Trial Outcomes & Findings for Pembrolizumab for Patients With PD-L1 Diffuse Large B Cell Lymphoma (DLBCL) (NCT NCT03990961)
NCT ID: NCT03990961
Last Updated: 2026-02-20
Results Overview
The overall response rate (ORR) summarizes the best overall response (BOR) rate of the individual patients whose BOR is complete response (CR) or partial response (PR). The ORR is expressed as a percentage of all treated participants with 95% confidence intervals obtained using the exact binomial distribution.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
4.5 years
Results posted on
2026-02-20
Participant Flow
Participant milestones
| Measure |
Pembrolizumab Treatment
Pembrolizumab: Subjects will receive pembrolizumab treatment at a dose of 200mg IV every 3 weeks for a duration of 2 years (35 cycles).
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Pembrolizumab Treatment
Pembrolizumab: Subjects will receive pembrolizumab treatment at a dose of 200mg IV every 3 weeks for a duration of 2 years (35 cycles).
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
The study was terminated
|
3
|
Baseline Characteristics
Pembrolizumab for Patients With PD-L1 Diffuse Large B Cell Lymphoma (DLBCL)
Baseline characteristics by cohort
| Measure |
Pembrolizumab Treatment
n=5 Participants
Pembrolizumab: Subjects will receive pembrolizumab treatment at a dose of 200mg IV every 3 weeks for a duration of 2 years (35 cycles).
|
|---|---|
|
Age, Continuous
|
59.6 years
STANDARD_DEVIATION 23.8 • n=14 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: 4.5 yearsThe overall response rate (ORR) summarizes the best overall response (BOR) rate of the individual patients whose BOR is complete response (CR) or partial response (PR). The ORR is expressed as a percentage of all treated participants with 95% confidence intervals obtained using the exact binomial distribution.
Outcome measures
| Measure |
Pembrolizumab Treatment
n=5 Participants
Pembrolizumab: Subjects will receive pembrolizumab treatment at a dose of 200mg IV every 3 weeks for a duration of 2 years (35 cycles).
|
|---|---|
|
Overall Response Rate (ORR) to Pembrolizumab Treatment Compared to Historical Controls.
|
80 percentage of participants
Interval 28.0 to 99.0
|
SECONDARY outcome
Timeframe: 4.5 yearsDuration of response (DOR) is defined as the time when complete response (CR) or partial response (PR) is first observed to the time of progressed disease (PD) or death for the subjects whose best overall response is complete response (CR) or partial response (PR).
Outcome measures
| Measure |
Pembrolizumab Treatment
n=5 Participants
Pembrolizumab: Subjects will receive pembrolizumab treatment at a dose of 200mg IV every 3 weeks for a duration of 2 years (35 cycles).
|
|---|---|
|
Duration of Response (DOR) to Pembrolizumab Treatment
|
2.76 months
Interval 1.4 to
NA due to the insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: 4.5 yearsProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of the target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions. Progression-free survival (PFS) is defined as the time from the first date of first treatment in the study until the progressive disease is confirmed or upon patient death.
Outcome measures
| Measure |
Pembrolizumab Treatment
n=5 Participants
Pembrolizumab: Subjects will receive pembrolizumab treatment at a dose of 200mg IV every 3 weeks for a duration of 2 years (35 cycles).
|
|---|---|
|
Progression-free Survival (PFS)
|
3.73 months
Interval 2.3 to 5.53
|
SECONDARY outcome
Timeframe: 4.5 yearsOverall Survival (OS) is defined as the time between the first date of first treatment in the study and the date of death from any cause or the last known date the patient was alive.
Outcome measures
| Measure |
Pembrolizumab Treatment
n=5 Participants
Pembrolizumab: Subjects will receive pembrolizumab treatment at a dose of 200mg IV every 3 weeks for a duration of 2 years (35 cycles).
|
|---|---|
|
Overall Survival (OS)
|
53.3 probability
Interval 6.8 to 86.3
|
Adverse Events
Pembrolizumab Treatment
Serious events: 3 serious events
Other events: 5 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Pembrolizumab Treatment
n=5 participants at risk
Pembrolizumab: Subjects will receive pembrolizumab treatment at a dose of 200mg IV every 3 weeks for a duration of 2 years (35 cycles).
