Study of Avelumab and/or Radiation Therapy in People With Advanced Merkel Cell Carcinoma (NCT04792073) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of Avelumab and/or Radiation Therapy in People With Advanced Merkel Cell Carcinoma
United States18 participantsStarted 2021-03-08
Plain-language summary
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 participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Biopsy proven Merkel cell carcinoma which is unresectable or metastatic, stage III or IV
* Prior first-line treatment with aPD1 monotherapy (defined as at least one dose of pembrolizumab, avelumab, nivolumab, etc.) with evidence of progression of disease ≥10 weeks after starting therapy, in the absence of significant clinical deterioration
* Patients with clinical deterioration during aPD1 monotherapy are eligible ≥6 weeks after starting aPD1 therapy
* Criteria for clinical deterioration to be determined and agreed upon by treating physician and Principal Investigator
* All detectable sites of MCC are amenable to comprehensive ablative radiation therapy in opinion of treating radiation oncologist and principal investigator
* ≥18 years of age
* Performance status ≤2 on the Eastern Cooperative Oncology Group Performance Scale
* Able to provide valid written informed consent
* Normal organ and marrow function
* Hematologic: Neutrophil count ≥1500/mm\^3, platelet count ≥100,000/mm\^3, hemoglobin ≥9 g/dL
* Hepatic: Total bilirubin ≤ 1.5 times the upper limit of normal, unless Gilbert's syndrome; aspartate transaminase and alanine transaminase ≤ 2.5 times the upper limit of normal (in the absence of hepatobiliary metastases); ≤ 3.0 times the upper limit of normal (in the presence of hepatobiliary metastases)
* Renal: Estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula.
Exclusion Criteria:
* Prior systemic therapy …