nutrition disorders
Hypocalcemia
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Metabolism and nutrition disorders
Hypoglycemia
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Metabolism and nutrition disorders
Obesity
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Cardiac disorders
Sinus tachycardia
29.6%
8/27 • Number of events 10 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Cardiac disorders
Atrial fibrillation
14.8%
4/27 • Number of events 5 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Cardiac disorders
Chest pain - cardiac
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Cardiac disorders
Ventricular tachycardia
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Cardiac disorders
Asystole
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Cardiac disorders
Atrial flutter
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Cardiac disorders
Cardiac disorders - Other
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Cardiac disorders
Sinus bradycardia
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Cardiac disorders
Supraventricular tachycardia
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Vascular disorders
Hypotension
14.8%
4/27 • Number of events 6 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Vascular disorders
Hypertension
14.8%
4/27 • Number of events 8 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Vascular disorders
Capillary leak syndrome
11.1%
3/27 • Number of events 3 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Vascular disorders
Vascular disorders - Other
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Renal and urinary disorders
Renal and urinary disorders - Other
22.2%
6/27 • Number of events 7 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Renal and urinary disorders
Acute kidney injury
22.2%
6/27 • Number of events 6 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Skin and subcutaneous tissue disorders
Rash maculo-papular
22.2%
6/27 • Number of events 9 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Skin and subcutaneous tissue disorders
Dry skin
11.1%
3/27 • Number of events 3 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Skin and subcutaneous tissue disorders
Pruritus
11.1%
3/27 • Number of events 4 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders -Other
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
General disorders
Fatigue
11.1%
3/27 • Number of events 3 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
General disorders
Fever
11.1%
3/27 • Number of events 4 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
General disorders
Edema limbs
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
General disorders
Pain
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
General disorders
Chills
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
General disorders
Flu like symptoms
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
General disorders
General disorders and administration site conditions -Other
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Gastrointestinal disorders
Diarrhea
7.4%
2/27 • Number of events 3 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Gastrointestinal disorders
Nausea
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Gastrointestinal disorders
Vomiting
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Gastrointestinal disorders
Abdominal pain
3.7%
1/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Gastrointestinal disorders
Constipation
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Gastrointestinal disorders
Dry mouth
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Gastrointestinal disorders
Dysphagia
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Blood and lymphatic system disorders
Leukocytosis
22.2%
6/27 • Number of events 10 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Blood and lymphatic system disorders
Anemia
3.7%
1/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Respiratory, thoracic and mediastinal disorders
Dyspnea
22.2%
6/27 • Number of events 6 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Respiratory, thoracic and mediastinal disorders
Hypoxia
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Respiratory, thoracic and mediastinal disorders
Pneumonitis
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Nervous system disorders
Headache
14.8%
4/27 • Number of events 5 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Nervous system disorders
Intracranial hemorrhage
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Nervous system disorders
Dizziness
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Nervous system disorders
Facial muscle weakness
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Nervous system disorders
Lethargy
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Nervous system disorders
Nervous system disorders - Other
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Nervous system disorders
Nystagmus
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Nervous system disorders
Tremor
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Musculoskeletal and connective tissue disorders
Arthralgia
14.8%
4/27 • Number of events 7 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Musculoskeletal and connective tissue disorders
Myalgia
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Infections and infestations
Infections and Infestations - Other
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Infections and infestations
Upper respiratory infection
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Endocrine disorders
Hyperthyroidism
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Eye disorders
Blurred vision
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
Reproductive system and breast disorders
Dyspareunia
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment

Additional Information

Jad Chahoud MD, MPH

Moffitt Cancer Center

Phone: 813-745-6926

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place