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

May 29, 2026 updated by: National Cancer Institute (NCI)

A Phase II and Pilot Trial of PD-1 Blockade With Pembrolizumab (MK-3475) in Patients With Resectable or Unresectable Desmoplastic Melanoma (DM)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the pathologic complete response rate (pCR) in patients with resectable desmoplastic melanoma treated with neoadjuvant pembrolizumab (MK-3475). (Cohort A) II. To evaluate the complete response rate (confirmed and unconfirmed) in patients with unresectable desmoplastic melanoma treated with pembrolizumab (MK-3475). (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 pembrolizumab (MK-3475) 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 pembrolizumab (MK-3475) 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 and circulating tumor deoxyribonucleic acid (DNA) profile from blood samples 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 enrolled 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.

Patients undergo computed tomography (CT) scan and may undergo position emission tomography (PET) and magnetic resonance imaging (MRI) throughout the study. Patients also undergo blood sample collection at screening and tumor biopsy throughout the study.

After completion of study treatment, patients are followed up at 6 weeks after the last dose, then every 12 weeks to the end of the first year, then every 6 months to the end of the fifth year after registration. After progression, patients are followed every 6 months for up to 2 years from the date of registration, then annually thereafter until 5 years from registration.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Fairbanks, Alaska, United States, 99701
        • Fairbanks Memorial Hospital
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Cancer Center at Saint Joseph's
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Mercy Hospital Fort Smith
      • Hot Springs, Arkansas, United States, 71913
        • CHI Saint Vincent Cancer Center Hot Springs
    • California
      • Arroyo Grande, California, United States, 93420
        • Mission Hope Medical Oncology - Arroyo Grande
      • Duarte, California, United States, 91010
        • City of Hope Comprehensive Cancer Center
      • Dublin, California, United States, 94568
        • Epic Care-Dublin
      • Emeryville, California, United States, 94608
        • Bay Area Breast Surgeons Inc
      • Emeryville, California, United States, 94608
        • Epic Care Partners in Cancer Care
      • Los Angeles, California, United States, 90033
        • USC / Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90095
        • UCLA / Jonsson Comprehensive Cancer Center
      • Los Angeles, California, United States, 90033
        • Los Angeles General Medical Center
      • Martinez, California, United States, 94553-3156
        • Contra Costa Regional Medical Center
      • Newport Beach, California, United States, 92663
        • USC Norris Oncology/Hematology-Newport Beach
      • Oakland, California, United States, 94609
        • Alta Bates Summit Medical Center - Summit Campus
      • Oakland, California, United States, 94609
        • Bay Area Tumor Institute
      • Pasadena, California, United States, 91105
        • Keck Medical Center of USC Pasadena
      • San Luis Obispo, California, United States, 93401
        • Pacific Central Coast Health Center-San Luis Obispo
      • Santa Maria, California, United States, 93444
        • Mission Hope Medical Oncology - Santa Maria
      • South Pasadena, California, United States, 91030
        • City of Hope South Pasadena
      • Upland, California, United States, 91786
        • City of Hope UPLAND
      • Walnut Creek, California, United States, 94597
        • Epic Care Cyberknife Center
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Centers-Aurora
      • Aurora, Colorado, United States, 80012
        • The Medical Center of Aurora
      • Boulder, Colorado, United States, 80303
        • Boulder Community Foothills Hospital
      • Boulder, Colorado, United States, 80304
        • Rocky Mountain Cancer Centers-Boulder
      • Centennial, Colorado, United States, 80112
        • Rocky Mountain Cancer Centers - Centennial
      • Colorado Springs, Colorado, United States, 80907
        • Penrose-Saint Francis Healthcare
      • Colorado Springs, Colorado, United States, 80907
        • Rocky Mountain Cancer Centers-Penrose
      • Denver, Colorado, United States, 80218
        • Presbyterian - Saint Lukes Medical Center - Health One
      • Denver, Colorado, United States, 80220
        • Rose Medical Center
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers-Midtown
