Prostaglandin Inhibition and PD-1/CTLA4 Blockade in Melanoma
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|ClinicalTrials.gov Identifier: NCT03396952|
Recruitment Status : Recruiting
First Posted : January 11, 2018
Last Update Posted : March 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stage III Cutaneous Melanoma AJCC v7 Stage IIIA Cutaneous Melanoma AJCC v7 Stage IIIB Cutaneous Melanoma AJCC v7 Stage IIIC Cutaneous Melanoma AJCC v7 Stage IV Cutaneous Melanoma AJCC v6 and v7||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)|
|Estimated Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prostaglandin Inhibition and PD-1/CTLA4 Blockade in Melanoma|
|Actual Study Start Date :||January 25, 2018|
|Estimated Primary Completion Date :||June 7, 2022|
|Estimated Study Completion Date :||June 7, 2023|
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) defined as the proportion of subjects for whom the best overall response at the time of data cutoff is confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 12 weeks ]Point estimates of ORR and 95% confidence intervals will be provided.
- Incidence of adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4 [ Time Frame: Up to 30 days after last dose ]
- Overall survival (OS) [ Time Frame: From study day 1 to death due to any cause, assessed up to 4.5 years ]The median duration of OS will be estimated using the Kaplan-Meier methods with the associated confidence intervals.
- Profession free survival (PFS) according to RECIST [ Time Frame: From the study day 1 to the earlier of disease progression or death due to any cause, assessed up to 6 months (182 days) ]95% confidence intervals will be provided. Median of PFS and duration of PFS will also be estimated using Kaplan-Meier methods with 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||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Adil I. Daud 877-827-3222 firstname.lastname@example.org|
|Principal Investigator: Adil I. Daud|
|Principal Investigator:||Adil Daud||University of California, San Francisco|