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Pembrolizumab Alone and In Combination With Acalabrutinib (ACP-196) in Subjects With Advanced Non-small Cell Lung Cancer (KEYNOTE166)

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ClinicalTrials.gov Identifier: NCT02448303
Recruitment Status : Completed
First Posted : May 19, 2015
Results First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Acerta Pharma BV

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Carcinoma, Non-Small-Cell Lung
Interventions Drug: Pembrolizumab
Drug: Acalabrutinib
Enrollment 74
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1 - Pembrolizumab Monotherapy Arm 2 - Acalabrutinib + Pembrolizumab
Hide Arm/Group Description Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W). Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
Period Title: Overall Study
Started 38 36
Enrolled 38 36
Received Study Medication 33 35
Discontinued Study 38 36
Completed 0 0
Not Completed 38 36
Arm/Group Title Arm 1 - Pembrolizumab Monotherapy Arm 2 - Acalabrutinib + Pembrolizumab Total
Hide Arm/Group Description Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W). Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W). Total of all reporting groups
Overall Number of Baseline Participants 33 35 68
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 35 participants 68 participants
63.7  (10.2) 64.6  (9.33) 64.2  (9.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 35 participants 68 participants
Female
15
  45.5%
20
  57.1%
35
  51.5%
Male
18
  54.5%
15
  42.9%
33
  48.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 35 participants 68 participants
Hispanic or Latino
1
   3.0%
1
   2.9%
2
   2.9%
Not Hispanic or Latino
32
  97.0%
34
  97.1%
66
  97.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 35 participants 68 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   6.1%
4
  11.4%
6
   8.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  12.1%
4
  11.4%
8
  11.8%
White
25
  75.8%
27
  77.1%
52
  76.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   6.1%
0
   0.0%
2
   2.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants 35 participants 68 participants
33 35 68
1.Primary Outcome
Title Number of Participants With Overall Response
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time Frame Every 12 weeks for up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description

The study participants had to have a minimum of one scan (for tumor assessment) after randomization/treatment in order to be considered analyzed.

And some of the participants didn’t make it to Wk 7 of treatment, hence reduction in the number of subjects analyzed.

Arm/Group Title Arm 1 - Pembrolizumab Monotherapy Arm 2 - Acalabrutinib + Pembrolizumab
Hide Arm/Group Description:
Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
Overall Number of Participants Analyzed 31 28
Measure Type: Count of Participants
Unit of Measure: Participants
4
  12.9%
4
  14.3%
