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A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer (PIVOT IO 020)

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: NCT04730349
Recruitment Status : Terminated (Business objectives have changed)
First Posted : January 29, 2021
Results First Posted : March 24, 2023
Last Update Posted : March 24, 2023
Sponsor:
Collaborator:
Nektar Therapeutics
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ependymoma
Ewing Sarcoma
High-grade Glioma
Leukemia and Lymphoma
Medulloblastoma
Miscellaneous Brain Tumors
Miscellaneous Solid Tumors
Neuroblastoma
Relapsed, Refractory Malignant Neoplasms
Rhabdomyosarcoma
Interventions Biological: Nivolumab
Biological: NKTR-214
Enrollment 15
Recruitment Details  
Pre-assignment Details 15 participants were treated in Part A. Study did not progress to Part B; therefore, no participants enrolled in Part B.
Arm/Group Title Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
Hide Arm/Group Description Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
Period Title: Overall Study
Started [1] 8 7
Completed [2] 1 2
Not Completed 7 5
Reason Not Completed
Participant withdrew consent             1             0
Disease progression             6             4
Study drug toxicity             0             1
[1]
Started = Started treatment
[2]
Completed = Completed treatment
Arm/Group Title Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg) Total
Hide Arm/Group Description Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks Total of all reporting groups
Overall Number of Baseline Participants 8 7 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 7 participants 15 participants
7.5  (3.9) 14.9  (1.5) 10.9  (4.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 15 participants
Female
4
  50.0%
2
  28.6%
6
  40.0%
Male
4
  50.0%
5
  71.4%
9
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 15 participants
Hispanic or Latino
1
  12.5%
0
   0.0%
1
   6.7%
Not Hispanic or Latino
4
  50.0%
6
  85.7%
10
  66.7%
Unknown or Not Reported
3
  37.5%
1
  14.3%
4
  26.7%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 8 participants 7 participants 15 participants
White
6
  75.0%
5
  71.4%
11
  73.3%
Black or African American
1
  12.5%
0
   0.0%
1
   6.7%
Other
1
  12.5%
2
  28.6%
3
  20.0%
[1]
Measure Description: Race
1.Primary Outcome
Title Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A
Hide Description 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).
Time Frame From first dose to 42 days after first dose
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in Part A
Arm/Group Title Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
Hide Arm/Group Description:
Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks
Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
Overall Number of Participants Analyzed 8 7
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Number of Participants With Adverse Events (AEs) - Part A
Hide Description 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.
Time Frame From first dose to 30 days after last dose (up to approximately 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in Part A
Arm/Group Title Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
Hide Arm/Group Description:
Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks
Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
Overall Number of Participants Analyzed 8 7
Measure Type: Count of Participants
Unit of Measure: Participants
8
 100.0%
7
 100.0%
3.Primary Outcome
Title Number of Participants With Serious Adverse Events (SAEs) - Part A
Hide Description 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.
Time Frame From first dose to 30 days after last dose (up to approximately 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in Part A
Arm/Group Title Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
Hide Arm/Group Description:
Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks
Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
Overall Number of Participants Analyzed 8 7
Measure Type: Count of Participants
Unit of Measure: Participants
6
  75.0%
5
  71.4%
4.Primary Outcome
Title Number of Participants With Drug-Related Adverse Events - Part A
Hide Description 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.
Time Frame From first dose to 30 days after last dose (up to approximately 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in Part A
Arm/Group Title Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
Hide Arm/Group Description:
Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks
Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
Overall Number of Participants Analyzed 8 7
Measure Type: Count of Participants
Unit of Measure: Participants
6
  75.0%
6
  85.7%
5.Primary Outcome
Title Number of Participants With Adverse Events Leading to Discontinuation - Part A
Hide Description 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.
Time Frame From first dose to 30 days after last dose (up to approximately 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in Part A
Arm/Group Title Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
Hide Arm/Group Description:
Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks
Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
Overall Number of Participants Analyzed 8 7
Measure Type: Count of Participants
Unit of Measure: Participants
2
  25.0%
3
  42.9%
6.Primary Outcome
Title Number of Participants Who Died - Part A
Hide Description Number of participants who died.