      • Denver, Colorado, United States, 80220
        • Rocky Mountain Cancer Centers-Rose
      • Denver, Colorado, United States, 80218
        • Colorado Blood Cancer Institute
      • Denver, Colorado, United States, 80204
        • Cancer Center of Colorado at Sloan's Lake
      • Denver, Colorado, United States, 80209
        • The Women's Imaging Center
      • Denver, Colorado, United States, 80206
        • National Jewish Health-Main Campus
      • Denver, Colorado, United States, 80220
        • Western Surgical Care
      • Denver, Colorado, United States, 80218
        • Saint Joseph Hospital - Cancer Centers of Colorado
      • Denver, Colorado, United States, 80210
        • AdventHealth Porter
      • Durango, Colorado, United States, 81301
        • Mercy Medical Center
      • Durango, Colorado, United States, 81301
        • CommonSpirit Cancer Center Mercy
      • Englewood, Colorado, United States, 80113
        • Mountain Blue Cancer Care Center - Swedish
      • Englewood, Colorado, United States, 80113
        • Swedish Medical Center
      • Golden, Colorado, United States, 80401
        • National Jewish Health-Western Hematology Oncology
      • Grand Junction, Colorado, United States, 81501
        • Saint Mary's Hospital and Regional Medical Center
      • Grand Junction, Colorado, United States, 81505
        • Grand Valley Oncology
      • Greeley, Colorado, United States, 80631
        • Banner North Colorado Medical Center
      • Lafayette, Colorado, United States, 80026
        • Good Samaritan Hospital - Cancer Centers of Colorado
      • Lakewood, Colorado, United States, 80228
        • CommonSpirit Saint Anthony Hospital Cancer Center
      • Littleton, Colorado, United States, 80120
        • Rocky Mountain Cancer Centers-Littleton
      • Littleton, Colorado, United States, 80122
        • AdventHealth Littleton
      • Lone Tree, Colorado, United States, 80124
        • Sky Ridge Medical Center
      • Lone Tree, Colorado, United States, 80124
        • Rocky Mountain Cancer Centers-Sky Ridge
      • Longmont, Colorado, United States, 80501
        • Longmont United Hospital
      • Longmont, Colorado, United States, 80501
        • Rocky Mountain Cancer Centers-Longmont
      • Loveland, Colorado, United States, 80539
        • Banner North Colorado Medical Center - Loveland Campus
      • Parker, Colorado, United States, 80138
        • AdventHealth Parker
      • Pueblo, Colorado, United States, 81004
        • Saint Mary Corwin Medical Center
      • Thornton, Colorado, United States, 80260
        • National Jewish Health-Northern Hematology Oncology
      • Wheat Ridge, Colorado, United States, 80401
        • Intermountain Health Lutheran Hospital
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
    • Florida
      • Aventura, Florida, United States, 33180
        • Mount Sinai Comprehensive Cancer Center at Aventura
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
      • Tampa, Florida, United States, 33607
        • Moffitt Cancer Center-International Plaza
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center - McKinley Campus
    • Georgia
      • Savannah, Georgia, United States, 31405
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
      • Savannah, Georgia, United States, 31405
        • Summit Cancer Care-Candler
      • Savannah, Georgia, United States, 31404
        • Low Country Cancer Care
    • Idaho
      • Boise, Idaho, United States, 83706
        • Saint Alphonsus Cancer Care Center-Boise
      • Caldwell, Idaho, United States, 83605
        • Saint Alphonsus Cancer Care Center-Caldwell
      • Coeur d'Alene, Idaho, United States, 83814
        • Kootenai Health - Coeur d'Alene
      • Emmett, Idaho, United States, 83617
        • Walter Knox Memorial Hospital
      • Meridian, Idaho, United States, 83642
        • Idaho Urologic Institute-Meridian
      • Nampa, Idaho, United States, 83687
        • Saint Alphonsus Cancer Care Center-Nampa
      • Post Falls, Idaho, United States, 83854
        • Kootenai Clinic Cancer Services - Post Falls
      • Sandpoint, Idaho, United States, 83864
        • Kootenai Clinic Cancer Services - Sandpoint
    • Illinois
      • Alton, Illinois, United States, 62002
        • OSF Saint Anthony's Health Center
      • Aurora, Illinois, United States, 60504
        • Rush-Copley Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Danville, Illinois, United States, 61832
        • Carle at The Riverfront
      • Effingham, Illinois, United States, 62401
        • Carle Physician Group-Effingham
      • Geneva, Illinois, United States, 60134
        • Northwestern Medicine Cancer Center Delnor
