Study of Avelumab and/or Radiation Therapy in People With Advanced Merkel Cell Carcinoma (NCT04792073)
🩺 Plain-English Summary (8th-Grade Level)
This study will test the use of comprehensive ablative radiation therapy (CART), with the immunotherapy drug avelumab, in people with Merkel cell carcinoma (MCC) that has progressed after treatment and cannot be removed with surgery. The study researchers want to find out if CART works well when combined with avelumab.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (12 items) and avoid the listed exclusions (24 items).
Location: Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge, New Jersey
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Prior systemic therapy for MCC other than first-line aPD1 monotherapy (ie, chemotherapy)
- Pregnancy or breastfeeding
- Adverse events due to prior cancer therapy which are grade 3 or higher and have not resolved °Patients with prior grade 3 or higher immune related adverse events are not eligible, even if they have resolved
- Prior severe hypersensitivity reaction (CTCAE version 5.0 grade ≥3) to avelumab
- Prior radiotherapy which precludes the ability to safely deliver comprehensive ablative radiation therapy in the opinion of the treating radiation oncologist and principal investigator °Institutional guidelines for reirradiation will be used when making this determination
- Known central nervous system metastases
- Known clinically significant cardiovascular disease, defined as:
- Stroke or myocardial infarction within 6 months of first dose of avelumab
- Symptomatic congestive heart failure (New York Heart Association Class 2 or higher)
- Serious arrhythmia requiring anti-arrhythmic agents
- Known Human Immunodeficiency Virus infection
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (7 Sites)
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey
- Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale, New Jersey
- Memorial Sloan Kettering Commack (All Protocol Activities) — Commack, New York
- Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York
- Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.