Trial Outcomes & Findings for Aldesleukin and Pembrolizumab in Treating Patients With Advanced or Metastatic Kidney Cancer (NCT NCT03260504)
NCT ID: NCT03260504
Last Updated: 2025-12-08
Results Overview
The safety analysis was based on subjects who experienced toxicities as defined by CTCAE v5.0 criteria. Safety was assessed by quantifying the toxicities and laboratory abnormalities by grades experienced, including any serious adverse events (SAEs). Only treatment-related adverse events with an incidence rate of at least 2.5% are reported.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
6 participants
Primary outcome timeframe
Adverse events were recorded from the time the consent form was signed through 30 days following the cessation of the study treatment for each participant. Each treatment course was 12 weeks and the maximum duration of treatment was 3 courses (36 weeks).
Results posted on
2025-12-08
Participant Flow
Participant milestones
| Measure |
Period 1: Dose Level 1 (Pembrolizumab + SQ IL-2)
Patients receive 200 mg pembrolizumab intravenously (IV) over 30 minutes on days 1, 22, 43, and 64.
Patients also receive aldesleukin subcutaneously (SC) at 250,000 U/kg/dose, daily, 5 days/wk, week 1; 125,000 U/kg/dose, daily, 5 days/wk, weeks 2-6.
|
Period 2: Dose Level 2 (Pembrolizumab + Low-Dose IV Bolus IL-2)
Patients receive 200 mg pembrolizumab intravenously (IV) over 30 minutes on days 1, 22, 43, and 64.
Patients also receive aldesleukin intravenously (IV) at 72,000 U/kg IV q 8 hrs x 14 doses days 2-6 (cycle 1); and days 23-27 (cycle 2) of a 12-week course.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Period 1: Dose Level 1 (Pembrolizumab + SQ IL-2)
Patients receive 200 mg pembrolizumab intravenously (IV) over 30 minutes on days 1, 22, 43, and 64.
Patients also receive aldesleukin subcutaneously (SC) at 250,000 U/kg/dose, daily, 5 days/wk, week 1; 125,000 U/kg/dose, daily, 5 days/wk, weeks 2-6.
|
Period 2: Dose Level 2 (Pembrolizumab + Low-Dose IV Bolus IL-2)
Patients receive 200 mg pembrolizumab intravenously (IV) over 30 minutes on days 1, 22, 43, and 64.
Patients also receive aldesleukin intravenously (IV) at 72,000 U/kg IV q 8 hrs x 14 doses days 2-6 (cycle 1); and days 23-27 (cycle 2) of a 12-week course.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Aldesleukin and Pembrolizumab in Treating Patients With Advanced or Metastatic Kidney Cancer
Baseline characteristics by cohort
| Measure |
Period 1: Dose Level 1 (Pembrolizumab + SQ IL-2)
n=3 Participants
Patients receive 200 mg pembrolizumab intravenously (IV) over 30 minutes on days 1, 22, 43, and 64.
Patients also receive aldesleukin subcutaneously (SC) at 250,000 U/kg/dose, daily, 5 days/wk, week 1; 125,000 U/kg/dose, daily, 5 days/wk, weeks 2-6.
|
Period 2: Dose Level 2 (Pembrolizumab + Low-Dose IV Bolus IL-2)
n=3 Participants
Patients receive 200 mg pembrolizumab intravenously (IV) over 30 minutes on days 1, 22, 43, and 64.
Patients also receive aldesleukin intravenously (IV) at 72,000 U/kg IV q 8 hrs x 14 doses days 2-6 (cycle 1); and days 23-27 (cycle 2) of a 12-week course.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 Year
n=9 Participants
|
59 Year
n=6 Participants
|
58 Year
n=9 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
6 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
6 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Adverse events were recorded from the time the consent form was signed through 30 days following the cessation of the study treatment for each participant. Each treatment course was 12 weeks and the maximum duration of treatment was 3 courses (36 weeks).The safety analysis was based on subjects who experienced toxicities as defined by CTCAE v5.0 criteria. Safety was assessed by quantifying the toxicities and laboratory abnormalities by grades experienced, including any serious adverse events (SAEs). Only treatment-related adverse events with an incidence rate of at least 2.5% are reported.
Outcome measures
| Measure |
Period 1: Dose Level 1 (Pembrolizumab + SQ IL-2)
n=3 Participants
Patients receive 200 mg pembrolizumab intravenously (IV) over 30 minutes on days 1, 22, 43, and 64.
Patients also receive aldesleukin subcutaneously (SC) at 250,000 U/kg/dose, daily, 5 days/wk, week 1; 125,000 U/kg/dose, daily, 5 days/wk, weeks 2-6.
|
Period 2: Dose Level 2 (Pembrolizumab + Low-Dose IV Bolus IL-2)
n=3 Participants
Patients receive 200 mg pembrolizumab intravenously (IV) over 30 minutes on days 1, 22, 43, and 64.