      • Lake Forest, Illinois, United States, 60045
        • Northwestern Medicine Lake Forest Hospital
      • Mattoon, Illinois, United States, 61938
        • Carle Physician Group-Mattoon/Charleston
      • Mount Vernon, Illinois, United States, 62864
        • SSM Health Good Samaritan
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
      • Urbana, Illinois, United States, 61801
        • The Carle Foundation Hospital
      • Warrenville, Illinois, United States, 60555
        • Northwestern Medicine Cancer Center Warrenville
      • Yorkville, Illinois, United States, 60560
        • Rush-Copley Healthcare Center
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Deaconess Clinic Downtown
      • Newburgh, Indiana, United States, 47630
        • Chancellor Center for Oncology
    • Iowa
      • Clive, Iowa, United States, 50325
        • Mercy Cancer Center-West Lakes
      • Clive, Iowa, United States, 50325
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
      • Council Bluffs, Iowa, United States, 51503
        • Alegent Health Mercy Hospital
      • Creston, Iowa, United States, 50801
        • Greater Regional Medical Center
      • Des Moines, Iowa, United States, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, United States, 50314
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
      • West Des Moines, Iowa, United States, 50266
        • Mercy Medical Center-West Lakes
    • Kansas
      • Coffeyville, Kansas, United States, 67337
        • Coffeyville Regional Medical Center
      • Fairway, Kansas, United States, 66205
        • University of Kansas Clinical Research Center
      • Garden City, Kansas, United States, 67846
        • Central Care Cancer Center - Garden City
      • Great Bend, Kansas, United States, 67530
        • Central Care Cancer Center - Great Bend
      • Hays, Kansas, United States, 67601
        • HaysMed
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Cancer Center
      • Kansas City, Kansas, United States, 66112
        • University of Kansas Cancer Center-West
      • Lawrence, Kansas, United States, 66044
        • Lawrence Memorial Hospital
      • Lenexa, Kansas, United States, 66219
        • Kansas Institute of Medicine Cancer and Blood Center
      • Lenexa, Kansas, United States, 66219
        • Minimally Invasive Surgery Hospital
      • Olathe, Kansas, United States, 66061
        • The University of Kansas Cancer Center - Olathe
      • Overland Park, Kansas, United States, 66210
        • University of Kansas Cancer Center-Overland Park
      • Overland Park, Kansas, United States, 66209
        • Menorah Medical Center
      • Pittsburg, Kansas, United States, 66762
        • Mercy Hospital Pittsburg
      • Salina, Kansas, United States, 67401
        • Salina Regional Health Center
      • Topeka, Kansas, United States, 66606
        • University of Kansas Health System Saint Francis Campus
      • Westwood, Kansas, United States, 66205
        • University of Kansas Hospital-Westwood Cancer Center
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Flaget Memorial Hospital
      • Corbin, Kentucky, United States, 40701
        • Commonwealth Cancer Center-Corbin
      • Lexington, Kentucky, United States, 40504
        • Saint Joseph Radiation Oncology Resource Center
      • Lexington, Kentucky, United States, 40509
        • Saint Joseph Hospital East
      • London, Kentucky, United States, 40741
        • Saint Joseph London
      • Louisville, Kentucky, United States, 40202
        • Jewish Hospital
      • Louisville, Kentucky, United States, 40245
        • UofL Health Medical Center Northeast
      • Louisville, Kentucky, United States, 40215
        • Saints Mary and Elizabeth Hospital
      • Shepherdsville, Kentucky, United States, 40165
        • Jewish Hospital Medical Center South
    • Michigan
      • Brownstown, Michigan, United States, 48183
        • Henry Ford Cancer Institute-Downriver
      • Clinton Township, Michigan, United States, 48038
        • Henry Ford Macomb Hospital-Clinton Township
      • Dearborn, Michigan, United States, 48126
        • Henry Ford Medical Center-Fairlane
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Jackson, Michigan, United States, 49201
        • Allegiance Health
      • Monroe, Michigan, United States, 48162
        • Monroe Cancer Center
      • Novi, Michigan, United States, 48377
        • Henry Ford Medical Center-Columbus
      • Shelby, Michigan, United States, 48315
        • Henry Ford Macomb Health Center - Shelby Township
      • West Bloomfield, Michigan, United States, 48322
        • Henry Ford West Bloomfield Hospital
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Burnsville, Minnesota, United States, 55337
