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

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Active, not recruiting
CT.gov ID
NCT02775851
Collaborator
(none)
56
Enrollment
283
Locations
2
Arms
145.4
Anticipated Duration (Months)
0.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Pembrolizumab
  • Procedure: Therapeutic Conventional Surgery
 Phase 2

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:
  1. 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:

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

  2. 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.

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

  4. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
56 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II and Pilot Trial of PD-1 Blockade With Pembrolizumab (MK-3475) in Patients With Resectable or Unresectable Desmoplastic Melanoma (DM)
Actual Study Start Date :
Oct 20, 2016
Anticipated Primary Completion Date :
Dec 1, 2028
Anticipated Study Completion Date :
Dec 1, 2028

Arms and Interventions

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.

Biological: Pembrolizumab
Given IV
Other Names:
  • Keytruda
  • Lambrolizumab
  • MK-3475
  • SCH 900475

    • Procedure: Therapeutic Conventional Surgery
    Undergo surgical resection
    Active Comparator: 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.

    Biological: Pembrolizumab
    Given IV
    Other Names:
  • Keytruda
  • Lambrolizumab
  • MK-3475
  • SCH 900475

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pathologic complete response (pCR) rate (Cohort A) [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. Will assess the association between overall mutational load and pCR rate.

    2. Complete response (CR) rate (Cohort B) [Up to 5 years]

      Complete response defined as disappearance of all target and non-target lesions. Will assess the association between overall mutational load and CR rate.

    Secondary Outcome Measures

    1. Overall response rate (Cohort A) [At 9 weeks]

      Estimated with a 95% confidence interval.

    2. Overall survival rate (Cohort A and B) [At 9 weeks]

      Estimated with a 95% confidence interval.

    3. Progression free survival (Cohort A and B) [At 9 weeks]

      Estimated with a 95% confidence interval.

    4. Incidence of toxicity (Cohort A) [Up to 9 weeks]

      Will be measured by the National Cancer Institute Common Terminology for Adverse Events version 4.0. Toxicity will be assessed across all patients receiving pembrolizumab.

    Other Outcome Measures

    1. Change in CD8 expression (Cohort A and B) [Baseline up to week 9]

      Will examine whether change in T-cell infiltration following treatment is higher in the DM patients who respond. The change in CD8 expression will be computed and compared to the change between responders and non-responders using a two-sample t-test.

    2. Change in T-cell receptor clonality (Cohort A and B) [Baseline up to week 9]

      Will be compared between responders and non-responders using a two-sample t-test with significance determined at the two-sided alpha=0.05 level.

    3. Change in PD-L1 expression (Cohort A and B) [Baseline up to week 9]

      Will examine adaptive immune resistance by first evaluating whether PD-L1 expression is increased at week 4 and week 9 as compared to baseline using paired t-tests and controlling the type I error at the two-sided alpha=0.05 level. The change in expression will be computed and then compared to the change between responders and non-responders using a two-sample t-test.

    4. Circulating tumor deoxyribonucleic acid (ctDNA) fraction (Cohort A and B) [Baseline up to week 4]

      Will assess the association between response and ctDNA fraction using a two-sample t-test at the two-sided alpha=0.05 level.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 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 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

    Exclusion Criteria:

    • 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 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fairbanks Memorial Hospital Fairbanks Alaska United States 99701
    2 Cancer Center at Saint Joseph's Phoenix Arizona United States 85004
    3 Mercy Hospital Fort Smith Fort Smith Arkansas United States 72903
    4 CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas United States 71913
    5 Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California United States 93420
    6 City of Hope Comprehensive Cancer Center Duarte California United States 91010
    7 Epic Care-Dublin Dublin California United States 94568
    8 Bay Area Breast Surgeons Inc Emeryville California United States 94608
    9 Epic Care Partners in Cancer Care Emeryville California United States 94608
    10 Los Angeles County-USC Medical Center Los Angeles California United States 90033
    11 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033
    12 UCLA / Jonsson Comprehensive Cancer Center Los Angeles California United States 90095
    13 Contra Costa Regional Medical Center Martinez California United States 94553-3156
    14 USC Norris Oncology/Hematology-Newport Beach Newport Beach California United States 92663
    15 Alta Bates Summit Medical Center - Summit Campus Oakland California United States 94609
    16 Bay Area Tumor Institute Oakland California United States 94609
    17 Keck Medical Center of USC Pasadena Pasadena California United States 91105
    18 Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California United States 93401
    19 Mission Hope Medical Oncology - Santa Maria Santa Maria California United States 93444
    20 City of Hope South Pasadena South Pasadena California United States 91030
    21 City of Hope Upland Upland California United States 91786
    22 Epic Care Cyberknife Center Walnut Creek California United States 94597
    23 Rocky Mountain Cancer Centers-Aurora Aurora Colorado United States 80012
    24 The Medical Center of Aurora Aurora Colorado United States 80012
    25 Boulder Community Hospital Boulder Colorado United States 80301
    26 Boulder Community Foothills Hospital Boulder Colorado United States 80303
    27 Rocky Mountain Cancer Centers-Boulder Boulder Colorado United States 80304
    28 Rocky Mountain Cancer Centers - Centennial Centennial Colorado United States 80112
    29 Penrose-Saint Francis Healthcare Colorado Springs Colorado United States 80907
    30 Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado United States 80907
    31 Cancer Center of Colorado at Sloan's Lake Denver Colorado United States 80204
    32 National Jewish Health-Main Campus Denver Colorado United States 80206
    33 The Women's Imaging Center Denver Colorado United States 80209
    34 Porter Adventist Hospital Denver Colorado United States 80210
    35 Colorado Blood Cancer Institute Denver Colorado United States 80218
    36 Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado United States 80218
    37 Rocky Mountain Cancer Centers-Midtown Denver Colorado United States 80218
    38 SCL Health Saint Joseph Hospital Denver Colorado United States 80218
    39 Rocky Mountain Cancer Centers-Rose Denver Colorado United States 80220
    40 Rose Medical Center Denver Colorado United States 80220
    41 Western Surgical Care Denver Colorado United States 80220
    42 Mercy Medical Center Durango Colorado United States 81301
    43 Southwest Oncology PC Durango Colorado United States 81301
    44 Mountain Blue Cancer Care Center - Swedish Englewood Colorado United States 80113
    45 Swedish Medical Center Englewood Colorado United States 80113
    46 National Jewish Health-Western Hematology Oncology Golden Colorado United States 80401
    47 Saint Mary's Hospital and Regional Medical Center Grand Junction Colorado United States 81501
    48 Grand Valley Oncology Grand Junction Colorado United States 81505
    49 North Colorado Medical Center Greeley Colorado United States 80631
    50 Good Samaritan Medical Center Lafayette Colorado United States 80026
    51 Saint Anthony Hospital Lakewood Colorado United States 80228
    52 Rocky Mountain Cancer Centers-Littleton Littleton Colorado United States 80120
    53 Littleton Adventist Hospital Littleton Colorado United States 80122
    54 Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado United States 80124
    55 Sky Ridge Medical Center Lone Tree Colorado United States 80124
    56 Longmont United Hospital Longmont Colorado United States 80501
    57 Rocky Mountain Cancer Centers-Longmont Longmont Colorado United States 80501
    58 McKee Medical Center Loveland Colorado United States 80539
    59 Parker Adventist Hospital Parker Colorado United States 80138
    60 Saint Mary Corwin Medical Center Pueblo Colorado United States 81004
    61 National Jewish Health-Northern Hematology Oncology Thornton Colorado United States 80260
    62 SCL Health Lutheran Medical Center Wheat Ridge Colorado United States 80033
    63 Hartford Hospital Hartford Connecticut United States 06102
    64 Mount Sinai Comprehensive Cancer Center at Aventura Aventura Florida United States 33180
