Pembrolizumab in Treating Patients with Desmoplastic Melanoma That Can or Cannot Be Removed by Surgery
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
Status: Active
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Arkansas
Ft. Smith
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California
Dublin
Status: Active
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Emeryville
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Phone: 510-835-9900
Status: Active
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Phone: 510-629-6682
Los Angeles
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Contact: Site Public Contact
Phone: 323-865-0451
Status: Active
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Phone: 888-798-0719
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Martinez
Status: Active
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Newport Beach
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Oakland
Status: Active
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Phone: 510-204-1414
Status: Active
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Pasadena
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Walnut Creek
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Colorado
Aurora
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Phone: 303-777-2663
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Status: Active
Contact: Site Public Contact
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Boulder
Status: Active
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Phone: 303-777-2663
Email: jbloomfield@co-cancerresearch.org
Status: Active
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Denver
Status: Active
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Phone: 303-777-2663
Status: Active
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Email: ccrp@co-cancerresearch.org
Status: Active
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Phone: 877-225-5654
Email: glicht@co-cancerresearch.org
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
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Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Status: Active
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Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Englewood
Status: Temporarily closed to accrual
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Phone: 303-777-2663
Email: WSCR@westernstatesncorp.org
Status: Active
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Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Golden
Status: Temporarily closed to accrual
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Phone: 303-777-2663
Email: glicht@co-cancerresearch.org
Grand Junction
Status: Active
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Phone: 303-777-2663
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Greeley
Status: Active
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Lafayette
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Phone: 303-673-1622
Littleton
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Lone Tree
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Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Status: Active
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Email: ccrp@co-cancerresearch.org
Loveland
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Thornton
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Wheat Ridge
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Connecticut
Hartford
Status: Active
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Phone: 860-545-5363
Florida
Aventura
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 305-674-2625
Email: yenrique@msmc.com
Fort Lauderdale
Status: Temporarily closed to accrual
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Phone: 954-267-7750
Miami Beach
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Contact: Site Public Contact
Phone: 305-674-2625
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Tampa
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Phone: 800-679-0775
Email: canceranswers@moffitt.org
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Contact: Site Public Contact
Phone: 800-679-0775
Email: canceranswers@moffitt.org
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Phone: 800-679-0775
Email: canceranswers@moffitt.org
Georgia
Savannah
Status: Active
Contact: Site Public Contact
Phone: 912-819-5704
Email: underberga@sjchs.org
Status: Temporarily closed to accrual
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Phone: 912-692-2000
Idaho
Boise
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Caldwell
Status: Active
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Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Coeur D'Alene
Status: Active
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Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Emmett
Status: Active
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Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Meridian
Status: Active
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Phone: 734-712-3671
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Nampa
Status: Active
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Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Post Falls
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Email: mccinfo@mtcancer.org
Sandpoint
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Phone: 406-969-6060
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Illinois
Aurora
Status: Active
Contact: Site Public Contact
Phone: 630-978-6212
Email: Cancer.Research@rushcopley.com
Chicago
Status: Active
Contact: Site Public Contact
Phone: 312-695-1301
Email: cancer@northwestern.edu
Danville
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Effingham
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Geneva
Status: Active
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Phone: 630-315-1918
Email: Claudine.Gamster@CadenceHealth.org
Lake Forest
Status: Active
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Email: cancertrials@northwestern.edu
Mattoon
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Mount Vernon
Status: Active
Contact: Site Public Contact
Phone: 618-242-4600
Urbana
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Status: Active
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Phone: 800-446-5532
Email: Research@carle.com
Warrenville
Status: Active
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Phone: 630-315-1918
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Yorkville
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Phone: 630-978-6212
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Indiana
Evansville
Status: Active
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Phone: 877-654-0311
Email: Research@Deaconess.com
Newburgh
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Phone: 877-654-0311
Email: Research@Deaconess.com
Kansas
Coffeyville
Status: Active
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Phone: 620-252-1606
Hays
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Phone: 785-623-5774
Kansas City
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Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Olathe
Status: Active
Contact: Site Public Contact
Phone: 913-791-3500
Email: Jeni.wakefield@olathehealth.org
Overland Park
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Pittsburg
Status: Active
Contact: Site Public Contact
Phone: 620-235-7900
Salina
Status: Active
Contact: Site Public Contact
Phone: 785-452-7038
Email: kkavoura@srhc.com
Topeka
Status: Active
Contact: Site Public Contact
Phone: 785-295-8000
Westwood
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Michigan
Brownstown
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Clinton Township
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Dearborn
Status: Active
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Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Detroit
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Jackson
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Monroe
Status: Active
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Novi
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
West Bloomfield
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Minnesota
Burnsville
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Cambridge
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Coon Rapids
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Edina
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Fridley
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Maple Grove
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Maplewood
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Minneapolis
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Monticello
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
New Ulm
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Princeton
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Robbinsdale
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Saint Louis Park
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Saint Paul
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Shakopee
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Stillwater
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Waconia
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Willmar
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Woodbury
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Wyoming
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Mississippi
Pascagoula
Status: Active
Contact: Site Public Contact
Phone: 228-809-5292
Missouri
Ballwin
Status: Active
Contact: Site Public Contact
Phone: 314-251-7058
Branson
Status: Active
Contact: Site Public Contact
Phone: 417-269-4520
Joplin
Status: Active
Contact: Site Public Contact
Phone: 417-347-4030
Email: LJCrockett@freemanhealth.com
Status: Active
Contact: Site Public Contact
Phone: 417-556-3074
Email: esmeralda.carrillo@mercy.net
Kansas City
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Status: Active
Contact: Site Public Contact
Phone: 816-404-4375
Lee's Summit
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Rolla
Status: Active
Contact: Site Public Contact
Phone: 573-458-8776
Email: kaysmith@phelpshealth.org
Status: Active
Contact: Site Public Contact
Phone: 573-458-8776
Email: kaysmith@phelpshealth.org
Saint Joseph
Status: Active
Contact: Site Public Contact
Phone: 816-271-7937
Email: linda.schumacher@mymlc.com
Saint Louis
Status: Active
Contact: Site Public Contact
Phone: 314-251-7066
Status: Active
Contact: Site Public Contact
Phone: 314-353-1870
Springfield
Status: Active
Contact: Site Public Contact
Phone: 417-269-4520
Status: Active
Contact: Site Public Contact
Phone: 417-269-4520
Washington
Status: Active
Contact: Site Public Contact
Phone: 636-390-1600
Montana
Anaconda
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Billings
Status: Active
Contact: Site Public Contact
Phone: 800-996-2663
Email: research@billingsclinic.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-648-6274
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Bozeman
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Butte
Status: Active
Contact: Site Public Contact
Phone: 406-723-2621
Great Falls
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Helena
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Kalispell
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Missoula
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
New York
Buffalo
Status: Active
Contact: Site Public Contact
Phone: 800-767-9355
Email: askroswell@roswellpark.org
North Carolina
Clinton
Status: Active
Contact: Site Public Contact
Phone: 919-587-9077
Email: ecooke@cancersmoc.com
Goldsboro
Status: Active
Contact: Site Public Contact
Phone: 919-587-9077
Email: ecooke@cancersmoc.com
Jacksonville
Status: Active
Contact: Site Public Contact
Phone: 910-353-0824
Email: ecooke@cancersmoc.com
Ohio
Belpre
Status: Active
Contact: Site Public Contact
Phone: 800-523-3977
Email: sheree@columbusccop.org
Chillicothe
Status: Active
Contact: Site Public Contact
Phone: 877-779-7585
Email: sheree@columbusccop.org
Columbus
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Status: Active
Contact: Site Public Contact
Phone: 614-566-3275
Email: sheree@columbusccop.org
Status: Active
Contact: Site Public Contact
Phone: 614-566-4475
Email: sheree@columbusccop.org
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Status: Active
Contact: Site Public Contact
Phone: 614-234-5433
Email: sheree@columbusccop.org
Status: Active
Contact: Site Public Contact
Phone: 800-293-5066
Email: Jamesline@osumc.edu
Status: Active
Contact: Site Public Contact
Phone: 614-566-4475
Email: sheree@columbusccop.org
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Delaware
Status: Active
Contact: Site Public Contact
Phone: 740-615-0227
Email: sheree@columbusccop.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Status: Active
Contact: Site Public Contact
Phone: 740-615-2403
Email: sheree@columbusccop.org
Dublin
Status: Active
Contact: Site Public Contact
Phone: 800-752-9119
Email: sheree@columbusccop.org
Lancaster
Status: Active
Contact: Site Public Contact
Phone: 740-687-8863
Email: sheree@columbusccop.org
Mansfield
Status: Active
Contact: Site Public Contact
Phone: 419-526-8018
Email: sheree@columbusccop.org
Marietta
Status: Active
Contact: Site Public Contact
Phone: 800-523-3977
Email: sheree@columbusccop.org
Marion
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Mount Vernon
Status: Active
Contact: Site Public Contact
Phone: 740-393-9000
Email: sheree@columbusccop.org
Newark
Status: Active
Contact: Site Public Contact
Phone: 740-348-4000
Email: sheree@columbusccop.org
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Portsmouth
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Sylvania
Status: Active
Contact: Site Public Contact
Phone: 419-824-1842
Toledo
Status: Active
Contact: Site Public Contact
Phone: 419-824-1842
Westerville
Status: Active
Contact: Site Public Contact
Phone: 614-234-5433
Email: sheree@columbusccop.org
Zanesville
Status: Active
Contact: Site Public Contact
Phone: 740-454-5232
Email: sheree@columbusccop.org
Oklahoma
Oklahoma City
Status: Active
Contact: Site Public Contact
Phone: 405-752-3402
Status: Active
Contact: Site Public Contact
Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu
Oregon
Baker City
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Ontario
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Utah
American Fork
Status: Active
Contact: Site Public Contact
Phone: 801-855-4100
Email: officeofresearch@imail.org
Cedar City
Status: Active
Contact: Site Public Contact
Phone: 435-868-5680
Email: officeofresearch@imail.org
Farmington
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-424-2100
Email: cancerinfo@hci.utah.edu
Logan
Status: Active
Contact: Site Public Contact
Phone: 435-716-6400
Email: officeofresearch@imail.org
Murray
Status: Active
Contact: Site Public Contact
Phone: 801-507-3950
Email: officeofresearch@imail.org
Ogden
Status: Active
Contact: Site Public Contact
Phone: 801-387-7426
Email: officeofresearch@imail.org
Provo
Status: Active
Contact: Site Public Contact
Phone: 801-357-7965
Email: officeofresearch@imail.org
Riverton
Status: Active
Contact: Site Public Contact
Phone: 801-507-3950
Email: officeofresearch@imail.org
Saint George
Status: Active
Contact: Site Public Contact
Phone: 435-688-4167
Email: officeofresearch@imail.org
Salt Lake City
Status: Active
Contact: Site Public Contact
Phone: 888-424-2100
Email: cancerinfo@hci.utah.edu
Status: Active
Contact: Site Public Contact
Phone: 801-408-1347
Email: officeofresearch@imail.org
Status: Active
Contact: Site Public Contact
Phone: 801-933-6070
Email: officeofresearch@imail.org
South Jordan
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-424-2100
Email: cancerinfo@hci.utah.edu
Washington
Auburn
Status: Active
Contact: Site Public Contact
Phone: 253-887-9333
Email: research@multicare.org
Gig Harbor
Status: Active
Contact: Site Public Contact
Phone: 253-403-2394
Email: research@multicare.org
Port Townsend
Status: Active
Contact: Site Public Contact
Phone: 360-344-3091
Puyallup
Status: Active
Contact: Site Public Contact
Phone: 800-351-7955
Email: research@multicare.org
Spokane
Status: Active
Contact: Site Public Contact
Phone: 253-402-7249
Email: research@multicare.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 253-403-7249
Email: research@multicare.org
Spokane Valley
Status: Active
Contact: Site Public Contact
Phone: 253-403-7249
Email: research@multicare.org
Tacoma
Status: Active
Contact: Site Public Contact
Phone: 253-403-1461
Email: research@multicare.org
Status: Active
Contact: Site Public Contact
Phone: 253-403-3229
Email: research@multicare.org
Wisconsin
New Richmond
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Wyoming
Cheyenne
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Cody
Status: Active
Contact: Site Public Contact
Phone: 800-996-2663
Email: research@billingsclinic.org
Sheridan
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
Treatment
Lead Organization
Lead Organization
SWOG
Principal Investigator
Kari L. Kendra