        • Minnesota Oncology - Burnsville
      • Cambridge, Minnesota, United States, 55008
        • Cambridge Medical Center
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, United States, 55432
        • Unity Hospital
      • Maple Grove, Minnesota, United States, 55369
        • Fairview Clinics and Surgery Center Maple Grove
      • Maplewood, Minnesota, United States, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, United States, 55454
        • Health Partners Inc
      • Monticello, Minnesota, United States, 55362
        • Monticello Cancer Center
      • New Ulm, Minnesota, United States, 56073
        • New Ulm Medical Center
      • Princeton, Minnesota, United States, 55371
        • Fairview Northland Medical Center
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Medical Health Center
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • Shakopee, Minnesota, United States, 55379
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, United States, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, United States, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology PA-Woodbury
      • Wyoming, Minnesota, United States, 55092
        • Fairview Lakes Medical Center
    • Mississippi
      • Pascagoula, Mississippi, United States, 39581
        • Singing River Hospital
    • Missouri
      • Ballwin, Missouri, United States, 63011
        • Mercy Oncology and Hematology - Clayton-Clarkson
      • Bolivar, Missouri, United States, 65613
        • Central Care Cancer Center - Bolivar
      • Branson, Missouri, United States, 65616
        • Cox Cancer Center Branson
      • Independence, Missouri, United States, 64057
        • Centerpoint Medical Center LLC
      • Joplin, Missouri, United States, 64804
        • Freeman Health System
      • Joplin, Missouri, United States, 64804
        • Mercy Hospital Joplin
      • Kansas City, Missouri, United States, 64154
        • University of Kansas Cancer Center - North
      • Kansas City, Missouri, United States, 64131
        • The University of Kansas Cancer Center-South
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
      • Kansas City, Missouri, United States, 64108
        • University Health Truman Medical Center
      • Lee's Summit, Missouri, United States, 64064
        • University of Kansas Cancer Center - Lee's Summit
      • Rolla, Missouri, United States, 65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Rolla, Missouri, United States, 65401
        • Phelps Health Delbert Day Cancer Institute
      • Saint Joseph, Missouri, United States, 64506
        • Heartland Regional Medical Center
      • Springfield, Missouri, United States, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, United States, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, United States, 63109
        • Mercy Infusion Center - Chippewa
      • St Louis, Missouri, United States, 63141
        • Mercy Hospital Saint Louis
      • St Louis, Missouri, United States, 63128
        • Mercy Hospital South
      • Washington, Missouri, United States, 63090
        • Mercy Hospital Washington
    • Montana
      • Anaconda, Montana, United States, 59711
        • Community Hospital of Anaconda
      • Billings, Montana, United States, 59101
        • Billings Clinic Cancer Center
      • Billings, Montana, United States, 59101
        • Saint Vincent Healthcare
      • Billings, Montana, United States, 59102
        • Saint Vincent Frontier Cancer Center
      • Bozeman, Montana, United States, 59715
        • Bozeman Health Deaconess Hospital
      • Butte, Montana, United States, 59701
        • Saint James Community Hospital and Cancer Treatment Center
      • Great Falls, Montana, United States, 59405
        • Great Falls Clinic
      • Great Falls, Montana, United States, 59405
        • Benefis Sletten Cancer Institute
      • Helena, Montana, United States, 59601
        • Saint Peter's Community Hospital
      • Kalispell, Montana, United States, 59901
        • Logan Health Medical Center
      • Missoula, Montana, United States, 59804
        • Community Medical Center
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Nebraska Cancer Specialists/Oncology Hematology West PC
      • Kearney, Nebraska, United States, 68847
        • CHI Health Good Samaritan
      • Lincoln, Nebraska, United States, 68510
        • Saint Elizabeth Regional Medical Center
      • Omaha, Nebraska, United States, 68124
        • Alegent Health Bergan Mercy Medical Center
      • Omaha, Nebraska, United States, 68122
        • Alegent Health Immanuel Medical Center
      • Omaha, Nebraska, United States, 68130
        • Alegent Health Lakeside Hospital
