Trial Outcomes & Findings for Low Dose Ipilimumab With Pembrolizumab in Treating Patients With Melanoma That Has Spread to the Brain (NCT NCT03873818)
NCT ID: NCT03873818
Last Updated: 2026-01-09
Results Overview
clinical benefit rate (CBR), defined as CR + PR + SD \> 6 months, in the brain in subjects with MBM per modified RECIST 1.1 criteria who are treatment naïve to anti-PD-1 agents in metastatic setting (prior adjuvant anti-PD1 allowed).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Baseline to 2 years
Results posted on
2026-01-09
Participant Flow
Low Dose Ipilimumab in Combination with Pembrolizumab in Metastatic Melanoma patients with brain metastases
Participant milestones
| Measure |
Cohort A: Treatment Naïve
Ipilimumab 1 mg/kg IV q3 wks (up to 4 doses) \& Pembrolizumab 200 mg IV q3 wks (up to 35 doses)
|
Cohort B: Previously Progressed on PD-1 Inhibitors
Ipilimumab 1 mg/kg IV q3 wks (up to 4 doses) \& pembrolizumab 200 mg IV q3 wks (up to 35 doses)
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
4
|
|
Overall Study
COMPLETED
|
10
|
1
|
|
Overall Study
NOT COMPLETED
|
10
|
3
|
Reasons for withdrawal
| Measure |
Cohort A: Treatment Naïve
Ipilimumab 1 mg/kg IV q3 wks (up to 4 doses) \& Pembrolizumab 200 mg IV q3 wks (up to 35 doses)
|
Cohort B: Previously Progressed on PD-1 Inhibitors
Ipilimumab 1 mg/kg IV q3 wks (up to 4 doses) \& pembrolizumab 200 mg IV q3 wks (up to 35 doses)
|
|---|---|---|
|
Overall Study
Death
|
9
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Low Dose Ipilimumab With Pembrolizumab in Treating Patients With Melanoma That Has Spread to the Brain
Baseline characteristics by cohort
| Measure |
Cohort A: Treatment Naïve
n=20 Participants
Ipilimumab 1 mg/kg IV q3 wks (up to 4 doses) \& Pembrolizumab 200 mg IV q3 wks (up to 35 doses)
|
Cohort B: Previously Progressed on PD-1 Inhibitors
n=4 Participants
Ipilimumab 1 mg/kg IV q3 wks (up to 4 doses) \& Pembrolizumab 200 mg IV q3 wks (up to 35 doses)
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=8 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=15 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=8 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=15 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=8 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=8 Participants
|
4 Participants
n=7 Participants
|
23 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=15 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=8 Participants
|
4 Participants
n=7 Participants
|
23 Participants
n=15 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=8 Participants
|
4 participants
n=7 Participants
|
24 participants
n=15 Participants
|
PRIMARY outcome
Timeframe: Baseline to 2 yearsPopulation: For Cohort B- as these patients were not PD-1 naïve, there is no data to be entered in this section. The CBR for this cohort is listed under Secondary outcome.
clinical benefit rate (CBR), defined as CR + PR + SD \> 6 months, in the brain in subjects with MBM per modified RECIST 1.1 criteria who are treatment naïve to anti-PD-1 agents in metastatic setting (prior adjuvant anti-PD1 allowed).
Outcome measures
| Measure |
Cohort A: Treatment Naïve
n=20 Participants
Ipilimumab 1 mg/kg IV q3 wks (up to 4 doses) \& Pembrolizumab 200 mg IV q3 wks (up to 35 doses)
|
Cohort B: Previously Progressed on PD-1 Inhibitors
Ipilimumab 1 mg/kg IV q3 wks (up to 4 doses) \& Pembrolizumab 200 mg IV q3 wks (up to 35 doses)
|
|---|---|---|
|
Clinical Benefit Rate (CBR) in PD-1 naïve Patients
|
68.4 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 2 yearsPopulation: This metric only applies to Cohort B, as this objective only looks ONLY at the patients who are PD-1 refractory (Cohort B by definition)
Assess CBR in the brain in subjects with MBM per modified RECIST 1.1 in patients who previously progressed on PD-1 inhibitors.
Outcome measures
| Measure |
Cohort A: Treatment Naïve
Ipilimumab 1 mg/kg IV q3 wks (up to 4 doses) \& Pembrolizumab 200 mg IV q3 wks (up to 35 doses)
|
Cohort B: Previously Progressed on PD-1 Inhibitors
n=4 Participants
Ipilimumab 1 mg/kg IV q3 wks (up to 4 doses) \& Pembrolizumab 200 mg IV q3 wks (up to 35 doses)
|
|---|---|---|
|
CBR for Patients Who Progressed on PD-1 Inhibitors
|
—
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to 2 yearsAssess OS and PFS.