Time Frame From first dose to 30 days after last dose (up to approximately 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in Part A
Arm/Group Title Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
Hide Arm/Group Description:
Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks
Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
Overall Number of Participants Analyzed 8 7
Measure Type: Count of Participants
Unit of Measure: Participants
2
  25.0%
0
   0.0%
7.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) - Part A
Hide Description Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.
Time Frame From first dose to 30 days after last dose (up to approximately 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not and will never be collected
Arm/Group Title Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
Hide Arm/Group Description:
Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks
Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Primary Outcome
Title Trough Observed Concentration (Ctrough) - Part A
Hide Description Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.
Time Frame From first dose to 30 days after last dose (up to approximately 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not and will never be collected
Arm/Group Title Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
Hide Arm/Group Description:
Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks
Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Primary Outcome
Title Area Under the Plasma Concentration (AUC) - Part A
Hide Description Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.
Time Frame From first dose to 30 days after last dose (up to approximately 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not and will never be collected
Arm/Group Title Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
Hide Arm/Group Description:
Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks
Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 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).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
Hide Arm/Group Description Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
All-Cause Mortality
Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
Affected / at Risk (%) Affected / at Risk (%)
Total   7/8 (87.50%)   2/7 (28.57%) 
Hide Serious Adverse Events
Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
Affected / at Risk (%) Affected / at Risk (%)
Total   8/8 (100.00%)   5/7 (71.43%) 
Blood and lymphatic system disorders     
Thrombocytopenia † 1  1/8 (12.50%)  0/7 (0.00%) 
General disorders     
Chest pain † 1  0/8 (0.00%)  1/7 (14.29%) 
Influenza like illness † 1  0/8 (0.00%)  1/7 (14.29%) 
Pain † 1  1/8 (12.50%)  0/7 (0.00%) 
Pyrexia † 1  2/8 (25.00%)  2/7 (28.57%) 
Injury, poisoning and procedural complications     
Skin wound † 1  1/8 (12.50%)  0/7 (0.00%) 
Metabolism and nutrition disorders     
Dehydration † 1  0/8 (0.00%)  1/7 (14.29%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  0/8 (0.00%)  1/7 (14.29%) 