      • Omaha, Nebraska, United States, 68131
        • Creighton University Medical Center
      • Papillion, Nebraska, United States, 68046
        • Midlands Community Hospital
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
    • North Carolina
      • Clinton, North Carolina, United States, 28328
        • Southeastern Medical Oncology Center-Clinton
      • Goldsboro, North Carolina, United States, 27534
        • Southeastern Medical Oncology Center-Goldsboro
      • Goldsboro, North Carolina, United States, 27534
        • Wayne Memorial Hospital
      • Jacksonville, North Carolina, United States, 28546
        • Southeastern Medical Oncology Center-Jacksonville
      • Jacksonville, North Carolina, United States, 28546
        • Onslow Memorial Hospital
    • Ohio
      • Belpre, Ohio, United States, 45714
        • Strecker Cancer Center-Belpre
      • Chillicothe, Ohio, United States, 45601
        • Adena Regional Medical Center
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital - Cincinnati
      • Cincinnati, Ohio, United States, 45242
        • Bethesda North Hospital
      • Cincinnati, Ohio, United States, 45247
        • TriHealth Cancer Institute-Westside
      • Cincinnati, Ohio, United States, 45255
        • TriHealth Cancer Institute-Anderson
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center
      • Columbus, Ohio, United States, 43219
        • The Mark H Zangmeister Center
      • Columbus, Ohio, United States, 43214
        • Columbus Oncology and Hematology Associates Inc
      • Columbus, Ohio, United States, 43228
        • Doctors Hospital
      • Columbus, Ohio, United States, 43213
        • Mount Carmel East Hospital
      • Columbus, Ohio, United States, 43215
        • Grant Medical Center
      • Columbus, Ohio, United States, 43222
        • Mount Carmel Health Center West
      • Delaware, Ohio, United States, 43015
        • Delaware Health Center-Grady Cancer Center
      • Delaware, Ohio, United States, 43015
        • Delaware Radiation Oncology
      • Delaware, Ohio, United States, 43015
        • Grady Memorial Hospital
      • Dublin, Ohio, United States, 43016
        • Dublin Methodist Hospital
      • Grove City, Ohio, United States, 43123
        • Mount Carmel Grove City Hospital
      • Lancaster, Ohio, United States, 43130
        • Fairfield Medical Center
      • Lima, Ohio, United States, 45801
        • Saint Rita's Medical Center
      • Mansfield, Ohio, United States, 44903
        • OhioHealth Mansfield Hospital
      • Marietta, Ohio, United States, 45750
        • Marietta Memorial Hospital
      • Marion, Ohio, United States, 43302
        • OhioHealth Marion General Hospital
      • Mount Vernon, Ohio, United States, 43050
        • Knox Community Hospital
      • Newark, Ohio, United States, 43055
        • Licking Memorial Hospital
      • Newark, Ohio, United States, 43055
        • Newark Radiation Oncology
      • Perrysburg, Ohio, United States, 43551
        • Mercy Health - Perrysburg Hospital
      • Portsmouth, Ohio, United States, 45662
        • Southern Ohio Medical Center
      • Sylvania, Ohio, United States, 43560
        • ProMedica Flower Hospital
      • Toledo, Ohio, United States, 43606
        • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
      • Toledo, Ohio, United States, 43623
        • Mercy Health - Saint Anne Hospital
      • Toledo, Ohio, United States, 43608
        • Mercy Health - Saint Vincent Hospital
      • Westerville, Ohio, United States, 43081
        • Saint Ann's Hospital
      • Zanesville, Ohio, United States, 43701
        • Genesis Healthcare System Cancer Care Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
      • Oklahoma City, Oklahoma, United States, 73120
        • Mercy Hospital Oklahoma City
    • Oregon
      • Baker City, Oregon, United States, 97814
        • Saint Alphonsus Cancer Care Center-Baker City
      • Ontario, Oregon, United States, 97914
        • Saint Alphonsus Cancer Care Center-Ontario
    • Texas
      • Bryan, Texas, United States, 77802
        • Saint Joseph Regional Cancer Center
    • Utah
      • American Fork, Utah, United States, 84003
        • American Fork Hospital / Huntsman Intermountain Cancer Center
      • Cedar City, Utah, United States, 84720
        • Sandra L Maxwell Cancer Center
      • Farmington, Utah, United States, 84025
        • Farmington Health Center
      • Logan, Utah, United States, 84321
        • Logan Regional Hospital
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
      • Ogden, Utah, United States, 84403
        • McKay-Dee Hospital Center
      • Provo, Utah, United States, 84604
        • Utah Valley Regional Medical Center
