Prostaglandin Inhibition and Immune Checkpoint Blockade in Melanoma
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|ClinicalTrials.gov Identifier: NCT03396952|
Recruitment Status : Active, not recruiting
First Posted : January 11, 2018
Results First Posted : June 10, 2021
Last Update Posted : June 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Stage III Cutaneous Melanoma Stage IIIA Cutaneous Melanoma Stage IIIB Cutaneous Melanoma Stage IIIC Cutaneous Melanoma Stage IV Cutaneous Melanoma||Drug: Aspirin Biological: Ipilimumab Other: Laboratory Biomarker Analysis Biological: Pembrolizumab||Phase 2|
I. To evaluate the overall response rate (ORR) by week 12 in patients with stage III unresectable/stage IV melanoma.
I. To determine the median progression free survival, overall survival, and toxicity profile of the combination of ipilimumab, pembrolizumab and high dose aspirin in patients with stage III unresectable/IV melanoma.
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1, ipilimumab IV over 60 minutes on day 1 for courses 1-4, and aspirin orally (PO) twice daily (BID) on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prostaglandin Inhibition and Programmed Cell Death Protein 1 (PD-1)/Cytotoxic T-lymphocyte-Associated Protein 4 (CTLA4) Blockade in Melanoma|
|Actual Study Start Date :||April 19, 2018|
|Actual Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||June 30, 2024|
Experimental: 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 PO BID (orally, twice a day) on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Objective Response Rate (ORR) [ Time Frame: Up to 12 weeks ]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.
- Number of Participants With Reported Treatment-related Adverse Events [ Time Frame: Within 30 days after last dose of study drug, up to 3 years ]Number 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.
- Proportion of Participants With Progression-free Survival (PFS) at 6 Months [ Time Frame: 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.
- Duration of PFS [ Time Frame: Assessed up to 4.5 years ]Defined as the time from the study day 1 to the earlier of disease progression or death due to any cause
- Overall Survival (OS) [ Time Frame: Assessed up to 4.5 years ]Duration 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 confidence intervals
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396952
|United States, California|
|University of Califonia, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Adil Daud, MD||University of California, San Francisco|