Patients also receive aldesleukin intravenously (IV) at 72,000 U/kg IV q 8 hrs x 14 doses days 2-6 (cycle 1); and days 23-27 (cycle 2) of a 12-week course.
|
|---|---|---|
|
Number of Adverse Events
|
3 Adverse Events (CTCAE v5.0)
|
1 Adverse Events (CTCAE v5.0)
|
SECONDARY outcome
Timeframe: Tumor imaging was collected at baseline after consent was obtained, every 12 weeks at end of a treatment course (max. 3 courses), and every 12 weeks after the cessation of study treatment for up to 1 year of surveillance follow-up for each participant.Population: In Dose Level 2, one participant died before any staging assessment was collected and therefore could not be evaluated for objective response.
Tumor imaging post-treatment compared to baseline imaging (MRI preferred or contrast CT); assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Best overall response rate (ORR) includes complete responders (CR): disappearance of all target lesions; and partial response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Period 1: Dose Level 1 (Pembrolizumab + SQ IL-2)
n=3 Participants
Patients receive 200 mg pembrolizumab intravenously (IV) over 30 minutes on days 1, 22, 43, and 64.
Patients also receive aldesleukin subcutaneously (SC) at 250,000 U/kg/dose, daily, 5 days/wk, week 1; 125,000 U/kg/dose, daily, 5 days/wk, weeks 2-6.
|
Period 2: Dose Level 2 (Pembrolizumab + Low-Dose IV Bolus IL-2)
n=2 Participants
Patients receive 200 mg pembrolizumab intravenously (IV) over 30 minutes on days 1, 22, 43, and 64.
Patients also receive aldesleukin intravenously (IV) at 72,000 U/kg IV q 8 hrs x 14 doses days 2-6 (cycle 1); and days 23-27 (cycle 2) of a 12-week course.
|
|---|---|---|
|
Number of Participants With Objective Response
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Tumor imaging was collected at baseline after consent was obtained, every 12 weeks at end of a treatment course (max. 3 courses), and every 12 weeks after the cessation of study treatment for up to 1 year of surveillance follow-up for each participant.Population: In Dose Level 2, one participant died before any staging assessment was collected and therefore could not be evaluated for objective response.
Tumor imaging post-treatment compared to baseline imaging (MRI preferred or contrast CT); assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Disease control rate includes CR; PR; stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (at least 20% in the sum of diameters of target lesions, taking as reference the smallest sum on study), taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Period 1: Dose Level 1 (Pembrolizumab + SQ IL-2)
n=3 Participants
Patients receive 200 mg pembrolizumab intravenously (IV) over 30 minutes on days 1, 22, 43, and 64.
Patients also receive aldesleukin subcutaneously (SC) at 250,000 U/kg/dose, daily, 5 days/wk, week 1; 125,000 U/kg/dose, daily, 5 days/wk, weeks 2-6.
|
Period 2: Dose Level 2 (Pembrolizumab + Low-Dose IV Bolus IL-2)
n=2 Participants
Patients receive 200 mg pembrolizumab intravenously (IV) over 30 minutes on days 1, 22, 43, and 64.
Patients also receive aldesleukin intravenously (IV) at 72,000 U/kg IV q 8 hrs x 14 doses days 2-6 (cycle 1); and days 23-27 (cycle 2) of a 12-week course.
|
|---|---|---|
|
Number of Participants With Objective Response or Stable Disease
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Tumor imaging was collected at baseline after consent was obtained, every 12 weeks at end of a treatment course (max. 3 courses), and every 12 weeks after the cessation of study treatment for up to 1 year of surveillance follow-up for each participant.Progression free survival is defined from the time when the consent form was signed to when progressive disease was determined at tumor imaging assessment per protocol defined schedule or when death was reported.
Outcome measures
| Measure |
Period 1: Dose Level 1 (Pembrolizumab + SQ IL-2)
n=3 Participants
Patients receive 200 mg pembrolizumab intravenously (IV) over 30 minutes on days 1, 22, 43, and 64.
Patients also receive aldesleukin subcutaneously (SC) at 250,000 U/kg/dose, daily, 5 days/wk, week 1; 125,000 U/kg/dose, daily, 5 days/wk, weeks 2-6.
|
Period 2: Dose Level 2 (Pembrolizumab + Low-Dose IV Bolus IL-2)
n=3 Participants
Patients receive 200 mg pembrolizumab intravenously (IV) over 30 minutes on days 1, 22, 43, and 64.
