Trial Outcomes & Findings for Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia (NCT NCT03514017)
NCT ID: NCT03514017
Last Updated: 2025-12-24
Results Overview
Response categories according to The International Workshop on Chronic Lymphocytic Leukemia (IWCLL): Complete remission (CR); Complete remission with incomplete marrow recovery (CRi); Partial remission (PR); Progressive disease (PD); Stable disease (SD), defined as not meeting criteria for CR, CRi, PR or PD.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2025-12-24
Participant Flow
Participant milestones
| Measure |
Pembrolizumab and Ibrutinib
Treatment with pembrolizumab and ibrutinib and follow-up period of up to 24 months.
Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
Ibrutinib is an inhibitor of Bruton's tyrosine kinase (BTK). Ibrutinib is a small-molecule inhibitor of BTK.
Pembrolizumab: Pembrolizumab will be administered intravenously (IV) at 200 mg every 3 weeks for 1 year and up to 2 years.
Ibrutinib: Ibrutinib will be administered orally once daily at approximately the same time each day at the dose of 420 mg daily (3 capsules of 140 mg daily).
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|---|---|
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Overall Study
STARTED
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5
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|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
Pembrolizumab and Ibrutinib
Treatment with pembrolizumab and ibrutinib and follow-up period of up to 24 months.
Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
Ibrutinib is an inhibitor of Bruton's tyrosine kinase (BTK). Ibrutinib is a small-molecule inhibitor of BTK.
Pembrolizumab: Pembrolizumab will be administered intravenously (IV) at 200 mg every 3 weeks for 1 year and up to 2 years.
Ibrutinib: Ibrutinib will be administered orally once daily at approximately the same time each day at the dose of 420 mg daily (3 capsules of 140 mg daily).
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|---|---|
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Overall Study
Death
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1
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Overall Study
Adverse Event
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1
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Baseline Characteristics
Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Pembrolizumab and Ibrutinib
n=5 Participants
Treatment with pembrolizumab and ibrutinib and follow-up period of up to 24 months.
Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
Ibrutinib is an inhibitor of Bruton's tyrosine kinase (BTK). Ibrutinib is a small-molecule inhibitor of BTK.
Pembrolizumab: Pembrolizumab will be administered intravenously (IV) at 200 mg every 3 weeks for 1 year and up to 2 years.
Ibrutinib: Ibrutinib will be administered orally once daily at approximately the same time each day at the dose of 420 mg daily (3 capsules of 140 mg daily).
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
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Age, Categorical
Between 18 and 65 years
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3 Participants
n=30 Participants
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Age, Categorical
>=65 years
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2 Participants
n=30 Participants
|
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Sex: Female, Male
Female
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1 Participants
n=30 Participants
|
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Sex: Female, Male
Male
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4 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
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5 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
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Region of Enrollment
United States
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5 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: evaluable participants
Response categories according to The International Workshop on Chronic Lymphocytic Leukemia (IWCLL): Complete remission (CR); Complete remission with incomplete marrow recovery (CRi); Partial remission (PR); Progressive disease (PD); Stable disease (SD), defined as not meeting criteria for CR, CRi, PR or PD.
Outcome measures
| Measure |
Pembrolizumab and Ibrutinib
n=3 Participants
Treatment with pembrolizumab and ibrutinib and follow-up period of up to 24 months.
Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
Ibrutinib is an inhibitor of Bruton's tyrosine kinase (BTK). Ibrutinib is a small-molecule inhibitor of BTK.
Pembrolizumab: Pembrolizumab will be administered intravenously (IV) at 200 mg every 3 weeks for 1 year and up to 2 years.
Ibrutinib: Ibrutinib will be administered orally once daily at approximately the same time each day at the dose of 420 mg daily (3 capsules of 140 mg daily).
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|---|---|
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Overall Response Rate (ORR) to the Therapeutic Intervention
Stable Disease
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1 participants
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Overall Response Rate (ORR) to the Therapeutic Intervention
CR/PR
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2 participants
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PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: evaluable participants
Time to best response to chronic lymphocytic leukemia (CLL) to the therapeutic intervention.
