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Testing the Addition of Radiation Therapy to Immunotherapy for Merkel Cell Carcinoma

Primary Purpose

Advanced Merkel Cell Carcinoma, Clinical Stage III Merkel Cell Carcinoma AJCC v8, Clinical Stage IV Merkel Cell Carcinoma AJCC v8

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pembrolizumab
Stereotactic Body Radiation Therapy
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Merkel Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must have pathologically (histologically or cytologically) proven diagnosis of MCC by local pathology review
  • Have measurable disease based on RECIST 1.1 including at least two cancerous deposits; at least one deposit must be RECIST measurable while at least one deposit must meet criteria for SBRT; non-radiated tumor will be identified prior to randomization on the protocol

  • Patients must have advanced or metastatic MCC defined as evidence of distant metastasis(es) on imaging

    • Patients with locoregionally confined disease are not eligible
  • No prior immunotherapy for advanced/metastatic MCC
  • Patients with known or suspected central nervous system (CNS) metastases, untreated CNS metastases, or with the CNS as the only site of disease are excluded; however, subjects with controlled brain metastases will be allowed to enroll; controlled brain metastases are defined as no radiographic progression for at least 4 weeks following radiation and/or surgical treatment (or 4 weeks of observation if no intervention is clinically indicated), and off of steroids for at least 2 weeks, and no new or progressive neurological signs and symptoms

  • Patients having received palliative radiotherapy for extracranial metastasis(es) are eligible as long as there are 2 cancerous deposits that have not received prior radiation therapy (RT) and they meet the following criteria

    • No prior radiation therapy (> 5 Gy) to the metastasis intended to be treated with SBRT

  • No history of the following:

    • Autoimmunity requiring systemic immunosuppression within 2 years

    • Patients known to be human immunodeficiency virus (HIV) positive are eligible if they meet the following:

      • CD4 counts >= 350 mm^3
      • Serum HIV viral load of < 25,000 IU/ml
  • No other active malignancy that the investigator determines would interfere with the treatment and safety analysis
  • Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown; therefore, for women of childbearing potential only, a negative (if your test schedule specifically indicates a urine or serum pregnancy test, add that information at this point) pregnancy test done =< 28 days prior to registration is required
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Hemoglobin >= 9.0 g/dl
  • Total bilirubin =< 2.0 mg/dl
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3.0 x upper limit of normal (ULN)
  • Systolic blood pressure (BP) =< 150 mg HG
  • Diastolic BP =< 90 mg HG
  • Albumin > 3 mg/dl
  • Blood urea nitrogen (BUN) =< 30 mg/dl
  • Creatinine =< 1.7 mg/dl
  • The following imaging workup to document metastases within 45 days prior to study registration are required: CT scans of the chest, abdomen and pelvis with radionuclide bone scan OR whole body (at least skull base to midthigh) positron emission tomography (PET)/CT