    65 Holy Cross Hospital Fort Lauderdale Florida United States 33308
    66 Mount Sinai Medical Center Miami Beach Florida United States 33140
    67 Moffitt Cancer Center-International Plaza Tampa Florida United States 33607
    68 Moffitt Cancer Center - McKinley Campus Tampa Florida United States 33612
    69 Moffitt Cancer Center Tampa Florida United States 33612
    70 Low Country Cancer Care Savannah Georgia United States 31404
    71 Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia United States 31405
    72 Summit Cancer Care-Candler Savannah Georgia United States 31405
    73 Saint Alphonsus Cancer Care Center-Boise Boise Idaho United States 83706
    74 Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho United States 83605
    75 Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho United States 83814
    76 Walter Knox Memorial Hospital Emmett Idaho United States 83617
    77 Idaho Urologic Institute-Meridian Meridian Idaho United States 83642
    78 Saint Alphonsus Medical Center-Nampa Nampa Idaho United States 83686
    79 Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho United States 83854
    80 Kootenai Cancer Clinic Sandpoint Idaho United States 83864
    81 Saint Anthony's Health Alton Illinois United States 62002
    82 Rush - Copley Medical Center Aurora Illinois United States 60504
    83 Northwestern University Chicago Illinois United States 60611
    84 Carle on Vermilion Danville Illinois United States 61832
    85 Carle Physician Group-Effingham Effingham Illinois United States 62401
    86 Northwestern Medicine Cancer Center Delnor Geneva Illinois United States 60134
    87 Northwestern Medicine Lake Forest Hospital Lake Forest Illinois United States 60045
    88 Carle Physician Group-Mattoon/Charleston Mattoon Illinois United States 61938
    89 Good Samaritan Regional Health Center Mount Vernon Illinois United States 62864
    90 Carle Cancer Center Urbana Illinois United States 61801
    91 The Carle Foundation Hospital Urbana Illinois United States 61801
    92 Northwestern Medicine Cancer Center Warrenville Warrenville Illinois United States 60555
    93 Rush-Copley Healthcare Center Yorkville Illinois United States 60560
    94 Deaconess Clinic Downtown Evansville Indiana United States 47713
    95 Chancellor Center for Oncology Newburgh Indiana United States 47630
    96 Medical Oncology and Hematology Associates-West Des Moines Clive Iowa United States 50325
    97 Mercy Cancer Center-West Lakes Clive Iowa United States 50325
    98 Alegent Health Mercy Hospital Council Bluffs Iowa United States 51503
    99 Greater Regional Medical Center Creston Iowa United States 50801
    100 Medical Oncology and Hematology Associates-Laurel Des Moines Iowa United States 50314
    101 Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
    102 Mercy Medical Center-West Lakes West Des Moines Iowa United States 50266
    103 Coffeyville Regional Medical Center Coffeyville Kansas United States 67337
    104 University of Kansas Clinical Research Center Fairway Kansas United States 66205
    105 Central Care Cancer Center - Garden City Garden City Kansas United States 67846
    106 Central Care Cancer Center - Great Bend Great Bend Kansas United States 67530
    107 HaysMed University of Kansas Health System Hays Kansas United States 67601
    108 University of Kansas Cancer Center-West Kansas City Kansas United States 66112
    109 University of Kansas Cancer Center Kansas City Kansas United States 66160
    110 Lawrence Memorial Hospital Lawrence Kansas United States 66044
    111 Kansas Institute of Medicine Cancer and Blood Center Lenexa Kansas United States 66219
    112 Minimally Invasive Surgery Hospital Lenexa Kansas United States 66219
    113 Olathe Health Cancer Center Olathe Kansas United States 66061
    114 Menorah Medical Center Overland Park Kansas United States 66209
    115 University of Kansas Cancer Center-Overland Park Overland Park Kansas United States 66210
    116 Ascension Via Christi - Pittsburg Pittsburg Kansas United States 66762
    117 Salina Regional Health Center Salina Kansas United States 67401
    118 University of Kansas Health System Saint Francis Campus Topeka Kansas United States 66606
    119 University of Kansas Hospital-Westwood Cancer Center Westwood Kansas United States 66205
    120 Flaget Memorial Hospital Bardstown Kentucky United States 40004
    121 Commonwealth Cancer Center-Corbin Corbin Kentucky United States 40701
    122 Saint Joseph Radiation Oncology Resource Center Lexington Kentucky United States 40504
    123 Saint Joseph Hospital East Lexington Kentucky United States 40509
    124 Saint Joseph London London Kentucky United States 40741
    125 Jewish Hospital Louisville Kentucky United States 40202
    126 Saints Mary and Elizabeth Hospital Louisville Kentucky United States 40215
    127 UofL Health Medical Center Northeast Louisville Kentucky United States 40245
    128 Jewish Hospital Medical Center South Shepherdsville Kentucky United States 40165
    129 Henry Ford Cancer Institute-Downriver Brownstown Michigan United States 48183
    130 Henry Ford Macomb Hospital-Clinton Township Clinton Township Michigan United States 48038