      • Riverton, Utah, United States, 84065
        • Riverton Hospital
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute/University of Utah
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists-Salt Lake City
      • Salt Lake City, Utah, United States, 84143
        • LDS Hospital
      • South Jordan, Utah, United States, 84009
        • South Jordan Health Center
      • St. George, Utah, United States, 84770
        • Saint George Regional Medical Center
    • Washington
      • Auburn, Washington, United States, 98001
        • MultiCare Auburn Medical Center
      • Burien, Washington, United States, 98166
        • Highline Medical Center-Main Campus
      • Enumclaw, Washington, United States, 98022
        • Saint Elizabeth Hospital
      • Federal Way, Washington, United States, 98003
        • Saint Francis Hospital
      • Gig Harbor, Washington, United States, 98335
        • MultiCare Gig Harbor Medical Park
      • Lakewood, Washington, United States, 98499
        • Saint Clare Hospital
      • Port Townsend, Washington, United States, 98368
        • Jefferson Healthcare
      • Poulsbo, Washington, United States, 98370
        • Harrison HealthPartners Hematology and Oncology-Poulsbo
      • Puyallup, Washington, United States, 98372
        • MultiCare Good Samaritan Hospital
      • Silverdale, Washington, United States, 98383
        • Saint Joseph Medical Center Hematology and Oncology - Silverdale
      • Spokane, Washington, United States, 99204
        • MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
      • Spokane, Washington, United States, 99218
        • MultiCare Deaconess Cancer and Blood Specialty Center - North
      • Spokane Valley, Washington, United States, 99216
        • MultiCare Deaconess Cancer and Blood Specialty Center - Valley
      • Tacoma, Washington, United States, 98405
        • Mary Bridge Children's Hospital and Health Center
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties PLLC
      • Tacoma, Washington, United States, 98405
        • MultiCare Tacoma General Hospital
      • Tacoma, Washington, United States, 98405
        • Franciscan Research Center-Northwest Medical Plaza
    • Wisconsin
      • New Richmond, Wisconsin, United States, 54017
        • Cancer Center of Western Wisconsin
    • Wyoming
      • Cheyenne, Wyoming, United States, 82001
        • Cheyenne Regional Medical Center-West
      • Cody, Wyoming, United States, 82414
        • Billings Clinic-Cody
      • Sheridan, Wyoming, United States, 82801
        • Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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, 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
  • Patients must be >= 18 years of age
  • 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 generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed
  • Patients known to be human immunodeficiency virus (HIV) positive prior to registration 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A (pembrolizumab, surgery)
Patients receive pembrolizumab 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. Patients undergo CT scan and may undergo PET and MRI throughout the study. Patients also undergo blood sample collection at screening and tumor biopsy throughout the study.
Biological: Pembrolizumab
Given IV
Other Names:
  • Keytruda
  • MK-3475
  • Lambrolizumab
  • SCH 900475
  • MK3475
  • SCH-900475
  • BCD-201
  • Pembrolizumab Biosimilar BCD-201
  • Pembrolizumab Biosimilar QL2107
  • QL2107
  • GME 751
  • GME751
  • Pembrolizumab Biosimilar GME751
  • MK 3475
  • SCH900475
  • Pembrolizumab Biosimilar RPH-075
  • RPH 075
  • RPH-075
  • RPH075
  • Pembrolizumab Biosimilar SB27
  • SB 27
  • SB-27
  • SB27
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Procedure: Positron Emission Tomography
Undergo PET scan
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • PT
  • Positron emission tomography (procedure)
Procedure: Computed Tomography
Undergo CT scan
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
  • Diagnostic CAT Scan
  • Diagnostic CAT Scan Service Type
Procedure: Therapeutic Conventional Surgery
Undergo surgical resection
Procedure: Magnetic Resonance Elastography
Undergo MRI
Other Names:
  • MRE
Procedure: Biopsy Procedure
Undergo tumor biopsy
Other Names:
  • Bx
  • BIOPSY_TYPE
  • Biopsy
Experimental: Cohort B (pembrolizumab)
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. Patients undergo CT scan and may undergo PET and MRI throughout the study. Patients also undergo blood sample collection at screening and tumor biopsy throughout the study.
Biological: Pembrolizumab
Given IV
Other Names:
  • Keytruda
  • MK-3475
  • Lambrolizumab