Sites / Locations

  • Anchorage Associates in Radiation Medicine
  • Alaska Breast Care and Surgery LLC
  • Alaska Oncology and Hematology LLC
  • Alaska Women's Cancer Care
  • Anchorage Oncology Centre
  • Katmai Oncology Group
  • Providence Alaska Medical Center
  • Banner University Medical Center - Tucson
  • University of Arizona Cancer Center-North Campus
  • Mercy Hospital Fort Smith
  • CHI Saint Vincent Cancer Center Hot Springs
  • PCR Oncology
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
  • Penrose-Saint Francis Healthcare
  • Rocky Mountain Cancer Centers-Penrose
  • Porter Adventist Hospital
  • Saint Anthony Hospital
  • Littleton Adventist Hospital
  • Longmont United Hospital
  • Parker Adventist Hospital
  • Saint Mary Corwin Medical Center
  • Rocky Mountain Cancer Centers-Thornton
  • Smilow Cancer Center/Yale-New Haven Hospital
  • Yale University
  • Mount Sinai Comprehensive Cancer Center at Aventura
  • Holy Cross Hospital
  • Mount Sinai Medical Center
  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
  • Saint Alphonsus Cancer Care Center-Boise
  • Saint Luke's Cancer Institute - Boise
  • Saint Alphonsus Cancer Care Center-Caldwell
  • Kootenai Health - Coeur d'Alene
  • Saint Luke's Cancer Institute - Fruitland
  • Idaho Urologic Institute-Meridian
  • Saint Luke's Cancer Institute - Meridian
  • Saint Luke's Cancer Institute - Nampa
  • Saint Alphonsus Cancer Care Center-Nampa
  • Kootenai Clinic Cancer Services - Post Falls
  • Kootenai Cancer Clinic
  • Saint Luke's Cancer Institute - Twin Falls
  • Rush - Copley Medical Center
  • Northwestern University
  • Rush University Medical Center
  • University of Chicago Comprehensive Cancer Center
  • Carle on Vermilion
  • Carle Physician Group-Effingham
  • Northwestern Medicine Lake Forest Hospital
  • Carle Physician Group-Mattoon/Charleston
  • Good Samaritan Regional Health Center
  • UC Comprehensive Cancer Center at Silver Cross
  • University of Chicago Medicine-Orland Park
  • Carle Cancer Center
  • The Carle Foundation Hospital
  • Rush-Copley Healthcare Center
  • Indiana University/Melvin and Bren Simon Cancer Center
  • Sidney and Lois Eskenazi Hospital
  • Medical Oncology and Hematology Associates-West Des Moines
  • Mercy Cancer Center-West Lakes
  • Greater Regional Medical Center
  • Iowa Methodist Medical Center
  • Medical Oncology and Hematology Associates-Des Moines
  • Broadlawns Medical Center
  • Mercy Medical Center - Des Moines
  • Mission Cancer and Blood - Laurel
  • Iowa Lutheran Hospital
  • Methodist West Hospital
  • Mercy Medical Center-West Lakes
  • Central Care Cancer Center - Garden City
  • Central Care Cancer Center - Great Bend
  • University of Kansas Cancer Center
  • Lawrence Memorial Hospital
  • Kansas Institute of Medicine Cancer and Blood Center
  • Minimally Invasive Surgery Hospital
  • Menorah Medical Center
  • University of Kansas Cancer Center-Overland Park
  • Saint Luke's South Hospital
  • University of Kansas Hospital-Westwood Cancer Center
  • Cancer Center of Kansas-Wichita Medical Arts Tower
  • Ascension Via Christi Hospitals Wichita
  • Cancer Center of Kansas - Wichita
  • Saint Joseph Radiation Oncology Resource Center
  • Saint Joseph Hospital East
  • Jewish Hospital
  • UofL Health Medical Center Northeast
  • Ochsner Health Center-Summa
  • Medical Center of Baton Rouge
  • Ochsner High Grove
  • Ochsner Medical Center Jefferson
  • Bronson Battle Creek
  • Helen DeVos Children's Hospital at Spectrum Health
  • Spectrum Health at Butterworth Campus
  • Trinity Health Grand Rapids Hospital
  • Bronson Methodist Hospital
  • West Michigan Cancer Center
  • Borgess Medical Center
  • Trinity Health Muskegon Hospital
  • Lakeland Hospital Niles
  • Cancer and Hematology Centers of Western Michigan - Norton Shores
  • Spectrum Health Reed City Hospital
  • Lakeland Medical Center Saint Joseph
  • Marie Yeager Cancer Center
  • Munson Medical Center
  • Metro Health Hospital
  • Sanford Joe Lueken Cancer Center
  • Fairview Ridges Hospital
  • Mercy Hospital
  • Fairview Southdale Hospital
  • Unity Hospital
  • Fairview Clinics and Surgery Center Maple Grove
  • Minnesota Oncology Hematology PA-Maplewood
  • Saint John's Hospital - Healtheast
  • Abbott-Northwestern Hospital
  • Hennepin County Medical Center
  • Health Partners Inc
  • Monticello Cancer Center
  • North Memorial Medical Health Center
  • Mayo Clinic in Rochester
  • Park Nicollet Clinic - Saint Louis Park
  • Regions Hospital
  • United Hospital
  • Saint Francis Regional Medical Center
  • Lakeview Hospital
  • Ridgeview Medical Center
  • Rice Memorial Hospital
  • Minnesota Oncology Hematology PA-Woodbury
  • Saint Louis Cancer and Breast Institute-Ballwin
  • Central Care Cancer Center - Bolivar
  • Siteman Cancer Center at West County Hospital
  • Centerpoint Medical Center LLC
  • Freeman Health System
  • Saint Luke's Hospital of Kansas City
  • Research Medical Center
  • Saint Luke's East - Lee's Summit
  • Delbert Day Cancer Institute at PCRMC
  • Mercy Clinic-Rolla-Cancer and Hematology
  • Heartland Regional Medical Center
  • Washington University School of Medicine
  • Mercy Hospital South
  • Siteman Cancer Center-South County
  • Mercy Hospital Saint Louis
  • Siteman Cancer Center at Saint Peters Hospital
  • Mercy Hospital Springfield
  • CoxHealth South Hospital
  • Community Hospital of Anaconda
  • Billings Clinic Cancer Center
  • Bozeman Deaconess Hospital
  • Benefis Healthcare- Sletten Cancer Institute
  • Great Falls Clinic
  • Saint Peter's Community Hospital
  • Kalispell Regional Medical Center
  • Community Medical Hospital
  • CHI Health Saint Francis
  • CHI Health Good Samaritan
  • Alegent Health Immanuel Medical Center
  • Alegent Health Bergan Mercy Medical Center
  • Alegent Health Lakeside Hospital
  • Creighton University Medical Center
  • Comprehensive Cancer Centers of Nevada - Henderson
  • OptumCare Cancer Care at Seven Hills
  • OptumCare Cancer Care at Charleston
  • Radiation Oncology Centers of Nevada Central
  • GenesisCare USA - Las Vegas
  • Radiation Oncology Centers of Nevada Southeast
  • Comprehensive Cancer Centers of Nevada - Northwest
  • OptumCare Cancer Care at MountainView
  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
  • Comprehensive Cancer Centers of Nevada-Summerlin
  • Comprehensive Cancer Centers of Nevada
  • OptumCare Cancer Care at Fort Apache
  • Comprehensive Cancer Centers of Nevada - Central Valley
  • Renown Regional Medical Center
  • Saint Mary's Regional Medical Center
  • Radiation Oncology Associates
  • Hackensack University Medical Center
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
  • Duke University Medical Center
  • Wake Forest University Health Sciences
  • Sanford Bismarck Medical Center
  • Sanford Broadway Medical Center
  • Sanford Roger Maris Cancer Center
  • Strecker Cancer Center-Belpre
  • Adena Regional Medical Center
  • Good Samaritan Hospital - Cincinnati
  • Bethesda North Hospital
  • MetroHealth Medical Center
  • Mount Carmel East Hospital
  • Columbus Oncology and Hematology Associates Inc
  • Riverside Methodist Hospital
  • Grant Medical Center
  • The Mark H Zangmeister Center
  • Mount Carmel Health Center West
  • Doctors Hospital
  • Delaware Health Center-Grady Cancer Center
  • Delaware Radiation Oncology
  • Grady Memorial Hospital
  • Dublin Methodist Hospital
  • Fairfield Medical Center
  • OhioHealth Mansfield Hospital
  • Marietta Memorial Hospital
  • OhioHealth Marion General Hospital
  • Knox Community Hospital
  • Licking Memorial Hospital
  • Newark Radiation Oncology
  • Southern Ohio Medical Center
  • Saint Ann's Hospital
  • Genesis Healthcare System Cancer Care Center
  • University of Oklahoma Health Sciences Center
  • Mercy Hospital Oklahoma City
  • Saint Charles Health System
  • Clackamas Radiation Oncology Center
  • Bay Area Hospital
  • Providence Newberg Medical Center
  • Providence Portland Medical Center
  • Providence Saint Vincent Medical Center
  • Geisinger Medical Center
  • Geisinger Medical Oncology-Lewisburg
  • Lewistown Hospital
  • University of Pennsylvania/Abramson Cancer Center
  • Geisinger Wyoming Valley/Henry Cancer Center
  • Medical University of South Carolina
  • Gibbs Cancer Center-Gaffney
  • Gibbs Cancer Center-Pelham
  • Spartanburg Medical Center
  • MGC Hematology Oncology-Union
  • Sanford Cancer Center Oncology Clinic
  • Sanford USD Medical Center - Sioux Falls
  • Memorial Hospital
  • Saint Joseph Regional Cancer Center
  • Virginia Commonwealth University/Massey Cancer Center
  • Providence Regional Cancer System-Aberdeen
  • Overlake Medical Center
  • PeaceHealth Saint Joseph Medical Center
  • Harrison HealthPartners Hematology and Oncology-Bremerton
  • Harrison Medical Center
  • Highline Medical Center-Main Campus
  • Providence Regional Cancer System-Centralia
  • Providence Regional Cancer Partnership
  • Swedish Cancer Institute-Issaquah
  • Kadlec Clinic Hematology and Oncology
  • Providence Regional Cancer System-Lacey
  • PeaceHealth Saint John Medical Center
  • Valley Medical Center
  • Swedish Medical Center-Ballard Campus
  • Kaiser Permanente Washington
  • Swedish Medical Center-First Hill
  • PeaceHealth United General Medical Center
  • Northwest Medical Specialties PLLC
  • PeaceHealth Southwest Medical Center
  • Providence Saint Mary Regional Cancer Center
  • Marshfield Medical Center-EC Cancer Center
  • Marshfield Medical Center-Marshfield
  • Marshfield Clinic-Minocqua Center
  • Cancer Center of Western Wisconsin
  • Marshfield Medical Center-Rice Lake
  • Marshfield Medical Center-River Region at Stevens Point
  • Marshfield Clinic-Wausau Center
  • Diagnostic and Treatment Center
  • Marshfield Medical Center - Weston
  • Billings Clinic-Cody