Outcome measures
| Measure |
Pembrolizumab and Ibrutinib
n=3 Participants
Treatment with pembrolizumab and ibrutinib and follow-up period of up to 24 months.
Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
Ibrutinib is an inhibitor of Bruton's tyrosine kinase (BTK). Ibrutinib is a small-molecule inhibitor of BTK.
Pembrolizumab: Pembrolizumab will be administered intravenously (IV) at 200 mg every 3 weeks for 1 year and up to 2 years.
Ibrutinib: Ibrutinib will be administered orally once daily at approximately the same time each day at the dose of 420 mg daily (3 capsules of 140 mg daily).
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|---|---|
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Time to Best Response
|
3.02 months
Standard Deviation 4.99
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SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Evaluable patients
Progressive disease (PD), defined as ≥ 50% rise in lymphocyte count to \> 5 x10\^9/L, ≥ 50% increase in lymphadenopathy, ≥ 50% increase in liver or spleen size, Richter's transformation, or new cytopenias due to CLL.
Outcome measures
| Measure |
Pembrolizumab and Ibrutinib
n=3 Participants
Treatment with pembrolizumab and ibrutinib and follow-up period of up to 24 months.
Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
Ibrutinib is an inhibitor of Bruton's tyrosine kinase (BTK). Ibrutinib is a small-molecule inhibitor of BTK.
Pembrolizumab: Pembrolizumab will be administered intravenously (IV) at 200 mg every 3 weeks for 1 year and up to 2 years.
Ibrutinib: Ibrutinib will be administered orally once daily at approximately the same time each day at the dose of 420 mg daily (3 capsules of 140 mg daily).
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|---|---|
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Progression-free Survival (PFS)
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16.57 months
Standard Deviation 1.58
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Adverse Events
Pembrolizumab and Ibrutinib
Serious events: 3 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Pembrolizumab and Ibrutinib
n=5 participants at risk
Treatment with pembrolizumab and ibrutinib and follow-up period of up to 24 months.
Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
Ibrutinib is an inhibitor of Bruton's tyrosine kinase (BTK). Ibrutinib is a small-molecule inhibitor of BTK.
Pembrolizumab: Pembrolizumab will be administered intravenously (IV) at 200 mg every 3 weeks for 1 year and up to 2 years.
Ibrutinib: Ibrutinib will be administered orally once daily at approximately the same time each day at the dose of 420 mg daily (3 capsules of 140 mg daily).
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|---|---|
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Infections and infestations
Gram negative sepsis
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
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Infections and infestations
Aseptic Meningitis
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
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Cardiac disorders
Atrial fibrilation
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
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Infections and infestations
Lung Infection
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
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Other adverse events
| Measure |
Pembrolizumab and Ibrutinib
n=5 participants at risk
Treatment with pembrolizumab and ibrutinib and follow-up period of up to 24 months.
Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
Ibrutinib is an inhibitor of Bruton's tyrosine kinase (BTK). Ibrutinib is a small-molecule inhibitor of BTK.
Pembrolizumab: Pembrolizumab will be administered intravenously (IV) at 200 mg every 3 weeks for 1 year and up to 2 years.
Ibrutinib: Ibrutinib will be administered orally once daily at approximately the same time each day at the dose of 420 mg daily (3 capsules of 140 mg daily).
