Trial Outcomes & Findings for Prostaglandin Inhibition and Immune Checkpoint Blockade in Melanoma (NCT NCT03396952)
NCT ID: NCT03396952
Last Updated: 2022-10-13
Results Overview
Defined as the proportion of subjects for whom the best overall response at week 12 is confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST). Point estimates of ORR and 95% confidence intervals will be provided. Only participants with confirmed response are included in this analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Up to 12 weeks
Results posted on
2022-10-13
Participant Flow
Participant milestones
| Measure |
Treatment (Pembrolizumab, Ipilimumab, Aspirin)
Patients receive pembrolizumab IV over 30 minutes on day 1, ipilimumab IV over 60 minutes on day 1 for courses 1-4, and aspirin orally, twice a day (PO BID) on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Aspirin: Given orally (PO)
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prostaglandin Inhibition and Immune Checkpoint Blockade in Melanoma
Baseline characteristics by cohort
| Measure |
Treatment (Pembrolizumab, Ipilimumab, Aspirin)
n=27 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1, ipilimumab IV over 60 minutes on day 1 for courses 1-4, and aspirin PO BID (orally, twice a day) on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Aspirin: Given PO
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Age, Customized
30-39 years old
|
3 Participants
n=99 Participants
|
|
Age, Customized
40-49 years old
|
3 Participants
n=99 Participants
|
|
Age, Customized
50-59 years old
|
3 Participants
n=99 Participants
|
|
Age, Customized
60-69 years old
|
8 Participants
n=99 Participants
|
|
Age, Customized
70-79 years old
|
7 Participants
n=99 Participants
|
|
Age, Customized
80-89 years old
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Only participants with confirmed response are included in this analysis.
Defined as the proportion of subjects for whom the best overall response at week 12 is confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST). Point estimates of ORR and 95% confidence intervals will be provided. Only participants with confirmed response are included in this analysis.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Ipilimumab, Aspirin)
n=23 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1, ipilimumab IV over 60 minutes on day 1 for courses 1-4, and aspirin PO BID (orally, twice a day) on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Aspirin: Given PO
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Objective Response Rate (ORR)
|
0.522 proportion of participants
Interval 0.33 to 0.708
|
SECONDARY outcome
Timeframe: Within 30 days after last dose of study drug, up to 3 yearsNumber of participants with reported treatment-related adverse events defined as having an attribution of definite, possible, and probable according to Common Terminology Criteria for Adverse Events (CTCAE) version 4 will be reported.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Ipilimumab, Aspirin)
n=27 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1, ipilimumab IV over 60 minutes on day 1 for courses 1-4, and aspirin PO BID (orally, twice a day) on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Aspirin: Given PO
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Number of Participants With Reported Treatment-related Adverse Events
|
5 particpants
|
SECONDARY outcome
Timeframe: Up to 6 months (182 days)PFS at 6 months is defined as the proportion of subjects alive and progression-free 6 months (182 days) after study day 1.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Ipilimumab, Aspirin)
n=27 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1, ipilimumab IV over 60 minutes on day 1 for courses 1-4, and aspirin PO BID (orally, twice a day) on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Aspirin: Given PO
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Proportion of Participants With Progression-free Survival (PFS) at 6 Months
|
0.566 proportion of participants
Interval 0.336 to 0.74
|
SECONDARY outcome
Timeframe: Up to 3 yearsDuration of PFS is defined as the time from the study day 1 to the earlier of disease progression or death due to any cause. The analysis of PFS will include only objective progression events per RECIST and clinical progression determined by the investigator may not be considered disease progression. The median duration of PFS will be estimated using the Kaplan-Meier methods with the associated 95% confidence interval.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Ipilimumab, Aspirin)
n=27 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1, ipilimumab IV over 60 minutes on day 1 for courses 1-4, and aspirin PO BID (orally, twice a day) on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Aspirin: Given PO
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Median Duration of PFS
|
7.6 months
Interval 4.9 to 11.0
|
SECONDARY outcome