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group I (pembrolizumab)

Group II (pembrolizumab, SBRT)

Arm Description

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT for 3 doses during cycle 1.

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)
Will compare PFS in non-radiated lesion(s) of patients receiving either (a) stereotactic body radiation therapy (SBRT) + pembrolizumab compared to (b) pembrolizumab alone in patients with advanced Merkel cell carcinoma. Kaplan- Meier curves will be constructed and median PFS times will be calculated for each arm.

Secondary Outcome Measures

PFS among all Response Evaluation Criteria in Solid Tumors lesions
Same as the primary endpoint, but includes both irradiated and non-radiated lesions. It is a time to event endpoint and will be evaluated using the Kaplan- Meier method. Median PFS times will be calculated for each arm and a cox proportional hazards model will be constructed to determine if there is a PFS benefit for patients receiving SBRT + pembrolizumab compared to pembrolizumab alone.
Overall response rate
Defined as partial response (PR) on 2 consecutive evaluations. Response rates will be calculated and compared across treatment arms utilizing a chi-square test.
Progression-free survival
The rates of success will be calculated and compared across treatment arms utilizing a chi-square test.
Incidence of adverse events
Graded according to National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0. Maximum grade adverse events will be summarized by treatment arm in a tabular setting.
Local control of stereotactic body radiation therapy treated lesion
The protocol irradiated tumors are considered to be controlled if they have no evidence of progression. No evidence of progression is defined as complete response, PR, or stable disease. Local control of the protocol-irradiated tumor will be described using the Kaplan-Meier technique.
Delivered radiation dose using cone-beam computed tomography (CT) images
Radiation doses will be summarized descriptively and compared to the planned dose.

