Trial Outcomes & Findings for High Dose IL-2 in Combination With Anti-PD-1 (NCT NCT03991130)
NCT ID: NCT03991130
Last Updated: 2026-08-06
Results Overview
Overall response rate of combined therapy with nivolumab and HD IL-2 in metastatic melanoma and renal cell carcinoma evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.1) for target lesions: 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
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Up to 45 months
Results posted on
2026-08-06
Participant Flow
Participant milestones
| Measure |
High Dose IL-2 and Nivolumab
IL-2 and Nivolumab: Course length will be 35 days. Subjects will receive 480 mg IV of nivolumab on day 1 of the cycle. The patient will be admitted to UCSD Jacobs Medical center for standard HD IL-2 which will be administered every 8 hrs for up to 14 doses days 8-12 per institutional practice. The patient will be readmitted days 22-28 for HD IL-2 every 8 hrs for up to 14 doses. Nivolumab 480 mg IV will be administered day 35. Scans for response will occur 4 weeks after day 35 nivolumab dose and response will be determined by RECIST 1.1 to determine if the patient will receive the next course.
|
|---|---|
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Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
High Dose IL-2 and Nivolumab
IL-2 and Nivolumab: Course length will be 35 days. Subjects will receive 480 mg IV of nivolumab on day 1 of the cycle. The patient will be admitted to UCSD Jacobs Medical center for standard HD IL-2 which will be administered every 8 hrs for up to 14 doses days 8-12 per institutional practice. The patient will be readmitted days 22-28 for HD IL-2 every 8 hrs for up to 14 doses. Nivolumab 480 mg IV will be administered day 35. Scans for response will occur 4 weeks after day 35 nivolumab dose and response will be determined by RECIST 1.1 to determine if the patient will receive the next course.
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|---|---|
|
Overall Study
screen failure
|
1
|
Baseline Characteristics
High Dose IL-2 in Combination With Anti-PD-1
Baseline characteristics by cohort
| Measure |
High Dose IL-2 and Nivolumab
n=5 Participants
IL-2 and Nivolumab: Course length will be 35 days. Subjects will receive 480 mg IV of nivolumab on day 1 of the cycle. The patient will be admitted to UCSD Jacobs Medical center for standard HD IL-2 which will be administered every 8 hrs for up to 14 doses days 8-12 per institutional practice. The patient will be readmitted days 22-28 for HD IL-2 every 8 hrs for up to 14 doses. Nivolumab 480 mg IV will be administered day 35. Scans for response will occur 4 weeks after day 35 nivolumab dose and response will be determined by RECIST 1.1 to determine if the patient will receive the next course.
|
|---|---|
|
Age, Continuous
|
47 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Tumor type
Melanoma
|
3 Participants
n=20 Participants
|
|
Tumor type
Renal cell carcinoma
|
2 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Up to 45 monthsOverall response rate of combined therapy with nivolumab and HD IL-2 in metastatic melanoma and renal cell carcinoma evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.1) for target lesions: 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
Outcome measures
| Measure |
High Dose IL-2 and Nivolumab
n=5 Participants
IL-2 and Nivolumab: Course length will be 35 days. Subjects will receive 480 mg IV of nivolumab on day 1 of the cycle. The patient will be admitted to UCSD Jacobs Medical center for standard HD IL-2 which will be administered every 8 hrs for up to 14 doses days 8-12 per institutional practice. The patient will be readmitted days 22-28 for HD IL-2 every 8 hrs for up to 14 doses. Nivolumab 480 mg IV will be administered day 35. Scans for response will occur 4 weeks after day 35 nivolumab dose and response will be determined by RECIST 1.1 to determine if the patient will receive the next course.
