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Study of the Combination of Acalabrutinib (ACP-196) and Pembrolizumab in Advanced Head and Neck Squamous Cell Carcinoma (KEYNOTE147)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02454179
Recruitment Status : Completed
First Posted : May 27, 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 Squamous Cell Carcinoma of the Head and Neck
Interventions Drug: pembrolizumab
Drug: Acalabrutinib
Enrollment 78
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mono Therapy of Pembrolizumab Arm 1 Combo Therapy Acalabrutinib + Pembrolizumab Arm 2
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 39 39
Enrolled 39 39
Received Study Medication 39 37
Discontinue Study 39 39
Completed 0 0
Not Completed 39 39
Arm/Group Title Mono Therapy Arm - Pembrolizumab Combo Therapy Arm - 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 39 37 76
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 37 participants 76 participants
62.1  (10.45) 61.4  (11.12) 61.8  (10.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 37 participants 76 participants
Female
5
  12.8%
2
   5.4%
7
   9.2%
Male
34
  87.2%
35
  94.6%
69
  90.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 37 participants 76 participants
Hispanic or Latino
4
  10.3%
2
   5.4%
6
   7.9%
Not Hispanic or Latino
35
  89.7%
35
  94.6%
70
  92.1%
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 39 participants 37 participants 76 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   5.1%
2
   5.4%
4
   5.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
6
  16.2%
6
   7.9%
White
37
  94.9%
29
  78.4%
66
  86.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants 37 participants 76 participants
39 37 76
1.Primary Outcome
Title Number of Participants With Overall Response
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) 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 52 weeks
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 Mono Therapy Arm - Pembrolizumab Combo Therapy Arm - Acalabrutinib and 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 37 30
Measure Type: Count of Participants
Unit of Measure: Participants
7
  18.9%
5
  16.7%
Time Frame Safety Analysis tracked from 0 day to 2 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 - Pembrolizumab Arm 2 - Acalabrutinib + Pembrolizumab
Hide Arm/Group Description Pembrolizumab Monotherapy Acalabrutinib in combination with Pembrolizumab
All-Cause Mortality
Arm 1 - Pembrolizumab Arm 2 - Acalabrutinib + Pembrolizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   26/39 (66.67%)   23/37 (62.16%) 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 - Pembrolizumab Arm 2 - Acalabrutinib + Pembrolizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   12/39 (30.77%)   25/37 (67.57%) 
Blood and lymphatic system disorders     
Neutropenia   0/39 (0.00%)  1/37 (2.70%) 
Cardiac disorders     
Cardiac Failure Congestive   2/39 (5.13%)  0/37 (0.00%) 
Atrial Flutter   1/39 (2.56%)  0/37 (0.00%) 
Cardio-Respiratory Arrest   1/39 (2.56%)  0/37 (0.00%) 
Pulseless Electrical Activity   0/39 (0.00%)  1/37 (2.70%) 
Gastrointestinal disorders     
Dysphagia   0/39 (0.00%)  1/37 (2.70%) 
Mouth Heamorrhage   1/39 (2.56%)  0/37 (0.00%) 
Nausea   0/39 (0.00%)  1/37 (2.70%) 
Oral Pain   0/39 (0.00%)  1/37 (2.70%) 
Vomiting   0/39 (0.00%)  1/37 (2.70%) 
General disorders     
Pyrexia  [1]  0/39 (0.00%)  2/37 (5.41%) 
Chest Pain  [1]  1/39 (2.56%)  0/37 (0.00%) 
Multiple Organ Dysfunction Syndrome  [2]  1/39 (2.56%)  0/37 (0.00%) 
Oedema  [2]  0/39 (0.00%)  1/37 (2.70%) 
Oedema Peripheral  [2]  0/39 (0.00%)  1/37 (2.70%) 
Hepatobiliary disorders     
Autoimmune Hepatitis   0/39 (0.00%)  1/37 (2.70%) 
Infections and infestations     
Urosepsis   0/39 (0.00%)  2/37 (5.41%) 