Patients also receive aldesleukin intravenously (IV) at 72,000 U/kg IV q 8 hrs x 14 doses days 2-6 (cycle 1); and days 23-27 (cycle 2) of a 12-week course.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
5.27 Months
Interval 2.33 to 5.4
|
2.67 Months
Interval 0.5 to 5.2
|
Adverse Events
Period 1: Dose Level 1 (Pembrolizumab + SQ IL-2)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Period 2: Dose Level 2 (Pembrolizumab + Low-Dose IV Bolus IL-2)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Period 1: Dose Level 1 (Pembrolizumab + SQ IL-2)
n=3 participants at risk
Patients receive 200 mg pembrolizumab intravenously (IV) over 30 minutes on days 1, 22, 43, and 64.
Patients also receive aldesleukin subcutaneously (SC) at 250,000 U/kg/dose, daily, 5 days/wk, week 1; 125,000 U/kg/dose, daily, 5 days/wk, weeks 2-6.
|
Period 2: Dose Level 2 (Pembrolizumab + Low-Dose IV Bolus IL-2)
n=3 participants at risk
Patients receive 200 mg pembrolizumab intravenously (IV) over 30 minutes on days 1, 22, 43, and 64.
Patients also receive aldesleukin intravenously (IV) at 72,000 U/kg IV q 8 hrs x 14 doses days 2-6 (cycle 1); and days 23-27 (cycle 2) of a 12-week course.
|
|---|---|---|
|
Cardiac disorders
Myocarditis
|
0.00%
0/3 • Adverse events were recorded from the time the consent form was signed through 30 days following the cessation of the study treatment for each participant. The maximum duration of treatment courses was 36 weeks. All-cause mortality was recorded from the time the consent form was signed for up to 1 year of surveillance following the end of study treatment for each participant.
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from the time the consent form was signed through 30 days following the cessation of the study treatment for each participant. The maximum duration of treatment courses was 36 weeks. All-cause mortality was recorded from the time the consent form was signed for up to 1 year of surveillance following the end of study treatment for each participant.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/3 • Adverse events were recorded from the time the consent form was signed through 30 days following the cessation of the study treatment for each participant. The maximum duration of treatment courses was 36 weeks. All-cause mortality was recorded from the time the consent form was signed for up to 1 year of surveillance following the end of study treatment for each participant.
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from the time the consent form was signed through 30 days following the cessation of the study treatment for each participant. The maximum duration of treatment courses was 36 weeks. All-cause mortality was recorded from the time the consent form was signed for up to 1 year of surveillance following the end of study treatment for each participant.
|
Other adverse events
| Measure |
Period 1: Dose Level 1 (Pembrolizumab + SQ IL-2)
n=3 participants at risk
Patients receive 200 mg pembrolizumab intravenously (IV) over 30 minutes on days 1, 22, 43, and 64.
Patients also receive aldesleukin subcutaneously (SC) at 250,000 U/kg/dose, daily, 5 days/wk, week 1; 125,000 U/kg/dose, daily, 5 days/wk, weeks 2-6.
|
Period 2: Dose Level 2 (Pembrolizumab + Low-Dose IV Bolus IL-2)
n=3 participants at risk
Patients receive 200 mg pembrolizumab intravenously (IV) over 30 minutes on days 1, 22, 43, and 64.
Patients also receive aldesleukin intravenously (IV) at 72,000 U/kg IV q 8 hrs x 14 doses days 2-6 (cycle 1); and days 23-27 (cycle 2) of a 12-week course.
|
|---|---|---|
|
General disorders
Generalized edema
|
100.0%
3/3 • Number of events 7 • Adverse events were recorded from the time the consent form was signed through 30 days following the cessation of the study treatment for each participant. The maximum duration of treatment courses was 36 weeks. All-cause mortality was recorded from the time the consent form was signed for up to 1 year of surveillance following the end of study treatment for each participant.
|
100.0%
3/3 • Number of events 7 • Adverse events were recorded from the time the consent form was signed through 30 days following the cessation of the study treatment for each participant. The maximum duration of treatment courses was 36 weeks. All-cause mortality was recorded from the time the consent form was signed for up to 1 year of surveillance following the end of study treatment for each participant.
|
|
General disorders
Chills
|
100.0%
3/3 • Number of events 6 • Adverse events were recorded from the time the consent form was signed through 30 days following the cessation of the study treatment for each participant. The maximum duration of treatment courses was 36 weeks. All-cause mortality was recorded from the time the consent form was signed for up to 1 year of surveillance following the end of study treatment for each participant.
|
100.0%
3/3 • Number of events 7 • Adverse events were recorded from the time the consent form was signed through 30 days following the cessation of the study treatment for each participant. The maximum duration of treatment courses was 36 weeks. All-cause mortality was recorded from the time the consent form was signed for up to 1 year of surveillance following the end of study treatment for each participant.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from the time the consent form was signed through 30 days following the cessation of the study treatment for each participant. The maximum duration of treatment courses was 36 weeks. All-cause mortality was recorded from the time the consent form was signed for up to 1 year of surveillance following the end of study treatment for each participant.
