Trial Outcomes & Findings for Biomarker-Driven Therapy With Nivolumab and Ipilimumab in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Expressing AR-V7 (NCT NCT02601014)
NCT ID: NCT02601014
Last Updated: 2022-02-03
Results Overview
Number of participants with greater than 50% decline in PSA from start of treatment, sustained for \>= 4 weeks, as defined by Prostate Cancer Working Group 2 (PCWG2) criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
up to 3 years
Results posted on
2022-02-03
Participant Flow
Two subjects were screen failures.
Participant milestones
| Measure |
Nivolumab and Ipilimumab
Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given 1 mg/kg IV
Nivolumab: Given 3 mg/kg IV
|
Enzalutamide Plus Nivolumab and Ipilimumab
Patients will continue on standard of care enzalutamide, with the addition of nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given 1 mg/kg IV
Nivolumab: Given 3 mg/kg IV
Enzalutamide: given orally per standard of care
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
10
|
12
|
Reasons for withdrawal
| Measure |
Nivolumab and Ipilimumab
Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given 1 mg/kg IV
Nivolumab: Given 3 mg/kg IV
|
Enzalutamide Plus Nivolumab and Ipilimumab
Patients will continue on standard of care enzalutamide, with the addition of nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given 1 mg/kg IV
Nivolumab: Given 3 mg/kg IV
Enzalutamide: given orally per standard of care
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
|
Overall Study
Death
|
3
|
1
|
|
Overall Study
Disease progression
|
4
|
8
|
Baseline Characteristics
Biomarker-Driven Therapy With Nivolumab and Ipilimumab in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Expressing AR-V7
Baseline characteristics by cohort
| Measure |
Nivolumab and Ipilimumab
n=15 Participants
Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given 1 mg/kg IV
Nivolumab: Given 3 mg/kg IV
|
Enzalutamide Plus Nivolumab and Ipilimumab
n=15 Participants
Patients will continue on standard of care enzalutamide, with the addition of nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given 1 mg/kg IV
Nivolumab: Given 3 mg/kg IV
Enzalutamide: given orally per standard of care
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
white
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
non-white
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 3 yearsNumber of participants with greater than 50% decline in PSA from start of treatment, sustained for \>= 4 weeks, as defined by Prostate Cancer Working Group 2 (PCWG2) criteria.
Outcome measures
| Measure |
Nivolumab and Ipilimumab
n=15 Participants
Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given 1 mg/kg IV
Nivolumab: Given 3 mg/kg IV
|
Enzalutamide Plus Nivolumab and Ipilimumab
n=15 Participants
Patients will continue on standard of care enzalutamide, with the addition of nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given 1 mg/kg IV
Nivolumab: Given 3 mg/kg IV
Enzalutamide: given orally per standard of care
|
|---|---|---|
|
Number of Participants With Change in PSA Response
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 3 yearsNumber of participants with PFS \>= 24 weeks. PFS is described as number of weeks from start of treatment until first evidence of clinical radiographic progression, or death.
Outcome measures
| Measure |
Nivolumab and Ipilimumab
n=15 Participants
Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given 1 mg/kg IV
Nivolumab: Given 3 mg/kg IV
|
Enzalutamide Plus Nivolumab and Ipilimumab
n=15 Participants
Patients will continue on standard of care enzalutamide, with the addition of nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given 1 mg/kg IV
Nivolumab: Given 3 mg/kg IV
Enzalutamide: given orally per standard of care
|
|---|---|---|
|
Durable Progression Free Survival (PFS)
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: up to 3 yearsNumber of participants experiencing Grade 3-4 adverse events, Grade 3-4 immune-related AEs (irAEs), as defined by National Cancer Institute (NIH) CTCAE version 4.0
Outcome measures
| Measure |
Nivolumab and Ipilimumab
n=15 Participants
Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given 1 mg/kg IV
Nivolumab: Given 3 mg/kg IV
|
Enzalutamide Plus Nivolumab and Ipilimumab
n=15 Participants
Patients will continue on standard of care enzalutamide, with the addition of nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given 1 mg/kg IV
Nivolumab: Given 3 mg/kg IV
Enzalutamide: given orally per standard of care
|
|---|---|---|
|
Number of Participants Experiencing Adverse Events
Grade 3-4
|
7 Participants
|
8 Participants
|
|
Number of Participants Experiencing Adverse Events
Grade 3-4 irAE
|
5 Participants
|
7 Participants
|
|
Number of Participants Experiencing Adverse Events
Grade 3-4 AE leading to treatment discontinuation
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: up to 3 yearsPopulation: Only 8/15 in Arm 1 and 9/15 in Arm 2 were evaluable for this outcome measure.
