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

< Back to search results
This clinical trial matches:
Show Search Criteria
Status: Active

Description

This pilot phase II trial studies how well pembrolizumab works in treating patients with desmoplastic melanoma (DM) that can or cannot be removed by surgery (unresectable). Monoclonal antibodies, like pembrolizumab, may block specific proteins which may strengthen the immune system and control tumor growth.

Eligibility Criteria

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
  • 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

Locations & Contacts

Alaska

Fairbanks
Fairbanks Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 907-458-3043
Email: cancerresearch@foundationhealth.org

Arkansas

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

California

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
Email: lradke@bati.org
Pasadena
Keck Medical Center of USC Pasadena
Status: Active
Contact: Site Public Contact
Phone: 323-865-0451
Walnut Creek
Epic Care Cyberknife Center
Status: Active
Contact: Site Public Contact
Phone: 510-465-8016
Email: somega@bati.org

Colorado

Aurora
Rocky Mountain Cancer Centers-Aurora
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
The Medical Center of Aurora
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Boulder
Boulder Community Hospital
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: jbloomfield@co-cancerresearch.org
Rocky Mountain Cancer Centers-Boulder
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
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
Email: ccrp@co-cancerresearch.org
National Jewish Health-Main Campus
Status: Active
Contact: Site Public Contact
Phone: 877-225-5654
Email: glicht@co-cancerresearch.org
Presbyterian - Saint Lukes Medical Center - Health One
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Rocky Mountain Cancer Centers-Midtown
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Rocky Mountain Cancer Centers-Rose
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Rose Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
SCL Health Saint Joseph Hospital
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
The Women's Imaging Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Western Surgical Care
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Englewood
Mountain Blue Cancer Care Center - Swedish
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: WSCR@westernstatesncorp.org
Swedish Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Golden
National Jewish Health-Western Hematology Oncology
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 303-777-2663
Email: glicht@co-cancerresearch.org
Grand Junction
Saint Mary's Hospital and Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Greeley
North Colorado Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
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
Email: ccrp@co-cancerresearch.org
Lone Tree
Rocky Mountain Cancer Centers-Sky Ridge
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Sky Ridge Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Loveland
McKee Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Thornton
National Jewish Health-Northern Hematology Oncology
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: glicht@co-cancerresearch.org
Wheat Ridge
SCL Health Lutheran Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org

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
Email: yenrique@msmc.com
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: Active
Contact: Site Public Contact
Phone: 305-674-2625
Email: yenrique@msmc.com
Tampa
Moffitt Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-679-0775
Email: canceranswers@moffitt.org
Moffitt Cancer Center - McKinley Campus
Status: Active
Contact: Site Public Contact
Phone: 800-679-0775
Email: canceranswers@moffitt.org
Moffitt Cancer Center-International Plaza
Status: Active
Contact: Site Public Contact
Phone: 800-679-0775
Email: canceranswers@moffitt.org

Georgia

Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: Active
Contact: Site Public Contact
Phone: 912-819-5704
Email: underberga@sjchs.org
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
Email: protocols@swog.org

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Coeur D'Alene
Kootenai Medical Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Emmett
Walter Knox Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Meridian
Idaho Urologic Institute-Meridian
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Nampa
Saint Alphonsus Medical Center-Nampa
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Post Falls
Kootenai Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Sandpoint
Kootenai Cancer Clinic
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Illinois

Aurora
Rush - Copley Medical Center
Status: Active
Contact: Site Public Contact
Phone: 630-978-6212
Email: Cancer.Research@rushcopley.com
Chicago
Northwestern University
Status: Active
Contact: Site Public Contact
Phone: 312-695-1301
Email: cancer@northwestern.edu
Danville
Carle on Vermilion
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Effingham
Carle Physician Group-Effingham
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Geneva
Northwestern Medicine Cancer Center Delnor
Status: Active
Contact: Site Public Contact
Phone: 630-315-1918
Email: Claudine.Gamster@CadenceHealth.org
Lake Forest
Northwestern Medicine Lake Forest Hospital
Status: Active
Contact: Site Public Contact
Email: cancertrials@northwestern.edu
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
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
Email: Research@carle.com
The Carle Foundation Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Warrenville
Northwestern Medicine Cancer Center Warrenville
Status: Active
Contact: Site Public Contact
Phone: 630-315-1918
Email: Claudine.Gamster@CadenceHealth.org
Yorkville
Rush-Copley Healthcare Center
Status: Active
Contact: Site Public Contact
Phone: 630-978-6212
Email: Cancer.Research@rushcopley.com