Full Information

First Posted
October 5, 2017
Last Updated
April 4, 2023
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03304639
Brief Title
Testing the Addition of Radiation Therapy to Immunotherapy for Merkel Cell Carcinoma
Official Title
A Randomized Phase II Study of Anti-PD1 Antibody [MK-3475 (Pembrolizumab)] Alone Versus Anti-PD1 Antibody Plus Stereotactic Body Radiation Therapy in Advanced Merkel Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
June 7, 2022 (Actual)
Study Completion Date
April 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This randomized phase II trial studies how well pembrolizumab with or without stereotactic body radiation therapy works in treating patients with Merkel cell cancer that has spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving pembrolizumab with stereotactic body radiation therapy may work better in treating patients with Merkel cell cancer.
Detailed Description
PRIMARY OBJECTIVE: I. To describe the progression-free survival (PFS) of stereotactic body radiation therapy (SBRT) + pembrolizumab (MK-3475) compared to pembrolizumab (MK-3475) alone in advanced/metastatic Merkel cell carcinoma (MCC) patients. SECONDARY OBJECTIVES: I. To describe the PFS of SBRT + MK-3475 compared to pembrolizumab (MK-3475) alone across Response Evaluation Criteria in Solid Tumors (RECIST) measurable (including both radiated and non-radiated) cancer deposits. II. To describe the overall response rate of SBRT + pembrolizumab (MK-3475) compared to pembrolizumab(MK-3475) alone in both radiated and in non-radiated deposit(s). III. To determine the PFS at 6 months of SBRT + pembrolizumab (MK-3475) compared to pembrolizumab (MK-3475) alone across all cancerous deposits by RECIST. IV. To determine the rate of grade > 3-4 adverse events, by organ system, by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. V. To determine the local control of SBRT treated tumors. VI. To calculate delivered radiation dose using cone-beam computed tomography (CT) images collected on the radiation treatment table in the final treatment position. CORRELATIVE SCIENCE OBJECTIVES: I. To test the utility of CT-based radiomics to predict radiation-induced pneumonitis and true delivered dose of SBRT based on cone beam collected imaging and diagnostic scans. II. Biobanking for future correlative science projects. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. GROUP II: Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT for 3 doses during cycle 1. After completion of study treatment, patients are followed up every 6 months for up to 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Merkel Cell Carcinoma, Clinical Stage III Merkel Cell Carcinoma AJCC v8, Clinical Stage IV Merkel Cell Carcinoma AJCC v8, Metastatic Merkel Cell Carcinoma, Pathologic Stage III Merkel Cell Carcinoma AJCC v8, Pathologic Stage IIIA Merkel Cell Carcinoma AJCC v8, Pathologic Stage IIIB Merkel Cell Carcinoma AJCC v8, Pathologic Stage IV Merkel Cell Carcinoma AJCC v8