Musculoskeletal chest pain † 1  0/8 (0.00%)  1/7 (14.29%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant neoplasm progression † 1  6/8 (75.00%)  2/7 (28.57%) 
Nervous system disorders     
Brain oedema † 1  0/8 (0.00%)  1/7 (14.29%) 
Seizure † 1  1/8 (12.50%)  0/7 (0.00%) 
Renal and urinary disorders     
Nephrotic syndrome † 1  1/8 (12.50%)  0/7 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  0/8 (0.00%)  1/7 (14.29%) 
Dyspnoea † 1  0/8 (0.00%)  1/7 (14.29%) 
Hypoxia † 1  1/8 (12.50%)  0/7 (0.00%) 
Pleural effusion † 1  1/8 (12.50%)  1/7 (14.29%) 
Pneumonitis † 1  0/8 (0.00%)  1/7 (14.29%) 
Respiratory failure † 1  1/8 (12.50%)  0/7 (0.00%) 
1
Term from vocabulary, 25.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
Affected / at Risk (%) Affected / at Risk (%)
Total   8/8 (100.00%)   7/7 (100.00%) 
Blood and lymphatic system disorders     
Anaemia † 1  1/8 (12.50%)  3/7 (42.86%) 
Eosinophilia † 1  1/8 (12.50%)  0/7 (0.00%) 
Febrile neutropenia † 1  0/8 (0.00%)  1/7 (14.29%) 
Thrombocytopenia † 1  1/8 (12.50%)  0/7 (0.00%) 
Cardiac disorders     
Sinus bradycardia † 1  0/8 (0.00%)  1/7 (14.29%) 
Sinus tachycardia † 1  0/8 (0.00%)  2/7 (28.57%) 
Ear and labyrinth disorders     
Hypoacusis † 1  0/8 (0.00%)  1/7 (14.29%) 
Endocrine disorders     
Hyperthyroidism † 1  0/8 (0.00%)  1/7 (14.29%) 
Hypothyroidism † 1  1/8 (12.50%)  1/7 (14.29%) 
Eye disorders     
Eye pain † 1  0/8 (0.00%)  1/7 (14.29%) 
Photophobia † 1  1/8 (12.50%)  0/7 (0.00%) 
Gastrointestinal disorders     
Abdominal pain † 1  1/8 (12.50%)  1/7 (14.29%) 
Constipation † 1  0/8 (0.00%)  2/7 (28.57%) 
Nausea † 1  0/8 (0.00%)  3/7 (42.86%) 
Tooth discolouration † 1  0/8 (0.00%)  1/7 (14.29%) 
Vomiting † 1  2/8 (25.00%)  2/7 (28.57%) 
General disorders     
Asthenia † 1  1/8 (12.50%)  0/7 (0.00%) 
Chest pain † 1  0/8 (0.00%)  1/7 (14.29%) 
Chills † 1  0/8 (0.00%)  1/7 (14.29%) 
Fatigue † 1  4/8 (50.00%)  2/7 (28.57%) 
Generalised oedema † 1  1/8 (12.50%)  1/7 (14.29%) 
Non-cardiac chest pain † 1  1/8 (12.50%)  0/7 (0.00%) 
Oedema peripheral † 1  1/8 (12.50%)  0/7 (0.00%) 
Pain † 1  1/8 (12.50%)  2/7 (28.57%) 
Pyrexia † 1  2/8 (25.00%)  3/7 (42.86%) 
Infections and infestations     
COVID-19 † 1  0/8 (0.00%)  1/7 (14.29%) 
Conjunctivitis † 1  1/8 (12.50%)  0/7 (0.00%) 
Cystitis † 1  0/8 (0.00%)  1/7 (14.29%) 
Lymphangitis † 1  1/8 (12.50%)  0/7 (0.00%) 
Pharyngitis † 1  1/8 (12.50%)  0/7 (0.00%) 
Rhinitis † 1  0/8 (0.00%)  1/7 (14.29%) 
Vaginal infection † 1  0/8 (0.00%)  1/7 (14.29%) 
Injury, poisoning and procedural complications     
Infusion related reaction † 1  1/8 (12.50%)  2/7 (28.57%) 
Ligament sprain † 1  0/8 (0.00%)  1/7 (14.29%) 
Investigations     
Alanine aminotransferase increased † 1  0/8 (0.00%)  3/7 (42.86%) 
Aspartate aminotransferase increased † 1  0/8 (0.00%)  2/7 (28.57%) 
Blood alkaline phosphatase increased † 1  0/8 (0.00%)  1/7 (14.29%) 
C-reactive protein increased † 1  1/8 (12.50%)  0/7 (0.00%) 
Gamma-glutamyltransferase increased † 1  0/8 (0.00%)  1/7 (14.29%) 
Lymphocyte count decreased † 1  1/8 (12.50%)  3/7 (42.86%) 
Neutrophil count decreased † 1  0/8 (0.00%)  1/7 (14.29%) 
White blood cell count decreased † 1  0/8 (0.00%)  3/7 (42.86%) 
