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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Platinum Resistant Metastatic Urothelial Cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab | Other | Arm 1: pembrolizumab monotherapy |
|
| ACP-196 in combination with pembrolizumab | Other | Arm 2: ACP-196 in combination with pembrolizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pembrolizumab | Drug |
| ||
| ACP-196 in combination with pembrolizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Overall Response | 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 | Every 12 weeks for up to 2 years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Acerta Clinical Trials | 1-888-292-9613; acertamc@dlss.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | United States | |||
| University of Michigan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Pembrolizumab Monotherapy | Arm 1: Pembrolizumab 200mg Administered as an intravenous (IV) infusion every 3 weeks (Q3W) |
| FG001 | Arm 2- Acalabrutinib+Pembrolizumab | Arm 2: Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 23, 2016 | Jul 19, 2019 |
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| Drug |
|
| Ann Arbor |
| Michigan |
| United States |
| Durham | North Carolina | United States |
| James Cancer Hospital | Columbus | Ohio | United States |
| Oregon Health and Science University | Portland | Oregon | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | United States |
| Enrolled |
|
| Received Study Medication |
|
| Discontinued Study |
|
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pembrolizumab | Arm 1: pembrolizumab monotherapy pembrolizumab |
| BG001 | ACP-196 in Combination With Pembrolizumab | Arm 2: ACP-196 in combination with pembrolizumab ACP-196 in combination with pembrolizumab |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Overall Response | 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 | 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. | Posted | Count of Participants | Participants | Every 12 weeks for up to 2 years. |
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|
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Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 730.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 - Pembrolizumab Monotherapy | Arm 1: Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W) | 25 | 35 | 15 | 35 | 34 | 35 |
| EG001 | Arm 2 - Acalabrutinib+Pembrolizumab | Arm 2: Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W) | 31 | 40 | 23 | 40 | 39 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Coronary Artery Disease | Cardiac disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ascites | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Autoimmune Colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Duodenitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haematemesis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Impaired Gastric Emptying | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pneumoperitoneum | Gastrointestinal disorders | Systematic Assessment |
| ||
| Rectal Hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment | General Disorders and Administration Site Conditions |
| |
| Pyrexia | General disorders | Systematic Assessment | General Disorders and Administration Site Conditions |
| |
| Pain | General disorders | Systematic Assessment | General Disorders and Administration Site Conditions |
| |
| Autoimmune Hepatitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hepatic Failure | Hepatobiliary disorders | Systematic Assessment |
| ||
| Immune-Mediated Hepatitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Clostridium Difficile Colitis | Infections and infestations | Systematic Assessment |
| ||
| Lower Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
| ||
| Peritonitis Bacterial | Infections and infestations | Systematic Assessment |
| ||
| Systemic Candida | Infections and infestations | Systematic Assessment |
| ||
| Urosepsis | Infections and infestations | Systematic Assessment |
| ||
| Femur Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Infusion Related Reaction | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Radiation Proctitis | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Alanine Aminotransferase Increased | Investigations | Systematic Assessment |
| ||
| Aspartate Aminotransferase | Investigations | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Failure to Thrive | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bone Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Groin Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Malignant Neoplasm Progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Metastases to Liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Spinal Cord Compression | Nervous system disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
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| Delirium | Psychiatric disorders | Systematic Assessment |
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| Acute Kidney Disease | Renal and urinary disorders | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | Systematic Assessment |
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| Urinary Tract Obstruction | Renal and urinary disorders | Systematic Assessment |
| ||
| Hydronephrosis | Renal and urinary disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary Alveolar Hemorrhage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Deep Vein Thrombosis | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Sinus Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
| ||
| Vision Blurred | Eye disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal Distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Proctalgia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal Discomfort | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment | General Disorders and Administration Site Conditions |
| |
| Pyrexia | General disorders | Systematic Assessment | General Disorders and Administration Site Conditions |
| |
| Oedema Peripheral | General disorders | Systematic Assessment | General Disorders and Administration Site Conditions |
| |
| Chills | General disorders | Systematic Assessment | General Disorders and Administration Site Conditions |
| |
| Non-Cardiac Chest pain | General disorders | Systematic Assessment | General Disorders and Administration Site Conditions |
| |
| Asthenia | General disorders | Systematic Assessment | General Disorders and Administration Site Conditions |
| |
| Gait Disturbance | General disorders | Systematic Assessment | General Disorders and Administration Site Conditions |
| |
| Peripheral Swelling | General disorders | Systematic Assessment | General Disorders and Administration Site Conditions |
| |
| Chest Pain | General disorders | Systematic Assessment | General Disorders and Administration Site Conditions |
| |
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
| ||
| Candida Infection | Infections and infestations | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Rhinitis | Infections and infestations | Systematic Assessment |
| ||
| Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Infusion Related Reaction | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Alanine Aminotransferase Increased | Investigations | Systematic Assessment |
| ||
| Aspartate Aminotransferase Increased | Investigations | Systematic Assessment |
| ||
| Weight Decreased | Investigations | Systematic Assessment |
| ||
| Blood Creatinine Increased | Investigations | Systematic Assessment |
| ||
| Amylase Increased | Investigations | Systematic Assessment |
| ||
| Lipase Increased | Investigations | Systematic Assessment |
| ||
| Blood Alkaline Phosphatase Increased | Investigations | Systematic Assessment |
| ||
| Platelet Count Decreased | Investigations | Systematic Assessment |
| ||
| Decreased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypophosphataemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypomagnesaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypocalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Acidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypercalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperuricaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in Extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscular Weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle Spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bone Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Flank Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Neuropathy Peripheral | Nervous system disorders | Systematic Assessment |
| ||
| Paraesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Presyncope | Nervous system disorders | Systematic Assessment |
| ||
| Balance Disorder | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness Postural | Nervous system disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Confusional State | Psychiatric disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Dysuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Bladder Spasm | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary Tract Obstruction | Renal and urinary disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hiccups | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dry Skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash Pruritic | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin Discoloration | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin Exfoliation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Joint Swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Priti Patel, MD, Executive Director - Head of Clinical Development | Acerta Pharma, LLC | 1-888-292-9613 | acertamc@dlss.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 30, 2018 | Jul 19, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| C000604908 | acalabrutinib |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|