Trial Outcomes & Findings for Anti-PD-1 Antibody With HD IL-2 in Metastatic Melanoma (NCT NCT03476174)
NCT ID: NCT03476174
Last Updated: 2024-10-02
Results Overview
Assess the response rate \[complete response (CR) + partial response (PR)\] of sequential therapy of pembrolizumab followed by HD IL-2 in subjects with stage IV malignant melanoma. Response assessment will be performed using revised RECIST 1.1
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
12 months
Results posted on
2024-10-02
Participant Flow
Participant milestones
| Measure |
Pembrolizumab and HD Interleukin 2
Pembrolizumab 200 mg IV over 30 minutes; Day 1 of each cycle 3 weeks (21 days) for 2 cycles. IL-2 600,000 IU/kg2 IV over 15 minutes every 8 hours for up to 14 doses over 5 days; Days 1-5 = Cycle 1; 9 days of rest in between; Days 15-19 = Cycle 2
Pembrolizumab: Subjects will receive 200 mg pembrolizumab every 3 weeks for two cycles. Cycle length is 21 days (i.e., 3 weeks). On the last day of Cycle 2 (+/- 3 days), disease status will be assessed via imaging.
Interleukin-2: Following the pembrolizumab treatment, HD IL-2 treatment will commence. After completing the 2 cycles of pembrolizumab, High Dose Interleukin-2 (HD IL-2) will be administered. This will require a hospital stay of at least 5 days for each treatment cycle. Established guidelines will be followed for safely administering HD-IL-2 and managing toxicities from this treatment. Two treatment cycles will be administered, Cycle 2 being separated from Cycle 1 by approximately 9 days after completion (assuming subject has recovered from Cycle 1 adequately to proceed with Cycle 2). Four weeks after completion of the 2 cycles (called a course of HD IL-2 therapy), disease status will be monitored via CT of the chest and abdomen/pelvis using revised RECIST guidelines
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anti-PD-1 Antibody With HD IL-2 in Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Pembrolizumab and HD Interleukin 2
n=1 Participants
Pembrolizumab 200 mg IV over 30 minutes; Day 1 of each cycle 3 weeks (21 days) for 2 cycles. IL-2 600,000 IU/kg2 IV over 15 minutes every 8 hours for up to 14 doses over 5 days; Days 1-5 = Cycle 1; 9 days of rest in between; Days 15-19 = Cycle 2
Pembrolizumab: Subjects will receive 200 mg pembrolizumab every 3 weeks for two cycles. Cycle length is 21 days (i.e., 3 weeks). On the last day of Cycle 2 (+/- 3 days), disease status will be assessed via imaging.
Interleukin-2: Following the pembrolizumab treatment, HD IL-2 treatment will commence. After completing the 2 cycles of pembrolizumab, High Dose Interleukin-2 (HD IL-2) will be administered. This will require a hospital stay of at least 5 days for each treatment cycle. Established guidelines will be followed for safely administering HD-IL-2 and managing toxicities from this treatment. Two treatment cycles will be administered, Cycle 2 being separated from Cycle 1 by approximately 9 days after completion (assuming subject has recovered from Cycle 1 adequately to proceed with Cycle 2). Four weeks after completion of the 2 cycles (called a course of HD IL-2 therapy), disease status will be monitored via CT of the chest and abdomen/pelvis using revised RECIST guidelines
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
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
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
|
ECOG Performance Status
ECOG PS =0
|
1 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG PS =1
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Due to the early termination of the study by the funder, data for this objective was not formally analyzed. Individual subject responses are reported.
Assess the response rate \[complete response (CR) + partial response (PR)\] of sequential therapy of pembrolizumab followed by HD IL-2 in subjects with stage IV malignant melanoma. Response assessment will be performed using revised RECIST 1.1
Outcome measures
| Measure |
Pembrolizumab and HD Interleukin 2
n=1 Participants
Pembrolizumab 200 mg IV over 30 minutes; Day 1 of each cycle 3 weeks (21 days) for 2 cycles. IL-2 600,000 IU/kg2 IV over 15 minutes every 8 hours for up to 14 doses over 5 days; Days 1-5 = Cycle 1; 9 days of rest in between; Days 15-19 = Cycle 2
Pembrolizumab: Subjects will receive 200 mg pembrolizumab every 3 weeks for two cycles. Cycle length is 21 days (i.e., 3 weeks). On the last day of Cycle 2 (+/- 3 days), disease status will be assessed via imaging.