Number of participants with complete response (CR) or partial response (PR) in measurable soft tissue lesions, as defined by RECIST version 1.1
Outcome measures
| Measure |
Nivolumab and Ipilimumab
n=8 Participants
Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given 1 mg/kg IV
Nivolumab: Given 3 mg/kg IV
|
Enzalutamide Plus Nivolumab and Ipilimumab
n=9 Participants
Patients will continue on standard of care enzalutamide, with the addition of nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given 1 mg/kg IV
Nivolumab: Given 3 mg/kg IV
Enzalutamide: given orally per standard of care
|
|---|---|---|
|
Objective Response Rate (ORR)
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 3 yearsNumber of months alive after start of treatment.
Outcome measures
| Measure |
Nivolumab and Ipilimumab
n=15 Participants
Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given 1 mg/kg IV
Nivolumab: Given 3 mg/kg IV
|
Enzalutamide Plus Nivolumab and Ipilimumab
n=15 Participants
Patients will continue on standard of care enzalutamide, with the addition of nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given 1 mg/kg IV
Nivolumab: Given 3 mg/kg IV
Enzalutamide: given orally per standard of care
|
|---|---|---|
|
Overall Survival
|
8.2 months
Interval 5.5 to 10.4
|
14.2 months
Interval 8.5 to
Insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: up to 3 yearsNumber of months from start of treatment until first evidence of progression, as defined by based on RECIST version 1.1 and PCWG2
Outcome measures
| Measure |
Nivolumab and Ipilimumab
n=15 Participants
Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given 1 mg/kg IV
Nivolumab: Given 3 mg/kg IV
|
Enzalutamide Plus Nivolumab and Ipilimumab
n=15 Participants
Patients will continue on standard of care enzalutamide, with the addition of nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given 1 mg/kg IV
Nivolumab: Given 3 mg/kg IV
Enzalutamide: given orally per standard of care
|
|---|---|---|
|
Progression Free Survival (PFS)
|
3.7 months
Interval 2.8 to 7.5
|
2.9 months
Interval 1.3 to 5.8
|
SECONDARY outcome
Timeframe: up to 3 yearsPopulation: Data was not collected for this outcome measure.
Change in AR-V7 expression is defined as converting from AR-V7-positive to AR-V7-negative during treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 3 yearsNumber of months until \>= 25% or \>=2 ng/mL increase in PSA, as defined per PCWG2 criteria
Outcome measures
| Measure |
Nivolumab and Ipilimumab
n=15 Participants
Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given 1 mg/kg IV
Nivolumab: Given 3 mg/kg IV
|
Enzalutamide Plus Nivolumab and Ipilimumab
n=15 Participants
Patients will continue on standard of care enzalutamide, with the addition of nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given 1 mg/kg IV
Nivolumab: Given 3 mg/kg IV
Enzalutamide: given orally per standard of care
|
|---|---|---|
|
PSA-PFS
|
3.0 months
Interval 2.1 to
Insufficient number of participants with events.
|
2.7 months
Interval 2.1 to 5.9
|
SECONDARY outcome
Timeframe: up to 12 monthsPopulation: Data was not evaluable for this outcome measure.
Number of months from first evidence of response until progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 3 yearsPopulation: Data was not collected for this outcome measure.
Change in AR-V7 is described as converting from AR-V7-positive to -negative, expressed as a ratio of AR-V7 to full-length AR (AR-FL)
Outcome measures
Outcome data not reported
Adverse Events
Nivolumab and Ipilimumab
Serious events: 6 serious events
Other events: 15 other events
Deaths: 9 deaths
Enzalutamide Plus Nivolumab and Ipilimumab
Serious events: 5 serious events
Other events: 15 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Nivolumab and Ipilimumab
n=15 participants at risk
Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given 1 mg/kg IV
Nivolumab: Given 3 mg/kg IV
|
Enzalutamide Plus Nivolumab and Ipilimumab
n=15 participants at risk
Patients will continue on standard of care enzalutamide, with the addition of nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given 1 mg/kg IV
Nivolumab: Given 3 mg/kg IV
Enzalutamide: given orally per standard of care
|
|---|---|---|
|
Nervous system disorders
intracranial hemorrhage
|
13.3%
2/15 • Number of events 2 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Vascular disorders
chronic subdural hematoma
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Investigations
elevated bilirubin
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Infections and infestations
hepatitis
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Hepatobiliary disorders
elevated liver function test
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
13.3%
2/15 • Number of events 2 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis
|
13.3%
2/15 • Number of events 2 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Injury, poisoning and procedural complications
allergic reaction to amoxicillin
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Gastrointestinal disorders
diarrhea
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
General disorders
generalized weakness
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Gastrointestinal disorders
vomiting
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Gastrointestinal disorders
nausea
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Injury, poisoning and procedural complications
infusion reaction
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
General disorders
fever
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Investigations
lactate elevation
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Psychiatric disorders
expressive aphasia
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Skin and subcutaneous tissue disorders
dermatitis
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Investigations
eosinophilia
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Metabolism and nutrition disorders
hyperglycemia
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Endocrine disorders
Addison's disease
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Hepatobiliary disorders
hepatic cyst
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Gastrointestinal disorders
immune related colitis
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Endocrine disorders
central adrenal insufficiency
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Endocrine disorders
hypothyroidism
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
Other adverse events
| Measure |
Nivolumab and Ipilimumab
n=15 participants at risk
Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given 1 mg/kg IV
Nivolumab: Given 3 mg/kg IV
|
Enzalutamide Plus Nivolumab and Ipilimumab
n=15 participants at risk
Patients will continue on standard of care enzalutamide, with the addition of nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given 1 mg/kg IV
Nivolumab: Given 3 mg/kg IV
Enzalutamide: given orally per standard of care
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
40.0%
6/15 • Number of events 16 • up to 3 years
|
40.0%
6/15 • Number of events 12 • up to 3 years
|
|
General disorders
edema
|
26.7%
4/15 • Number of events 5 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Blood and lymphatic system disorders
anemia
|
53.3%
8/15 • Number of events 14 • up to 3 years
|
33.3%
5/15 • Number of events 7 • up to 3 years
|
|
Hepatobiliary disorders
Alkaline phosphatase increased
|
20.0%
3/15 • Number of events 5 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
33.3%
5/15 • Number of events 6 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis
|
6.7%
1/15 • Number of events 2 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
General disorders
leg weakness
|
13.3%
2/15 • Number of events 2 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Renal and urinary disorders
difficulty urinating
|
13.3%
2/15 • Number of events 2 • up to 3 years
|
13.3%
2/15 • Number of events 2 • up to 3 years
|
|
Investigations
Alanine Aminotransferase increased
|
20.0%
3/15 • Number of events 6 • up to 3 years
|
20.0%
3/15 • Number of events 3 • up to 3 years
|
|
Investigations
lipase increased
|
26.7%
4/15 • Number of events 4 • up to 3 years
|
13.3%
2/15 • Number of events 6 • up to 3 years
|
|
Blood and lymphatic system disorders
hematocrit count decreased
|
46.7%
7/15 • Number of events 8 • up to 3 years
|
13.3%
2/15 • Number of events 2 • up to 3 years
|
|
Blood and lymphatic system disorders
platelet count decreased
|
46.7%
7/15 • Number of events 9 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Investigations
amylase increased
|
33.3%
5/15 • Number of events 5 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
20.0%
3/15 • Number of events 3 • up to 3 years
|
13.3%
2/15 • Number of events 3 • up to 3 years
|
|
General disorders
fatigue
|
73.3%
11/15 • Number of events 14 • up to 3 years
|
66.7%
10/15 • Number of events 12 • up to 3 years
|
|
Metabolism and nutrition disorders
anorexia
|
46.7%
7/15 • Number of events 8 • up to 3 years
|
46.7%
7/15 • Number of events 7 • up to 3 years
|
|
Gastrointestinal disorders
vomiting
|
20.0%
3/15 • Number of events 3 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Gastrointestinal disorders
nausea
|
20.0%
3/15 • Number of events 4 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Investigations
lymphocyte count decreased
|
13.3%
2/15 • Number of events 2 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Investigations
aspartate transaminase increased
|
60.0%
9/15 • Number of events 10 • up to 3 years
|
13.3%
2/15 • Number of events 2 • up to 3 years
|
|
Investigations
creatine increased
|
20.0%
3/15 • Number of events 4 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Investigations
total bilirubin increased
|
6.7%
1/15 • Number of events 3 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Gastrointestinal disorders
pain abdomen
|
13.3%
2/15 • Number of events 3 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Gastrointestinal disorders