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (pembrolizumab)
Arm Type
Active Comparator
Arm Description
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Arm Title
Group II (pembrolizumab, SBRT)
Arm Type
Experimental
Arm Description
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT for 3 doses during cycle 1.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
Keytruda, Lambrolizumab, MK-3475, SCH 900475
Intervention Description
Given IV
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy
Other Intervention Name(s)
SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Intervention Description
Undergo SBRT
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
Will compare PFS in non-radiated lesion(s) of patients receiving either (a) stereotactic body radiation therapy (SBRT) + pembrolizumab compared to (b) pembrolizumab alone in patients with advanced Merkel cell carcinoma. Kaplan- Meier curves will be constructed and median PFS times will be calculated for each arm.
Time Frame
From randomization to either disease progression or death (without progression), assessed up to 5 years
Secondary Outcome Measure Information:
Title
PFS among all Response Evaluation Criteria in Solid Tumors lesions
Description
Same as the primary endpoint, but includes both irradiated and non-radiated lesions. It is a time to event endpoint and will be evaluated using the Kaplan- Meier method. Median PFS times will be calculated for each arm and a cox proportional hazards model will be constructed to determine if there is a PFS benefit for patients receiving SBRT + pembrolizumab compared to pembrolizumab alone.
Time Frame
From randomization to either evidence of disease progression or death (without evidence of progression), assessed up to 5 years
Title
Overall response rate
Description
Defined as partial response (PR) on 2 consecutive evaluations. Response rates will be calculated and compared across treatment arms utilizing a chi-square test.
Time Frame
Up to 5 years
Title
Progression-free survival
Description
The rates of success will be calculated and compared across treatment arms utilizing a chi-square test.
Time Frame
At 6 months
Title
Incidence of adverse events
Description
Graded according to National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0. Maximum grade adverse events will be summarized by treatment arm in a tabular setting.
Time Frame
Up to 3 months
Title
Local control of stereotactic body radiation therapy treated lesion
Description
The protocol irradiated tumors are considered to be controlled if they have no evidence of progression. No evidence of progression is defined as complete response, PR, or stable disease. Local control of the protocol-irradiated tumor will be described using the Kaplan-Meier technique.
Time Frame
Up to 5 years
Title
Delivered radiation dose using cone-beam computed tomography (CT) images
Description
Radiation doses will be summarized descriptively and compared to the planned dose.
Time Frame
Up to 5 years
Other Pre-specified Outcome Measures:
Title
Utility of CT-based radiomics
Description
Will test the utility of CT-based radiomics algorithms to predict radiation-induced and drug induced pneumonitis. Patient imaging will be analyzed based on known radiomic signatures and correlated to incidence of pneumonitis reported as adverse events. The incidence of pneumonitis in total as well as by radiomic signatures will be descriptively summarized.
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have pathologically (histologically or cytologically) proven diagnosis of MCC by local pathology review Have measurable disease based on RECIST 1.1 including at least two cancerous deposits; at least one deposit must be RECIST measurable while at least one deposit must meet criteria for SBRT; non-radiated tumor will be identified prior to randomization on the protocol Patients must have advanced or metastatic MCC defined as evidence of distant metastasis(es) on imaging Patients with locoregionally confined disease are not eligible No prior immunotherapy for advanced/metastatic MCC Patients with known or suspected central nervous system (CNS) metastases, untreated CNS metastases, or with the CNS as the only site of disease are excluded; however, subjects with controlled brain metastases will be allowed to enroll; controlled brain metastases are defined as no radiographic progression for at least 4 weeks following radiation and/or surgical treatment (or 4 weeks of observation if no intervention is clinically indicated), and off of steroids for at least 2 weeks, and no new or progressive neurological signs and symptoms Patients having received palliative radiotherapy for extracranial metastasis(es) are eligible as long as there are 2 cancerous deposits that have not received prior radiation therapy (RT) and they meet the following criteria No prior radiation therapy (> 5 Gy) to the metastasis intended to be treated with SBRT No history of the following: Autoimmunity requiring systemic immunosuppression within 2 years Patients known to be human immunodeficiency virus (HIV) positive are eligible if they meet the following: CD4 counts >= 350 mm^3 Serum HIV viral load of < 25,000 IU/ml No other active malignancy that the investigator determines would interfere with the treatment and safety analysis Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown; therefore, for women of childbearing potential only, a negative (if your test schedule specifically indicates a urine or serum pregnancy test, add that information at this point) pregnancy test done =< 28 days prior to registration is required Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Absolute neutrophil count (ANC) >= 1,500/mm^3 Platelet count >= 100,000/mm^3 Hemoglobin >= 9.0 g/dl Total bilirubin =< 2.0 mg/dl Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3.0 x upper limit of normal (ULN) Systolic blood pressure (BP) =< 150 mg HG Diastolic BP =< 90 mg HG Albumin > 3 mg/dl Blood urea nitrogen (BUN) =< 30 mg/dl Creatinine =< 1.7 mg/dl The following imaging workup to document metastases within 45 days prior to study registration are required: CT scans of the chest, abdomen and pelvis with radionuclide bone scan OR whole body (at least skull base to midthigh) positron emission tomography (PET)/CT
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason J Luke
Organizational Affiliation
Alliance for Clinical Trials in Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anchorage Associates in Radiation Medicine
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
98508
Country
United States
Facility Name
Alaska Breast Care and Surgery LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Alaska Oncology and Hematology LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Alaska Women's Cancer Care
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Anchorage Oncology Centre
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Katmai Oncology Group
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Providence Alaska Medical Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Banner University Medical Center - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
University of Arizona Cancer Center-North Campus
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Mercy Hospital Fort Smith
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72903
Country
United States
Facility Name
CHI Saint Vincent Cancer Center Hot Springs
