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Trial record 25 of 37 for:    Acerta Pharma

Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Platinum Resistant Urothelial Bladder Cancer (KEYNOTE143)

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: NCT02351739
Recruitment Status : Completed
First Posted : January 30, 2015
Results First Posted : September 10, 2019
Last Update Posted : September 10, 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 Metastatic Urothelial Carcinoma
Interventions Drug: pembrolizumab
Drug: ACP-196 in combination with pembrolizumab
Enrollment 78
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1: Pembrolizumab Monotherapy Arm 2- Acalabrutinib+Pembrolizumab
Hide Arm/Group Description Arm 1: Pembrolizumab 200mg Administered as an intravenous (IV) infusion every 3 weeks (Q3W) Arm 2: Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W)
Period Title: Overall Study
Started 38 40
Enrolled 38 40
Received Study Medication 35 40
Discontinued Study 38 40
Completed 0 0
Not Completed 38 40
Arm/Group Title Pembrolizumab ACP-196 in Combination With Pembrolizumab Total
Hide Arm/Group Description

Arm 1: pembrolizumab monotherapy

pembrolizumab

Arm 2: ACP-196 in combination with pembrolizumab

ACP-196 in combination with pembrolizumab

Total of all reporting groups
Overall Number of Baseline Participants 35 40 75
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 40 participants 75 participants
65.8  (11.08) 66.4  (8.53) 66.1  (9.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 40 participants 75 participants
Female
28
  80.0%
29
  72.5%
57
  76.0%
Male
7
  20.0%
11
  27.5%
18
  24.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 40 participants 75 participants
Hispanic or Latino
1
   2.9%
0
   0.0%
1
   1.3%
Not Hispanic or Latino
34
  97.1%
40
 100.0%
74
  98.7%
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 35 participants 40 participants 75 participants
American Indian or Alaska Native
1
   2.9%
0
   0.0%
1
   1.3%
Asian
0
   0.0%
1
   2.5%
1
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   5.7%
1
   2.5%
3
   4.0%
White
32
  91.4%
37
  92.5%
69
  92.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   2.5%
1
   1.3%
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 Pembrolizumab ACP-196 in Combination With Pembrolizumab
Hide Arm/Group Description:

Arm 1: pembrolizumab monotherapy

pembrolizumab

Arm 2: ACP-196 in combination with pembrolizumab

ACP-196 in combination with pembrolizumab

Overall Number of Participants Analyzed 31 34
Measure Type: Count of Participants
Unit of Measure: Participants
9
  29.0%
8
  23.5%
Time Frame Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 730.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 - Pembrolizumab Monotherapy Arm 2 - Acalabrutinib+Pembrolizumab
Hide Arm/Group Description Arm 1: Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W) Arm 2: 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   25/35 (71.43%)   31/40 (77.50%) 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 - Pembrolizumab Monotherapy Arm 2 - Acalabrutinib+Pembrolizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   15/35 (42.86%)   23/40 (57.50%) 
Blood and lymphatic system disorders     
Anaemia   0/35 (0.00%)  1/40 (2.50%) 
Cardiac disorders     
Coronary Artery Disease   0/35 (0.00%)  1/40 (2.50%) 
Gastrointestinal disorders     
Nausea   2/35 (5.71%)  0/40 (0.00%) 
Ascites   0/35 (0.00%)  2/40 (5.00%) 
Vomiting   1/35 (2.86%)  0/40 (0.00%) 
Autoimmune Colitis   0/35 (0.00%)  1/40 (2.50%) 
Colitis   0/35 (0.00%)  1/40 (2.50%) 
Diarrhea   1/35 (2.86%)  0/40 (0.00%) 
Duodenitis   0/35 (0.00%)  1/40 (2.50%) 
Gastritis   0/35 (0.00%)  1/40 (2.50%) 
Haematemesis   0/35 (0.00%)  1/40 (2.50%) 
Impaired Gastric Emptying   1/35 (2.86%)  0/40 (0.00%) 
Pneumoperitoneum   0/35 (0.00%)  1/40 (2.50%) 
Rectal Hemorrhage   1/35 (2.86%)  0/40 (0.00%) 
General disorders     
Fatigue  [1]  1/35 (2.86%)  1/40 (2.50%) 
Pyrexia  [1]  1/35 (2.86%)  0/40 (0.00%) 
Pain  [1]  1/35 (2.86%)  0/40 (0.00%) 
Hepatobiliary disorders     
Autoimmune Hepatitis   0/35 (0.00%)  1/40 (2.50%) 
Hepatic Failure   1/35 (2.86%)  0/40 (0.00%) 
Immune-Mediated Hepatitis   0/35 (0.00%)  1/40 (2.50%) 
Infections and infestations     
Sepsis   1/35 (2.86%)  3/40 (7.50%) 
Urinary Tract Infection   2/35 (5.71%)  2/40 (5.00%) 
Pneumonia   2/35 (5.71%)  1/40 (2.50%) 
Cellulitis   1/35 (2.86%)  0/40 (0.00%) 
Clostridium Difficile Colitis   0/35 (0.00%)  1/40 (2.50%) 
Lower Respiratory Tract Infection   0/35 (0.00%)  1/40 (2.50%) 
Peritonitis Bacterial   1/35 (2.86%)  0/40 (0.00%) 
Systemic Candida   0/35 (0.00%)  1/40 (2.50%) 
Urosepsis   0/35 (0.00%)  1/40 (2.50%) 
Injury, poisoning and procedural complications     
Femur Fracture   1/35 (2.86%)  0/40 (0.00%) 
Infusion Related Reaction   0/35 (0.00%)  1/40 (2.50%) 
Radiation Proctitis   1/35 (2.86%)  0/40 (0.00%) 
Investigations     
Alanine Aminotransferase Increased   0/35 (0.00%)  1/40 (2.50%) 
Aspartate Aminotransferase   0/35 (0.00%)  1/40 (2.50%) 
Metabolism and nutrition disorders     
Dehydration   0/35 (0.00%)  1/40 (2.50%) 
Failure to Thrive   0/35 (0.00%)  1/40 (2.50%) 
Hyperglycaemia   0/35 (0.00%)  1/40 (2.50%) 
Hyperkalaemia   1/35 (2.86%)  0/40 (0.00%) 
Hyponatraemia   1/35 (2.86%)  0/40 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia   1/35 (2.86%)  0/40 (0.00%) 
Back Pain   1/35 (2.86%)  0/40 (0.00%) 
Bone Pain   0/35 (0.00%)  1/40 (2.50%) 
Groin Pain   1/35 (2.86%)  0/40 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant Neoplasm Progression   0/35 (0.00%)  1/40 (2.50%) 
Metastases to Liver   0/35 (0.00%)  1/40 (2.50%) 
