Study on Ibrutinib for Treating Patients with Advanced Skin Melanoma That Hasn't Responded to Previous Treatments
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02581930
This clinical trial is testing how well the drug ibrutinib works for patients with stage IV skin melanoma that hasn't responded to other treatments. Ibrutinib may help stop tumor growth by blocking certain enzymes needed for cancer cells to grow.
Patient Parameters
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Program Overview
This phase II study is investigating the effectiveness of ibrutinib in treating patients with stage IV melanoma of the skin that has not responded to previous treatments. Ibrutinib works by blocking enzymes that are necessary for tumor cell growth, potentially stopping the cancer from progressing.
Description
The main goal of this study is to see how well ibrutinib works in shrinking tumors in patients whose melanoma has not responded to immune checkpoint inhibitors or MAPK inhibitors, or who cannot take these treatments. Researchers will also look at how long patients live without the cancer getting worse and overall survival rates after starting ibrutinib.
Patients will take ibrutinib by mouth once a day in 28-day cycles, continuing as long as the cancer does not progress and side effects are manageable. After finishing the treatment, patients will have follow-up visits every three months for up to two years.
The study will also explore how ibrutinib affects certain proteins in melanoma cells and immune cells, and how the body processes the drug. Patients will provide blood samples at different times to help with these analyses.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with stage IV melanoma of the skin or metastatic melanoma from an unknown primary source.
- Have at least one measurable tumor that can be accurately measured by scans or physical exam.
- If the cancer has a BRAFV600 mutation, it must have not responded to at least one BRAF or MEK inhibitor.
- The cancer must not have responded to at least one PD1/PD-L1 inhibitor.
- Previous treatment side effects must have resolved to a mild level, except for hair loss or certain permanent side effects.
- Must be able to perform daily activities with some limitations (ECOG score of 0-2).
- Life expectancy of more than three months.
- Meet specific blood count and organ function criteria.
- Patients with stable brain metastases are allowed if they meet certain conditions.
- Must agree to use effective birth control during the study and for 90 days after.
- Women must have a negative pregnancy test before starting treatment.
- Must be able to swallow pills.
- Willing to provide tumor tissue samples for research purposes.
- Must understand and agree to the study requirements and sign a consent form.
Exclusion Criteria
- Have melanoma of mucosal or ocular origin.
- Have received chemotherapy, immunotherapy, or certain other treatments recently.
- Are taking other investigational or cancer treatments.
- Have a history of severe allergic reactions to similar drugs.
- Have uncontrolled health conditions that could interfere with the study.
- Are pregnant or breastfeeding.
- Have uncontrolled autoimmune conditions affecting blood cells.
- Need high doses of corticosteroids.
- Have taken ibrutinib or similar drugs before.
- Have other active cancers, except for certain non-threatening types.
- Have significant heart disease or recent heart attack.
- Have digestive issues affecting medication absorption.
- Have active hepatitis B or C infections.
- Have had a stroke or brain bleed recently.
- Are taking blood thinners or have bleeding disorders.
- Have liver problems or are taking certain medications that interact with ibrutinib.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Los Angeles General Medical Center | 90033 | Los Angeles | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| University of California Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| UCHealth University of Colorado Hospital | 80045 | Aurora | Colorado |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| University of Kentucky/Markey Cancer Center | 40536 | Lexington | Kentucky |
| Washington University School of Medicine | 63110 | St Louis | Missouri |
| UNC Lineberger Comprehensive Cancer Center | 27599 | Chapel Hill | North Carolina |
| Duke University Medical Center | 27710 | Durham | North Carolina |
| Case Western Reserve University | 44106 | Cleveland | Ohio |
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