Time Frame Safety Analysis tracked from 0 day to 2 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 - Pembrolizumab Monotherapy Arm 2 - Acalabrutinib + Pembrolizumab
Hide Arm/Group Description Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W). Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
All-Cause Mortality
Arm 1 - Pembrolizumab Monotherapy Arm 2 - Acalabrutinib + Pembrolizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   18/33 (54.55%)   23/35 (65.71%) 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 - Pembrolizumab Monotherapy Arm 2 - Acalabrutinib + Pembrolizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   12/33 (36.36%)   18/35 (51.43%) 
Blood and lymphatic system disorders     
Anaemia   1/33 (3.03%)  1/35 (2.86%) 
Pancytopenia   0/33 (0.00%)  1/35 (2.86%) 
Cardiac disorders     
Atrial Fibrillation   0/33 (0.00%)  1/35 (2.86%) 
Gastrointestinal disorders     
Dysphagia   2/33 (6.06%)  1/35 (2.86%) 
Vomiting   0/33 (0.00%)  1/35 (2.86%) 
Gastrointestinal Haemorrhage   1/33 (3.03%)  0/35 (0.00%) 
Large Intestine Haemorrhage   1/33 (3.03%)  0/35 (0.00%) 
Nausea   0/33 (0.00%)  1/35 (2.86%) 
Stomatitis   1/33 (3.03%)  0/35 (0.00%) 
General disorders     
Asthenia  [1]  1/33 (3.03%)  0/35 (0.00%) 
Pain  [1]  0/33 (0.00%)  1/35 (2.86%) 
Hepatobiliary disorders     
Bile Duct Obstructions   0/33 (0.00%)  1/35 (2.86%) 
Infections and infestations     
Pneumonia   1/33 (3.03%)  3/35 (8.57%) 
Cellulitis   0/33 (0.00%)  1/35 (2.86%) 
Clostridium Difficile Colitis   0/33 (0.00%)  1/35 (2.86%) 
Oral Candidiasis   1/33 (3.03%)  0/35 (0.00%) 
Pneumonia Viral   0/33 (0.00%)  1/35 (2.86%) 
Metabolism and nutrition disorders     
Dehydration   2/33 (6.06%)  1/35 (2.86%) 
Failure to Thrive   0/33 (0.00%)  1/35 (2.86%) 
Musculoskeletal and connective tissue disorders     
Arthralgia   0/33 (0.00%)  1/35 (2.86%) 
Pathological Fracture   1/33 (3.03%)  0/35 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastases to Central Nervous System   0/33 (0.00%)  1/35 (2.86%) 
Nervous system disorders     
Syncope   1/33 (3.03%)  1/35 (2.86%) 
Headache   1/33 (3.03%)  0/35 (0.00%) 
Tremor   0/33 (0.00%)  1/35 (2.86%) 
Psychiatric disorders     
Mental Status Changes   1/33 (3.03%)  1/35 (2.86%) 
Renal and urinary disorders     
Acute Kidney Injury   1/33 (3.03%)  0/35 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea   1/33 (3.03%)  4/35 (11.43%) 
Hypoxia   2/33 (6.06%)  1/35 (2.86%) 
Pneumonitis   2/33 (6.06%)  0/35 (0.00%) 
Acute Respiratory Failure   0/33 (0.00%)  1/35 (2.86%) 
Asthma   1/33 (3.03%)  0/35 (0.00%) 
Chronic Obstructive Pulmonary Disease   0/33 (0.00%)  1/35 (2.86%) 
Haemoptysis   0/33 (0.00%)  1/35 (2.86%) 
Pleural Effusion   0/33 (0.00%)  1/35 (2.86%) 
Pneumonia Aspiration   0/33 (0.00%)  1/35 (2.86%) 
Pulmonary Embolism   1/33 (3.03%)  0/35 (0.00%) 
Respiratory Failure   0/33 (0.00%)  1/35 (2.86%) 
Skin and subcutaneous tissue disorders     
Rash Maculo-Papular   0/33 (0.00%)  1/35 (2.86%) 
Vascular disorders     
