Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000854-85 | EudraCT Number |
Not provided
Not provided
Business objectives have changed
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Nektar Therapeutics | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to first, in Part A, assess the safety, tolerability and drug levels of Bempegaldesleukin (BEMPEG) in combination with nivolumab and then, in Part B, to estimate the preliminary efficacy in children, adolescents and young adults with recurrent or treatment-resistant cancer.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1W Dosing schema | Experimental |
| |
| A1F Dosing schema | Experimental |
| |
| A2W Dosing schema | Experimental |
| |
| A2F Dosing schema | Experimental |
| |
| Part B: Cohort B1 Neuroblastoma | Experimental |
| |
| Part B: Cohort B2 Ewing sarcoma | Experimental |
| |
| Part B: Cohort B3 Rhabdomyosarcoma | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A | Number of participants with dose-limiting toxicities (DLTs). DLTs were collected and evaluated for Part A within the DLT evaluation period, which started on Cycle 1 Day 1 (first dose) and ended at Day 42 (42 days after first dose of the study therapy). | From first dose to 42 days after first dose |
| Number of Participants With Adverse Events (AEs) - Part A | Number of participants with adverse events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. | From first dose to 30 days after last dose (up to approximately 6 months) |
| Number of Participants With Serious Adverse Events (SAEs) - Part A | Number of participants with serious adverse events (SAEs). SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. | From first dose to 30 days after last dose (up to approximately 6 months) |
| Number of Participants With Drug-Related Adverse Events - Part A | Number of participants with drug-related adverse events. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0029 | Little Rock | Arkansas | 72202 | United States | ||
| Local Institution - 0011 |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| FDA Safety Alerts and Recalls |
Not provided
15 participants were treated in Part A. Study did not progress to Part B; therefore, no participants enrolled in Part B.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) | Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks |
| FG001 | Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg) |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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 | Nov 28, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Part B: Cohort B4 Miscellaneous solid tumors | Experimental |
|
| Part B: Cohort B5 NHL/leukemia | Experimental |
|
| Part B: Cohort B6 High-grade glioma | Experimental |
|
| Part B: Cohort B7 Medulloblastoma and Embryonal Tumors | Experimental |
|
| Part B: Cohort B8 Ependymoma | Experimental |
|
| Part B: Cohort B9 Miscellaneous brain tumors | Experimental |
|
|
| NKTR-214 | Biological | Specified dose on specified days |
|
|
| From first dose to 30 days after last dose (up to approximately 6 months) |
| Number of Participants With Adverse Events Leading to Discontinuation - Part A | Number of participants with adverse events leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. | From first dose to 30 days after last dose (up to approximately 6 months) |
| Number of Participants Who Died - Part A | Number of participants who died. | From first dose to 30 days after last dose (up to approximately 6 months) |
| Maximum Observed Plasma Concentration (Cmax) - Part A | Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data. | From first dose to 30 days after last dose (up to approximately 6 months) |
| Trough Observed Concentration (Ctrough) - Part A | Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data. | From first dose to 30 days after last dose (up to approximately 6 months) |
| Area Under the Plasma Concentration (AUC) - Part A | Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data. | From first dose to 30 days after last dose (up to approximately 6 months) |
| St Louis |
| Missouri |
| 63110 |
| United States |
| Local Institution - 0001 | Randwick | New South Wales | 2031 | Australia |
| Local Institution | South Brisbane | Queensland | 4101 | Australia |
| Local Institution - 0002 | Parkville | Victoria | 3052 | Australia |
| Local Institution - 0003 | Perth | Western Australia | 6009 | Australia |
| Local Institution - 0013 | Villejuif | Val-de-Marne | 94805 | France |
| Local Institution - 0014 | Lyon | 69373 cedex 03 | France |
| Local Institution - 0016 | Marseille | 13385 | France |
| Local Institution - 0015 | Paris | 75005 | France |
| Local Institution - 0038 | Hamburg | 20246 | Germany |
| Local Institution - 0039 | Tübingen | 72076 | Germany |
| Local Institution - 0037 | Würzburg | 97080 | Germany |
| Local Institution - 0027 | Milan | 20133 | Italy |
| Local Institution - 0009 | Madrid | Madrid, Comunidad de | 28009 | Spain |
| Local Institution - 0008 | Barcelona | 08035 | Spain |
| Local Institution - 0059 | Seville | 41013 | Spain |
| Local Institution - 0028 | Valencia | 46026 | Spain |
Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
|
| COMPLETED | Completed = Completed treatment |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) | Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks |
| BG001 | Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg) | Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks |
| 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/Ethnicity, Customized | Race | 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 Dose-Limiting Toxicities (DLTs) - Part A | Number of participants with dose-limiting toxicities (DLTs). DLTs were collected and evaluated for Part A within the DLT evaluation period, which started on Cycle 1 Day 1 (first dose) and ended at Day 42 (42 days after first dose of the study therapy). | All treated participants in Part A | Posted | Count of Participants | Participants | From first dose to 42 days after first dose |
|
|
| |||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events (AEs) - Part A | Number of participants with adverse events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. | All treated participants in Part A | Posted | Count of Participants | Participants | From first dose to 30 days after last dose (up to approximately 6 months) |
|
| ||||||||||||||||||||||||||||||
| Primary | Number of Participants With Serious Adverse Events (SAEs) - Part A | Number of participants with serious adverse events (SAEs). SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. | All treated participants in Part A | Posted | Count of Participants | Participants | From first dose to 30 days after last dose (up to approximately 6 months) |