|
|---|---|
|
Cardiac disorders
Heart failure
|
20.0%
1/5 • 4.5 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
40.0%
2/5 • 4.5 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
20.0%
1/5 • 4.5 years
|
|
Infections and infestations
Sepsis
|
20.0%
1/5 • 4.5 years
|
|
Investigations
White blood cell decreased
|
20.0%
1/5 • 4.5 years
|
|
Investigations
Alkaline phosphatase increased
|
20.0%
1/5 • 4.5 years
|
|
Investigations
Platelet count decreased
|
20.0%
1/5 • 4.5 years
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
1/5 • 4.5 years
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
1/5 • 4.5 years
|
|
Nervous system disorders
Stroke
|
20.0%
1/5 • 4.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
20.0%
1/5 • 4.5 years
|
Other adverse events
| Measure |
Pembrolizumab Treatment
n=5 participants at risk
Pembrolizumab: Subjects will receive pembrolizumab treatment at a dose of 200mg IV every 3 weeks for a duration of 2 years (35 cycles).
|
|---|---|
|
General disorders
Fever
|
40.0%
2/5 • 4.5 years
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
20.0%
1/5 • 4.5 years
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
20.0%
1/5 • 4.5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
40.0%
2/5 • 4.5 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
20.0%
1/5 • 4.5 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
20.0%
1/5 • 4.5 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
20.0%
1/5 • 4.5 years
|
|
Cardiac disorders
Hypertension
|
20.0%
1/5 • 4.5 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
20.0%
1/5 • 4.5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
1/5 • 4.5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
40.0%
2/5 • 4.5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
1/5 • 4.5 years
|
|
Vascular disorders
Hypotension
|
20.0%
1/5 • 4.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
20.0%
1/5 • 4.5 years
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • 4.5 years
|
|
Investigations
Investigations - Other, specify
|
20.0%
1/5 • 4.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
20.0%
1/5 • 4.5 years
|
|
Investigations
Lymphocyte count decreased
|
20.0%
1/5 • 4.5 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
20.0%
1/5 • 4.5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
20.0%
1/5 • 4.5 years
|
|
Investigations
Neutrophil count decreased
|
40.0%
2/5 • 4.5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5 • 4.5 years
|
|
Investigations
Platelet count decreased
|
20.0%
1/5 • 4.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
20.0%
1/5 • 4.5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
1/5 • 4.5 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
20.0%
1/5 • 4.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
20.0%
1/5 • 4.5 years
|
|
Cardiac disorders
Sinus tachycardia
|
20.0%
1/5 • 4.5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
40.0%
2/5 • 4.5 years
|
|
Vascular disorders
Thromboembolic event
|
40.0%
2/5 • 4.5 years
|
|
Renal and urinary disorders
Urinary frequency
|
20.0%
1/5 • 4.5 years
|
|
Investigations
Weight gain
|
40.0%
2/5 • 4.5 years
|
|
Investigations
Weight loss
|
20.0%
1/5 • 4.5 years
|
|
Investigations
White blood cell decreased
|
40.0%
2/5 • 4.5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
40.0%
2/5 • 4.5 years
|
|
Investigations
Alanine aminotransferase increased
|
40.0%
2/5 • 4.5 years
|
|
Investigations
Alkaline phosphatase increased
|
20.0%
1/5 • 4.5 years
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
1/5 • 4.5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
1/5 • 4.5 years
|
|
Psychiatric disorders
Anxiety
|
20.0%
1/5 • 4.5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • 4.5 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
20.0%
1/5 • 4.5 years
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
1/5 • 4.5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
1/5 • 4.5 years
|
|
Investigations
Blood bilirubin increased
|
20.0%
1/5 • 4.5 years
|
|
Cardiac disorders
Cardiac troponin I increased
|
20.0%
1/5 • 4.5 years
|
|
General disorders
Chills
|
20.0%
1/5 • 4.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
2/5 • 4.5 years
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
2/5 • 4.5 years
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • 4.5 years
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
1/5 • 4.5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
60.0%
3/5 • 4.5 years
|
|
Gastrointestinal disorders
Dysphagia
|
20.0%
1/5 • 4.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
40.0%
2/5 • 4.5 years
|
|
General disorders
Edema limbs
|
40.0%
2/5 • 4.5 years
|
|
Nervous system disorders
Encephalopathy
|
20.0%
1/5 • 4.5 years
|
|
General disorders
Fatigue
|
60.0%
3/5 • 4.5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place