Metabolism and nutrition disorders     
Decreased appetite † 1  1/8 (12.50%)  3/7 (42.86%) 
Hyperglycaemia † 1  0/8 (0.00%)  1/7 (14.29%) 
Hypoalbuminaemia † 1  1/8 (12.50%)  0/7 (0.00%) 
Hypocalcaemia † 1  0/8 (0.00%)  2/7 (28.57%) 
Hypokalaemia † 1  0/8 (0.00%)  3/7 (42.86%) 
Hyponatraemia † 1  0/8 (0.00%)  1/7 (14.29%) 
Hypophosphataemia † 1  0/8 (0.00%)  2/7 (28.57%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  0/8 (0.00%)  1/7 (14.29%) 
Bone pain † 1  0/8 (0.00%)  1/7 (14.29%) 
Muscle spasms † 1  0/8 (0.00%)  1/7 (14.29%) 
Musculoskeletal chest pain † 1  0/8 (0.00%)  1/7 (14.29%) 
Myalgia † 1  0/8 (0.00%)  1/7 (14.29%) 
Pain in extremity † 1  1/8 (12.50%)  1/7 (14.29%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumour haemorrhage † 1  0/8 (0.00%)  1/7 (14.29%) 
Nervous system disorders     
Ataxia † 1  1/8 (12.50%)  0/7 (0.00%) 
Dizziness † 1  1/8 (12.50%)  2/7 (28.57%) 
Dysgeusia † 1  1/8 (12.50%)  0/7 (0.00%) 
Headache † 1  3/8 (37.50%)  2/7 (28.57%) 
Neuralgia † 1  1/8 (12.50%)  0/7 (0.00%) 
Presyncope † 1  0/8 (0.00%)  1/7 (14.29%) 
Psychiatric disorders     
Behaviour disorder † 1  1/8 (12.50%)  0/7 (0.00%) 
Insomnia † 1  1/8 (12.50%)  0/7 (0.00%) 
Sleep disorder † 1  1/8 (12.50%)  0/7 (0.00%) 
Renal and urinary disorders     
Urinary incontinence † 1  1/8 (12.50%)  0/7 (0.00%) 
Reproductive system and breast disorders     
Scrotal oedema † 1  1/8 (12.50%)  0/7 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  1/8 (12.50%)  1/7 (14.29%) 
Dyspnoea † 1  1/8 (12.50%)  2/7 (28.57%) 
Hypoxia † 1  0/8 (0.00%)  1/7 (14.29%) 
Lung disorder † 1  0/8 (0.00%)  1/7 (14.29%) 
Nasal congestion † 1  0/8 (0.00%)  2/7 (28.57%) 
Pleural effusion † 1  0/8 (0.00%)  1/7 (14.29%) 
Pneumonitis † 1  0/8 (0.00%)  1/7 (14.29%) 
Pneumothorax † 1  0/8 (0.00%)  1/7 (14.29%) 
Pulmonary embolism † 1  0/8 (0.00%)  1/7 (14.29%) 
Rhinitis allergic † 1  1/8 (12.50%)  0/7 (0.00%) 
Rhinorrhoea † 1  0/8 (0.00%)  1/7 (14.29%) 
Skin and subcutaneous tissue disorders     
Dermatitis allergic † 1  1/8 (12.50%)  0/7 (0.00%) 
Dry skin † 1  0/8 (0.00%)  1/7 (14.29%) 
Photosensitivity reaction † 1  0/8 (0.00%)  1/7 (14.29%) 
Pruritus † 1  1/8 (12.50%)  1/7 (14.29%) 
Rash † 1  3/8 (37.50%)  1/7 (14.29%) 
Rash maculo-papular † 1  0/8 (0.00%)  2/7 (28.57%) 
Urticaria † 1  1/8 (12.50%)  0/7 (0.00%) 
Vascular disorders     
Hypotension † 1  0/8 (0.00%)  1/7 (14.29%) 
1
Term from vocabulary, 25.0
†
Indicates events were collected by 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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
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.
Results Point of Contact
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Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Phone: Please Email
EMail: Clinical.Trials@bms.com
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04730349    
Other Study ID Numbers: CA045-020
2020-000854-85 ( EudraCT Number )
First Submitted: January 26, 2021
First Posted: January 29, 2021
Results First Submitted: December 21, 2022
Results First Posted: March 24, 2023
Last Update Posted: March 24, 2023