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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| Janssen Scientific Affairs, LLC | INDUSTRY |
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The purpose of this study is to evaluate the impact of sequential overlapping treatment with PD-1 monoclonal antibody (mAb), pembrolizumab/MK-1375, followed by ibrutinib on endogenous immune function in previously untreated, high-risk CLL patients. Immune function will be evaluated through various laboratory correlative tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab and Ibrutinib | Experimental | Treatment with pembrolizumab and ibrutinib and follow-up period of up to 24 months. Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Ibrutinib is an inhibitor of Bruton's tyrosine kinase (BTK). Ibrutinib is a small-molecule inhibitor of BTK. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Drug | Pembrolizumab will be administered intravenously (IV) at 200 mg every 3 weeks for 1 year and up to 2 years. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) to the Therapeutic Intervention | Response categories according to The International Workshop on Chronic Lymphocytic Leukemia (IWCLL): Complete remission (CR); Complete remission with incomplete marrow recovery (CRi); Partial remission (PR); Progressive disease (PD); Stable disease (SD), defined as not meeting criteria for CR, CRi, PR or PD. | Up to 2 years |
| Time to Best Response | Time to best response to chronic lymphocytic leukemia (CLL) to the therapeutic intervention. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | Progressive disease (PD), defined as ≥ 50% rise in lymphocyte count to > 5 x10^9/L, ≥ 50% increase in lymphadenopathy, ≥ 50% increase in liver or spleen size, Richter's transformation, or new cytopenias due to CLL. | Up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julio Chavez, M.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
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| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pembrolizumab and Ibrutinib | Treatment with pembrolizumab and ibrutinib and follow-up period of up to 24 months. Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Ibrutinib is an inhibitor of Bruton's tyrosine kinase (BTK). Ibrutinib is a small-molecule inhibitor of BTK. Pembrolizumab: Pembrolizumab will be administered intravenously (IV) at 200 mg every 3 weeks for 1 year and up to 2 years. Ibrutinib: Ibrutinib will be administered orally once daily at approximately the same time each day at the dose of 420 mg daily (3 capsules of 140 mg daily). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pembrolizumab and Ibrutinib | Treatment with pembrolizumab and ibrutinib and follow-up period of up to 24 months. Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Ibrutinib is an inhibitor of Bruton's tyrosine kinase (BTK). Ibrutinib is a small-molecule inhibitor of BTK. Pembrolizumab: Pembrolizumab will be administered intravenously (IV) at 200 mg every 3 weeks for 1 year and up to 2 years. Ibrutinib: Ibrutinib will be administered orally once daily at approximately the same time each day at the dose of 420 mg daily (3 capsules of 140 mg daily). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Overall Response Rate (ORR) to the Therapeutic Intervention | Response categories according to The International Workshop on Chronic Lymphocytic Leukemia (IWCLL): Complete remission (CR); Complete remission with incomplete marrow recovery (CRi); Partial remission (PR); Progressive disease (PD); Stable disease (SD), defined as not meeting criteria for CR, CRi, PR or PD. | evaluable participants | Posted | Number | participants | Up to 2 years |
|
Adverse events were collected from date of informed consent until 90 days after last dose of pembrolizumab and 30 days after last dose of ibrutinib, an average of 8.8 months. All-cause mortality was assessed through study completion, up to 24 months.
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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 | Pembrolizumab and Ibrutinib | Treatment with pembrolizumab and ibrutinib and follow-up period of up to 24 months. Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Ibrutinib is an inhibitor of Bruton's tyrosine kinase (BTK). Ibrutinib is a small-molecule inhibitor of BTK. Pembrolizumab: Pembrolizumab will be administered intravenously (IV) at 200 mg every 3 weeks for 1 year and up to 2 years. Ibrutinib: Ibrutinib will be administered orally once daily at approximately the same time each day at the dose of 420 mg daily (3 capsules of 140 mg daily). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gram negative sepsis | Infections and infestations | CTCAE 5.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE 5.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julio Chavez, MD, MS | Moffitt Cancer Center | 813-745-4294 | julio.c.chavez@moffitt.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2018 | Aug 28, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 31, 2019 | Aug 28, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D001855 | Bone Marrow Diseases |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| C551803 | ibrutinib |
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| Ibrutinib | Drug | Ibrutinib will be administered orally once daily at approximately the same time each day at the dose of 420 mg daily (3 capsules of 140 mg daily). |
|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Time to Best Response | Time to best response to chronic lymphocytic leukemia (CLL) to the therapeutic intervention. | evaluable participants | Posted | Median | Standard Deviation | months | Up to 2 years |
|
|
|
| Secondary | Progression-free Survival (PFS) | Progressive disease (PD), defined as ≥ 50% rise in lymphocyte count to > 5 x10^9/L, ≥ 50% increase in lymphadenopathy, ≥ 50% increase in liver or spleen size, Richter's transformation, or new cytopenias due to CLL. | Evaluable patients | Posted | Median | Standard Deviation | months | Up to 2 years |
|
|
|
| 1 |
| 5 |
| 3 |
| 5 |
| 5 |
| 5 |
| Aseptic Meningitis | Infections and infestations | CTCAE 5.0 | Non-systematic Assessment |
|
| Atrial fibrilation | Cardiac disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Lung Infection | Infections and infestations | CTCAE 5.0 | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Fecal incontinence | Gastrointestinal disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE 5.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Periodontal disease | Gastrointestinal disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Proctitis | Gastrointestinal disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Chills | General disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Pain | General disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Flu like symptoms | General disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Malaise | General disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE 5.0 | Non-systematic Assessment |
|
| Blood urea nitrogen increased | Investigations | CTCAE 5.0 | Non-systematic Assessment |
|
| Blood CO2 decreased | Investigations | CTCAE 5.0 | Non-systematic Assessment |
|
| Platelet count increased | Investigations | CTCAE 5.0 | Non-systematic Assessment |
|
| Neutrophil Count Increased | Investigations | CTCAE 5.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE 5.0 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE 5.0 | Non-systematic Assessment |
|
| Thyroid stimulating hormone increased | Investigations | CTCAE 5.0 | Non-systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE 5.0 | Non-systematic Assessment |
|
| Hemoglobin increased | Investigations | CTCAE 5.0 | Non-systematic Assessment |
|
| Blood urea nitrogen decreased | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Blood Urea Nitrogen Increased | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Hyperphosphatemia | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Hypochloremia | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Iron decreased | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Lactic Acid Increased | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| LDL increased | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Serum protein decreased | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Serm chloride decreased | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Serum Chloride decreased | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Total protein decreased | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Uric acid decreased | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Hyperphosphatemia | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Infections and Infestations -Other | Infections and infestations | CTCAE 5.0 | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | CTCAE 5.0 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE 5.0 | Non-systematic Assessment |
|
| Meningitis | Infections and infestations | CTCAE 5.0 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE 5.0 | Non-systematic Assessment |
|
| Soft tissue infection | Infections and infestations | CTCAE 5.0 | Non-systematic Assessment |
|
| Thrush | Infections and infestations | CTCAE 5.0 | Non-systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE 5.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Hematoma | Vascular disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Eye pain | Eye disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Macular wrinkle left eye | Eye disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Eye swelling/redness | Eye disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Periorbital edema | Eye disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Photophobia | Eye disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | CTCAE 5.0 | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Hypogammaglobulinemia | Immune system disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Squamous cell carcinoma, right calf | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE 5.0 | Non-systematic Assessment |
|
| Nodule on dorsal aspect of left food | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE 5.0 | Non-systematic Assessment |
|
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| D006425 |
| Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |