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Pembrolizumab in Patients Failing to Respond to or Relapsing After CAR T Cell Therapy for Relapsed or Refractory Lymphomas

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ClinicalTrials.gov Identifier: NCT02650999
Recruitment Status : Active, not recruiting
First Posted : January 8, 2016
Results First Posted : May 12, 2020
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions CD19+ Diffuse Large B-cell Lymphomas
Follicular Lymphomas
Mantle Cell Lymphomas
Intervention Drug: Pembrolizumab
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pembrolizumab
Hide Arm/Group Description Pembrolizumab: 200mg intravenously (IV)
Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title Single Arm
Hide Arm/Group Description Pembrolizumab: 200mg intravenously (IV)
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
  50.0%
>=65 years
6
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
1
   8.3%
Male
11
  91.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
12
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Dose-limiting Toxicity
Hide Description Percentage of subjects who discontinued therapy due to dose-limiting toxicity
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm
Hide Arm/Group Description:
Pembrolizumab: 200mg intravenously (IV)
Overall Number of Participants Analyzed 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
8.33
(0.4 to 40.2)
2.Secondary Outcome
Title Overall Response Rates
Hide Description 3 months Overall response rates
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm
Hide Arm/Group Description:
Pembrolizumab: 200mg intravenously (IV)
Overall Number of Participants Analyzed 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
25
(6.7 to 57.2)
Time Frame Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse Event Reporting Description Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
 
Arm/Group Title Single Arm
Hide Arm/Group Description Pembrolizumab: 200mg intravenously (IV)
All-Cause Mortality
Single Arm
Affected / at Risk (%)
Total   0/12 (0.00%) 
Hide Serious Adverse Events
Single Arm
Affected / at Risk (%)
Total   8/12 (66.67%) 
Eye disorders   
optic disorder  1  1/12 (8.33%) 
Gastrointestinal disorders   
other: odynophagia  1 [1]  1/12 (8.33%) 
dysphagia  1  1/12 (8.33%) 
General disorders   
fever  1  1/12 (8.33%) 
Hepatobiliary disorders   
blood bilirubin increased  1  1/12 (8.33%) 
Immune system disorders   
Cytokine Release Syndrome  1  1/12 (8.33%) 
Infections and infestations   
sepsis  1  1/12 (8.33%) 
Investigations   
hypercalcemia  1  1/12 (8.33%) 
Metabolism and nutrition disorders   
acidosis  1  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders   
non-cardiac chest pain  1  1/12 (8.33%) 
Psychiatric disorders   
delirium  1  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders   
pleural effusion  1  1/12 (8.33%) 
hypoxia  1  1/12 (8.33%) 
Skin and subcutaneous tissue disorders   
rash maculo-papular  1  1/12 (8.33%) 
1
Term from vocabulary, CTCAE (5.0)
Indicates events were collected by systematic assessment
[1]
odynophagia
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Single Arm
Affected / at Risk (%)
Total   12/12 (100.00%) 
Cardiac disorders   
tachycardia  1  1/12 (8.33%) 
atrial fibrillation/atrial flutter  1  1/12 (8.33%) 
Gastrointestinal disorders   
nausea  1  5/12 (41.67%) 
diarrhea  1  3/12 (25.00%) 
vomiting  1  3/12 (25.00%) 
dry mouth  1  1/12 (8.33%) 
Dysphagia  1  1/12 (8.33%) 
GI disorders, other: odynophagia  1  1/12 (8.33%) 
Bloating  1  1/12 (8.33%) 
Abdominal distension  1  1/12 (8.33%) 