Clostridia Sepsis   0/39 (0.00%)  1/37 (2.70%) 
Clostridium Difficile Infection   0/39 (0.00%)  1/37 (2.70%) 
Epiglottistis   0/39 (0.00%)  1/37 (2.70%) 
Influenza   0/39 (0.00%)  1/37 (2.70%) 
Osteomyelitis   0/39 (0.00%)  1/37 (2.70%) 
Pneumonia   2/39 (5.13%)  3/37 (8.11%) 
Sepsis   0/39 (0.00%)  2/37 (5.41%) 
Injury, poisoning and procedural complications     
Spinal Compression Fracture   1/39 (2.56%)  0/37 (0.00%) 
Stoma Site Haemorrhage   0/39 (0.00%)  1/37 (2.70%) 
Metabolism and nutrition disorders     
Decreased Appetite   1/39 (2.56%)  1/37 (2.70%) 
Dehydration   0/39 (0.00%)  1/37 (2.70%) 
Hyponatraemia   1/39 (2.56%)  0/37 (0.00%) 
Malnutrition   0/39 (0.00%)  1/37 (2.70%) 
Musculoskeletal and connective tissue disorders     
Back Pain   1/39 (2.56%)  0/37 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumour Heaorrhage   3/39 (7.69%)  0/37 (0.00%) 
Tumour Pain   1/39 (2.56%)  0/37 (0.00%) 
Nervous system disorders     
Cerebrovascular Accident   1/39 (2.56%)  0/37 (0.00%) 
Hypoxic-Ischaemic Encephalopathy   1/39 (2.56%)  0/37 (0.00%) 
Syncope   1/39 (2.56%)  0/37 (0.00%) 
Psychiatric disorders     
Confusional State   0/39 (0.00%)  1/37 (2.70%) 
Delusion   0/39 (0.00%)  1/37 (2.70%) 
Renal and urinary disorders     
Acute Kidney Injury   0/39 (0.00%)  3/37 (8.11%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea   0/39 (0.00%)  4/37 (10.81%) 
Respiratory Failure   0/39 (0.00%)  2/37 (5.41%) 
Acute Respiratory Failure   2/39 (5.13%)  0/37 (0.00%) 
Hypnoxia   0/39 (0.00%)  1/37 (2.70%) 
Atelectasis   0/39 (0.00%)  1/37 (2.70%) 
Chronic Obstructive Pulmonary Disease   0/39 (0.00%)  1/37 (2.70%) 
Hypercapnia   0/39 (0.00%)  1/37 (2.70%) 
Obstructive Airways Disorder   1/39 (2.56%)  0/37 (0.00%) 
Pleural Effusion   0/39 (0.00%)  1/37 (2.70%) 
Pulmonary Embolism   1/39 (2.56%)  0/37 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash   0/39 (0.00%)  1/37 (2.70%) 
Vascular disorders     
Aneurysm   0/39 (0.00%)  1/37 (2.70%) 
Embolism   0/39 (0.00%)  1/37 (2.70%) 
Haemorrhage   0/39 (0.00%)  1/37 (2.70%) 
Hypotension   1/39 (2.56%)  0/37 (0.00%) 
Orthrostatic Hypotension   1/39 (2.56%)  0/37 (0.00%) 
Indicates events were collected by systematic assessment
[1]
General disorders and administration site conditions.
[2]
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 Arm 2 - Acalabrutinib + Pembrolizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   39/39 (100.00%)   37/37 (100.00%) 
Blood and lymphatic system disorders     
Anaemia   2/39 (5.13%)  12/37 (32.43%) 
Cardiac disorders     
Tachycardia   2/39 (5.13%)  2/37 (5.41%) 
Sinus Tachycardia   0/39 (0.00%)  3/37 (8.11%) 
Endocrine disorders     
Hypothyroidism   4/39 (10.26%)  2/37 (5.41%) 
Eye disorders     
Vision Blurred   0/39 (0.00%)  2/37 (5.41%) 
Gastrointestinal disorders     
Aptyalism   2/39 (5.13%)  0/37 (0.00%) 
Dry Mouth   2/39 (5.13%)  0/37 (0.00%) 
Vomiting   5/39 (12.82%)  7/37 (18.92%) 
Dysphagia   3/39 (7.69%)  4/37 (10.81%) 
Gastrooesophageal Reflux Disease   4/39 (10.26%)  2/37 (5.41%) 
Abdominal Pain   1/39 (2.56%)  3/37 (8.11%) 
Dyspepsia   2/39 (5.13%)  3/37 (8.11%) 
Stomatitis   1/39 (2.56%)  3/37 (8.11%) 
Oral Pain   3/39 (7.69%)  0/37 (0.00%) 
Mouth Haemorrhage   2/39 (5.13%)  1/37 (2.70%) 
Nausea   4/39 (10.26%)  9/37 (24.32%) 
Diarrhea   6/39 (15.38%)  11/37 (29.73%) 
Constipation   5/39 (12.82%)  8/37 (21.62%) 
General disorders     
Mucosal Inflammation  [1]  0/39 (0.00%)  2/37 (5.41%) 
Oedema  [1]  0/39 (0.00%)  2/37 (5.41%) 
Fatigue  [1]  20/39 (51.28%)  14/37 (37.84%) 
Oedema Peripheral  [1]  4/39 (10.26%)  9/37 (24.32%) 
Pyrexia  [1]  5/39 (12.82%)  8/37 (21.62%) 
Asthenia  [1]  2/39 (5.13%)  7/37 (18.92%) 
Non-Cardiac Chest Pain  [1]  2/39 (5.13%)  1/37 (2.70%) 
Chills  [1]  2/39 (5.13%)  1/37 (2.70%) 