Outcome measures
| Measure |
Cohort A: Treatment Naïve
n=20 Participants
Ipilimumab 1 mg/kg IV q3 wks (up to 4 doses) \& Pembrolizumab 200 mg IV q3 wks (up to 35 doses)
|
Cohort B: Previously Progressed on PD-1 Inhibitors
n=4 Participants
Ipilimumab 1 mg/kg IV q3 wks (up to 4 doses) \& Pembrolizumab 200 mg IV q3 wks (up to 35 doses)
|
|---|---|---|
|
Overall Survival (OS) & Progression-free Survival (PFS)
PFS
|
11.8 months
Interval 1.4 to
The upper 95% CI is not estimated due to insufficient number of participants with events.
|
1.4 months
Interval 1.3 to
The upper 95% CI is not estimated due to insufficient number of participants with events.
|
|
Overall Survival (OS) & Progression-free Survival (PFS)
OS
|
NA months
Interval 5.7 to
Median OS not reached due to insufficient number of participants with events.
|
11.0 months
Interval 8.8 to
The upper 95% CI is not estimated due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Baseline to 2 yearsEvaluate the brain-specific safety and tolerability of the combination regimen in subjects with or without SRT received prior to study entry, or on study.
Outcome measures
| Measure |
Cohort A: Treatment Naïve
n=20 Participants
Ipilimumab 1 mg/kg IV q3 wks (up to 4 doses) \& Pembrolizumab 200 mg IV q3 wks (up to 35 doses)
|
Cohort B: Previously Progressed on PD-1 Inhibitors
n=4 Participants
Ipilimumab 1 mg/kg IV q3 wks (up to 4 doses) \& Pembrolizumab 200 mg IV q3 wks (up to 35 doses)
|
|---|---|---|
|
Brain-specific Safety and Tolerability
CNS concerns
|
0 Participants
|
0 Participants
|
|
Brain-specific Safety and Tolerability
Treatment related grade 3 or 4 AEs
|
5 Participants
|
0 Participants
|
Adverse Events
Cohort A: Treatment Naïve
Serious events: 10 serious events
Other events: 20 other events
Deaths: 9 deaths
Cohort B: Previously Progressed on PD-1 Inhibitors
Serious events: 1 serious events
Other events: 4 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Cohort A: Treatment Naïve
n=20 participants at risk
Ipilimumab 1 mg/kg IV q3 wks (up to 4 doses) \& Pembrolizumab 200 mg IV q3 wks (up to 35 doses)
|
Cohort B: Previously Progressed on PD-1 Inhibitors
n=4 participants at risk
Ipilimumab 1 mg/kg IV q3 wks (up to 4 doses) \& Pembrolizumab 200 mg IV q3 wks (up to 35 doses)
|
|---|---|---|
|
General disorders
Fall
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough/dyspnea
|
10.0%
2/20 • Number of events 2 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Vascular disorders
Thromboembolic event
|
10.0%
2/20 • Number of events 2 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
10.0%
2/20 • Number of events 2 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Investigations
ALT increased
|
10.0%
2/20 • Number of events 2 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Investigations
AST increased
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Investigations
Lymphocyte count decrased
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Metabolism and nutrition disorders
Anorexia
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Vascular disorders
Hypotension
|
10.0%
2/20 • Number of events 2 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Nervous system disorders
Nervous system disorders - Other, left sided hemiparesis
|
0.00%
0/20 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/20 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Gastrointestinal disorders
Colonic perforation
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Nervous system disorders
Syncope
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Psychiatric disorders
Confusion
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
Other adverse events
| Measure |
Cohort A: Treatment Naïve
n=20 participants at risk
Ipilimumab 1 mg/kg IV q3 wks (up to 4 doses) \& Pembrolizumab 200 mg IV q3 wks (up to 35 doses)
|
Cohort B: Previously Progressed on PD-1 Inhibitors
n=4 participants at risk
Ipilimumab 1 mg/kg IV q3 wks (up to 4 doses) \& Pembrolizumab 200 mg IV q3 wks (up to 35 doses)
|
|---|---|---|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.0%
1/20 • Number of events 2 • Approximately 4 years and 10 months
|
50.0%
2/4 • Number of events 2 • Approximately 4 years and 10 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.0%
2/20 • Number of events 2 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Metabolism and nutrition disorders
Headache
|
45.0%
9/20 • Number of events 14 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Vascular disorders
Hot flashes
|
10.0%
2/20 • Number of events 2 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
30.0%
6/20 • Number of events 11 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
35.0%
7/20 • Number of events 11 • Approximately 4 years and 10 months
|
100.0%
4/4 • Number of events 4 • Approximately 4 years and 10 months
|
|
Investigations
Hyperkalemia
|
10.0%
2/20 • Number of events 2 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 2 • Approximately 4 years and 10 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Vascular disorders
Hypertension
|
20.0%
4/20 • Number of events 4 • Approximately 4 years and 10 months
|
100.0%
4/4 • Number of events 4 • Approximately 4 years and 10 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
15.0%
3/20 • Number of events 3 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
10.0%
2/20 • Number of events 2 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Metabolism and nutrition disorders
Hypokalmeia
|
5.0%
1/20 • Number of events 2 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
5/20 • Number of events 5 • Approximately 4 years and 10 months
|
50.0%
2/4 • Number of events 2 • Approximately 4 years and 10 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
20.0%
4/20 • Number of events 6 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Vascular disorders