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
PCR Oncology
City
Arroyo Grande
State/Province
California
ZIP/Postal Code
93420
Country
United States
Facility Name
Providence Saint Joseph Medical Center/Disney Family Cancer Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Penrose-Saint Francis Healthcare
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Rocky Mountain Cancer Centers-Penrose
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Porter Adventist Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Saint Anthony Hospital
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Littleton Adventist Hospital
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80122
Country
United States
Facility Name
Longmont United Hospital
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Parker Adventist Hospital
City
Parker
State/Province
Colorado
ZIP/Postal Code
80138
Country
United States
Facility Name
Saint Mary Corwin Medical Center
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81004
Country
United States
Facility Name
Rocky Mountain Cancer Centers-Thornton
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80260
Country
United States
Facility Name
Smilow Cancer Center/Yale-New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Mount Sinai Comprehensive Cancer Center at Aventura
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Saint Alphonsus Cancer Care Center-Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Saint Luke's Cancer Institute - Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Saint Alphonsus Cancer Care Center-Caldwell
City
Caldwell
State/Province
Idaho
ZIP/Postal Code
83605
Country
United States
Facility Name
Kootenai Health - Coeur d'Alene
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Saint Luke's Cancer Institute - Fruitland
City
Fruitland
State/Province
Idaho
ZIP/Postal Code
83619
Country
United States
Facility Name
Idaho Urologic Institute-Meridian
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Saint Luke's Cancer Institute - Meridian
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Saint Luke's Cancer Institute - Nampa
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
Saint Alphonsus Cancer Care Center-Nampa
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83687
Country
United States
Facility Name
Kootenai Clinic Cancer Services - Post Falls
City
Post Falls
State/Province
Idaho
ZIP/Postal Code
83854
Country
United States
Facility Name
Kootenai Cancer Clinic
City
Sandpoint
State/Province
Idaho
ZIP/Postal Code
83864
Country
United States
Facility Name
Saint Luke's Cancer Institute - Twin Falls
City
Twin Falls
State/Province
Idaho
ZIP/Postal Code
83301
Country
United States
Facility Name
Rush - Copley Medical Center
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Carle on Vermilion
City
Danville
State/Province
Illinois
ZIP/Postal Code
61832
Country
United States
Facility Name
Carle Physician Group-Effingham
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Facility Name
Northwestern Medicine Lake Forest Hospital
City
Lake Forest
State/Province
Illinois
ZIP/Postal Code
60045
Country
United States
Facility Name
Carle Physician Group-Mattoon/Charleston
City
Mattoon
State/Province
Illinois
ZIP/Postal Code
61938
Country
United States
Facility Name
Good Samaritan Regional Health Center
City
Mount Vernon
State/Province
Illinois
ZIP/Postal Code
62864
Country
United States
Facility Name
UC Comprehensive Cancer Center at Silver Cross
City
New Lenox
State/Province
Illinois
ZIP/Postal Code
60451
Country
United States
Facility Name
University of Chicago Medicine-Orland Park
City
Orland Park
State/Province
Illinois
ZIP/Postal Code
60462
Country
United States
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
The Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Rush-Copley Healthcare Center
City
Yorkville
State/Province
Illinois
ZIP/Postal Code
60560
Country
United States
Facility Name
Indiana University/Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Sidney and Lois Eskenazi Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Medical Oncology and Hematology Associates-West Des Moines
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Mercy Cancer Center-West Lakes
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Greater Regional Medical Center
City
Creston
State/Province
Iowa
ZIP/Postal Code
50801
Country
United States
Facility Name
Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates-Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Broadlawns Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Mercy Medical Center - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Mission Cancer and Blood - Laurel
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Iowa Lutheran Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50316
Country
United States
Facility Name
Methodist West Hospital
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266-7700
Country
United States
Facility Name
Mercy Medical Center-West Lakes
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Central Care Cancer Center - Garden City
City
Garden City
State/Province
Kansas
ZIP/Postal Code
67846
Country
United States
Facility Name
Central Care Cancer Center - Great Bend
City
Great Bend
State/Province
Kansas
ZIP/Postal Code
67530
Country
United States
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Lawrence Memorial Hospital
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66044
Country
United States
Facility Name
Kansas Institute of Medicine Cancer and Blood Center
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Minimally Invasive Surgery Hospital
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Menorah Medical Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
University of Kansas Cancer Center-Overland Park
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Saint Luke's South Hospital
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66213
Country
United States
Facility Name
University of Kansas Hospital-Westwood Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Cancer Center of Kansas-Wichita Medical Arts Tower
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Ascension Via Christi Hospitals Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cancer Center of Kansas - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Saint Joseph Radiation Oncology Resource Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Saint Joseph Hospital East
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Jewish Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
UofL Health Medical Center Northeast
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40245
Country
United States
Facility Name
Ochsner Health Center-Summa
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Medical Center of Baton Rouge
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70816
Country
United States
Facility Name
Ochsner High Grove
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70836
Country
United States
Facility Name
Ochsner Medical Center Jefferson
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Bronson Battle Creek
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49017
Country
United States
Facility Name
Helen DeVos Children's Hospital at Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Spectrum Health at Butterworth Campus
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Trinity Health Grand Rapids Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Trinity Health Muskegon Hospital
