US Cancer Center conducts a Study of Avelumab and/or Radiation Therapy in People With Advanced Merkel Cell Carcinoma

Memorial Sloan Kettering Cancer Center is recruiting patients for the clinical trial of Study of Avelumab and/or Radiation Therapy in People With Advanced Merkel Cell Carcinoma.

This study will test the use of comprehensive ablative radiation therapy (CART), with and without 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 whether CART works better when is given with avelumab than it does when given alone to prevent the cancer from getting worse.

March 8, 2021 is the study start date. The indicative completion of the clinical trial will be expected in March 2024.

Among primary outcome measures are the progression free survival and measured by RECIST 1.1.

The study will take place at the Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey; Memorial Sloan Kettering Monmouth, Middletown, New Jersey; Memorial Sloan Kettering Bergen, Montvale, New Jersey; Memorial Sloan Kettering Commack, Commack, New York; Memorial Sloan Kettering Westchester, Harrison, New York; Memorial Sloan Kettering Cancer Center, New York, New York and Memorial Sloan Kettering Nassau, Uniondale, New York, United States.

There are a number of conditions that do not allow participation, such as:

• 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.
• 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.
• Known central nervous system metastases.
• Known clinically significant cardiovascular disease.
• Known Human Immunodeficiency Virus infection.
• Known Hepatitis B or C infection requiring ongoing treatment.
• Vaccination within 4 weeks of first dose of avelumab.

The full list can be viewed at the link below.

The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT04792073