Immune system disorders     
Seasonal Allergy   2/39 (5.13%)  0/37 (0.00%) 
Infections and infestations     
Pneumonia   4/39 (10.26%)  5/37 (13.51%) 
Upper Respiratory Tract Infection   2/39 (5.13%)  6/37 (16.22%) 
Candida Infection   2/39 (5.13%)  2/37 (5.41%) 
Cellulitis   1/39 (2.56%)  4/37 (10.81%) 
Urinary Tract Infection   3/39 (7.69%)  0/37 (0.00%) 
Oral Candidiasis   2/39 (5.13%)  0/37 (0.00%) 
Injury, poisoning and procedural complications     
Fall   3/39 (7.69%)  3/37 (8.11%) 
Contusion   0/39 (0.00%)  2/37 (5.41%) 
Investigations     
White Blood Cell Count Decreased   1/39 (2.56%)  2/37 (5.41%) 
Weight Decreased   5/39 (12.82%)  9/37 (24.32%) 
Blood Creatinine Increased   2/39 (5.13%)  6/37 (16.22%) 
Alanine Aminotransferase Increased   0/39 (0.00%)  4/37 (10.81%) 
Aspartate Aminotransferase Increased   0/39 (0.00%)  4/37 (10.81%) 
Platelet Count Decreased   1/39 (2.56%)  2/37 (5.41%) 
Metabolism and nutrition disorders     
Decreased Appetite   7/39 (17.95%)  11/37 (29.73%) 
Dehydration   2/39 (5.13%)  10/37 (27.03%) 
Hypokalaemia   3/39 (7.69%)  6/37 (16.22%) 
Hypomagnesaemia   1/39 (2.56%)  6/37 (16.22%) 
Hyperglycaemia   3/39 (7.69%)  3/37 (8.11%) 
Hyponatraemia   3/39 (7.69%)  3/37 (8.11%) 
Hypocalcaemia   4/39 (10.26%)  1/37 (2.70%) 
Hypercalcaemia   2/39 (5.13%)  1/37 (2.70%) 
Hyperuricaemia   2/39 (5.13%)  0/37 (0.00%) 
Hypoalbuminaemia   0/39 (0.00%)  2/37 (5.41%) 
Hyperkalaemia   0/39 (0.00%)  2/37 (5.41%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletel Pain   2/39 (5.13%)  3/37 (8.11%) 
Muscular Weakness   3/39 (7.69%)  2/37 (5.41%) 
Musculoskeletal Chest Pain   3/39 (7.69%)  1/37 (2.70%) 
Pain in extremity   2/39 (5.13%)  2/37 (5.41%) 
Pain in Jaw   1/39 (2.56%)  3/37 (8.11%) 
Myalgia   2/39 (5.13%)  1/37 (2.70%) 
Arthralgia   7/39 (17.95%)  4/37 (10.81%) 
Back Pain   3/39 (7.69%)  6/37 (16.22%) 
Muscle Spasms   3/39 (7.69%)  4/37 (10.81%) 
Neck Pain   4/39 (10.26%)  3/37 (8.11%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Infected Neoplasm   3/39 (7.69%)  0/37 (0.00%) 
Nervous system disorders     
Headache   8/39 (20.51%)  7/37 (18.92%) 
Dizziness   2/39 (5.13%)  6/37 (16.22%) 
Speech Disorder   2/39 (5.13%)  0/37 (0.00%) 
Syncope   2/39 (5.13%)  0/37 (0.00%) 
Psychiatric disorders     
Insomnia   2/39 (5.13%)  8/37 (21.62%) 
Anxiety   2/39 (5.13%)  1/37 (2.70%) 
Depression   1/39 (2.56%)  2/37 (5.41%) 
Eating Disorder   2/39 (5.13%)  0/37 (0.00%) 
Renal and urinary disorders     
Acute Kidney Injury   0/39 (0.00%)  3/37 (8.11%) 
Nocturia   2/39 (5.13%)  0/37 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea   5/39 (12.82%)  11/37 (29.73%) 
Cough   8/39 (20.51%)  7/37 (18.92%) 
Productive Cough   5/39 (12.82%)  3/37 (8.11%) 
Hypoxia   3/39 (7.69%)  3/37 (8.11%) 
Wheezing   2/39 (5.13%)  4/37 (10.81%) 
Oropharyngeal Pain   2/39 (5.13%)  3/37 (8.11%) 
Aspiration   1/39 (2.56%)  3/37 (8.11%) 
Haemoptysis   1/39 (2.56%)  3/37 (8.11%) 
Chronic Obstructive Pulmonary Disease   0/39 (0.00%)  2/37 (5.41%) 
Pneumonia Aspiration   0/39 (0.00%)  2/37 (5.41%) 
Skin and subcutaneous tissue disorders     
Rash   6/39 (15.38%)  5/37 (13.51%) 
Pruritis   7/39 (17.95%)  2/37 (5.41%) 
Rash Maculo-Papular   2/39 (5.13%)  4/37 (10.81%) 
Swelling Face   0/39 (0.00%)  3/37 (8.11%) 
Decubitus Ulcer   0/39 (0.00%)  2/37 (5.41%) 
Vascular disorders     
Hypotension   5/39 (12.82%)  6/37 (16.22%) 
Hypertension   3/39 (7.69%)  3/37 (8.11%) 
Indicates events were collected by systematic assessment
[1]
General Disorders and 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: NCT02454179     History of Changes
Other Study ID Numbers: ACE-ST-006
First Submitted: May 22, 2015
First Posted: May 27, 2015
Results First Submitted: July 19, 2019
Results First Posted: September 12, 2019
Last Update Posted: September 12, 2019