    131 Henry Ford Medical Center-Fairlane Dearborn Michigan United States 48126
    132 Henry Ford Hospital Detroit Michigan United States 48202
    133 Allegiance Health Jackson Michigan United States 49201
    134 Monroe Cancer Center Monroe Michigan United States 48162
    135 Henry Ford Medical Center-Columbus Novi Michigan United States 48377
    136 Henry Ford Macomb Health Center - Shelby Township Shelby Michigan United States 48315
    137 Henry Ford West Bloomfield Hospital West Bloomfield Michigan United States 48322
    138 Fairview Ridges Hospital Burnsville Minnesota United States 55337
    139 Minnesota Oncology - Burnsville Burnsville Minnesota United States 55337
    140 Cambridge Medical Center Cambridge Minnesota United States 55008
    141 Mercy Hospital Coon Rapids Minnesota United States 55433
    142 Fairview Southdale Hospital Edina Minnesota United States 55435
    143 Unity Hospital Fridley Minnesota United States 55432
    144 Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota United States 55369
    145 Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota United States 55109
    146 Saint John's Hospital - Healtheast Maplewood Minnesota United States 55109
    147 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
    148 Hennepin County Medical Center Minneapolis Minnesota United States 55415
    149 Health Partners Inc Minneapolis Minnesota United States 55454
    150 Monticello Cancer Center Monticello Minnesota United States 55362
    151 New Ulm Medical Center New Ulm Minnesota United States 56073
    152 Fairview Northland Medical Center Princeton Minnesota United States 55371
    153 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
    154 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
    155 Regions Hospital Saint Paul Minnesota United States 55101
    156 United Hospital Saint Paul Minnesota United States 55102
    157 Saint Francis Regional Medical Center Shakopee Minnesota United States 55379
    158 Lakeview Hospital Stillwater Minnesota United States 55082
    159 Ridgeview Medical Center Waconia Minnesota United States 55387
    160 Rice Memorial Hospital Willmar Minnesota United States 56201
    161 Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota United States 55125
    162 Fairview Lakes Medical Center Wyoming Minnesota United States 55092
    163 Singing River Hospital Pascagoula Mississippi United States 39581
    164 Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri United States 63011
    165 Central Care Cancer Center - Bolivar Bolivar Missouri United States 65613
    166 Cox Cancer Center Branson Branson Missouri United States 65616
    167 Centerpoint Medical Center LLC Independence Missouri United States 64057
    168 Freeman Health System Joplin Missouri United States 64804
    169 Mercy Hospital Joplin Joplin Missouri United States 64804
    170 Truman Medical Centers Kansas City Missouri United States 64108
    171 The University of Kansas Cancer Center-South Kansas City Missouri United States 64131
    172 Research Medical Center Kansas City Missouri United States 64132
    173 University of Kansas Cancer Center - North Kansas City Missouri United States 64154
    174 University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri United States 64064
    175 Delbert Day Cancer Institute at PCRMC Rolla Missouri United States 65401
    176 Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri United States 65401
    177 Heartland Regional Medical Center Saint Joseph Missouri United States 64506
    178 Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri United States 63109
    179 Mercy Hospital South Saint Louis Missouri United States 63128
    180 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    181 Mercy Hospital Springfield Springfield Missouri United States 65804
    182 CoxHealth South Hospital Springfield Missouri United States 65807
    183 Mercy Hospital Washington Washington Missouri United States 63090
    184 Community Hospital of Anaconda Anaconda Montana United States 59711
    185 Billings Clinic Cancer Center Billings Montana United States 59101
    186 Saint Vincent Healthcare Billings Montana United States 59101
    187 Saint Vincent Frontier Cancer Center Billings Montana United States 59102
    188 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    189 Saint James Community Hospital and Cancer Treatment Center Butte Montana United States 59701
    190 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    191 Great Falls Clinic Great Falls Montana United States 59405
    192 Saint Peter's Community Hospital Helena Montana United States 59601
    193 Kalispell Regional Medical Center Kalispell Montana United States 59901
    194 Community Medical Hospital Missoula Montana United States 59804
    195 CHI Health Saint Francis Grand Island Nebraska United States 68803
    196 CHI Health Good Samaritan Kearney Nebraska United States 68847
    197 Saint Elizabeth Regional Medical Center Lincoln Nebraska United States 68510
    198 Alegent Health Immanuel Medical Center Omaha Nebraska United States 68122