Abdominal pain  1  1/12 (8.33%) 
General disorders   
fatigue  1  6/12 (50.00%) 
fever  1  4/12 (33.33%) 
infusion related reaction  1  1/12 (8.33%) 
lower extremity edema  1  1/12 (8.33%) 
Facial pain  1  1/12 (8.33%) 
Facial edema (left side)  1  1/12 (8.33%) 
Flank pain  1  1/12 (8.33%) 
Flu-like symptoms  1  1/12 (8.33%) 
gait disturbance  1  1/12 (8.33%) 
Infections and infestations   
Infections, other: Zoster  1  2/12 (16.67%) 
Upper respiratory infection  1  1/12 (8.33%) 
urinary tract infection  1  1/12 (8.33%) 
Investigations   
Neutropenia  1  4/12 (33.33%) 
Lymphocyte count decreased  1  7/12 (58.33%) 
Anemia  1  4/12 (33.33%) 
INR increased  1  2/12 (16.67%) 
AST elevated  1  5/12 (41.67%) 
ALT elevated  1  4/12 (33.33%) 
thrombocytopenia  1  2/12 (16.67%) 
alkaline phosphatase elevated  1  1/12 (8.33%) 
PTT prolonged  1  2/12 (16.67%) 
Blood bilirubin increased  1  2/12 (16.67%) 
WBC decreased  1  3/12 (25.00%) 
Investigations - Other, Platelets elevated  1  1/12 (8.33%) 
Investigations - Other, WBC increased  1  1/12 (8.33%) 
Investigations - Other, ANC increased  1  1/12 (8.33%) 
Weight loss  1  1/12 (8.33%) 
Investigations, other: low serum total protein  1  1/12 (8.33%) 
Investigations, other: elevated urine pH  1  1/12 (8.33%) 
Investigations, other: elevated MHC  1  1/12 (8.33%) 
Investigations, other: elevated CO2  1  1/12 (8.33%) 
Blood LDH increased  1  1/12 (8.33%) 
Metabolism and nutrition disorders   
hyperglycemia  1  4/12 (33.33%) 
hypoglycemia  1  2/12 (16.67%) 
hyponatremia  1  3/12 (25.00%) 
hypokalemia  1  1/12 (8.33%) 
hypoalbuminemia  1  2/12 (16.67%) 
hypophosphatemia  1  3/12 (25.00%) 
hypocalcemia  1  1/12 (8.33%) 
Hypercalcemia  1  2/12 (16.67%) 
dehydration  1  2/12 (16.67%) 
Hypomagnesemia  1  1/12 (8.33%) 
Metabolism and nutrition disorders - other, phosphorus elevated  1  1/12 (8.33%) 
Anorexia  1  2/12 (16.67%) 
Musculoskeletal and connective tissue disorders   
Synovitis (MCP, middle finger, left hand)  1  1/12 (8.33%) 
pain (back, buttock, right leg / sciatica distribution)  1  1/12 (8.33%) 
Non-cardiac chest pain  1  3/12 (25.00%) 
Lower back pain  1  1/12 (8.33%) 
Nervous system disorders   
Neuralgia  1  1/12 (8.33%) 
Post-herpetic neuralgia  1  1/12 (8.33%) 
Nervous system - Other, cauda equina syndrome  1  1/12 (8.33%) 
Trigeminal nerve disorder  1  1/12 (8.33%) 
Psychiatric disorders   
Confusion  1  2/12 (16.67%) 
Insomnia  1  1/12 (8.33%) 
Anxiety  1  1/12 (8.33%) 
Renal and urinary disorders   
Dysuria  1  1/12 (8.33%) 
Urinary frequency  1  1/12 (8.33%) 
Hematuria  1  2/12 (16.67%) 
Proteinuria  1  1/12 (8.33%) 
urinary hesitancy  1  1/12 (8.33%) 
Acute kidney injury  1  2/12 (16.67%) 
urinary retention  1  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  6/12 (50.00%) 
pleural effusion  1  2/12 (16.67%) 
dyspnea  1  1/12 (8.33%) 
hypoxia  1  1/12 (8.33%) 
Nasal congestion  1  2/12 (16.67%) 
Hoarseness  1  2/12 (16.67%) 
Skin and subcutaneous tissue disorders   
rash  1  3/12 (25.00%) 
Skin disorders, other: inflammation  1  1/12 (8.33%) 
1
Term from vocabulary, CTCAE (5.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ellen Napier, Nurse Pracitioner
Organization: University of Pennsylvania, Clinical Research Unit
Phone: 215.279.1972
EMail: ellen.napier@pennmedicine.upenn.edu
Layout table for additonal information
Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02650999    
Other Study ID Numbers: UPCC 46415
First Submitted: January 7, 2016
First Posted: January 8, 2016
Results First Submitted: April 28, 2020
Results First Posted: May 12, 2020
Last Update Posted: May 12, 2020