|
| ||||||||||||||||||||||||||||||
| Primary | Number of Participants With Drug-Related Adverse Events - Part A | Number of participants with drug-related adverse events. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. | All treated participants in Part A | Posted | Count of Participants | Participants | From first dose to 30 days after last dose (up to approximately 6 months) |
|
| ||||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events Leading to Discontinuation - Part A | Number of participants with adverse events leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. | All treated participants in Part A | Posted | Count of Participants | Participants | From first dose to 30 days after last dose (up to approximately 6 months) |
|
| ||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Died - Part A | Number of participants who died. | All treated participants in Part A | Posted | Count of Participants | Participants | From first dose to 30 days after last dose (up to approximately 6 months) |
|
| ||||||||||||||||||||||||||||||
| Primary | Maximum Observed Plasma Concentration (Cmax) - Part A | Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data. | Data was not and will never be collected | Posted | From first dose to 30 days after last dose (up to approximately 6 months) |
|
| ||||||||||||||||||||||||||||||||
| Primary | Trough Observed Concentration (Ctrough) - Part A | Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data. | Data was not and will never be collected | Posted | From first dose to 30 days after last dose (up to approximately 6 months) |
|
| ||||||||||||||||||||||||||||||||
| Primary | Area Under the Plasma Concentration (AUC) - Part A | Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data. | Data was not and will never be collected | Posted | From first dose to 30 days after last dose (up to approximately 6 months) |
|
|
Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) | Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks | 7 | 8 | 8 | 8 | 8 | 8 |
| EG001 | Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg) | Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks | 2 | 7 | 5 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | 25.0 | Systematic Assessment |
| |
| Chest pain | General disorders | 25.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | 25.0 | Systematic Assessment |
| |
| Pain | General disorders | 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 25.0 | Systematic Assessment |
| |
| Skin wound | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 25.0 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | 25.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | 25.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 25.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | 25.0 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | 25.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | 25.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | 25.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | 25.0 | Systematic Assessment |
| |
| Photophobia | Eye disorders | 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Tooth discolouration | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 25.0 | Systematic Assessment |
| |
| Chest pain | General disorders | 25.0 | Systematic Assessment |
| |
| Chills | General disorders | 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 25.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | 25.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 25.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 25.0 | Systematic Assessment |
| |
| Pain | General disorders | 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Lymphangitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | 25.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | 25.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 25.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 25.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | 25.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | 25.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | 25.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | 25.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 25.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 25.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 25.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | 25.0 | Systematic Assessment |
| |
| Behaviour disorder | Psychiatric disorders | 25.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 25.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | 25.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | 25.0 | Systematic Assessment |
| |
| Scrotal oedema | Reproductive system and breast disorders | 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 25.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | 25.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | 25.0 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | 25.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 25.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 25.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | 25.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 25.0 | Systematic Assessment |
|
On 14-Apr-2022, a joint decision was made to end the clinical development program for bempegaldesleukin in combination with nivolumab, resulting in the termination of this study. This results disclosure report provides analyses from CA045-020 Part A safety analyses only. Part B of the study (expansion phase) did not enroll any participants.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please Email | Clinical.Trials@bms.com |
| Dec 21, 2022 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D004806 | Ependymoma |
| D012512 | Sarcoma, Ewing |
| D005910 | Glioma |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D008527 | Medulloblastoma |
| D009447 | Neuroblastoma |
| D012008 | Recurrence |
| D009369 | Neoplasms |
| D012208 | Rhabdomyosarcoma |
| D015448 | Leukemia, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D012516 | Osteosarcoma |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D012509 | Sarcoma |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009217 | Myosarcoma |
| D009379 | Neoplasms, Muscle Tissue |
| D007945 | Leukemia, Lymphoid |
| D018358 | Neuroendocrine Tumors |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| C000611752 | bempegaldesleukin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Other |
|
|
|
|
|
|
|
|
|