diarrhea
|
26.7%
4/15 • Number of events 7 • up to 3 years
|
26.7%
4/15 • Number of events 4 • up to 3 years
|
|
Metabolism and nutrition disorders
hypernatremia
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Renal and urinary disorders
urea nitrogen
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Investigations
direct bilirubin increased
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Gastrointestinal disorders
constipation
|
13.3%
2/15 • Number of events 2 • up to 3 years
|
33.3%
5/15 • Number of events 5 • up to 3 years
|
|
Vascular disorders
thromboembolic event
|
13.3%
2/15 • Number of events 2 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Endocrine disorders
hypothyroidism
|
26.7%
4/15 • Number of events 4 • up to 3 years
|
26.7%
4/15 • Number of events 4 • up to 3 years
|
|
Investigations
decreased T3Free
|
13.3%
2/15 • Number of events 2 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Gastrointestinal disorders
dry mouth
|
13.3%
2/15 • Number of events 2 • up to 3 years
|
13.3%
2/15 • Number of events 2 • up to 3 years
|
|
Infections and infestations
mouth sore
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Endocrine disorders
Thyroid-stimulating hormone increased
|
13.3%
2/15 • Number of events 2 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Investigations
decreased T4
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
General disorders
teeth hemorrhage
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Nervous system disorders
dysgeusia
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
20.0%
3/15 • Number of events 3 • up to 3 years
|
|
Skin and subcutaneous tissue disorders
skin and subcutaneous disease
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Gastrointestinal disorders
flatulence
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Endocrine disorders
hyperthyroidism
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Gastrointestinal disorders
colitis
|
13.3%
2/15 • Number of events 3 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
General disorders
generalized weakness
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
20.0%
3/15 • Number of events 3 • up to 3 years
|
|
Eye disorders
dry eye
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Nervous system disorders
seizure
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Cardiac disorders
hypertension
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Gastrointestinal disorders
gastroesophageal reflux disease
|
13.3%
2/15 • Number of events 2 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Investigations
weight loss
|
13.3%
2/15 • Number of events 2 • up to 3 years
|
13.3%
2/15 • Number of events 2 • up to 3 years
|
|
Vascular disorders
hot flashes
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Skin and subcutaneous tissue disorders
pruritus
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
46.7%
7/15 • Number of events 10 • up to 3 years
|
|
Investigations
decreased white blood cells
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Blood and lymphatic system disorders
ANC decreased
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Endocrine disorders
night sweats
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Cardiac disorders
tachycardia
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Infections and infestations
thrush
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Ear and labyrinth disorders
hearing loss
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Renal and urinary disorders
urinary incontinence
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
0.00%
0/15 • up to 3 years
|
|
General disorders
chills
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
General disorders
fever
|
0.00%
0/15 • up to 3 years
|
13.3%
2/15 • Number of events 2 • up to 3 years
|
|
Renal and urinary disorders
gross hematuria
|
0.00%
0/15 • up to 3 years
|
13.3%
2/15 • Number of events 2 • up to 3 years
|
|
Gastrointestinal disorders
dyspepsia
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
General disorders
flu like symptoms
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/15 • up to 3 years
|
40.0%
6/15 • Number of events 7 • up to 3 years
|
|
Nervous system disorders
syncope
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
General disorders
nasal congestion
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 2 • up to 3 years
|
|
Nervous system disorders
dizziness
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Psychiatric disorders
confusion
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Metabolism and nutrition disorders
hypocalcemia
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
General disorders
pain throat
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
General disorders
pain sternum/chest
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
General disorders
pain bursitis forearm
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
General disorders
pain face
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Nervous system disorders
neuropathy fingers
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Psychiatric disorders
memory impairment
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Blood and lymphatic system disorders
purpura
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Blood and lymphatic system disorders
lymph node enlargement
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Gastrointestinal disorders
dysphagia
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Metabolism and nutrition disorders
hyperglycemia
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 3 • up to 3 years
|
|
Hepatobiliary disorders
hepatic cyst
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 2 • up to 3 years
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Eye disorders
blepharitis
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Gastrointestinal disorders
hemorrhoids
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
General disorders
gait disturbance
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Psychiatric disorders
insomnia
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Skin and subcutaneous tissue disorders
right elbow ulceration
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Metabolism and nutrition disorders
dehydration
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
|
Metabolism and nutrition disorders
increased phosphate
|
0.00%
0/15 • up to 3 years
|
6.7%
1/15 • Number of events 1 • up to 3 years
|
Additional Information
Emmanuel Antonarakis, MD
University of Minnesota Division of Hematology, Oncology and Transplantation
Phone: 612-301-2180
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place