|
100.0%
3/3 • Number of events 12 • Adverse events were recorded from the time the consent form was signed through 30 days following the cessation of the study treatment for each participant. The maximum duration of treatment courses was 36 weeks. All-cause mortality was recorded from the time the consent form was signed for up to 1 year of surveillance following the end of study treatment for each participant.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Number of events 5 • Adverse events were recorded from the time the consent form was signed through 30 days following the cessation of the study treatment for each participant. The maximum duration of treatment courses was 36 weeks. All-cause mortality was recorded from the time the consent form was signed for up to 1 year of surveillance following the end of study treatment for each participant.
|
100.0%
3/3 • Number of events 6 • Adverse events were recorded from the time the consent form was signed through 30 days following the cessation of the study treatment for each participant. The maximum duration of treatment courses was 36 weeks. All-cause mortality was recorded from the time the consent form was signed for up to 1 year of surveillance following the end of study treatment for each participant.
|
|
Investigations
Creatinine increased
|
66.7%
2/3 • Number of events 2 • Adverse events were recorded from the time the consent form was signed through 30 days following the cessation of the study treatment for each participant. The maximum duration of treatment courses was 36 weeks. All-cause mortality was recorded from the time the consent form was signed for up to 1 year of surveillance following the end of study treatment for each participant.
|
100.0%
3/3 • Number of events 6 • Adverse events were recorded from the time the consent form was signed through 30 days following the cessation of the study treatment for each participant. The maximum duration of treatment courses was 36 weeks. All-cause mortality was recorded from the time the consent form was signed for up to 1 year of surveillance following the end of study treatment for each participant.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
100.0%
3/3 • Number of events 4 • Adverse events were recorded from the time the consent form was signed through 30 days following the cessation of the study treatment for each participant. The maximum duration of treatment courses was 36 weeks. All-cause mortality was recorded from the time the consent form was signed for up to 1 year of surveillance following the end of study treatment for each participant.
|
100.0%
3/3 • Number of events 3 • Adverse events were recorded from the time the consent form was signed through 30 days following the cessation of the study treatment for each participant. The maximum duration of treatment courses was 36 weeks. All-cause mortality was recorded from the time the consent form was signed for up to 1 year of surveillance following the end of study treatment for each participant.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
66.7%
2/3 • Number of events 3 • Adverse events were recorded from the time the consent form was signed through 30 days following the cessation of the study treatment for each participant. The maximum duration of treatment courses was 36 weeks. All-cause mortality was recorded from the time the consent form was signed for up to 1 year of surveillance following the end of study treatment for each participant.
|
33.3%
1/3 • Number of events 3 • Adverse events were recorded from the time the consent form was signed through 30 days following the cessation of the study treatment for each participant. The maximum duration of treatment courses was 36 weeks. All-cause mortality was recorded from the time the consent form was signed for up to 1 year of surveillance following the end of study treatment for each participant.
|
|
General disorders
Fever
|
100.0%
3/3 • Number of events 4 • Adverse events were recorded from the time the consent form was signed through 30 days following the cessation of the study treatment for each participant. The maximum duration of treatment courses was 36 weeks. All-cause mortality was recorded from the time the consent form was signed for up to 1 year of surveillance following the end of study treatment for each participant.
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from the time the consent form was signed through 30 days following the cessation of the study treatment for each participant. The maximum duration of treatment courses was 36 weeks. All-cause mortality was recorded from the time the consent form was signed for up to 1 year of surveillance following the end of study treatment for each participant.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Adverse events were recorded from the time the consent form was signed through 30 days following the cessation of the study treatment for each participant. The maximum duration of treatment courses was 36 weeks. All-cause mortality was recorded from the time the consent form was signed for up to 1 year of surveillance following the end of study treatment for each participant.
|
66.7%
2/3 • Number of events 5 • Adverse events were recorded from the time the consent form was signed through 30 days following the cessation of the study treatment for each participant. The maximum duration of treatment courses was 36 weeks. All-cause mortality was recorded from the time the consent form was signed for up to 1 year of surveillance following the end of study treatment for each participant.
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • Number of events 3 • Adverse events were recorded from the time the consent form was signed through 30 days following the cessation of the study treatment for each participant. The maximum duration of treatment courses was 36 weeks. All-cause mortality was recorded from the time the consent form was signed for up to 1 year of surveillance following the end of study treatment for each participant.
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from the time the consent form was signed through 30 days following the cessation of the study treatment for each participant. The maximum duration of treatment courses was 36 weeks. All-cause mortality was recorded from the time the consent form was signed for up to 1 year of surveillance following the end of study treatment for each participant.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place