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

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ClinicalTrials.gov Identifier: NCT04792073
Recruitment Status : Recruiting
First Posted : March 10, 2021
Last Update Posted : March 10, 2021
Sponsor:
Collaborator:
EMD Serono
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
This study will test the use of comprehensive ablative radiation therapy (CART), with and without 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 whether CART works better when is given with avelumab than it does when given alone to prevent the cancer from getting worse.

Condition or disease Intervention/treatment Phase
Merkel Cell Carcinoma Drug: Avelumab Radiation: Comprehensive Ablative Radiation Therapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a prospective, open-label, single-center, phase II randomized parallel two-arm clinical trial of comprehensive ablative radiation therapy (CART) with or without avelumab for patients with metastatic or unresectable Merkel cell carcinoma (MCC).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Parallel Two-Arm Clinical Trial Assessing Comprehensive Ablative Radiation Therapy With or Without Avelumab in Unresectable and Metastatic Merkel Cell Carcinoma (CARTA)
Actual Study Start Date : March 8, 2021
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024


Arm Intervention/treatment
Experimental: Avelumab and Radiation Therapy
Will receive avelumab at the FDA approved dose and schedule of 800 mg IV over 60 minutes every 2 weeks (+/- 3 days) until treatment intolerance or disease progression occurs.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
Drug: Avelumab
Avelumab 800 mg given intravenously over 60 minutes every 2 weeks (+/- 3 days)

Radiation: Comprehensive Ablative Radiation Therapy
Comprehensive ablative radiation therapy 24 Gy in 3 fractions every 2-3 days

Experimental: Radiation Therapy alone
Will receive Comprehensive Ablative Radiation Therapy (CART) alone
Radiation: Comprehensive Ablative Radiation Therapy
Comprehensive ablative radiation therapy 24 Gy in 3 fractions every 2-3 days




Primary Outcome Measures :
  1. progression free survival [ Time Frame: at 12 weeks ]
    measured by RECIST 1.1


Secondary Outcome Measures :
  1. overall response rate [ Time Frame: up to 12 weeks ]
    measured by RECIST 1.1



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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

    °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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04792073


Contacts
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Contact: Christoper Barker, MD 212-639-8168 barkerc@mskcc.org
Contact: Sandra D'Angelo, MD 646-888-4159

Locations
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United States, New Jersey
Memorial Sloan Kettering Basking Ridge (All Protocol Activities) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Christopher Barker, MD    212-639-8168      
Memorial Sloan Kettering Monmouth (All Protocol Activities) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Christopher Barker, MD    212-639-8168      
Memorial Sloan Kettering Bergen (All Protocol Activities) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Christopher Barker, MD    212-639-8168      
United States, New York
Memorial Sloan Kettering Commack (All Protocol Activities) Recruiting
Commack, New York, United States, 11725
Contact: Christopher Barker, MD    212-639-8168      
Memorial Sloan Kettering Westchester (All Protocol Activities) Recruiting
Harrison, New York, United States, 10604
Contact: Christopher Barker, MD    212-639-8168      
Memorial Sloan Kettering Cancer Center (All Protocol Activities) Recruiting
New York, New York, United States, 10065
Contact: Christopher Barker, MD    212-639-8168      
Contact: MD         
Memorial Sloan Kettering Nassau (All Protocol Activities) Recruiting
Uniondale, New York, United States, 11553
Contact: Christopher Barker, MD    212-639-8168      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
EMD Serono
Investigators
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Principal Investigator: Christoper Barker, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04792073    
Other Study ID Numbers: 20-195
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
unresectable
metastatic
stage III
stage IV
Comprehensive Ablative Radiation Therapy
Avelumab
20-195
Additional relevant MeSH terms:
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Carcinoma, Merkel Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Polyomavirus Infections
DNA Virus Infections
Virus Diseases
Infections
Tumor Virus Infections
Carcinoma, Neuroendocrine
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue
Avelumab
Antineoplastic Agents, Immunological
Antineoplastic Agents