Haematoma   0/33 (0.00%)  1/35 (2.86%) 
Orthostatic Hypotension   1/33 (3.03%)  0/35 (0.00%) 
Indicates events were collected by systematic assessment
[1]
General Disorders and Administration Site Conditions.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1 - Pembrolizumab Monotherapy Arm 2 - Acalabrutinib + Pembrolizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   33/33 (100.00%)   35/35 (100.00%) 
Blood and lymphatic system disorders     
Anaemia   5/33 (15.15%)  9/35 (25.71%) 
Ear and labyrinth disorders     
Ear Pain   2/33 (6.06%)  0/35 (0.00%) 
Tinnitus   0/33 (0.00%)  2/35 (5.71%) 
Endocrine disorders     
Hypothyroidism   2/33 (6.06%)  2/35 (5.71%) 
Eye disorders     
Diplopia   0/33 (0.00%)  2/35 (5.71%) 
Gastrointestinal disorders     
Diarrhea   7/33 (21.21%)  11/35 (31.43%) 
Nausea   5/33 (15.15%)  12/35 (34.29%) 
Vomiting   3/33 (9.09%)  13/35 (37.14%) 
Constipation   3/33 (9.09%)  7/35 (20.00%) 
Dry Mouth   3/33 (9.09%)  5/35 (14.29%) 
Abdominal Pain Upper   1/33 (3.03%)  4/35 (11.43%) 
Gastrooesophageal Reflux Disease   2/33 (6.06%)  2/35 (5.71%) 
Abdominal Discomfort   0/33 (0.00%)  3/35 (8.57%) 
Dysphagia   0/33 (0.00%)  3/35 (8.57%) 
Oesophagitis   1/33 (3.03%)  2/35 (5.71%) 
Stomatitis   1/33 (3.03%)  2/35 (5.71%) 
General disorders     
Fatigue  [1]  15/33 (45.45%)  9/35 (25.71%) 
Oedema Peripheral  [1]  5/33 (15.15%)  7/35 (20.00%) 
Pyrexia  [1]  3/33 (9.09%)  4/35 (11.43%) 
Non-Cardiac Chest Pain  [1]  1/33 (3.03%)  5/35 (14.29%) 
Asthenia  [1]  0/33 (0.00%)  2/35 (5.71%) 
Chest Pain  [1]  2/33 (6.06%)  0/35 (0.00%) 
Chills  [1]  1/33 (3.03%)  3/35 (8.57%) 
Mucosal Inflammation  [1]  2/33 (6.06%)  0/35 (0.00%) 
Pain  [1]  1/33 (3.03%)  2/35 (5.71%) 
Immune system disorders     
Seasonal Allergy   2/33 (6.06%)  1/35 (2.86%) 
Infections and infestations     
Upper Respiratory Tract Infection   1/33 (3.03%)  5/35 (14.29%) 
Pneumonia   2/33 (6.06%)  2/35 (5.71%) 
Urinary Tract Infection   2/33 (6.06%)  2/35 (5.71%) 
Oral Candidiasis   2/33 (6.06%)  2/35 (5.71%) 
Bronchitis   2/33 (6.06%)  1/35 (2.86%) 
Nasopharyngitis   3/33 (9.09%)  0/35 (0.00%) 
Sinusitis   0/33 (0.00%)  2/35 (5.71%) 
Injury, poisoning and procedural complications     
Contusion   0/33 (0.00%)  3/35 (8.57%) 
Investigations     
Aspartate Aminotransferase Increased   2/33 (6.06%)  5/35 (14.29%) 
Weight Decreased   3/33 (9.09%)  5/35 (14.29%) 
Blood Creatinine Increased   2/33 (6.06%)  4/35 (11.43%) 
Alanine Aminotransferase Increased   0/33 (0.00%)  3/35 (8.57%) 
Electrocardiogram QT Prolonged   1/33 (3.03%)  3/35 (8.57%) 
Lymphocyte Count Decreased   1/33 (3.03%)  2/35 (5.71%) 
Amylase Increased   2/33 (6.06%)  0/35 (0.00%) 
Weight Increased   2/33 (6.06%)  0/35 (0.00%) 
Metabolism and nutrition disorders     
Decreased Appetite   6/33 (18.18%)  12/35 (34.29%) 
Dehydration   6/33 (18.18%)  6/35 (17.14%) 
Hyponatraemia   3/33 (9.09%)  5/35 (14.29%) 
Hyperglycaemia   3/33 (9.09%)  3/35 (8.57%) 
Hypokalaemia   3/33 (9.09%)  2/35 (5.71%) 
Hypomagnesaemia   4/33 (12.12%)  1/35 (2.86%) 