City
Muskegon
State/Province
Michigan
ZIP/Postal Code
49444
Country
United States
Facility Name
Lakeland Hospital Niles
City
Niles
State/Province
Michigan
ZIP/Postal Code
49120
Country
United States
Facility Name
Cancer and Hematology Centers of Western Michigan - Norton Shores
City
Norton Shores
State/Province
Michigan
ZIP/Postal Code
49444
Country
United States
Facility Name
Spectrum Health Reed City Hospital
City
Reed City
State/Province
Michigan
ZIP/Postal Code
49677
Country
United States
Facility Name
Lakeland Medical Center Saint Joseph
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Marie Yeager Cancer Center
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Munson Medical Center
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Metro Health Hospital
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Sanford Joe Lueken Cancer Center
City
Bemidji
State/Province
Minnesota
ZIP/Postal Code
56601
Country
United States
Facility Name
Fairview Ridges Hospital
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337
Country
United States
Facility Name
Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Fairview Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Unity Hospital
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Fairview Clinics and Surgery Center Maple Grove
City
Maple Grove
State/Province
Minnesota
ZIP/Postal Code
55369
Country
United States
Facility Name
Minnesota Oncology Hematology PA-Maplewood
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Saint John's Hospital - Healtheast
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Abbott-Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Health Partners Inc
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
Monticello Cancer Center
City
Monticello
State/Province
Minnesota
ZIP/Postal Code
55362
Country
United States
Facility Name
North Memorial Medical Health Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Park Nicollet Clinic - Saint Louis Park
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
United Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Saint Francis Regional Medical Center
City
Shakopee
State/Province
Minnesota
ZIP/Postal Code
55379
Country
United States
Facility Name
Lakeview Hospital
City
Stillwater
State/Province
Minnesota
ZIP/Postal Code
55082
Country
United States
Facility Name
Ridgeview Medical Center
City
Waconia
State/Province
Minnesota
ZIP/Postal Code
55387
Country
United States
Facility Name
Rice Memorial Hospital
City
Willmar
State/Province
Minnesota
ZIP/Postal Code
56201
Country
United States
Facility Name
Minnesota Oncology Hematology PA-Woodbury
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Saint Louis Cancer and Breast Institute-Ballwin
City
Ballwin
State/Province
Missouri
ZIP/Postal Code
63011
Country
United States
Facility Name
Central Care Cancer Center - Bolivar
City
Bolivar
State/Province
Missouri
ZIP/Postal Code
65613
Country
United States
Facility Name
Siteman Cancer Center at West County Hospital
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Centerpoint Medical Center LLC
City
Independence
State/Province
Missouri
ZIP/Postal Code
64057
Country
United States
Facility Name
Freeman Health System
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Saint Luke's East - Lee's Summit
City
Lee's Summit
State/Province
Missouri
ZIP/Postal Code
64086
Country
United States
Facility Name
Delbert Day Cancer Institute at PCRMC
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
Mercy Clinic-Rolla-Cancer and Hematology
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
Heartland Regional Medical Center
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mercy Hospital South
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Siteman Cancer Center-South County
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63129
Country
United States
Facility Name
Mercy Hospital Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Siteman Cancer Center at Saint Peters Hospital
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
Mercy Hospital Springfield
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
CoxHealth South Hospital
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Community Hospital of Anaconda
City
Anaconda
State/Province
Montana
ZIP/Postal Code
59711
Country
United States
Facility Name
Billings Clinic Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Bozeman Deaconess Hospital
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Benefis Healthcare- Sletten Cancer Institute
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Great Falls Clinic
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Saint Peter's Community Hospital
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Facility Name
Kalispell Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Community Medical Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
CHI Health Saint Francis
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
CHI Health Good Samaritan
City
Kearney
State/Province
Nebraska
ZIP/Postal Code
68847
Country
United States
Facility Name
Alegent Health Immanuel Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68122
Country
United States
Facility Name
Alegent Health Bergan Mercy Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Alegent Health Lakeside Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Creighton University Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada - Henderson
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
OptumCare Cancer Care at Seven Hills
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
OptumCare Cancer Care at Charleston
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Radiation Oncology Centers of Nevada Central
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
GenesisCare USA - Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Radiation Oncology Centers of Nevada Southeast
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada - Northwest
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
OptumCare Cancer Care at MountainView
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada-Summerlin
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
OptumCare Cancer Care at Fort Apache
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada - Central Valley
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Renown Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Saint Mary's Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89503
Country
United States
Facility Name
Radiation Oncology Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89509
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Sanford Bismarck Medical Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Sanford Broadway Medical Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Sanford Roger Maris Cancer Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Strecker Cancer Center-Belpre
City
Belpre
State/Province
Ohio
ZIP/Postal Code
45714
Country
United States
Facility Name
Adena Regional Medical Center
City
Chillicothe
State/Province
Ohio
ZIP/Postal Code
45601
Country
United States
Facility Name
Good Samaritan Hospital - Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Bethesda North Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Mount Carmel East Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Columbus Oncology and Hematology Associates Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Grant Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