Interleukin-2: Following the pembrolizumab treatment, HD IL-2 treatment will commence. After completing the 2 cycles of pembrolizumab, High Dose Interleukin-2 (HD IL-2) will be administered. This will require a hospital stay of at least 5 days for each treatment cycle. Established guidelines will be followed for safely administering HD-IL-2 and managing toxicities from this treatment. Two treatment cycles will be administered, Cycle 2 being separated from Cycle 1 by approximately 9 days after completion (assuming subject has recovered from Cycle 1 adequately to proceed with Cycle 2). Four weeks after completion of the 2 cycles (called a course of HD IL-2 therapy), disease status will be monitored via CT of the chest and abdomen/pelvis using revised RECIST guidelines
|
|---|---|
|
Response Rate
Complete Response
|
1 Participants
|
|
Response Rate
Partial Response
|
0 Participants
|
|
Response Rate
Stable Disease
|
0 Participants
|
|
Response Rate
Progressive Disease
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsAssess adverse events via CTCAE v4.03
Outcome measures
| Measure |
Pembrolizumab and HD Interleukin 2
n=1 Participants
Pembrolizumab 200 mg IV over 30 minutes; Day 1 of each cycle 3 weeks (21 days) for 2 cycles. IL-2 600,000 IU/kg2 IV over 15 minutes every 8 hours for up to 14 doses over 5 days; Days 1-5 = Cycle 1; 9 days of rest in between; Days 15-19 = Cycle 2
Pembrolizumab: Subjects will receive 200 mg pembrolizumab every 3 weeks for two cycles. Cycle length is 21 days (i.e., 3 weeks). On the last day of Cycle 2 (+/- 3 days), disease status will be assessed via imaging.
Interleukin-2: Following the pembrolizumab treatment, HD IL-2 treatment will commence. After completing the 2 cycles of pembrolizumab, High Dose Interleukin-2 (HD IL-2) will be administered. This will require a hospital stay of at least 5 days for each treatment cycle. Established guidelines will be followed for safely administering HD-IL-2 and managing toxicities from this treatment. Two treatment cycles will be administered, Cycle 2 being separated from Cycle 1 by approximately 9 days after completion (assuming subject has recovered from Cycle 1 adequately to proceed with Cycle 2). Four weeks after completion of the 2 cycles (called a course of HD IL-2 therapy), disease status will be monitored via CT of the chest and abdomen/pelvis using revised RECIST guidelines
|
|---|---|
|
Assess Adverse Events
ENCEPHALOPATHY GR 4
|
1 participants experiencing adverse event
|
|
Assess Adverse Events
HEPATIC FAILURE GR 4
|
1 participants experiencing adverse event
|
|
Assess Adverse Events
HYPOXIA GR 4
|
1 participants experiencing adverse event
|
|
Assess Adverse Events
RESPIRATORY FAILURE GR 4
|
1 participants experiencing adverse event
|
|
Assess Adverse Events
CREATININE INCREASED GR 3
|
1 participants experiencing adverse event
|
|
Assess Adverse Events
HYPOTENSION GR 3
|
1 participants experiencing adverse event
|
|
Assess Adverse Events
ALLERGIC REACTION GR 2
|
1 participants experiencing adverse event
|
|
Assess Adverse Events
TREMOR GR 2
|
1 participants experiencing adverse event
|
|
Assess Adverse Events
WEIGHT LOSS GR 2
|
1 participants experiencing adverse event
|
|
Assess Adverse Events
EDEMA LIMBS GR 1
|
1 participants experiencing adverse event
|
|
Assess Adverse Events
EDEMA TRUNK GR 1
|
1 participants experiencing adverse event
|
|
Assess Adverse Events
LETHARGY GR 1
|
1 participants experiencing adverse event
|
|
Assess Adverse Events
WEIGHT GAIN GR 1
|
1 participants experiencing adverse event
|
|
Assess Adverse Events
DIARRHEA GR 2
|
1 participants experiencing adverse event
|
|
Assess Adverse Events
DIZZINESS GR 2
|
1 participants experiencing adverse event
|
|
Assess Adverse Events
HOARSENESS GR 2
|
1 participants experiencing adverse event
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Due to the early termination of the study by the funder, data for this objective was not collected or analyzed
Measure Progression-Free Survival (PFS) using revised RECIST guideline (version 1.1) after completion of 2 cycles of pembrolizumab and 2 cycles of HD IL-2 in all the subjects enrolled in the study. PFS is defined as the time from treatment initiation until objective tumor progression or death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Due to the early termination of the study by the funder, data for this objective was not collected or analyzed
Measure overall survival (OS) at 12 months in subjects with stage IV malignant melanoma who showed a response \[stable disease (SD), complete response (CR) or partial response (PR)\] following completion of 2 cycles of pembrolizumab and 2 cycles of HD IL-2. OS is defined as time from treatment initiation until death from any cause
Outcome measures
Outcome data not reported
Adverse Events
Pembrolizumab and HD Interleukin 2
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pembrolizumab and HD Interleukin 2
n=1 participants at risk
Pembrolizumab 200 mg IV over 30 minutes; Day 1 of each cycle 3 weeks (21 days) for 2 cycles. IL-2 600,000 IU/kg2 IV over 15 minutes every 8 hours for up to 14 doses over 5 days; Days 1-5 = Cycle 1; 9 days of rest in between; Days 15-19 = Cycle 2
Pembrolizumab: Subjects will receive 200 mg pembrolizumab every 3 weeks for two cycles. Cycle length is 21 days (i.e., 3 weeks). On the last day of Cycle 2 (+/- 3 days), disease status will be assessed via imaging.