Indiana

Evansville
Deaconess Clinic Downtown
Status: Active
Contact: Site Public Contact
Phone: 877-654-0311
Email: Research@Deaconess.com
Newburgh
Chancellor Center for Oncology
Status: Active
Contact: Site Public Contact
Phone: 877-654-0311
Email: Research@Deaconess.com

Kansas

Coffeyville
Coffeyville Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 620-252-1606
Hays
Hays Medical Center
Status: Active
Contact: Site Public Contact
Phone: 785-623-5774
Kansas City
University of Kansas Cancer Center-West
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Olathe
Olathe Medical Center
Status: Active
Contact: Site Public Contact
Phone: 913-791-3500
Email: Jeni.wakefield@olathehealth.org
Overland Park
University of Kansas Cancer Center-Overland Park
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Pittsburg
Via Christi Hospital-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
Email: kkavoura@srhc.com
Topeka
Saint Francis Hospital and Medical Center - Topeka
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: 913-945-7552
Email: ctnursenav@kumc.edu

Michigan

Brownstown
Henry Ford Cancer Institute-Downriver
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Clinton Township
Henry Ford Macomb Hospital-Clinton Township
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Dearborn
Henry Ford Medical Center-Fairlane
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Detroit
Henry Ford Hospital
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Jackson
Allegiance Health
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Monroe
Monroe Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Novi
Henry Ford Medical Center-Columbus
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
West Bloomfield
Henry Ford West Bloomfield Hospital
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org

Minnesota

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

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
Branson
Cox Cancer Center Branson
Status: Active
Contact: Site Public Contact
Phone: 417-269-4520
Joplin
Freeman Health System
Status: Active
Contact: Site Public Contact
Phone: 417-347-4030
Email: LJCrockett@freemanhealth.com
Mercy Hospital Joplin
Status: Active
Contact: Site Public Contact
Phone: 417-556-3074
Email: esmeralda.carrillo@mercy.net
Kansas City
The University of Kansas Cancer Center-North
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
The University of Kansas Cancer Center-South
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Truman Medical Center
Status: Active
Contact: Site Public Contact
Phone: 816-404-4375
Lee's Summit
The University of Kansas Cancer Center-Lee's Summit
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Rolla
Delbert Day Cancer Institute at PCRMC
Status: Active
Contact: Site Public Contact
Phone: 573-458-7504
Email: jrichards@research.pcrmc.com
Mercy Clinic-Rolla-Cancer and Hematology
Status: Active
Contact: Site Public Contact
Phone: 573-458-7504
Email: jrichards@research.pcrmc.com
Saint Joseph
Heartland Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 816-271-7937
Email: linda.schumacher@mymlc.com
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
Email: janet.lesko@mercy.net
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
Email: mccinfo@mtcancer.org
Billings
Billings Clinic Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-996-2663
Email: research@billingsclinic.org
Saint Vincent Frontier Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-648-6274
Saint Vincent Healthcare
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Bozeman
Bozeman Deaconess Hospital
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
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
Email: mccinfo@mtcancer.org
Great Falls Clinic
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Helena
Saint Peter's Community Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Kalispell
Kalispell Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Missoula
Community Medical Hospital
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org

New York

Buffalo
Roswell Park Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 800-767-9355
Email: askroswell@roswellpark.org

North Carolina

Clinton
Southeastern Medical Oncology Center-Clinton
Status: Active
Contact: Site Public Contact
Phone: 919-587-9077
Email: ecooke@cancersmoc.com
Goldsboro
Southeastern Medical Oncology Center-Goldsboro
Status: Active
Contact: Site Public Contact
Phone: 919-587-9077
Email: ecooke@cancersmoc.com
Jacksonville
Southeastern Medical Oncology Center-Jacksonville
Status: Active
Contact: Site Public Contact
Phone: 910-353-0824
Email: ecooke@cancersmoc.com

