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Pembrolizumab in Treating Patients with Desmoplastic Melanoma That Can or Cannot Be Removed by Surgery

Trial Status: Active

This pilot phase II trial studies how well pembrolizumab works in treating patients with desmoplastic melanoma (DM) that can be removed by surgery (resectable) or cannot be removed by surgery (unresectable). 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.

Inclusion Criteria

  • COHORT A: Patients must have histologically or cytologically confirmed primary desmoplastic melanoma that is deemed resectable; the decision to perform surgery on patients must be based on good clinical judgment; eligible patients for surgical resection must have disease that, in the judgment of the surgeon, is deemed completely resectable resulting in free surgical margins; patients must have residual disease after initial biopsy which can be measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; residual disease can either be confirmed with fine-needle aspiration (FNA) or if measurable disease is present, no FNA needs to be obtained OR
  • COHORT B: Patients must have histologically or cytologically confirmed primary desmoplastic melanoma that is unresectable; patients in Cohort B must have measurable disease per RECIST 1.1
  • Contrast-enhanced computed tomography (CT) scans of the chest, abdomen and pelvis are required; a whole body positron emission tomography (PET)/CT scan with diagnostic quality images and intravenous iodinated contrast may be used in lieu of a contrast enhanced CT of the chest, abdomen and pelvis; imaging of the head and neck is required only if the patient has a head/neck primary; contrast may be omitted if the treating investigator believes that exposure to contrast poses an excessive risk to the patient; if skin lesions are being followed as measurable disease, photograph with a ruler included and physician measurements, must be kept in the patient’s chart as source documentation; all measurable lesions must be assessed within 28 days prior to registration; tests to assess non-measurable disease must be performed within 42 days prior to registration; all disease must be assessed and documented on the baseline tumor assessment form (RECIST 1.1)
  • Patients must not have known brain metastases unless brain metastases have been treated and patient is asymptomatic with no residual neurological dysfunction and has not received enzyme-reducing anti-epileptic drugs or corticosteroids for at least 14 days prior to registration
  • Patients must not have received prior systemic treatment for this melanoma
  • Patients must not be planning to receive concomitant other biologic therapy, radiation therapy, hormonal therapy, other chemotherapy, anti-cancer surgery or other anti-cancer therapy while on this protocol
  • Patients must not have received radiation therapy, non-cytotoxic agents or investigational agents or systemic corticosteroids within 14 days prior to registration
  • Patients may have received prior surgery; all adverse events associated with prior surgery must have resolved to =< grade 1 (per Common Terminology Criteria for Adverse Events [CTCAE] 4.0) prior to registration
  • Absolute neutrophil count (ANC) >= 1,500/mcl (obtained within 28 days prior to registration)
  • Platelets >= 50,000/mcl (obtained within 28 days prior to registration)
  • Hemoglobin >= 8 g/dL (obtained within 28 days prior to registration)
  • Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (or =< 3.0 x IULN with Gilbert's syndrome) (obtained within 28 days prior to registration)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x IULN (or < 5 x IULN for patients with known liver metastases) (obtained within 28 days prior to registration)
  • Patients must have lactate dehydrogenase (LDH) performed within 28 days prior to registration
  • Patients must have Zubrod performance status =< 2
  • Patients must not have history of (non-infectious) pneumonitis that required steroids or current pneumonitis
  • Patients must not have an active infection requiring systemic therapy
  • Patients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
  • Patients must not have received live vaccines within 42 days prior to registration; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, Bacillus Calmette–Guerin (BCG), and typhoid (oral) vaccine; seasonal influenza vaccines for injection are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist) are not allowed
  • Patients known to be human immunodeficiency virus (HIV) positive are eligible if they meet the following criteria within 30 days prior to registration: stable and adequate CD4 counts (>= 350 mm^3), and serum HIV viral load of < 25,000 IU/ml; patients must be on a stable anti-viral therapy
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated in situ cancer, adequately treated stage I or II cancer (including multiple primary melanomas) from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years
  • Women of childbearing potential must have a negative urine or serum pregnancy test within 28 days prior to registration; women/men of reproductive potential must have agreed to use an effective contraceptive method for the course of the study through 120 days after the last dose of study medication; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures; patients must not be pregnant or nursing due to unknown teratogenic side effects
  • Patients must have specimens available and institutions must be planning to submit for centralized pathology review and for integrated translational medicine objectives
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • As a part of the Oncology Patient Enrollment Network (OPEN) registration process, the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Alaska

Fairbanks
Fairbanks Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-458-3043

