Study on Avelumab for Treating Merkel Cell Cancer After Surgery or Radiation
Sponsor: University of Washington
ClinicalTrials ID:NCT03271372
This clinical trial is testing how well the drug avelumab works in patients with Merkel cell cancer that has spread to the lymph nodes and who have already had surgery or radiation. Avelumab is an immunotherapy that may help the immune system attack cancer cells and stop them from growing and spreading.
Patient Parameters
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Program Overview
This study is looking at whether avelumab, an immunotherapy drug, can help treat Merkel cell cancer that has spread to the lymph nodes after patients have had surgery or radiation. The drug works by helping the immune system target and destroy cancer cells, potentially preventing them from growing and spreading further.
Description
In this study, patients are randomly assigned to one of two groups:
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Group 1: Patients receive avelumab through an IV (intravenous) drip over one hour. This is done every 15 days for the first 4 months, then every 30 days for the next 4 months, and finally every 120 days for up to 2 years, as long as the cancer does not progress and there are no severe side effects.
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Group 2: Patients receive a placebo (a substance with no active drug) through an IV in the same schedule as Group 1.
After finishing the study treatment, patients will have follow-up visits every 6 months for 5 years, and then once a year until the study ends.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with Merkel cell cancer that has spread to nearby lymph nodes.
- Completed surgery and/or radiation for the primary cancer and lymph node involvement.
- Aged 18 years or older, open to all genders and ethnic groups.
- Expected to live more than 3 years.
- Must start the study treatment within 120 days of completing surgery or radiation.
- In good general health with a performance status score of 0 or 1.
- Meet specific blood test requirements for neutrophils, platelets, hemoglobin, liver function, and kidney function.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 30 days after the last treatment.
- Must understand and agree to sign a consent form.
- Agree to provide a sample of tumor tissue for research purposes.
Exclusion Criteria
- Signs of remaining Merkel cell cancer at the start of the study.
- History of cancer spreading beyond local or regional areas.
- Previous systemic treatment for Merkel cell cancer.
- Recent local treatment for Merkel cell cancer within 180 days.
- Ongoing side effects from previous treatments that are severe.
- Other cancers diagnosed within the last 3 years, except for certain low-risk types.
- Use of immunosuppressive medications within the last 3 months, except for specific low-dose or short-term uses.
- Conditions that weaken the immune system, such as HIV, severe diabetes, or other serious illnesses.
- Uncontrolled illnesses, including serious infections, hepatitis B or C, or mental health issues that could affect study participation.
- Significant heart disease or recent heart events.
- History of serious autoimmune diseases or organ transplants.
- Severe allergies to the study drug or its components.
- Pregnant or breastfeeding women.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California Irvine Chao Family Comprehensive Cancer Center | 92868 | Orange | California |
| University of Colorado Cancer Center University of Colorado Anschutz Medical Campus | 80045 | Aurora | Colorado |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Northwestern University | 60611 | Chicago | Illinois |
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
| University of Michigan Comprehensive Cancer Center | 48109 | Ann Arbor | Michigan |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| University of North Carolina Lineberger Comprehensive Cancer Center | 27599 | Chapel Hill | North Carolina |
| Fred Hutch/University of Washington Cancer Consortium | 98109 | Seattle | Washington |
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