Timeframe: Up to 3 yearsDuration of OS is defined as the time from study day 1 to death due to any cause. For subjects who are alive at the time of data cutoff or are permanently lost to follow-up, duration of OS will be right censored at the date the subject was last known to be alive. The median duration of OS will be estimated using the Kaplan-Meier methods with the associated 95% confidence interval.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Ipilimumab, Aspirin)
n=27 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1, ipilimumab IV over 60 minutes on day 1 for courses 1-4, and aspirin PO BID (orally, twice a day) on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Aspirin: Given PO
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Median Overall Survival (OS)
|
8.9 months
Interval 5.0 to 11.3
|
Adverse Events
Treatment (Pembrolizumab, Ipilimumab, Aspirin)
Serious events: 3 serious events
Other events: 26 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Treatment (Pembrolizumab, Ipilimumab, Aspirin)
n=27 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1, ipilimumab IV over 60 minutes on day 1 for courses 1-4, and aspirin PO BID (orally, twice a day) on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Aspirin: Given PO
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
7.4%
2/27 • Number of events 2 • Up to 3 years
|
|
General disorders
Fever
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
Other adverse events
| Measure |
Treatment (Pembrolizumab, Ipilimumab, Aspirin)
n=27 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1, ipilimumab IV over 60 minutes on day 1 for courses 1-4, and aspirin PO BID (orally, twice a day) on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Aspirin: Given PO
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
40.7%
11/27 • Number of events 14 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
37.0%
10/27 • Number of events 19 • Up to 3 years
|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
9/27 • Number of events 13 • Up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
33.3%
9/27 • Number of events 10 • Up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
11.1%
3/27 • Number of events 4 • Up to 3 years
|
|
Gastrointestinal disorders
Dry mouth
|
11.1%
3/27 • Number of events 3 • Up to 3 years
|
|
Gastrointestinal disorders
Gastritis
|
11.1%
3/27 • Number of events 3 • Up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
3/27 • Number of events 3 • Up to 3 years
|
|
Gastrointestinal disorders
Colitis
|
7.4%
2/27 • Number of events 2 • Up to 3 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.4%
2/27 • Number of events 3 • Up to 3 years
|
|
General disorders
Fatigue
|
63.0%
17/27 • Number of events 19 • Up to 3 years
|
|
General disorders
Fever
|
22.2%
6/27 • Number of events 6 • Up to 3 years
|
|
General disorders
Pain
|
14.8%
4/27 • Number of events 6 • Up to 3 years
|
|
General disorders
Non-cardiac chest pain
|
7.4%
2/27 • Number of events 2 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
29.6%
8/27 • Number of events 10 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.9%
7/27 • Number of events 8 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
11.1%
3/27 • Number of events 3 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.4%
2/27 • Number of events 2 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.4%
2/27 • Number of events 2 • Up to 3 years
|
|
Endocrine disorders
Adrenal insufficiency
|
29.6%
8/27 • Number of events 8 • Up to 3 years
|
|
Endocrine disorders
Hypothyroidism
|
22.2%
6/27 • Number of events 8 • Up to 3 years
|
|
Endocrine disorders
Hyperthyroidism
|
11.1%
3/27 • Number of events 3 • Up to 3 years
|
|
Nervous system disorders
Headache
|
37.0%
10/27 • Number of events 10 • Up to 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.1%
3/27 • Number of events 3 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.5%
5/27 • Number of events 6 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.8%
4/27 • Number of events 4 • Up to 3 years
|
|
Investigations
Serum amylase increased
|
11.1%
3/27 • Number of events 3 • Up to 3 years
|
|
Investigations
Alanine aminotransferase increased
|
7.4%
2/27 • Number of events 2 • Up to 3 years
|
|
Investigations
Lipase increased
|
7.4%
2/27 • Number of events 3 • Up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
11.1%
3/27 • Number of events 3 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.1%
3/27 • Number of events 4 • Up to 3 years
|
|
Ear and labyrinth disorders
Tinnitus
|
7.4%
2/27 • Number of events 2 • Up to 3 years
|
|
Eye disorders
Eye disorders - Other
|
7.4%
2/27 • Number of events 2 • Up to 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
7.4%
2/27 • Number of events 4 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.8%
4/27 • Number of events 5 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.8%
4/27 • Number of events 4 • Up to 3 years
|
Additional Information
Dr. Adil Daud, MD
University of California, San Francisco
Phone: (415) 353-7392
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place