Hypoalbuminaemia   2/33 (6.06%)  0/35 (0.00%) 
Hypoalbuminaemia   1/33 (3.03%)  2/35 (5.71%) 
Hypercalcaemia   2/33 (6.06%)  1/35 (2.86%) 
Hypocalcaemia   2/33 (6.06%)  1/35 (2.86%) 
Hypophosphataemia   2/33 (6.06%)  1/35 (2.86%) 
Hyperuricaemia   2/33 (6.06%)  0/35 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia   3/33 (9.09%)  7/35 (20.00%) 
Back Pain   3/33 (9.09%)  4/35 (11.43%) 
Musculoskeletal Pain   3/33 (9.09%)  4/35 (11.43%) 
Myalgia   2/33 (6.06%)  3/35 (8.57%) 
Pain in Extremity   2/33 (6.06%)  3/35 (8.57%) 
Muscular Weakness   1/33 (3.03%)  3/35 (8.57%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumour Pain   2/33 (6.06%)  0/35 (0.00%) 
Nervous system disorders     
Dizziness   4/33 (12.12%)  7/35 (20.00%) 
Headache   6/33 (18.18%)  6/35 (17.14%) 
Dysgeusia   2/33 (6.06%)  2/35 (5.71%) 
Neuropathy Peripheral   3/33 (9.09%)  1/35 (2.86%) 
Somnolence   1/33 (3.03%)  2/35 (5.71%) 
Psychiatric disorders     
Anxiety   2/33 (6.06%)  4/35 (11.43%) 
Depression   2/33 (6.06%)  3/35 (8.57%) 
Insomnia   1/33 (3.03%)  3/35 (8.57%) 
Confusional State   1/33 (3.03%)  2/35 (5.71%) 
Sleep Disorder   0/33 (0.00%)  2/35 (5.71%) 
Renal and urinary disorders     
Acute Kidney Injury   2/33 (6.06%)  4/35 (11.43%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea   8/33 (24.24%)  11/35 (31.43%) 
Cough   6/33 (18.18%)  10/35 (28.57%) 
Wheezing   5/33 (15.15%)  3/35 (8.57%) 
Oropharyngeal Pain   4/33 (12.12%)  1/35 (2.86%) 
Pleural Effusion   1/33 (3.03%)  4/35 (11.43%) 
Productive Cough   3/33 (9.09%)  2/35 (5.71%) 
Epistaxis   1/33 (3.03%)  2/35 (5.71%) 
Hypoxia   2/33 (6.06%)  2/35 (5.71%) 
Haemoptysis   0/33 (0.00%)  3/35 (8.57%) 
Upper-Airway Cough Syndrome   1/33 (3.03%)  2/35 (5.71%) 
Sinus Congestion   2/33 (6.06%)  0/35 (0.00%) 
Rash Maculo-Papular   1/33 (3.03%)  4/35 (11.43%) 
Decubitus Ulcer   1/33 (3.03%)  2/35 (5.71%) 
Petechiae   0/33 (0.00%)  3/35 (8.57%) 
Skin and subcutaneous tissue disorders     
Rash   5/33 (15.15%)  3/35 (8.57%) 
Dry Skin   2/33 (6.06%)  3/35 (8.57%) 
Rash Maculo-Papular   1/33 (3.03%)  4/35 (11.43%) 
Decubitus Ulcer   1/33 (3.03%)  2/35 (5.71%) 
Petechiae   0/33 (0.00%)  3/35 (8.57%) 
Purpura   0/33 (0.00%)  2/35 (5.71%) 
Vascular disorders     
Hypotension   2/33 (6.06%)  5/35 (14.29%) 
Hypertension   2/33 (6.06%)  4/35 (11.43%) 
Hot Flush   2/33 (6.06%)  0/35 (0.00%) 
Indicates events were collected by systematic assessment
[1]
General Disorders & Administration Site Conditions.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Priti Patel, MD, Executive Director - Head of Clinical Development
Organization: Acerta Pharma, LLC
Phone: 1-888-292-9613
EMail: acertamc@dlss.com
Layout table for additonal information
Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02448303     History of Changes
Other Study ID Numbers: ACE-ST-007
First Submitted: May 14, 2015
First Posted: May 19, 2015
Results First Submitted: July 19, 2019
Results First Posted: September 12, 2019
Last Update Posted: September 12, 2019