Nervous system disorders     
Spinal Cord Compression   0/35 (0.00%)  1/40 (2.50%) 
Syncope   0/35 (0.00%)  1/40 (2.50%) 
Psychiatric disorders     
Delirium   0/35 (0.00%)  1/40 (2.50%) 
Renal and urinary disorders     
Acute Kidney Disease   2/35 (5.71%)  5/40 (12.50%) 
Haematuria   1/35 (2.86%)  2/40 (5.00%) 
Urinary Tract Obstruction   1/35 (2.86%)  1/40 (2.50%) 
Hydronephrosis   0/35 (0.00%)  1/40 (2.50%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea   0/35 (0.00%)  1/40 (2.50%) 
Haemoptysis   0/35 (0.00%)  1/40 (2.50%) 
Pneumonitis   1/35 (2.86%)  0/40 (0.00%) 
Pulmonary Alveolar Hemorrhage   0/35 (0.00%)  1/40 (2.50%) 
Pulmonary Oedema   0/35 (0.00%)  1/40 (2.50%) 
Respiratory Failure   0/35 (0.00%)  1/40 (2.50%) 
Vascular disorders     
Deep Vein Thrombosis   1/35 (2.86%)  0/40 (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   34/35 (97.14%)   39/40 (97.50%) 
Blood and lymphatic system disorders     
Anaemia   8/35 (22.86%)  13/40 (32.50%) 
Cardiac disorders     
Tachycardia   1/35 (2.86%)  4/40 (10.00%) 
Atrial Fibrillation   0/35 (0.00%)  2/40 (5.00%) 
Sinus Tachycardia   0/35 (0.00%)  2/40 (5.00%) 
Ear and labyrinth disorders     
Vertigo   2/35 (5.71%)  0/40 (0.00%) 
Endocrine disorders     
Hypothyroidism   6/35 (17.14%)  3/40 (7.50%) 
Eye disorders     
Vision Blurred   2/35 (5.71%)  1/40 (2.50%) 
Gastrointestinal disorders     
Vomiting   10/35 (28.57%)  13/40 (32.50%) 
Diarrhea   7/35 (20.00%)  16/40 (40.00%) 
Nausea   11/35 (31.43%)  10/40 (25.00%) 
Constipation   5/35 (14.29%)  12/40 (30.00%) 
Abdominal Pain   6/35 (17.14%)  10/40 (25.00%) 
Abdominal Distension   4/35 (11.43%)  3/40 (7.50%) 
Dry Mouth   3/35 (8.57%)  3/40 (7.50%) 
Dysepsia   1/35 (2.86%)  2/40 (5.00%) 
Dysphagia   2/35 (5.71%)  1/40 (2.50%) 
Gastrooesophageal Reflux Disease   1/35 (2.86%)  2/40 (5.00%) 
Proctalgia   1/35 (2.86%)  2/40 (5.00%) 
Abdominal Discomfort   0/35 (0.00%)  2/40 (5.00%) 
General disorders     
Fatigue  [1]  16/35 (45.71%)  34/40 (85.00%) 
Pyrexia  [1]  6/35 (17.14%)  10/40 (25.00%) 
Oedema Peripheral  [1]  4/35 (11.43%)  7/40 (17.50%) 
Chills  [1]  2/35 (5.71%)  3/40 (7.50%) 
Non-Cardiac Chest pain  [1]  1/35 (2.86%)  4/40 (10.00%) 
Asthenia  [1]  2/35 (5.71%)  2/40 (5.00%) 
Gait Disturbance  [1]  3/35 (8.57%)  1/40 (2.50%) 
Peripheral Swelling  [1]  3/35 (8.57%)  1/40 (2.50%) 
Chest Pain  [1]  1/35 (2.86%)  2/40 (5.00%) 
Infections and infestations     
Urinary Tract Infection   9/35 (25.71%)  7/40 (17.50%) 
Candida Infection   0/35 (0.00%)  3/40 (7.50%) 
Cellulitis   2/35 (5.71%)  1/40 (2.50%) 
Pneumonia   2/35 (5.71%)  1/40 (2.50%) 
Rhinitis   2/35 (5.71%)  1/40 (2.50%) 
Upper Respiratory Tract Infection   0/35 (0.00%)  2/40 (5.00%) 
Injury, poisoning and procedural complications     
Fall   6/35 (17.14%)  5/40 (12.50%) 
Contusion   2/35 (5.71%)  3/40 (7.50%) 
Infusion Related Reaction   2/35 (5.71%)  0/40 (0.00%) 
Investigations     
Alanine Aminotransferase Increased   3/35 (8.57%)  14/40 (35.00%) 
Aspartate Aminotransferase Increased   2/35 (5.71%)  11/40 (27.50%) 
Weight Decreased   3/35 (8.57%)  8/40 (20.00%) 
Blood Creatinine Increased   5/35 (14.29%)  5/40 (12.50%) 
Amylase Increased   1/35 (2.86%)  4/40 (10.00%) 
Lipase Increased   1/35 (2.86%)  4/40 (10.00%) 