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|---|---|
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Overall Response Rate
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 6 months or start of a new anti-cancer therapy or deathPercentage of subjects with grade 3 or higher adverse events as defined by CTCAE v 5.0
Outcome measures
| Measure |
High Dose IL-2 and Nivolumab
n=5 Participants
IL-2 and Nivolumab: Course length will be 35 days. Subjects will receive 480 mg IV of nivolumab on day 1 of the cycle. The patient will be admitted to UCSD Jacobs Medical center for standard HD IL-2 which will be administered every 8 hrs for up to 14 doses days 8-12 per institutional practice. The patient will be readmitted days 22-28 for HD IL-2 every 8 hrs for up to 14 doses. Nivolumab 480 mg IV will be administered day 35. Scans for response will occur 4 weeks after day 35 nivolumab dose and response will be determined by RECIST 1.1 to determine if the patient will receive the next course.
|
|---|---|
|
Drug Toxicity
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 45 monthsProgression Free Survival of combined therapy with nivolumab and HD IL-2 in metastatic melanoma and renal cell carcinoma evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.1): 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
High Dose IL-2 and Nivolumab
n=5 Participants
IL-2 and Nivolumab: Course length will be 35 days. Subjects will receive 480 mg IV of nivolumab on day 1 of the cycle. The patient will be admitted to UCSD Jacobs Medical center for standard HD IL-2 which will be administered every 8 hrs for up to 14 doses days 8-12 per institutional practice. The patient will be readmitted days 22-28 for HD IL-2 every 8 hrs for up to 14 doses. Nivolumab 480 mg IV will be administered day 35. Scans for response will occur 4 weeks after day 35 nivolumab dose and response will be determined by RECIST 1.1 to determine if the patient will receive the next course.
|
|---|---|
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Progression Free Survival
|
1.4 months
Interval 0.8 to 45.0
|
Adverse Events
High Dose IL-2 and Nivolumab
Serious events: 0 serious events
Other events: 5 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Dose IL-2 and Nivolumab
n=5 participants at risk
IL-2 and Nivolumab: Course length will be 35 days. Subjects will receive 480 mg IV of nivolumab on day 1 of the cycle. The patient will be admitted to UCSD Jacobs Medical center for standard HD IL-2 which will be administered every 8 hrs for up to 14 doses days 8-12 per institutional practice. The patient will be readmitted days 22-28 for HD IL-2 every 8 hours for up to 14 doses. Nivolumab 480 mg IV will be administered day 35. Scans for response will occur 4 weeks after day 35 nivolumab dose and response will be determined by RECIST 1.1 to determine if the patient will receive the next course.
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|---|---|
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Gastrointestinal disorders
Clostridium difficile colitis
|
20.0%
1/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
Gastrointestinal disorders
Colitis
|
20.0%
1/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
Renal and urinary disorders
Decreased urine output
|
20.0%
1/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
1/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
1/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
20.0%
1/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
1/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
20.0%
1/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
Hepatobiliary disorders
Liver dysfunction
|
20.0%
1/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
Hepatobiliary disorders
Transaminitis
|
20.0%
1/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
General disorders
Fatigue
|
40.0%
2/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
Cardiac disorders
Hypotension
|
40.0%
2/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
40.0%
2/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
Metabolism and nutrition disorders
Acidosis
|
20.0%
1/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia
|
20.0%
1/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
20.0%
1/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
Infections and infestations
Sepsis or systemic inflammatory response syndrome
|
20.0%
1/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
Cardiac disorders
Ventricular fibrillation
|
20.0%
1/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
Gastrointestinal disorders
Acute cholecystitis
|
20.0%
1/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
1/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
Investigations
Aspartate aminotransferase elevation
|
20.0%
1/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
Cardiac disorders
Atrial fibrillation
|
20.0%
1/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
Cardiac disorders
Bradycardia
|
20.0%
1/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
100.0%
5/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
Renal and urinary disorders
Renal Injury
|
80.0%
4/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
60.0%
3/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
60.0%
3/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
Psychiatric disorders
Altered level of consciousness
|
60.0%
3/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
60.0%
3/5 • Adverse events: Up to 6 months or start of a new anti-cancer therapy or death. Mortality: Up to 45 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place