Hypotension
|
15.0%
3/20 • Number of events 3 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Endocrine disorders
Hypothyroidism
|
20.0%
4/20 • Number of events 4 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Investigations
INR increased
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Psychiatric disorders
Insomnia
|
15.0%
3/20 • Number of events 3 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Musculoskeletal and connective tissue disorders
Joint rang of motion decreased
|
10.0%
2/20 • Number of events 2 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
General disorders
Localized edema
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Nervous system disorders
Lethargy
|
0.00%
0/20 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Infections and infestations
Lung infection
|
10.0%
2/20 • Number of events 2 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Blood and lymphatic system disorders
Lymph node pain
|
10.0%
2/20 • Number of events 3 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Investigations
Lymphocyte count decreased
|
10.0%
2/20 • Number of events 2 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Nervous system disorders
Memory impairment
|
10.0%
2/20 • Number of events 2 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Musculoskeletal and connective tissue disorders
Leg cramp
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
2/20 • Number of events 3 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Nervous system disorders
Left sided hemiparesis
|
0.00%
0/20 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
2/20 • Number of events 2 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Gastrointestinal disorders
Nausea
|
45.0%
9/20 • Number of events 13 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Gastrointestinal disorders
Oral dysesthesia
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
General disorders
Pain
|
35.0%
7/20 • Number of events 8 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Nervous system disorders
Paraesthesia
|
20.0%
4/20 • Number of events 4 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Investigations
Platelet count decreased
|
10.0%
2/20 • Number of events 2 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
15.0%
3/20 • Number of events 4 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Renal and urinary disorders
Proteinuria
|
20.0%
4/20 • Number of events 4 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
45.0%
9/20 • Number of events 13 • Approximately 4 years and 10 months
|
75.0%
3/4 • Number of events 3 • Approximately 4 years and 10 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/20 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
30.0%
6/20 • Number of events 9 • Approximately 4 years and 10 months
|
75.0%
3/4 • Number of events 4 • Approximately 4 years and 10 months
|
|
Renal and urinary disorders
Renal calculi
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/20 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Cardiac disorders
Sick sinus syndrome
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Cardiac disorders
Sinus bradycardia
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Nervous system disorders
Sinus pain
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Cardiac disorders
Sinus tachycardia
|
10.0%
2/20 • Number of events 3 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
15.0%
3/20 • Number of events 5 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Renal and urinary disorders
Urinary frequency
|
5.0%
1/20 • Number of events 2 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Renal and urinary disorders
Urinary tract pain
|
5.0%
1/20 • Number of events 2 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Renal and urinary disorders
Urine discoloration
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Eye disorders
Uveitis
|
5.0%
1/20 • Number of events 2 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Ear and labyrinth disorders
Vestibular disorder
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
3/20 • Number of events 3 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Investigations
Weight loss
|
20.0%
4/20 • Number of events 4 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Investigations
White blood cell decreased
|
20.0%
4/20 • Number of events 4 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Ear and labyrinth disorders
Left ear hearing changes
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Endocrine disorders
T4 increased
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Endocrine disorders
T4 decreased
|
10.0%
2/20 • Number of events 2 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Endocrine disorders
T3 decreased
|
10.0%
2/20 • Number of events 2 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Eye disorders
Halo effect aroung light
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Eye disorders
Visual disturbance
|
10.0%
2/20 • Number of events 2 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Eye disorders
Loss of vision- rt side
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Infections and infestations
COVID
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Immune system disorders
Autonomic Dystunction
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Infections and infestations
Oral fungal infection
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Investigations
WBC elevated
|
10.0%
2/20 • Number of events 3 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Investigations
Hyperphosphatemia
|
10.0%
2/20 • Number of events 2 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Investigations
ANC increased
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Investigations
T4 increased
|
5.0%