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|---|---|
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Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
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|
Gastrointestinal disorders
Oral pain
|
20.0%
1/5 • Number of events 4 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Gastrointestinal disorders
Periodontal disease
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Gastrointestinal disorders
Proctitis
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
General disorders
Fatigue
|
80.0%
4/5 • Number of events 9 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
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|
General disorders
Fever
|
60.0%
3/5 • Number of events 5 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
General disorders
Chills
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
2/5 • Number of events 6 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
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Blood and lymphatic system disorders
Febrile neutropenia
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Gastrointestinal disorders
Diarrhea
|
60.0%
3/5 • Number of events 7 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Gastrointestinal disorders
Abdominal Pain
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
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|
Gastrointestinal disorders
Fecal incontinence
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
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|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
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|
Gastrointestinal disorders
Gingival pain
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
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|
Gastrointestinal disorders
Mucositis oral
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
General disorders
Pain
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
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|
General disorders
Flu like symptoms
|
20.0%
1/5 • Number of events 3 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
General disorders
Malaise
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
General disorders
Non-cardiac chest pain
|
20.0%
1/5 • Number of events 3 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
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Investigations
Alanine aminotransferase increased
|
80.0%
4/5 • Number of events 7 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
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|
Investigations
Blood urea nitrogen increased
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
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|
Investigations
Blood CO2 decreased
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
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|
Investigations
Platelet count increased
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Investigations
Neutrophil Count Increased
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Investigations
Aspartate aminotransferase increased
|
60.0%
3/5 • Number of events 8 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Investigations
Neutrophil count decreased
|
40.0%
2/5 • Number of events 6 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Investigations
Thyroid stimulating hormone increased
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Investigations
Creatinine increased
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Investigations
Hemoglobin increased
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Metabolism and nutrition disorders
Blood urea nitrogen decreased
|
20.0%
1/5 • Number of events 6 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
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Metabolism and nutrition disorders
Blood Urea Nitrogen Increased
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
40.0%
2/5 • Number of events 3 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
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Metabolism and nutrition disorders
Hypochloremia
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Metabolism and nutrition disorders
Iron decreased
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Metabolism and nutrition disorders
Lactic Acid Increased
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Metabolism and nutrition disorders
LDL increased
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Metabolism and nutrition disorders
Serum protein decreased
|
40.0%
2/5 • Number of events 3 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Metabolism and nutrition disorders
Serm chloride decreased
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Metabolism and nutrition disorders
Serum Chloride decreased
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Metabolism and nutrition disorders
Total protein decreased
|
40.0%
2/5 • Number of events 4 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Metabolism and nutrition disorders
Uric acid decreased
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
80.0%
4/5 • Number of events 5 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
60.0%
3/5 • Number of events 6 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
60.0%
3/5 • Number of events 5 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
60.0%
3/5 • Number of events 6 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
40.0%
2/5 • Number of events 4 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
20.0%
1/5 • Number of events 3 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
1/5 • Number of events 4 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Infections and infestations
Infections and Infestations -Other
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Infections and infestations
Folliculitis
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Infections and infestations
Lung infection
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Infections and infestations
Meningitis
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Infections and infestations
Sepsis
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Infections and infestations
Soft tissue infection
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Infections and infestations
Thrush
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Infections and infestations
Upper respiratory infection
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
60.0%
3/5 • Number of events 4 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
40.0%
2/5 • Number of events 3 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Nervous system disorders
Headache
|
40.0%
2/5 • Number of events 3 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Nervous system disorders
Neuralgia
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Psychiatric disorders
Insomnia
|
80.0%
4/5 • Number of events 4 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Psychiatric disorders
Anxiety
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Psychiatric disorders
Confusion
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
80.0%
4/5 • Number of events 6 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
60.0%
3/5 • Number of events 4 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
40.0%
2/5 • Number of events 4 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
40.0%
2/5 • Number of events 4 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
40.0%
2/5 • Number of events 3 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Vascular disorders
Flushing
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Vascular disorders
Hematoma
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Vascular disorders
Hypertension
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Cardiac disorders
Atrial fibrillation
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Cardiac disorders
Cardiac arrest
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Cardiac disorders
Sinus tachycardia
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Eye disorders
Eye pain
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Eye disorders
Blurred vision
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Eye disorders
Macular wrinkle left eye
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Eye disorders
Eye swelling/redness
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Eye disorders
Periorbital edema
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Eye disorders
Photophobia
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Injury, poisoning and procedural complications
Bruising
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Ear and labyrinth disorders
Ear pain
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Immune system disorders
Hypogammaglobulinemia
|
40.0%
2/5 • Number of events 3 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma, right calf
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nodule on dorsal aspect of left food
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place