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Acalabrutinib (ACP-196) Alone and in Combination With Pembrolizumab in Ovarian Cancer (KEYNOTE191)

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ClinicalTrials.gov Identifier: NCT02537444
Recruitment Status : Completed
First Posted : September 1, 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: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ovarian Cancer
Interventions Drug: Acalabrutinib
Drug: acalabrutinib and pembrolizumab combination
Enrollment 78
Recruitment Details  
Pre-assignment Details Enrolled 2 extra subjects, 1 withdrew from the study and did not receive treatment.
Arm/Group Title Arm 1 - Acalabrutinib Monotherapy Arm 2 - Acalabrutinib + Pembrolizumab
Hide Arm/Group Description Acalabrutinib 100mg administered orally (PO) twice daily BID. 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 38 39
Discontinued Study 39 39
Completed 0 0
Not Completed 39 39
Arm/Group Title Arm 1 - Acalabrutinib Monotherapy Arm 2 - Acalabrutinib + Pembrolizumab Total
Hide Arm/Group Description Acalabrutinib 100mg administered orally (PO) twice daily BID. 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 38 39 77
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 39 participants 77 participants
64.6  (11.52) 64.2  (12.75) 64.4  (12.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 39 participants 77 participants
Female
38
 100.0%
39
 100.0%
77
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 39 participants 77 participants
Hispanic or Latino
1
   2.6%
3
   7.7%
4
   5.2%
Not Hispanic or Latino
37
  97.4%
36
  92.3%
73
  94.8%
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 38 participants 39 participants 77 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   5.3%
1
   2.6%
3
   3.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   2.6%
3
   7.7%
4
   5.2%
White
33
  86.8%
34
  87.2%
67
  87.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   5.3%
1
   2.6%
3
   3.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 38 participants 39 participants 77 participants
38 39 77
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
[Not Specified]
Arm/Group Title Arm 1 - Acalabrutinib Monotherapy Arm 2 - Acalabrutinib + Pembrolizumab
Hide Arm/Group Description:
Acalabrutinib 100mg administered orally (PO) twice daily.
Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
Overall Number of Participants Analyzed 35 33
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.9%
3
   9.1%
Time Frame Safety Analysis tracked from 0 day to 2 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 - Acalabrutinib Monotherapy Arm 2 - Acalabrutinib + Pembrolizumab
Hide Arm/Group Description Acalabrutinib 100mg administered orally (PO) twice daily (BID). Acalabrutinib 100mg plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
All-Cause Mortality
Arm 1 - Acalabrutinib Monotherapy Arm 2 - Acalabrutinib + Pembrolizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   16/38 (42.11%)   22/39 (56.41%) 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 - Acalabrutinib Monotherapy Arm 2 - Acalabrutinib + Pembrolizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   8/38 (21.05%)   16/39 (41.03%) 
Cardiac disorders     
Cardio-Respiratory Arrest   0/38 (0.00%)  1/39 (2.56%) 
Pericardial Effusion   1/38 (2.63%)  0/39 (0.00%) 
Gastrointestinal disorders     
Small Intestinal Obstruction   1/38 (2.63%)  5/39 (12.82%) 
Ascites   0/38 (0.00%)  1/39 (2.56%) 
Ileus   0/38 (0.00%)  1/39 (2.56%) 
Gastrointestinal Haemorrhage   0/38 (0.00%)  1/39 (2.56%) 
Nausea   0/38 (0.00%)  1/39 (2.56%) 
Rectal Haemorrhage   0/38 (0.00%)  1/39 (2.56%) 
Vomiting   1/38 (2.63%)  0/39 (0.00%) 
General disorders     
Pyrexia  [1]  1/38 (2.63%)  1/39 (2.56%) 
Non-Cardiac Chest Pain  [1]  1/38 (2.63%)  0/39 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis   0/38 (0.00%)  1/39 (2.56%) 
Infections and infestations     
Cellulitis   1/38 (2.63%)  0/39 (0.00%) 
Pneumonia   0/38 (0.00%)  1/39 (2.56%) 
Clostridium Difficile Colitis   0/38 (0.00%)  1/39 (2.56%) 
Lung Infection   0/38 (0.00%)  1/39 (2.56%) 
Sepsis   1/38 (2.63%)  0/39 (0.00%) 
Investigations     
Alanine Aminotransferase Increased   1/38 (2.63%)  3/39 (7.69%) 
Aspartate Aminotransferase Increased   1/38 (2.63%)  3/39 (7.69%) 
Blood Alkaline Phosphatase Increased   1/38 (2.63%)  0/39 (0.00%) 
Platelet Count Decreased   0/38 (0.00%)  1/39 (2.56%) 
Metabolism and nutrition disorders     
Dehydration   0/38 (0.00%)  1/39 (2.56%) 
Decreased Appetite   0/38 (0.00%)  1/39 (2.56%) 
Musculoskeletal and connective tissue disorders     
Muscular Weakness   0/38 (0.00%)  1/39 (2.56%) 
Renal and urinary disorders     
Acute Kidney Injury   0/38 (0.00%)  1/39 (2.56%) 
Hydronephrosis   0/38 (0.00%)  1/39 (2.56%) 
Respiratory, thoracic and mediastinal disorders     
Pleural Effusion   3/38 (7.89%)  0/39 (0.00%) 
Pneumonia Aspiration   0/38 (0.00%)  1/39 (2.56%) 
Pneumonia Embolism   0/38 (0.00%)  1/39 (2.56%) 
Respiratory Failure   1/38 (2.63%)  0/39 (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 - Acalabrutinib Monotherapy Arm 2 - Acalabrutinib + Pembrolizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   34/38 (89.47%)   39/39 (100.00%) 
Blood and lymphatic system disorders     
Anaemia   2/38 (5.26%)  12/39 (30.77%) 
Lymphadenopathy   1/38 (2.63%)  3/39 (7.69%) 
Cardiac disorders     
Sinus Tachycardia   1/38 (2.63%)  2/39 (5.13%) 
Tachycardia   2/38 (5.26%)  1/39 (2.56%) 
Ear and labyrinth disorders     
Tinnitus   2/38 (5.26%)  1/39 (2.56%) 
Endocrine disorders     
Hypothyroidism   0/38 (0.00%)  2/39 (5.13%) 
Eye disorders     
Vision Blurred   1/38 (2.63%)  2/39 (5.13%) 
Gastrointestinal disorders     
Nausea   16/38 (42.11%)  29/39 (74.36%) 
Diarrhea   17/38 (44.74%)  11/39 (28.21%) 
Vomiting   7/38 (18.42%)  21/39 (53.85%) 
Abdominal Pain   9/38 (23.68%)  14/39 (35.90%) 
Abdominal Distension   7/38 (18.42%)  6/39 (15.38%) 
Constipation   3/38 (7.89%)  8/39 (20.51%) 
Dyspepsia   1/38 (2.63%)  7/39 (17.95%) 
Abdominal Pain Upper   4/38 (10.53%)  3/39 (7.69%) 
Gastrooesophageal Reflux Disease   3/38 (7.89%)  3/39 (7.69%) 
Ascites   2/38 (5.26%)  2/39 (5.13%) 
Abdominal Pain Lower   1/38 (2.63%)  2/39 (5.13%) 
Dry Mouth   0/38 (0.00%)  5/39 (12.82%) 
Stomatitis   0/38 (0.00%)  3/39 (7.69%) 
Dysphagia   0/38 (0.00%)  2/39 (5.13%) 
Oral Pain   0/38 (0.00%)  2/39 (5.13%) 
General disorders     
Fatigue  [1]  16/38 (42.11%)  20/39 (51.28%) 
Oedema Peripheral  [1]  3/38 (7.89%)  4/39 (10.26%) 
Chills  [1]  4/38 (10.53%)  5/39 (12.82%) 
Pyrexia  [1]  2/38 (5.26%)  5/39 (12.82%) 
Pain  [1]  1/38 (2.63%)  2/39 (5.13%) 
Non-Cardiac Chest Pain  [1]  2/38 (5.26%)  1/39 (2.56%) 
Infections and infestations     