1/20 • Number of events 2 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Renal and urinary disorders
Urination Hesitation
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Skin and subcutaneous tissue disorders
Lesion scalp
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Skin and subcutaneous tissue disorders
Lesion face
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Skin and subcutaneous tissue disorders
Perioral erythema
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Skin and subcutaneous tissue disorders
Lichen Planus
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Skin and subcutaneous tissue disorders
Perleche
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/20 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Endocrine disorders
TSH elevated (mildly)
|
0.00%
0/20 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
8/20 • Number of events 12 • Approximately 4 years and 10 months
|
100.0%
4/4 • Number of events 5 • Approximately 4 years and 10 months
|
|
General disorders
Flu like symptoms
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
General disorders
Gait disturbance
|
25.0%
5/20 • Number of events 5 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
2/20 • Number of events 2 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
35.0%
7/20 • Number of events 7 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Investigations
Aspartate aminotransferase increased
|
40.0%
8/20 • Number of events 18 • Approximately 4 years and 10 months
|
50.0%
2/4 • Number of events 2 • Approximately 4 years and 10 months
|
|
Nervous system disorders
Ataxia
|
10.0%
2/20 • Number of events 2 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/20 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.0%
2/20 • Number of events 2 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Infections and infestations
Bladder Infection
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Blood and lymphatic system disorders
Blood bilirubin increased
|
10.0%
2/20 • Number of events 3 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 2 • Approximately 4 years and 10 months
|
|
Eye disorders
Blurred vision
|
20.0%
4/20 • Number of events 4 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Injury, poisoning and procedural complications
Brusing
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Investigations
Cardiac troponin T increased
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
General disorders
Chills
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Investigations
Cholesterol High
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Nervous system disorders
Cognitive disturbance
|
30.0%
6/20 • Number of events 6 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Gastrointestinal disorders
Colitis
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Gastrointestinal disorders
Constipation
|
10.0%
2/20 • Number of events 2 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
35.0%
7/20 • Number of events 7 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Investigations
Creatinine increased
|
45.0%
9/20 • Number of events 15 • Approximately 4 years and 10 months
|
100.0%
4/4 • Number of events 4 • Approximately 4 years and 10 months
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
2/20 • Number of events 2 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Gastrointestinal disorders
Diarrhea
|
35.0%
7/20 • Number of events 13 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Nervous system disorders
Dizziness
|
20.0%
4/20 • Number of events 4 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
15.0%
3/20 • Number of events 3 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Nervous system disorders
Dysgeusia
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
2/20 • Number of events 2 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
30.0%
6/20 • Number of events 6 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
General disorders
Edema limbs
|
20.0%
4/20 • Number of events 4 • Approximately 4 years and 10 months
|
50.0%
2/4 • Number of events 2 • Approximately 4 years and 10 months
|
|
Endocrine disorders
Encephalopathy
|
0.00%
0/20 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
General disorders
Fatigue
|
65.0%
13/20 • Number of events 25 • Approximately 4 years and 10 months
|
75.0%
3/4 • Number of events 4 • Approximately 4 years and 10 months
|
|
General disorders
Fever
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Eye disorders
Flashing lights
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Eye disorders
Floaters
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 1 • Approximately 4 years and 10 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Cardiac disorders
Acute coronary syndrome
|
5.0%
1/20 • Number of events 1 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/20 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 2 • Approximately 4 years and 10 months
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/20 • Approximately 4 years and 10 months
|
25.0%
1/4 • Number of events 2 • Approximately 4 years and 10 months
|
|
Psychiatric disorders
Agitation
|
5.0%
1/20 • Number of events 2 • Approximately 4 years and 10 months
|
0.00%
0/4 • Approximately 4 years and 10 months
|
|
Investigations
Alanine aminotransferase increased
|
45.0%
9/20 • Number of events 19 • Approximately 4 years and 10 months
|
50.0%
2/4 • Number of events 2 • Approximately 4 years and 10 months
|
|
Investigations
Alkaline phosphatase increased
|
30.0%
6/20 • Number of events 8 • Approximately 4 years and 10 months
|
50.0%
2/4 • Number of events 2 • Approximately 4 years and 10 months
|
Additional Information
Isabella C Glitza, MD,PHD
The University of Texas MD Anderson Cancer Center
Phone: (713) 792-2921
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place