Trial Outcomes & Findings for Pembrolizumab and Ipilimumab After Prior Immunotherapy for Melanoma (NCT NCT02743819)

NCT ID: NCT02743819

Last Updated: 2025-06-10

Results Overview

Per Response Evaluation Criteria for use in trials testing immunotherapeutics (iRECIST) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 70 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2025-06-10

Participant Flow

Participant milestones

Measure	Treatment Treatment with the combination of pembrolizumab and ipilimumab. Pembrolizumab: Pembrolizumab given every 3 weeks (200 mg) by IV infusion. Ipilimumab: Ipilimumab given every 3 weeks (200 mg) by IV infusion for total of 4 doses.
Overall Study STARTED	70
Overall Study COMPLETED	62
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Treatment Treatment with the combination of pembrolizumab and ipilimumab. Pembrolizumab: Pembrolizumab given every 3 weeks (200 mg) by IV infusion. Ipilimumab: Ipilimumab given every 3 weeks (200 mg) by IV infusion for total of 4 doses.
Overall Study Lack of Efficacy	5
Overall Study Death	2
Overall Study Adverse Event	1

Baseline Characteristics

Pembrolizumab and Ipilimumab After Prior Immunotherapy for Melanoma

Baseline characteristics by cohort

Measure	Treatment n=70 Participants Treatment with the combination of pembrolizumab and ipilimumab. Pembrolizumab: Pembrolizumab given every 3 weeks (200 mg) by IV infusion. Ipilimumab: Ipilimumab given every 3 weeks (200 mg) by IV infusion for total of 4 doses.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants
Age, Categorical >=65 years	36 Participants n=5 Participants
Age, Continuous	64 years n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	68 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	1 Participants n=5 Participants
Race (NIH/OMB) White	68 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	70 Participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Per Response Evaluation Criteria for use in trials testing immunotherapeutics (iRECIST) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Outcome measures

Measure	Treatment n=70 Participants Treatment with the combination of pembrolizumab and ipilimumab. Pembrolizumab: Pembrolizumab given every 3 weeks (200 mg) by IV infusion. Ipilimumab: Ipilimumab given every 3 weeks (200 mg) by IV infusion for total of 4 doses.
Overall Response Rate (OR) Per irRECIST	20 Participants

SECONDARY outcome

Timeframe: 24 months

Time to disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Measure	Treatment n=70 Participants Treatment with the combination of pembrolizumab and ipilimumab. Pembrolizumab: Pembrolizumab given every 3 weeks (200 mg) by IV infusion. Ipilimumab: Ipilimumab given every 3 weeks (200 mg) by IV infusion for total of 4 doses.
Progression Free Survival Using the Kaplan Meier Method	5 months Interval 2.8 to 8.3

SECONDARY outcome

Timeframe: 30 days after the end of treatment

Any treatment-related adverse event

Outcome measures

Measure	Treatment n=70 Participants Treatment with the combination of pembrolizumab and ipilimumab. Pembrolizumab: Pembrolizumab given every 3 weeks (200 mg) by IV infusion. Ipilimumab: Ipilimumab given every 3 weeks (200 mg) by IV infusion for total of 4 doses.
Number of Participants With Adverse Events	62 Participants

Adverse Events

Treatment

Serious events: 20 serious events

Other events: 62 other events

Deaths: 28 deaths

Serious adverse events

Measure	Treatment n=70 participants at risk Treatment with the combination of pembrolizumab and ipilimumab. Pembrolizumab: Pembrolizumab given every 3 weeks (200 mg) by IV infusion. Ipilimumab: Ipilimumab given every 3 weeks (200 mg) by IV infusion for total of 4 doses.
Gastrointestinal disorders Abdominal pain	1.4% 1/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Renal and urinary disorders Acute kidney injury	1.4% 1/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Cardiac disorders Atrial fibrillation	1.4% 1/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Musculoskeletal and connective tissue disorders Avascular necrosis	1.4% 1/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Infections and infestations Bone infection	1.4% 1/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Colitis	2.9% 2/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Colonic perforation	1.4% 1/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Psychiatric disorders Confusion	2.9% 2/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Constipation	1.4% 1/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Diarrhea	2.9% 2/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.3% 3/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Esophageal obstruction	1.4% 1/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Fatigue	2.9% 2/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Gastritis	1.4% 1/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Gastrointestinal disorders - other	1.4% 1/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	1.4% 1/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Vascular disorders Hematoma	1.4% 1/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Hyperglycemia	1.4% 1/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Hypomagnesemia	1.4% 1/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Hyponatremia	1.4% 1/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	1.4% 1/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Infections and infestations Lung infection	1.4% 1/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Nausea	1.4% 1/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Musculoskeletal and connective tissue disorders Neck pain	1.4% 1/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Cardiac disorders Pericardial effusion	1.4% 1/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Skin and subcutaneous tissue disorders Rash maculo-papular	1.4% 1/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Infections and infestations Sepsis	2.9% 2/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - other	1.4% 1/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Infections and infestations Skin infection	1.4% 1/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Nervous system disorders Stroke	1.4% 1/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Surgical and medical procedures Surgical and medical procedures - other	2.9% 2/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Vascular disorders Thromboembolic event	1.4% 1/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Ear and labyrinth disorders Vestibular disorder	1.4% 1/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Vomiting	1.4% 1/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Other adverse events