Interleukin-2: Following the pembrolizumab treatment, HD IL-2 treatment will commence. After completing the 2 cycles of pembrolizumab, High Dose Interleukin-2 (HD IL-2) will be administered. This will require a hospital stay of at least 5 days for each treatment cycle. Established guidelines will be followed for safely administering HD-IL-2 and managing toxicities from this treatment. Two treatment cycles will be administered, Cycle 2 being separated from Cycle 1 by approximately 9 days after completion (assuming subject has recovered from Cycle 1 adequately to proceed with Cycle 2). Four weeks after completion of the 2 cycles (called a course of HD IL-2 therapy), disease status will be monitored via CT of the chest and abdomen/pelvis using revised RECIST guidelines
|
|---|---|
|
Nervous system disorders
ENCEPHALOPATHY GR 4
|
100.0%
1/1 • Number of events 1 • From screening until subject discontinuation due to termination of the study at nine months.
|
|
Hepatobiliary disorders
HEPATIC FAILURE GR 4
|
100.0%
1/1 • Number of events 1 • From screening until subject discontinuation due to termination of the study at nine months.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA GR 4
|
100.0%
1/1 • Number of events 1 • From screening until subject discontinuation due to termination of the study at nine months.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE GR 4
|
100.0%
1/1 • Number of events 1 • From screening until subject discontinuation due to termination of the study at nine months.
|
Other adverse events
| Measure |
Pembrolizumab and HD Interleukin 2
n=1 participants at risk
Pembrolizumab 200 mg IV over 30 minutes; Day 1 of each cycle 3 weeks (21 days) for 2 cycles. IL-2 600,000 IU/kg2 IV over 15 minutes every 8 hours for up to 14 doses over 5 days; Days 1-5 = Cycle 1; 9 days of rest in between; Days 15-19 = Cycle 2
Pembrolizumab: Subjects will receive 200 mg pembrolizumab every 3 weeks for two cycles. Cycle length is 21 days (i.e., 3 weeks). On the last day of Cycle 2 (+/- 3 days), disease status will be assessed via imaging.
Interleukin-2: Following the pembrolizumab treatment, HD IL-2 treatment will commence. After completing the 2 cycles of pembrolizumab, High Dose Interleukin-2 (HD IL-2) will be administered. This will require a hospital stay of at least 5 days for each treatment cycle. Established guidelines will be followed for safely administering HD-IL-2 and managing toxicities from this treatment. Two treatment cycles will be administered, Cycle 2 being separated from Cycle 1 by approximately 9 days after completion (assuming subject has recovered from Cycle 1 adequately to proceed with Cycle 2). Four weeks after completion of the 2 cycles (called a course of HD IL-2 therapy), disease status will be monitored via CT of the chest and abdomen/pelvis using revised RECIST guidelines
|
|---|---|
|
Investigations
CREATININE INCREASED GR 3
|
100.0%
1/1 • Number of events 1 • From screening until subject discontinuation due to termination of the study at nine months.
|
|
Cardiac disorders
HYPOTENSION GR 3
|
100.0%
1/1 • Number of events 1 • From screening until subject discontinuation due to termination of the study at nine months.
|
|
Immune system disorders
ALLERGIC REACTION GR 2
|
100.0%
1/1 • Number of events 1 • From screening until subject discontinuation due to termination of the study at nine months.
|
|
Gastrointestinal disorders
DIARRHEA GR 2
|
100.0%
1/1 • Number of events 1 • From screening until subject discontinuation due to termination of the study at nine months.
|
|
Nervous system disorders
DIZZINESS GR 2
|
100.0%
1/1 • Number of events 1 • From screening until subject discontinuation due to termination of the study at nine months.
|
|
Respiratory, thoracic and mediastinal disorders
HOARSENESS GR 2
|
100.0%
1/1 • Number of events 1 • From screening until subject discontinuation due to termination of the study at nine months.
|
|
Nervous system disorders
TREMOR GR 2
|
100.0%
1/1 • Number of events 1 • From screening until subject discontinuation due to termination of the study at nine months.
|
|
Investigations
WEIGHT LOSS GR 2
|
100.0%
1/1 • Number of events 1 • From screening until subject discontinuation due to termination of the study at nine months.
|
|
General disorders
EDEMA LIMBS GR 1
|
100.0%
1/1 • Number of events 1 • From screening until subject discontinuation due to termination of the study at nine months.
|
|
General disorders
EDEMA TRUNK GR 1
|
100.0%
1/1 • Number of events 1 • From screening until subject discontinuation due to termination of the study at nine months.
|
|
Nervous system disorders
LETHARGY GR 1
|
100.0%
1/1 • Number of events 1 • From screening until subject discontinuation due to termination of the study at nine months.
|
|
Investigations
WEIGHT GAIN GR 1
|
100.0%
1/1 • Number of events 1 • From screening until subject discontinuation due to termination of the study at nine months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place