The Mark H Zangmeister Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
Mount Carmel Health Center West
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Doctors Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43228
Country
United States
Facility Name
Delaware Health Center-Grady Cancer Center
City
Delaware
State/Province
Ohio
ZIP/Postal Code
43015
Country
United States
Facility Name
Delaware Radiation Oncology
City
Delaware
State/Province
Ohio
ZIP/Postal Code
43015
Country
United States
Facility Name
Grady Memorial Hospital
City
Delaware
State/Province
Ohio
ZIP/Postal Code
43015
Country
United States
Facility Name
Dublin Methodist Hospital
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Facility Name
Fairfield Medical Center
City
Lancaster
State/Province
Ohio
ZIP/Postal Code
43130
Country
United States
Facility Name
OhioHealth Mansfield Hospital
City
Mansfield
State/Province
Ohio
ZIP/Postal Code
44903
Country
United States
Facility Name
Marietta Memorial Hospital
City
Marietta
State/Province
Ohio
ZIP/Postal Code
45750
Country
United States
Facility Name
OhioHealth Marion General Hospital
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
Knox Community Hospital
City
Mount Vernon
State/Province
Ohio
ZIP/Postal Code
43050
Country
United States
Facility Name
Licking Memorial Hospital
City
Newark
State/Province
Ohio
ZIP/Postal Code
43055
Country
United States
Facility Name
Newark Radiation Oncology
City
Newark
State/Province
Ohio
ZIP/Postal Code
43055
Country
United States
Facility Name
Southern Ohio Medical Center
City
Portsmouth
State/Province
Ohio
ZIP/Postal Code
45662
Country
United States
Facility Name
Saint Ann's Hospital
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43081
Country
United States
Facility Name
Genesis Healthcare System Cancer Care Center
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Mercy Hospital Oklahoma City
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Saint Charles Health System
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Clackamas Radiation Oncology Center
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Facility Name
Bay Area Hospital
City
Coos Bay
State/Province
Oregon
ZIP/Postal Code
97420
Country
United States
Facility Name
Providence Newberg Medical Center
City
Newberg
State/Province
Oregon
ZIP/Postal Code
97132
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Providence Saint Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Geisinger Medical Oncology-Lewisburg
City
Lewisburg
State/Province
Pennsylvania
ZIP/Postal Code
17837
Country
United States
Facility Name
Lewistown Hospital
City
Lewistown
State/Province
Pennsylvania
ZIP/Postal Code
17044
Country
United States
Facility Name
University of Pennsylvania/Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Geisinger Wyoming Valley/Henry Cancer Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Gibbs Cancer Center-Gaffney
City
Gaffney
State/Province
South Carolina
ZIP/Postal Code
29341
Country
United States
Facility Name
Gibbs Cancer Center-Pelham
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Spartanburg Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
MGC Hematology Oncology-Union
City
Union
State/Province
South Carolina
ZIP/Postal Code
29379
Country
United States
Facility Name
Sanford Cancer Center Oncology Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Sanford USD Medical Center - Sioux Falls
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5134
Country
United States
Facility Name
Memorial Hospital
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Saint Joseph Regional Cancer Center
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Virginia Commonwealth University/Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Providence Regional Cancer System-Aberdeen
City
Aberdeen
State/Province
Washington
ZIP/Postal Code
98520
Country
United States
Facility Name
Overlake Medical Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
PeaceHealth Saint Joseph Medical Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Harrison HealthPartners Hematology and Oncology-Bremerton
City
Bremerton
State/Province
Washington
ZIP/Postal Code
98310
Country
United States
Facility Name
Harrison Medical Center
City
Bremerton
State/Province
Washington
ZIP/Postal Code
98310
Country
United States
Facility Name
Highline Medical Center-Main Campus
City
Burien
State/Province
Washington
ZIP/Postal Code
98166
Country
United States
Facility Name
Providence Regional Cancer System-Centralia
City
Centralia
State/Province
Washington
ZIP/Postal Code
98531
Country
United States
Facility Name
Providence Regional Cancer Partnership
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Swedish Cancer Institute-Issaquah
City
Issaquah
State/Province
Washington
ZIP/Postal Code
98029
Country
United States
Facility Name
Kadlec Clinic Hematology and Oncology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Providence Regional Cancer System-Lacey
City
Lacey
State/Province
Washington
ZIP/Postal Code
98503
Country
United States
Facility Name
PeaceHealth Saint John Medical Center
City
Longview
State/Province
Washington
ZIP/Postal Code
98632
Country
United States
Facility Name
Valley Medical Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
Facility Name
Swedish Medical Center-Ballard Campus
City
Seattle
State/Province
Washington
ZIP/Postal Code
98107
Country
United States
Facility Name
Kaiser Permanente Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98112
Country
United States
Facility Name
Swedish Medical Center-First Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
PeaceHealth United General Medical Center
City
Sedro-Woolley
State/Province
Washington
ZIP/Postal Code
98284
Country
United States
Facility Name
Northwest Medical Specialties PLLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
PeaceHealth Southwest Medical Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Providence Saint Mary Regional Cancer Center
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
Marshfield Medical Center-EC Cancer Center
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54701
Country
United States
Facility Name
Marshfield Medical Center-Marshfield
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Marshfield Clinic-Minocqua Center
City
Minocqua
State/Province
Wisconsin
ZIP/Postal Code
54548
Country
United States
Facility Name
Cancer Center of Western Wisconsin
City
New Richmond
State/Province
Wisconsin
ZIP/Postal Code
54017
Country
United States
Facility Name
Marshfield Medical Center-Rice Lake
City
Rice Lake
State/Province
Wisconsin
ZIP/Postal Code
54868
Country
United States
Facility Name
Marshfield Medical Center-River Region at Stevens Point
City
Stevens Point
State/Province
Wisconsin
ZIP/Postal Code
54482
Country
United States
Facility Name
Marshfield Clinic-Wausau Center
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Facility Name
Diagnostic and Treatment Center
City
Weston
State/Province
Wisconsin
ZIP/Postal Code
54476
Country
United States
Facility Name
Marshfield Medical Center - Weston
City
Weston
State/Province
Wisconsin
ZIP/Postal Code
54476
Country
United States
Facility Name
Billings Clinic-Cody
City
Cody
State/Province
Wyoming
ZIP/Postal Code
82414
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Testing the Addition of Radiation Therapy to Immunotherapy for Merkel Cell Carcinoma

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