Urinary Tract Infection   5/38 (13.16%)  5/39 (12.82%) 
Upper Respiratory Tract Infection   2/38 (5.26%)  0/39 (0.00%) 
Injury, poisoning and procedural complications     
Contusion   8/38 (21.05%)  6/39 (15.38%) 
Investigations     
Alanine Aminotransferase Increased   4/38 (10.53%)  10/39 (25.64%) 
Aspartate Aminotransferase Increased   4/38 (10.53%)  9/39 (23.08%) 
Blood Creatinine Increased   2/38 (5.26%)  3/39 (7.69%) 
Weight Decreased   1/38 (2.63%)  2/39 (5.13%) 
Blood Lactate Dehydrogenase Increased   1/38 (2.63%)  3/39 (7.69%) 
Lymphocyte Count Decreased   1/38 (2.63%)  3/39 (7.69%) 
Platelet Count Decreased   0/38 (0.00%)  3/39 (7.69%) 
White Blood Cell Count Decreased   0/38 (0.00%)  4/39 (10.26%) 
Breath Sounds Abnormal   0/38 (0.00%)  3/39 (7.69%) 
Protein Total Decreased   0/38 (0.00%)  3/39 (7.69%) 
Carbohydrate Antigen 125 Increased   0/38 (0.00%)  2/39 (5.13%) 
Metabolism and nutrition disorders     
Decreased Appetite   9/38 (23.68%)  10/39 (25.64%) 
Dehydration   3/38 (7.89%)  7/39 (17.95%) 
Hypokalaemia   1/38 (2.63%)  6/39 (15.38%) 
Hyponatraemia   1/38 (2.63%)  3/39 (7.69%) 
Hypocalcaemia   0/38 (0.00%)  4/39 (10.26%) 
Hyperglycaemia   0/38 (0.00%)  2/39 (5.13%) 
Hypoalbuminaemia   0/38 (0.00%)  2/39 (5.13%) 
Hypomagnesaemia   0/38 (0.00%)  2/39 (5.13%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletel Pain   2/38 (5.26%)  1/39 (2.56%) 
Back Pain   3/38 (7.89%)  9/39 (23.08%) 
Arthralgia   3/38 (7.89%)  4/39 (10.26%) 
Myalgia   1/38 (2.63%)  6/39 (15.38%) 
Muscle Spasms   0/38 (0.00%)  4/39 (10.26%) 
Muscular Weakness   0/38 (0.00%)  4/39 (10.26%) 
Pain in Extremity   2/38 (5.26%)  2/39 (5.13%) 
Nervous system disorders     
Headache   17/38 (44.74%)  21/39 (53.85%) 
Neuropathy Peripheral   2/38 (5.26%)  4/39 (10.26%) 
Peripheral Motor Neuropathy   0/38 (0.00%)  2/39 (5.13%) 
Dizziness   9/38 (23.68%)  9/39 (23.08%) 
Psychiatric disorders     
Insomnia   1/38 (2.63%)  7/39 (17.95%) 
Depression   2/38 (5.26%)  1/39 (2.56%) 
Renal and urinary disorders     
Dysuria   2/38 (5.26%)  0/39 (0.00%) 
Haematuria   0/38 (0.00%)  2/39 (5.13%) 
Reproductive system and breast disorders     
Vaginal Haematuria   0/38 (0.00%)  2/39 (5.13%) 
Respiratory, thoracic and mediastinal disorders     
Cough   3/38 (7.89%)  10/39 (25.64%) 
Dyspnoea   5/38 (13.16%)  7/39 (17.95%) 
Epistaxis   1/38 (2.63%)  3/39 (7.69%) 
Nasal Congestion   0/38 (0.00%)  2/39 (5.13%) 
Oropharyngeal Pain   1/38 (2.63%)  3/39 (7.69%) 
Rhinorrhoea   2/38 (5.26%)  2/39 (5.13%) 
Upper-Airway Cough Syndrome   0/38 (0.00%)  2/39 (5.13%) 
Skin and subcutaneous tissue disorders     
Pruritus   3/38 (7.89%)  7/39 (17.95%) 
Rash   0/38 (0.00%)  7/39 (17.95%) 
Rash Maculo-Papular   0/38 (0.00%)  5/39 (12.82%) 
Alopecia   0/38 (0.00%)  2/39 (5.13%) 
Dry Skin   1/38 (2.63%)  3/39 (7.69%) 
Petechiae   3/38 (7.89%)  2/39 (5.13%) 
Urticaria   2/38 (5.26%)  0/39 (0.00%) 
Ecchymosis   0/38 (0.00%)  2/39 (5.13%) 
Hyperhidrosis   0/38 (0.00%)  2/39 (5.13%) 
Vascular disorders     
Hot Flush   2/38 (5.26%)  3/39 (7.69%) 
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: NCT02537444     History of Changes
Other Study ID Numbers: ACE-ST-208
First Submitted: August 28, 2015
First Posted: September 1, 2015
Results First Submitted: August 5, 2019
Results First Posted: September 12, 2019
Last Update Posted: September 12, 2019