Study of Avelumab and/or Radiation Therapy in People With Advanced Merkel Cell Carcinoma
A Phase II Single-Arm Clinical Trial Assessing Comprehensive Ablative Radiation Therapy With Avelumab in Unresectable and Metastatic Merkel Cell Carcinoma (CARTA)
1 other identifier
interventional
18
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2021
Longer than P75 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2021
CompletedStudy Start
First participant enrolled
March 8, 2021
CompletedFirst Posted
Study publicly available on registry
March 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedAugust 11, 2025
August 1, 2025
5 years
March 8, 2021
August 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
progression free survival
measured by RECIST 1.1
at 12 weeks
Secondary Outcomes (1)
overall response rate
up to 12 weeks
Study Arms (1)
Avelumab and Radiation Therapy
EXPERIMENTALWill receive avelumab at the FDA approved dose and schedule of 800 mg IV over 60 minutes (+20 minutes / -10 minutes) every 2 weeks (+/- 3 days) until treatment intolerance or disease progression occurs or 2 years of study therapy have been administered; standard of care Avelumab therapy after 2 years is permitted. Comprehensive Ablative Radiation Therapy (CART) will be initiated between the first and second dose of Avelumab. Comprehensive ablative radiation therapy will be given according to guidelines.
Interventions
Avelumab 800 mg given intravenously over 60 minutes (+20 minutes / -10 minutes) every 2 weeks (+/- 3 days)
Comprehensive ablative radiation therapy 24 Gy in 3 fractions every 2-3 days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- Known Hepatitis B or C infection requiring ongoing treatment
- Vaccination within 4 weeks of first dose of avelumab
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- EMD Seronocollaborator
Study Sites (7)
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christoper Barker, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2021
First Posted
March 10, 2021
Study Start
March 8, 2021
Primary Completion
March 1, 2026
Study Completion
March 1, 2026
Last Updated
August 11, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.