Blood Alkaline Phosphatase Increased   0/35 (0.00%)  4/40 (10.00%) 
Platelet Count Decreased   0/35 (0.00%)  3/40 (7.50%) 
Metabolism and nutrition disorders     
Decreased Appetite   14/35 (40.00%)  16/40 (40.00%) 
Dehydration   1/35 (2.86%)  10/40 (25.00%) 
Hypokalaemia   2/35 (5.71%)  6/40 (15.00%) 
Hyperkalaemia   2/35 (5.71%)  4/40 (10.00%) 
Hypophosphataemia   0/35 (0.00%)  5/40 (12.50%) 
Hyperglycaemia   1/35 (2.86%)  3/40 (7.50%) 
Hypomagnesaemia   2/35 (5.71%)  3/40 (7.50%) 
Hyponatraemia   2/35 (5.71%)  3/40 (7.50%) 
Hypocalcaemia   2/35 (5.71%)  1/40 (2.50%) 
Acidosis   1/35 (2.86%)  2/40 (5.00%) 
Hypercalcaemia   0/35 (0.00%)  3/40 (7.50%) 
Hyperuricaemia   0/35 (0.00%)  2/40 (5.00%) 
Musculoskeletal and connective tissue disorders     
Back Pain   7/35 (20.00%)  4/40 (10.00%) 
Arthralgia   6/35 (17.14%)  3/40 (7.50%) 
Pain in Extremity   3/35 (8.57%)  3/40 (7.50%) 
Muscular Weakness   0/35 (0.00%)  5/40 (12.50%) 
Muscle Spasms   1/35 (2.86%)  3/40 (7.50%) 
Myalgia   3/35 (8.57%)  2/40 (5.00%) 
Bone Pain   2/35 (5.71%)  2/40 (5.00%) 
Flank Pain   1/35 (2.86%)  2/40 (5.00%) 
Musculoskeletal Pain   1/35 (2.86%)  2/40 (5.00%) 
Joint Swelling   2/35 (5.71%)  0/40 (0.00%) 
Nervous system disorders     
Headache   4/35 (11.43%)  8/40 (20.00%) 
Dizziness   4/35 (11.43%)  6/40 (15.00%) 
Dysgeusia   1/35 (2.86%)  4/40 (10.00%) 
Neuropathy Peripheral   3/35 (8.57%)  2/40 (5.00%) 
Paraesthesia   2/35 (5.71%)  2/40 (5.00%) 
Presyncope   1/35 (2.86%)  3/40 (7.50%) 
Balance Disorder   0/35 (0.00%)  2/40 (5.00%) 
Dizziness Postural   0/35 (0.00%)  2/40 (5.00%) 
Psychiatric disorders     
Anxiety   6/35 (17.14%)  4/40 (10.00%) 
Insomnia   2/35 (5.71%)  7/40 (17.50%) 
Confusional State   2/35 (5.71%)  4/40 (10.00%) 
Depression   3/35 (8.57%)  2/40 (5.00%) 
Renal and urinary disorders     
Haematuria   2/35 (5.71%)  4/40 (10.00%) 
Dysuria   4/35 (11.43%)  1/40 (2.50%) 
Acute Kidney Injury   2/35 (5.71%)  2/40 (5.00%) 
Bladder Spasm   2/35 (5.71%)  2/40 (5.00%) 
Urinary Retention   2/35 (5.71%)  0/40 (0.00%) 
Urinary Tract Obstruction   0/35 (0.00%)  2/40 (5.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea   5/35 (14.29%)  12/40 (30.00%) 
Cough   9/35 (25.71%)  8/40 (20.00%) 
Haemoptysis   1/35 (2.86%)  4/40 (10.00%) 
Hypoxia   2/35 (5.71%)  3/40 (7.50%) 
Rhinitis Allergic   0/35 (0.00%)  5/40 (12.50%) 
Dyspnoea Exertional   1/35 (2.86%)  2/40 (5.00%) 
Oropharyngeal Pain   1/35 (2.86%)  2/40 (5.00%) 
Hiccups   0/35 (0.00%)  2/40 (5.00%) 
Skin and subcutaneous tissue disorders     
Pruritus   5/35 (14.29%)  4/40 (10.00%) 
Rash   5/35 (14.29%)  5/40 (12.50%) 
Rash Maculo-Papular   4/35 (11.43%)  5/40 (12.50%) 
Dry Skin   3/35 (8.57%)  5/40 (12.50%) 
Hyperhidrosis   4/35 (11.43%)  3/40 (7.50%) 
Rash Pruritic   1/35 (2.86%)  2/40 (5.00%) 
Skin Discoloration   2/35 (5.71%)  0/40 (0.00%) 
Skin Exfoliation   0/35 (0.00%)  2/40 (5.00%) 
Vascular disorders     
Hypotension   6/35 (17.14%)  8/40 (20.00%) 
Hypertension   2/35 (5.71%)  3/40 (7.50%) 
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: NCT02351739     History of Changes
Other Study ID Numbers: ACE-ST-005
First Submitted: January 28, 2015
First Posted: January 30, 2015
Results First Submitted: July 19, 2019
Results First Posted: September 10, 2019
Last Update Posted: September 10, 2019