NCT03396952

Prostaglandin Inhibition and Immune Checkpoint Blockade in Melanoma

Prostaglandin Inhibition and Programmed Cell Death Protein 1 (PD-1)/Cytotoxic T-lymphocyte-Associated Protein 4 (CTLA4) Blockade in Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well pembrolizumab, ipilimumab, and aspirin work in treating patients with melanoma that has spread to other places in the body or cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Aspirin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab, ipilimumab, and aspirin may work better in treating patients with melanoma.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the overall response rate (ORR) by week 12 in patients with stage III unresectable/stage IV melanoma. SECONDARY OBJECTIVES: 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. OUTLINE: 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.

Conditions

• Stage III Cutaneous Melanoma
• Stage IIIA Cutaneous Melanoma
• Stage IIIB Cutaneous Melanoma
• Stage IIIC Cutaneous Melanoma
• Stage IV Cutaneous Melanoma

Interventions

Type	Name	Description
DRUG	Aspirin	Given PO
BIOLOGICAL	Ipilimumab	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2018-04-19
• Primary completion: 2020-04-30
• Completion: 2022-06-30
• First posted: 2018-01-11
• Last updated: 2022-10-13
• Results posted: 2021-06-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study