ACTIVE_NOT_RECRUITING

Study of Avelumab and/or Radiation Therapy in People With Advanced Merkel Cell Carcinoma

Conditions

Merkel Cell Carcinoma unresectable metastatic stage III stage IV Comprehensive Ablative Radiation Therapy Avelumab 20-195

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-03-08

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04792073

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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, 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 * Active autoimmune disease that may cause clinical deterioration during immunotherapy * Inflammatory bowel disease or immune colitis * 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

Inclusion Criteria

Exclusion 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.

* 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, 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
* Active autoimmune disease that may cause clinical deterioration during immunotherapy
* Inflammatory bowel disease or immune colitis
* 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

Contacts and Locations

Principal Investigator

Christoper Barker, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Commack (All Protocol Activities)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Christoper Barker, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-08

Study Completion Date2026-03

Study Record Updates

Study Start Date2021-03-08

Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

unresectable
metastatic
stage III
stage IV
Comprehensive Ablative Radiation Therapy
Avelumab
20-195

Additional Relevant MeSH Terms

Merkel Cell Carcinoma