Trial Outcomes & Findings for A Phase II Study of High Dose Bolus IL2 in Patients With Inoperable Stage III or Stage IV Melanoma Who Have Failed Prior Anti-PD1 Immunotherapy: Efficacy and Biomarker Study (NCT NCT02796352)
NCT ID: NCT02796352
Last Updated: 2018-04-20
Results Overview
Percentage of complete responses (CR) plus partial responses (PR), based upon Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
Up to 15 months for accrual, plus 6 months of intervention for last subject enrolled (21 months)
Results posted on
2018-04-20
Participant Flow
Participant milestones
| Measure |
High Dose Bolus Interleukin-2 (HD IL2)
High dose bolus interleukin-2 (HD IL2): Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle).
The planned treatment consists of 3 courses (6 cycles) of HD IL-2.
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|---|---|
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Overall Study
STARTED
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1
|
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Overall Study
COMPLETED
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1
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase II Study of High Dose Bolus IL2 in Patients With Inoperable Stage III or Stage IV Melanoma Who Have Failed Prior Anti-PD1 Immunotherapy: Efficacy and Biomarker Study
Baseline characteristics by cohort
| Measure |
High Dose Bolus Interleukin-2 (HD IL2)
n=1 Participants
High dose bolus interleukin-2 (HD IL2): Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle).
The planned treatment consists of 3 courses (6 cycles) of HD IL-2.
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|---|---|
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Age, Continuous
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63 years
n=5 Participants
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|
Sex: Female, Male
Female
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1 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Up to 15 months for accrual, plus 6 months of intervention for last subject enrolled (21 months)Percentage of complete responses (CR) plus partial responses (PR), based upon Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
Outcome measures
| Measure |
High Dose Bolus Interleukin-2 (HD IL2)
n=1 Participants
High dose bolus interleukin-2 (HD IL2): Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle).
The planned treatment consists of 3 courses (6 cycles) of HD IL-2.
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|---|---|
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Response Rate
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0 Participants
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SECONDARY outcome
Timeframe: Up to 15 months for accrual, plus 6 months of intervention for last subject enrolled, plus 5 years of follow-up (6 years, 9 months)Number of months of survival without disease progression from start of protocol therapy until objective tumor progression or death, per RECIST v1.1
Outcome measures
| Measure |
High Dose Bolus Interleukin-2 (HD IL2)
n=1 Participants
High dose bolus interleukin-2 (HD IL2): Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle).
The planned treatment consists of 3 courses (6 cycles) of HD IL-2.
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|---|---|
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Progression Free Survival (PFS)
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0 months
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SECONDARY outcome
Timeframe: Up to 15 months for accrual, plus 6 months of intervention for last subject enrolled, plus 5 years of follow-up (6 years, 9 months)Number of months from start of protocol therapy until death from any cause.
Outcome measures
| Measure |
High Dose Bolus Interleukin-2 (HD IL2)
n=1 Participants
High dose bolus interleukin-2 (HD IL2): Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle).
The planned treatment consists of 3 courses (6 cycles) of HD IL-2.
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|---|---|
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Overall Survival (OS)
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4 months
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SECONDARY outcome
Timeframe: Up to 21 monthsPopulation: No data displayed because data were not collected for this Outcome Measure, thus zero total participants analyzed.
Levels of HD IL2 biomarker in the blood of patients that received at least course 1 of therapy, and have had their disease re-evaluated will be considered evaluable for response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) version 1.1
Outcome measures
Outcome data not reported
Adverse Events
High Dose Bolus Interleukin-2 (HD IL2)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Dose Bolus Interleukin-2 (HD IL2)
n=1 participants at risk
High dose bolus interleukin-2 (HD IL2): Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle).
The planned treatment consists of 3 courses (6 cycles) of HD IL-2.
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|---|---|
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Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
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Endocrine disorders
Hyperthyroidism
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100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
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Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
|
General disorders
Chills
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
|
Infections and infestations
Infections and infestations - Other, specify
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
|
Investigations
Alkaline phosphatase increased
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
|
Investigations
Blood bilirubin increased
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
|
Investigations
Creatinine increased
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
|
Investigations
Investigations - Other, specify
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
|
Investigations
Lymphocyte count decreased
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
|
Investigations
Platelet count decreased
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
|
Nervous system disorders
Paresthesia
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
|
Psychiatric disorders
Delirium
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
|
Vascular disorders
Hypotension
|
100.0%
1/1 • Number of events 1 • From study entry until end of treatment (4 months)
|
Additional Information
Barbara Stadterman, Regulatory Supervisor
University of Pittsburgh Cancer Institute
Phone: (412) 647-5554
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place