Arkansas

Ft. Smith
Mercy Hospital Fort Smith
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-378-9373

California

Duarte
City of Hope Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-826-4673
Dublin
Epic Care-Dublin
Status: ACTIVE
Contact: Site Public Contact
Phone: 925-875-1677
Emeryville
Bay Area Breast Surgeons Inc
Status: ACTIVE
Contact: Site Public Contact
Phone: 510-835-9900
Epic Care Partners in Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 510-629-6682
Los Angeles
Los Angeles County-USC Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 323-865-0451
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-798-0719
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 323-865-0451
Martinez
Contra Costa Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 925-957-5400
Newport Beach
USC Norris Oncology / Hematology-Newport Beach
Status: ACTIVE
Contact: Site Public Contact
Phone: 323-865-0451
Oakland
Alta Bates Summit Medical Center - Summit Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 510-204-1414
Bay Area Tumor Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 510-465-2242
Pasadena
Keck Medical Center of USC Pasadena
Status: ACTIVE
Contact: Site Public Contact
Phone: 323-865-0451
South Pasadena
City of Hope South Pasadena
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-826-4673
Upland
City of Hope Upland
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-826-4673
Walnut Creek
Epic Care Cyberknife Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 510-465-8016

Colorado

Aurora
Rocky Mountain Cancer Centers-Aurora
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
The Medical Center of Aurora
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Boulder
Boulder Community Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Rocky Mountain Cancer Centers-Boulder
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Denver
Cancer Center of Colorado at Sloan's Lake
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Colorado Blood Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
National Jewish Health-Main Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-225-5654
Presbyterian - Saint Lukes Medical Center - Health One
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Rocky Mountain Cancer Centers-Midtown
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Rocky Mountain Cancer Centers-Rose
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Rose Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
SCL Health Saint Joseph Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
The Women's Imaging Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Western Surgical Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Englewood
Mountain Blue Cancer Care Center - Swedish
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Swedish Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Golden
National Jewish Health-Western Hematology Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Grand Junction
Grand Valley Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 970-644-4460
Saint Mary's Hospital and Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Greeley
North Colorado Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Lafayette
Good Samaritan Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-673-1622
Littleton
Rocky Mountain Cancer Centers-Littleton
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Lone Tree
Rocky Mountain Cancer Centers-Sky Ridge
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Sky Ridge Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Loveland
McKee Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Thornton
National Jewish Health-Northern Hematology Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Wheat Ridge
SCL Health Lutheran Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663

Connecticut

Hartford
Hartford Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 860-545-5363

Florida

Aventura
Mount Sinai Comprehensive Cancer Center at Aventura
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 305-674-2625
Fort Lauderdale
Holy Cross Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 954-267-7750
Miami Beach
Mount Sinai Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 305-674-2625
Tampa
Moffitt Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-679-0775
Moffitt Cancer Center - McKinley Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-679-0775
Moffitt Cancer Center-International Plaza
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-679-0775

Georgia

Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: ACTIVE
Contact: Site Public Contact
Phone: 912-819-5704
Low Country Cancer Care Associates PC
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 912-692-2000
Summit Cancer Care-Candler
Status: ACTIVE
Contact: Site Public Contact

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Coeur D'Alene
Kootenai Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Emmett
Walter Knox Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Meridian
Idaho Urologic Institute-Meridian
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Nampa
Saint Alphonsus Medical Center-Nampa
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Post Falls
Kootenai Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Sandpoint
Kootenai Cancer Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060

Illinois

Aurora
Rush - Copley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-978-6212
Chicago
Northwestern University
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-695-1301
Danville
Carle on Vermilion
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Effingham
Carle Physician Group-Effingham
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Geneva
Northwestern Medicine Cancer Center Delnor
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-352-5360
Lake Forest
Northwestern Medicine Lake Forest Hospital
Status: ACTIVE
Contact: Site Public Contact
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Mount Vernon
Good Samaritan Regional Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-242-4600
Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
The Carle Foundation Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Warrenville
Northwestern Medicine Cancer Center Warrenville
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-352-5360
Yorkville
Rush-Copley Healthcare Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-978-6212

Indiana

Evansville
Deaconess Clinic Downtown
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-654-0311
Newburgh
Chancellor Center for Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-654-0311

