A Phase II Single-Arm Clinical Trial Assessing Comprehensive Ablative Radiation Therapy With Avelumab in Unresectable and Metastatic Merkel Cell Carcinoma (CARTA)

  • STATUS
    Recruiting
  • End date
    Mar 18, 2024
  • participants needed
    18
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 18 October 2022
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neutrophil count

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.

Details
Condition Merkel Cell Carcinoma
Treatment Avelumab, Comprehensive Ablative Radiation Therapy
Clinical Study IdentifierNCT04792073
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on18 October 2022

Eligibility

Yes No Not Sure

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 progression in only one of several responding metastases will not be eligible
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: Lymphocyte count ≥800/mm^3, neutrophil count ≥1500/mm^3, platelet count ≥75,000/mm^3, leukocyte count ≥3000/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 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 radiotherapy which precludes the ability to safely deliver comprehensive ablative radiation therapy in the opinion of the treating radiation oncologist and principal investigator
Prior severe hypersensitivity reaction (CTCAE version 5.0 grade ≥3) to avelumab
determination
°Institutional guidelines for reirradiation will be used when making this
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
Known Hepatitis B or C infection requiring ongoing treatment
Vaccination within 4 weeks of first dose of avelumab
Iatrogenic immunosuppression with daily systemic corticosteroid equivalent of >10 mg of prednisone
°Inactivated vaccines are permissible
Active autoimmune disease that may cause clinical deterioration during immunotherapy
Inflammatory bowel disease or immune colitis
°Including, but not limited to
Immune mediated pneumonitis or pulmonary fibrosis
History of solid organ or hematopoietic transplant
Active infection requiring systemic therapy
Active suicidal ideation or behavior
Comorbid or diagnostic abnormalities which would interfere with interpretation of study results
Known hematopoietic cancer or dysfunction (i.e., leukemia, lymphoma)
Known non-MCC solid tumor with known metastasis or estimated risk of metastasis >20% within 3 months
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