Ohio

Belpre
Strecker Cancer Center-Belpre
Status: Active
Contact: Site Public Contact
Phone: 800-523-3977
Email: sheree@columbusccop.org
Chillicothe
Adena Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 877-779-7585
Email: sheree@columbusccop.org
Columbus
Columbus Oncology and Hematology Associates Inc
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Doctors Hospital
Status: Active
Contact: Site Public Contact
Phone: 614-566-3275
Email: sheree@columbusccop.org
Grant Medical Center
Status: Active
Contact: Site Public Contact
Phone: 614-566-4475
Email: sheree@columbusccop.org
Mount Carmel East Hospital
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Mount Carmel Health Center West
Status: Active
Contact: Site Public Contact
Phone: 614-234-5433
Email: sheree@columbusccop.org
Ohio State University Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-293-5066
Email: Jamesline@osumc.edu
Riverside Methodist Hospital
Status: Active
Contact: Site Public Contact
Phone: 614-566-4475
Email: sheree@columbusccop.org
The Mark H Zangmeister Center
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Delaware
Delaware Health Center-Grady Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 740-615-0227
Email: sheree@columbusccop.org
Delaware Radiation Oncology
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Grady Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 740-615-2403
Email: sheree@columbusccop.org
Dublin
Dublin Methodist Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-752-9119
Email: sheree@columbusccop.org
Lancaster
Fairfield Medical Center
Status: Active
Contact: Site Public Contact
Phone: 740-687-8863
Email: sheree@columbusccop.org
Mansfield
OhioHealth Mansfield Hospital
Status: Active
Contact: Site Public Contact
Phone: 419-526-8018
Email: sheree@columbusccop.org
Marietta
Marietta Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-523-3977
Email: sheree@columbusccop.org
Marion
OhioHealth Marion General Hospital
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Mount Vernon
Knox Community Hospital
Status: Active
Contact: Site Public Contact
Phone: 740-393-9000
Email: sheree@columbusccop.org
Newark
Licking Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 740-348-4000
Email: sheree@columbusccop.org
Newark Radiation Oncology
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Portsmouth
Southern Ohio Medical Center
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Sylvania
ProMedica Flower Hospital
Status: Active
Contact: Site Public Contact
Phone: 419-824-1842
Toledo
The Toledo Hospital / Toledo 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
Email: sheree@columbusccop.org
Zanesville
Genesis Healthcare System Cancer Care Center
Status: Active
Contact: Site Public Contact
Phone: 740-454-5232
Email: sheree@columbusccop.org

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
Email: ou-clinical-trials@ouhsc.edu

Oregon

Baker City
Saint Alphonsus Medical Center-Baker City
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Ontario
Saint Alphonsus Medical Center-Ontario
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org

Utah

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

Washington

Auburn
MultiCare Auburn Medical Center
Status: Active
Contact: Site Public Contact
Phone: 253-887-9333
Email: research@multicare.org
Gig Harbor
MultiCare Gig Harbor Medical Park
Status: Active
Contact: Site Public Contact
Phone: 253-403-2394
Email: research@multicare.org
Port Townsend
Jefferson Healthcare
Status: Active
Contact: Site Public Contact
Phone: 360-344-3091
Puyallup
MultiCare Good Samaritan Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-351-7955
Email: research@multicare.org
Spokane
Rockwood Cancer Treatment Center-DHEC-Downtown
Status: Active
Contact: Site Public Contact
Phone: 509-724-4454
Email: apope@rockwoodclinic.com
Rockwood North Cancer Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 509-724-4454
Email: apope@rockwoodclinic.com
Spokane Valley
Rockwood Clinic Cancer Treatment Center-Valley
Status: Active
Contact: Site Public Contact
Phone: 509-724-4454
Email: apope@rockwoodclinic.com
Tacoma
Mary Bridge Children's Hospital and Health Center
Status: Active
Contact: Site Public Contact
Phone: 253-403-1461
Email: research@multicare.org
MultiCare Tacoma General Hospital
Status: Active
Contact: Site Public Contact
Phone: 253-403-3229
Email: research@multicare.org

Wisconsin

New Richmond
Cancer Center of Western Wisconsin
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Wyoming

Cheyenne
Cheyenne Regional Medical Center-West
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Cody
Billings Clinic-Cody
Status: Active
Contact: Site Public Contact
Phone: 800-996-2663
Email: research@billingsclinic.org
Sheridan
Welch Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Trial Objectives and Outline

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 & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
SWOG

Principal Investigator
Kari L. Kendra

Trial IDs

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