Kansas

Coffeyville
Coffeyville Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 620-252-1606
Fairway
University of Kansas Clinical Research Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-588-3671
Garden City
Central Care Cancer Center - Garden City
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Great Bend
Central Care Cancer Center - Great Bend
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Hays
HaysMed University of Kansas Health System
Status: ACTIVE
Contact: Site Public Contact
Phone: 785-623-5774
Kansas City
University of Kansas Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-588-3671
University of Kansas Cancer Center-West
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671
Lenexa
Kansas Institute of Medicine Cancer and Blood Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Minimally Invasive Surgery Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Olathe
Olathe Health Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-355-8000
Overland Park
Menorah Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
University of Kansas Cancer Center-Overland Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671
Pittsburg
Ascension Via Christi - Pittsburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 620-235-7900
Salina
Salina Regional Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 785-452-7038
Topeka
University of Kansas Health System Saint Francis Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 785-295-8000
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671

Michigan

Brownstown
Henry Ford Cancer Institute-Downriver
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Clinton Township
Henry Ford Macomb Hospital-Clinton Township
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Dearborn
Henry Ford Medical Center-Fairlane
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Detroit
Henry Ford Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Jackson
Allegiance Health
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Monroe
Monroe Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-823-5923
Novi
Henry Ford Medical Center-Columbus
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Shelby Township
Henry Ford Macomb Health Center - Shelby Township
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-1784
West Bloomfield
Henry Ford West Bloomfield Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721

Minnesota

Burnsville
Fairview Ridges Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Cambridge
Cambridge Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Coon Rapids
Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Edina
Fairview Southdale Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Fridley
Unity Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Maple Grove
Fairview Clinics and Surgery Center Maple Grove
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Saint John's Hospital - Healtheast
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Minneapolis
Abbott-Northwestern Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Health Partners Inc
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Hennepin County Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Monticello
Monticello Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
New Ulm
New Ulm Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Princeton
Fairview Northland Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Robbinsdale
North Memorial Medical Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Saint Paul
Regions Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
United Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Shakopee
Saint Francis Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Stillwater
Lakeview Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Waconia
Ridgeview Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Willmar
Rice Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Woodbury
Minnesota Oncology Hematology PA-Woodbury
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Wyoming
Fairview Lakes Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517

Mississippi

Pascagoula
Singing River Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 228-809-5292

Missouri

Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-251-7058
Bolivar
Central Care Cancer Center - Bolivar
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Branson
Cox Cancer Center Branson
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520
Independence
Centerpoint Medical Center LLC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Joplin
Freeman Health System
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-347-4030
Mercy Hospital Joplin
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-556-3074
Kansas City
Research Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
The University of Kansas Cancer Center-South
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-945-7552
Truman Medical Centers
Status: ACTIVE
Contact: Site Public Contact
Phone: 816-404-4375
University of Kansas Cancer Center - North
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671
Lee's Summit
University of Kansas Cancer Center - Lee's Summit
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671
Rolla
Delbert Day Cancer Institute at PCRMC
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-458-8776
Mercy Clinic-Rolla-Cancer and Hematology
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-458-6379
Saint Joseph
Heartland Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 816-271-7937
Saint Louis
Mercy Hospital Saint Louis
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-251-7066
Mercy Hospital South
Status: ACTIVE
Contact: Site Public Contact
Saint Louis Cancer and Breast Institute-South City
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-353-1870
Springfield
CoxHealth South Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520
Mercy Hospital Springfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520
Washington
Mercy Hospital Washington
Status: ACTIVE
Contact: Site Public Contact
Phone: 636-390-1600

Montana

Anaconda
Community Hospital of Anaconda
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Billings
Billings Clinic Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-996-2663
Saint Vincent Frontier Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-648-6274
Saint Vincent Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Bozeman
Bozeman Deaconess Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Butte
Saint James Community Hospital and Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-723-2621
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Great Falls Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Helena
Saint Peter's Community Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Kalispell
Kalispell Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Missoula
Community Medical Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060

New York

Buffalo
Roswell Park Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-767-9355

North Carolina

Clinton
Southeastern Medical Oncology Center-Clinton
Status: ACTIVE
Contact: Site Public Contact
Phone: 919-587-9084
Goldsboro
Southeastern Medical Oncology Center-Goldsboro
Status: ACTIVE
Contact: Site Public Contact
Phone: 919-587-9084
Wayne Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 919-731-6687
Jacksonville
Onslow Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 910-353-0824
Southeastern Medical Oncology Center-Jacksonville
Status: ACTIVE
Contact: Site Public Contact
Phone: 910-587-9084

