Prostaglandin Inhibition and Immune Checkpoint Blockade in Melanoma

Conditions

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

Eligibility Criteria

Sex

ALL

Age

19 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Aspirin — DRUG
  Given PO
• Ipilimumab — BIOLOGICAL
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Pembrolizumab — BIOLOGICAL
  Given IV

Study Details

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.

Key Dates

Start date

Apr 19, 2018

Status verified

Sep 2022

Primary completion

Apr 30, 2020

Completion

Jun 30, 2022

Study Design

Enrollment

27 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to 12 weeks ]

Locations (1)

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