Measure	Treatment n=70 participants at risk Treatment with the combination of pembrolizumab and ipilimumab. Pembrolizumab: Pembrolizumab given every 3 weeks (200 mg) by IV infusion. Ipilimumab: Ipilimumab given every 3 weeks (200 mg) by IV infusion for total of 4 doses.
Gastrointestinal disorders Abdominal pain	18.6% 13/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Endocrine disorders Adrenal insufficiency	7.1% 5/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Alanine aminotransferase increased	20.0% 14/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Alkaline phosphatase increased	11.4% 8/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Blood and lymphatic system disorders Anemia	24.3% 17/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Anorexia	22.9% 16/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Musculoskeletal and connective tissue disorders Arthralgia	15.7% 11/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Aspartate aminotransferase increased	15.7% 11/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Musculoskeletal and connective tissue disorders Back pain	11.4% 8/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Bloating	12.9% 9/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Injury, poisoning and procedural complications Bruising	5.7% 4/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Chills	5.7% 4/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Colitis	7.1% 5/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Constipation	27.1% 19/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Respiratory, thoracic and mediastinal disorders Cough	18.6% 13/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Creatinine increased	11.4% 8/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Dehydration	11.4% 8/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Diarrhea	48.6% 34/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Nervous system disorders Dizziness	11.4% 8/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Dry mouth	10.0% 7/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Nervous system disorders Dysgeusia	8.6% 6/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Respiratory, thoracic and mediastinal disorders Dyspnea	22.9% 16/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Edema limbs	11.4% 8/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Endocrine disorders Endocrine disorders - other	5.7% 4/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Fatigue	37.1% 26/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Fever	10.0% 7/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Flatulence	11.4% 8/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	14.3% 10/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Nervous system disorders Headache	22.9% 16/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Vascular disorders Hot flashes	8.6% 6/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Hyperglycemia	7.1% 5/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Hyperkalemia	24.3% 17/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Vascular disorders Hypertension	20.0% 14/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Hypoalbuminemia	18.6% 13/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Hypocalcemia	5.7% 4/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Hypomagnesemia	7.1% 5/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Hyponatremia	10.0% 7/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Endocrine disorders Hypothyroidism	14.3% 10/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Vascular disorders Hypotension	8.6% 6/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Infections and infestations Infections and infestations - other	5.7% 4/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Psychiatric disorders Insomnia	12.9% 9/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Investigations - other	10.0% 7/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Lipase increased	5.7% 4/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Lymphocyte count decreased	24.3% 17/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Nervous system disorders Memory impairment	5.7% 4/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - other	8.6% 6/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Musculoskeletal and connective tissue disorders Myalgia	12.9% 9/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Respiratory, thoracic and mediastinal disorders Nasal congestion	8.6% 6/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Nausea	32.9% 23/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified - other	7.1% 5/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Nervous system disorders Nervous system disorders - other	5.7% 4/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Nervous system disorders Neuropathy-sensory	10.0% 7/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Pain	12.9% 9/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Musculoskeletal and connective tissue disorders Pain in extremity	5.7% 4/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Platelet count decreased	8.6% 6/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.7% 4/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Respiratory, thoracic and mediastinal disorders Postnasal drip	5.7% 4/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Respiratory, thoracic and mediastinal disorders Productive cough	5.7% 4/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Skin and subcutaneous tissue disorders Pruritis	41.4% 29/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Skin and subcutaneous tissue disorders Rash maculo-papular	32.9% 23/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Serum amylase increased	5.7% 4/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Cardiac disorders Sinus bradycardia	10.0% 7/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - other	7.1% 5/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Vascular disorders Thromboembolic event	10.0% 7/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Infections and infestations Upper respiratory infection	8.6% 6/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Renal and urinary disorders Urinary frequency	7.1% 5/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Infections and infestations Urinary tract infection	8.6% 6/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Vomiting	25.7% 18/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Weight gain	7.1% 5/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Weight loss	17.1% 12/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Investigations White blood cell decreased	5.7% 4/70 • Adverse event data was followed for each patient from receiving their first dose of study therapy up through two years following drug discontinuation. Adverse events were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Additional Information

Daniel Olson, Clinical Instructor

University of Chicago

Phone: 773-834-4183

Email: daniel.olson2@uchospitals.edu

Results disclosure agreements

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