Merkel Cell CarcinomaPhase 2NCT04792073
Study of Avelumab and/or Radiation Therapy in People With Advanced Merkel Cell Carcinoma
A Phase 2 study testing Avelumab and Comprehensive Ablative Radiation Therapy in people with Merkel Cell Carcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Merkel Cell Carcinoma
- What is being tested?
- Avelumab and Comprehensive Ablative Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 7 sitesUnited States
- Study dates
- 8 Mar 2021to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- °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
- °Inactivated vaccines are permissible
- Iatrogenic immunosuppression with daily systemic corticosteroid equivalent of >10 mg of prednisone
- Active autoimmune disease that may cause clinical deterioration during immunotherapy
- °Including, but not limited to:
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack (All Protocol Activities)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553
About this study
Official title: A Phase II Single-Arm Clinical Trial Assessing Comprehensive Ablative Radiation Therapy With Avelumab in Unresectable and Metastatic Merkel Cell Carcinoma (CARTA)
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.
- Conditions
- Merkel Cell Carcinoma
- Being tested
- Avelumab, Comprehensive Ablative Radiation Therapy
- Keywords
- unresectable, metastatic, stage III, stage IV, Comprehensive Ablative Radiation Therapy, Avelumab, 20-195
- Medical subject headings
- Carcinoma, Merkel Cell, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvelumabDrug
Avelumab 800 mg given intravenously over 60 minutes (+20 minutes / -10 minutes) every 2 weeks (+/- 3 days)
Comprehensive Ablative Radiation TherapyRadiation
Comprehensive ablative radiation therapy 24 Gy in 3 fractions every 2-3 days
| Study group | Role | What they receive |
|---|---|---|
| Avelumab and Radiation Therapy | Experimental | Will 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. Receives: Drug: Avelumab; Radiation: Comprehensive Ablative Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
measured by RECIST 1.1
Measured: at 12 weeks
Secondary outcomes (1)
overall response rate
measured by RECIST 1.1
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start8 Mar 2021
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Merkel Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A Phase II Single-Arm Clinical Trial Assessing Comprehensive Ablative Radiation Therapy with Avelumab in Unresectable and Metastatic Merkel Cell Carcinoma (CARTA)
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- EMD Serono
- Responsible party
- Sponsor
- Investigators
- Christoper Barker, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792073
- Sponsor's protocol ID
- 20-195
- Status last verified
- Apr 2026
- First submitted
- 8 Mar 2021
- Last updated
- 7 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Single-Arm Clinical Trial Assessing Comprehensive Ablative Radiation Therapy With Avelumab in Unresectable and Metastatic Merkel Cell Carcinoma (CARTA)
- ClinicalTrials.gov ID
- NCT04792073
- Acronym / sponsor ID
- 20-195
- Conditions
- Merkel Cell Carcinoma
- Keywords
- unresectable, metastatic, stage III, stage IV, Comprehensive Ablative Radiation Therapy, Avelumab, 20-195
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- EMD Serono
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Phase II Single-Arm Clinical Trial Assessing Comprehensive Ablative Radiation Therapy with Avelumab in Unresectable and Metastatic Merkel Cell Carcinoma (CARTA)
| Arm | Type | Receives |
|---|---|---|
| Avelumab and Radiation Therapy | Experimental | Drug: Avelumab, Radiation: Comprehensive Ablative Radiation TherapyWill 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- 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
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvelumabAvelumab 800 mg given intravenously over 60 minutes (+20 minutes / -10 minutes) every 2 weeks (+/- 3 days) | Drug | Avelumab and Radiation Therapy |
| Comprehensive Ablative Radiation TherapyComprehensive ablative radiation therapy 24 Gy in 3 fractions every 2-3 days | Radiation | Avelumab and Radiation Therapy |
Primary outcome
progression free survival
Time frame: at 12 weeks
measured by RECIST 1.1
1 secondary outcome
overall response rate
Time frame: up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoper Barker, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avelumab and Comprehensive Ablative Radiation Therapy in people with Merkel Cell Carcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.