Trial Outcomes & Findings for Study of Benralizumab in People With Skin Side Effects Caused by Cancer Therapies (NCT NCT04552288)
NCT ID: NCT04552288
Last Updated: 2026-04-16
Results Overview
To evaluate the percent reduction in CTCAE grade 2/3 eosinophil-related cutaneous adverse events to grade ≤1 resulting from checkpoint inhibitors (CPIs) or targeted therapies with absolute blood eosinophil counts of at least .3 K/mcl.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
4 weeks
Results posted on
2026-04-16
Participant Flow
Participant milestones
| Measure |
Participants With Eosinophil-related Cutaneous Events
Study participants will have grade 2/3 eosinophil-related cutaneous adverse events
Benralizumab: All eligible patients will receive a benralizumab dose of 30 mg SC administered by a healthcare provider once every 4 weeks for the first 3 doses, followed by once every 8 weeks for 3 additional doses.
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
37
|
Reasons for withdrawal
| Measure |
Participants With Eosinophil-related Cutaneous Events
Study participants will have grade 2/3 eosinophil-related cutaneous adverse events
Benralizumab: All eligible patients will receive a benralizumab dose of 30 mg SC administered by a healthcare provider once every 4 weeks for the first 3 doses, followed by once every 8 weeks for 3 additional doses.
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Protocol Violation
|
9
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Disease progression, Complicated disease, Ineligible
|
10
|
Baseline Characteristics
Study of Benralizumab in People With Skin Side Effects Caused by Cancer Therapies
Baseline characteristics by cohort
| Measure |
Participants With Eosinophil-related Cutaneous Events
n=51 Participants
Study participants will have grade 2/3 eosinophil-related cutaneous adverse events
Benralizumab: All eligible patients will receive a benralizumab dose of 30 mg SC administered by a healthcare provider once every 4 weeks for the first 3 doses, followed by once every 8 weeks for 3 additional doses.
|
|---|---|
|
Age, Continuous
|
63 years
n=193 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=193 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=193 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=193 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=193 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=193 Participants
|
|
Region of Enrollment
United States
|
51 Participants
n=193 Participants
|
PRIMARY outcome
Timeframe: 4 weeksTo evaluate the percent reduction in CTCAE grade 2/3 eosinophil-related cutaneous adverse events to grade ≤1 resulting from checkpoint inhibitors (CPIs) or targeted therapies with absolute blood eosinophil counts of at least .3 K/mcl.
Outcome measures
| Measure |
Participants With Eosinophil-related Cutaneous Events
n=51 Participants
Study participants will have grade 2/3 eosinophil-related cutaneous adverse events
Benralizumab: All eligible patients will receive a benralizumab dose of 30 mg SC administered by a healthcare provider once every 4 weeks for the first 3 doses, followed by once every 8 weeks for 3 additional doses.
|
|---|---|
|
Percent Reduction in CTCAE Grade 2/3 Eosinophil-related Cutaneous Adverse Events
Participants who responded to treatment
|
32 Participants
|
|
Percent Reduction in CTCAE Grade 2/3 Eosinophil-related Cutaneous Adverse Events
Participants who did not respond to treatment
|
10 Participants
|
|
Percent Reduction in CTCAE Grade 2/3 Eosinophil-related Cutaneous Adverse Events
Participants not evaluable
|
9 Participants
|
Adverse Events
Participants With Eosinophil-related Cutaneous Events
Serious events: 4 serious events
Other events: 37 other events
Deaths: 29 deaths
Serious adverse events
| Measure |
Participants With Eosinophil-related Cutaneous Events
n=51 participants at risk
Study participants will have grade 2/3 eosinophil-related cutaneous adverse events
Benralizumab: All eligible patients will receive a benralizumab dose of 30 mg SC administered by a healthcare provider once every 4 weeks for the first 3 doses, followed by once every 8 weeks for 3 additional doses.
|
|---|---|
|
General disorders
Death - Not other specified
|
3.9%
2/51 • 4 weeks
|
|
Gastrointestinal disorders
Gastric Perforation
|
2.0%
1/51 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
1/51 • 4 weeks
|
Other adverse events
| Measure |
Participants With Eosinophil-related Cutaneous Events
n=51 participants at risk
Study participants will have grade 2/3 eosinophil-related cutaneous adverse events
Benralizumab: All eligible patients will receive a benralizumab dose of 30 mg SC administered by a healthcare provider once every 4 weeks for the first 3 doses, followed by once every 8 weeks for 3 additional doses.
|
|---|---|
|
Nervous system disorders
Somnolence
|
2.0%
1/51 • 4 weeks
|
|
Gastrointestinal disorders
Oral pain
|
2.0%
1/51 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Odynophagia
|
2.0%
1/51 • 4 weeks
|
|
Gastrointestinal disorders
Swelling of gums/lips
|
2.0%
1/51 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
1/51 • 4 weeks
|
|
Cardiac disorders
Heart failure
|
2.0%
1/51 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.9%
2/51 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
2.0%
1/51 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
1/51 • 4 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.0%
1/51 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.0%
1/51 • 4 weeks
|
|
General disorders
Pain
|
2.0%
1/51 • 4 weeks
|
|
General disorders
Fatigue
|
3.9%
2/51 • 4 weeks
|
|
Gastrointestinal disorders
Vomiting/Nausea
|
5.9%
3/51 • 4 weeks
|
|
Immune system disorders
Allergic reaction
|
2.0%
1/51 • 4 weeks
|
|
Gastrointestinal disorders
Gastric perforation
|
2.0%
1/51 • 4 weeks
|
|
Gastrointestinal disorders
Mucositis oral
|
5.9%
3/51 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
EV Rash
|
2.0%
1/51 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
2.0%
1/51 • 4 weeks
|
|
Gastrointestinal disorders
Cheilitis
|
2.0%
1/51 • 4 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
2.0%
1/51 • 4 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
1/51 • 4 weeks
|
|
Gastrointestinal disorders
Stomatits
|
5.9%
3/51 • 4 weeks
|
|
Investigations
Elevated liver enzymes
|
2.0%
1/51 • 4 weeks
|
|
Vascular disorders
Hypotension
|
2.0%
1/51 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Xerosis
|
2.0%
1/51 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Purpura
|
2.0%
1/51 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
2.0%
1/51 • 4 weeks
|
|
General disorders
Edema Limbs
|
2.0%
1/51 • 4 weeks
|
Additional Information
Dr. Alina Markova, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-608-2342
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place