Status:
COMPLETED
Prostaglandin Inhibition and Immune Checkpoint Blockade in Melanoma
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Stage III Cutaneous Melanoma
Stage IIIA Cutaneous Melanoma
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief 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. Monoclo...
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...
Eligibility Criteria
Inclusion
- Patients must have histologically confirmed melanoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Leukocytes \>= 3,000/microliter (mcL)
- Absolute neutrophil count \>= 1,500/mcL
- Platelets \>= 100,000/mcL
- Total bilirubin within normal institutional limits
- Total bilirubin =\< 1.5 X institutional upper limit
- Aspartate aminotransferase (AST) \[serum glutamic-oxaloacetic transaminase (SGOT)\] =\< 2.5 X institutional upper limit of normal
- Alanine aminotransferase (ALT) \[serum glutamate pyruvate transaminase (SGPT)\] =\< 2.5 X institutional upper limit of normal
- Creatinine =\< 1.5 X upper limit of normal (ULN)
- Women of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study drug; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Women of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
- Men of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
- Ability to understand a written informed consent document, and the willingness to sign it
Exclusion
- Any mental or physical condition or disease or past medical history that mitigates against following the protocol
- History of active autoimmune diseases such as but not limited to Crohn?s disease, ulcerative colitis, Sjogren's syndrome, requiring active immune suppression; patient may have hay fever or controlled asthma
- Any solid organ transplant or bone marrow transplant
- Any other disseminated malignancy. Exceptions include: localized prostate cancer, basal or squamous cell skin cancer, localized cervical cancer, and localized breast cancer.
- Uncontrolled central nervous system (CNS) metastasis; patients with CNS metastasis can be eligible if definitively treated with radiotherapy or surgery
- Any coexistent medical condition interfering with drug absorption
- History of gastritis or malabsorption syndrome or aspirin intolerance or allergy
- Live vaccination within the last 30 days
- History of multiple sclerosis, type 1 diabetes mellitus (DM) or Guillain-Barre syndrome
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment
Key Trial Info
Start Date :
April 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03396952
Start Date
April 19 2018
End Date
June 30 2022
Last Update
October 13 2022
Active Locations (1)
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1
University of Califonia, San Francisco
San Francisco, California, United States, 94143