Ohio

Belpre
Strecker Cancer Center-Belpre
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-523-3977
Chillicothe
Adena Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-779-7585
Columbus
Columbus Oncology and Hematology Associates Inc
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Doctors Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-566-3275
Grant Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-566-4475
Mount Carmel East Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Mount Carmel Health Center West
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-234-5433
Ohio State University Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-293-5066
Riverside Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-566-4475
The Mark H Zangmeister Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Delaware
Delaware Health Center-Grady Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-615-0227
Delaware Radiation Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118
Grady Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-615-2403
Dublin
Dublin Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-752-9119
Grove City
Mount Carmel Grove City Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-779-7585
Lancaster
Fairfield Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-687-8863
Mansfield
OhioHealth Mansfield Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 419-526-8018
Marietta
Marietta Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-523-3977
Marion
OhioHealth Marion General Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Mount Vernon
Knox Community Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-393-9000
Newark
Licking Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-348-4000
Newark Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Portsmouth
Southern Ohio Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Sylvania
ProMedica Flower Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 419-824-1842
Toledo
ProMedica Toledo Hospital / Russell J Ebeid Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 419-824-1842
Westerville
Saint Ann's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-234-5433
Zanesville
Genesis Healthcare System Cancer Care Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-454-5232

Oklahoma

Oklahoma City
Mercy Hospital Oklahoma City
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-752-3402
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-271-8777

Oregon

Baker City
Saint Alphonsus Medical Center-Baker City
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Ontario
Saint Alphonsus Medical Center-Ontario
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671

Utah

American Fork
American Fork Hospital / Huntsman Intermountain Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-855-4100
Cedar City
Sandra L Maxwell Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 435-868-5680
Farmington
Farmington Health Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-424-2100
Logan
Logan Regional Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 435-716-6400
Murray
Intermountain Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-507-3950
Ogden
McKay-Dee Hospital Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-387-7426
Provo
Utah Valley Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-357-7965
Riverton
Riverton Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-507-3950
Saint George
Dixie Medical Center Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 435-688-4167
Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-424-2100
LDS Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-408-1347
Utah Cancer Specialists-Salt Lake City
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-933-6070
South Jordan
South Jordan Health Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-424-2100

Washington

Auburn
MultiCare Auburn Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-887-9333
Gig Harbor
MultiCare Gig Harbor Medical Park
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-403-2394
Port Townsend
Jefferson Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-344-3091
Puyallup
MultiCare Good Samaritan Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-351-7955
Spokane
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-403-7249
MultiCare Deaconess Cancer and Blood Specialty Center - North
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-402-7249
Spokane Valley
MultiCare Deaconess Cancer and Blood Specialty Center - Valley
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-403-7249
Tacoma
Mary Bridge Children's Hospital and Health Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-403-1461
MultiCare Tacoma General Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-403-3229

Wisconsin

New Richmond
Cancer Center of Western Wisconsin
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517

Wyoming

Cheyenne
Cheyenne Regional Medical Center-West
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Cody
Billings Clinic-Cody
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-996-2663
Sheridan
Welch Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060

PRIMARY OBJECTIVES:

I. To evaluate the pathologic complete response rate (pCR) in patients with resectable desmoplastic melanoma treated with neoadjuvant MK-3475 (pembrolizumab). (Cohort A)

II. To evaluate the complete response rate (confirmed and unconfirmed) in patients with unresectable desmoplastic melanoma treated with MK-3475 (pembrolizumab). (Cohort B)

SECONDARY OBJECTIVES:

I. To estimate the 9 week response rate (RR) (unconfirmed complete and partial responses) among patients with measurable disease. (Cohort A)

II. To estimate the median overall survival (OS). (Cohort A)

III. To evaluate safety and tolerability of MK-3475 (pembrolizumab) in the neoadjuvant setting. (Cohort A)

IV. To estimate the median progression-free survival (PFS). (Cohort B)

V. To estimate the median overall survival (OS). (Cohort B)

VI. To evaluate safety and tolerability of MK-3475 (pembrolizumab) in this setting. (Cohort B)

OTHER OBJECTIVES:

I. To evaluate the hypothesis that higher mutational load in the patient derived baseline tumor biopsy samples is associated with higher pathologic complete response (pCR).

II. To evaluate T cell infiltration into the tumors in DM patients and correlate with response to programmed cell death protein 1 (PD-1) blockade.

III. To evaluate the clonality of tumor infiltrating T cells in DM patients and correlate with response to PD-1 blockade.

IV. To evaluate adaptive immune resistant mechanism in DM tumors.

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHORT A: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles. Patients with potentially resectable disease undergo surgery. Patients with tumor progression and unresectable disease may receive one additional cycle of pembrolizumab.

COHORT B: Patients with unresectable disease receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 34 cycles in the absence of disease progression or toxicity.

After completion of study treatment, patients are followed up at 6 and 12 weeks, then every 3 months for 1 year, and every 6 months for 4 years.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
SWOG

Principal Investigator
Kari L. Kendra

  • Primary ID S1512
  • Secondary IDs NCI-2016-00666
  • Clinicaltrials.gov ID NCT02775851