  • SCH 900475
  • MK3475
  • SCH-900475
  • BCD-201
  • Pembrolizumab Biosimilar BCD-201
  • Pembrolizumab Biosimilar QL2107
  • QL2107
  • GME 751
  • GME751
  • Pembrolizumab Biosimilar GME751
  • MK 3475
  • SCH900475
  • Pembrolizumab Biosimilar RPH-075
  • RPH 075
  • RPH-075
  • RPH075
  • Pembrolizumab Biosimilar SB27
  • SB 27
  • SB-27
  • SB27
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Procedure: Positron Emission Tomography
Undergo PET scan
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • PT
  • Positron emission tomography (procedure)
Procedure: Computed Tomography
Undergo CT scan
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
  • Diagnostic CAT Scan
  • Diagnostic CAT Scan Service Type
Procedure: Therapeutic Conventional Surgery
Undergo surgical resection
Procedure: Biopsy Procedure
Undergo tumor biopsy
Other Names:
  • Bx
  • BIOPSY_TYPE
  • Biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathologic Complete Response (pCR) Rate (Cohort A)
Time Frame: Up to 5 years
Pathologic complete response is defined as no evidence of viable tumor cells on complete pathological evaluation of the surgical specimen per institutional standard of care.
Up to 5 years
Complete Response (CR) Rate (Cohort B)
Time Frame: Up to 5 years
Complete response (per RECIST 1.1) defined as: disappearance of all target and non-target lesions no new lesions, no disease related symptoms, and any lymph nodes must have reduction in short axis to < 1.0 cm.
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
9 Week Response Rate (Cohort A)
Time Frame: Up to 3 months
Unconfirmed complete (CR) and partial responses (PR) at end of neoadjuvant treatment assessment among patients with measurable disease. CR and PR per response evaluation criteria in solid tumors (RECIST v1.1): CR is complete disappearance of all target and non-target lesions, no new lesions, no disease related symptoms, and lymph nodes must have reduction in short axis to <1.0cm. PR is greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions, no unequivocal progression of non-measurable disease, and no new lesions. Overall response = CR + PR.
Up to 3 months
Overall Survival (Cohort A and B)
Time Frame: Up to 5 years
From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Up to 5 years
Progression Free Survival (Cohort B)
Time Frame: Up to 5 years
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive without report of progression are censored at date of last contact. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.1), as 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm, unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided), appearance of any new lesion/site, or death due to disease without prior documentation of progression and without symptomatic deterioration
Up to 5 years
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Time Frame: Duration of treatment and follow-up until death or 5 years post registration.
Only adverse events that are possibly, probably or definitely related to study drug are reported. CTCAE Version 4.0 was used for all AE reporting.
Duration of treatment and follow-up until death or 5 years post registration.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline Mutational Load (Cohort A and B)
Time Frame: Up to 5 years
Will assess the association between per megabase mutation rate and pCR or CR status.
Up to 5 years
Change in T-cell Infiltration (Cohort A and B)
Time Frame: Up to 5 years
Will compare change in CD8 expression following treatment between responders and non-responders.
Up to 5 years
ctDNA Fraction
Time Frame: Up to 5 years
Will assess the association between response and ctDNA fraction.
Up to 5 years
Clonality of Tumor Infiltrating T Cells (Cohort A and B)
Time Frame: Up to 5 years
Will compare change from baseline in TCR clonality metric between responders and non-responders.
Up to 5 years
Adaptive Immune Resistant Mechanism (Cohort A and B)
Time Frame: Up to 5 years
Will compare change in PD-L1 expression between responders and non-responders.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Kari L Kendra, SWOG Cancer Research Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2017

Primary Completion (Actual)

April 14, 2023

Study Completion (Estimated)

May 15, 2027

Study Registration Dates

First Submitted

May 16, 2016

First Submitted That Met QC Criteria

May 16, 2016

First Posted (Estimated)

May 18, 2016

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2016-00666 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA180888 (U.S. NIH Grant/Contract)
  • S1512 (Other Identifier: CTEP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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