    199 Alegent Health Bergan Mercy Medical Center Omaha Nebraska United States 68124
    200 Alegent Health Lakeside Hospital Omaha Nebraska United States 68130
    201 Creighton University Medical Center Omaha Nebraska United States 68131
    202 Midlands Community Hospital Papillion Nebraska United States 68046
    203 Roswell Park Cancer Institute Buffalo New York United States 14263
    204 Southeastern Medical Oncology Center-Clinton Clinton North Carolina United States 28328
    205 Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina United States 27534
    206 Wayne Memorial Hospital Goldsboro North Carolina United States 27534
    207 Onslow Memorial Hospital Jacksonville North Carolina United States 28546
    208 Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina United States 28546
    209 Strecker Cancer Center-Belpre Belpre Ohio United States 45714
    210 Adena Regional Medical Center Chillicothe Ohio United States 45601
    211 Good Samaritan Hospital - Cincinnati Cincinnati Ohio United States 45220
    212 Bethesda North Hospital Cincinnati Ohio United States 45242
    213 TriHealth Cancer Institute-Westside Cincinnati Ohio United States 45247
    214 TriHealth Cancer Institute-Anderson Cincinnati Ohio United States 45255
    215 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
    216 Mount Carmel East Hospital Columbus Ohio United States 43213
    217 Columbus Oncology and Hematology Associates Inc Columbus Ohio United States 43214
    218 Riverside Methodist Hospital Columbus Ohio United States 43214
    219 Grant Medical Center Columbus Ohio United States 43215
    220 The Mark H Zangmeister Center Columbus Ohio United States 43219
    221 Mount Carmel Health Center West Columbus Ohio United States 43222
    222 Doctors Hospital Columbus Ohio United States 43228
    223 Delaware Health Center-Grady Cancer Center Delaware Ohio United States 43015
    224 Delaware Radiation Oncology Delaware Ohio United States 43015
    225 Grady Memorial Hospital Delaware Ohio United States 43015
    226 Dublin Methodist Hospital Dublin Ohio United States 43016
    227 Mount Carmel Grove City Hospital Grove City Ohio United States 43123
    228 Fairfield Medical Center Lancaster Ohio United States 43130
    229 Saint Rita's Medical Center Lima Ohio United States 45801
    230 OhioHealth Mansfield Hospital Mansfield Ohio United States 44903
    231 Marietta Memorial Hospital Marietta Ohio United States 45750
    232 OhioHealth Marion General Hospital Marion Ohio United States 43302
    233 Knox Community Hospital Mount Vernon Ohio United States 43050
    234 Licking Memorial Hospital Newark Ohio United States 43055
    235 Newark Radiation Oncology Newark Ohio United States 43055
    236 Mercy Health Perrysburg Cancer Center Perrysburg Ohio United States 43551
    237 Southern Ohio Medical Center Portsmouth Ohio United States 45662
    238 ProMedica Flower Hospital Sylvania Ohio United States 43560
    239 ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio United States 43606
    240 Saint Vincent Mercy Medical Center Toledo Ohio United States 43608
    241 Mercy Health - Saint Anne Hospital Toledo Ohio United States 43623
    242 Saint Ann's Hospital Westerville Ohio United States 43081
    243 Genesis Healthcare System Cancer Care Center Zanesville Ohio United States 43701
    244 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    245 Mercy Hospital Oklahoma City Oklahoma City Oklahoma United States 73120
    246 Saint Alphonsus Medical Center-Baker City Baker City Oregon United States 97814
    247 Saint Alphonsus Medical Center-Ontario Ontario Oregon United States 97914
    248 Saint Joseph Regional Cancer Center Bryan Texas United States 77802
    249 American Fork Hospital / Huntsman Intermountain Cancer Center American Fork Utah United States 84003
    250 Sandra L Maxwell Cancer Center Cedar City Utah United States 84720
    251 Farmington Health Center Farmington Utah United States 84025
    252 Logan Regional Hospital Logan Utah United States 84321
    253 Intermountain Medical Center Murray Utah United States 84107
    254 McKay-Dee Hospital Center Ogden Utah United States 84403
    255 Utah Valley Regional Medical Center Provo Utah United States 84604
    256 Riverton Hospital Riverton Utah United States 84065
    257 Saint George Regional Medical Center Saint George Utah United States 84770
    258 Utah Cancer Specialists-Salt Lake City Salt Lake City Utah United States 84106
    259 Huntsman Cancer Institute/University of Utah Salt Lake City Utah United States 84112
    260 LDS Hospital Salt Lake City Utah United States 84143
    261 South Jordan Health Center South Jordan Utah United States 84009
    262 MultiCare Auburn Medical Center Auburn Washington United States 98001
    263 Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington United States 98310
    264 Harrison Medical Center Bremerton Washington United States 98310
    265 Highline Medical Center-Main Campus Burien Washington United States 98166
    266 Saint Elizabeth Hospital Enumclaw Washington United States 98022
    267 Saint Francis Hospital Federal Way Washington United States 98003
    268 MultiCare Gig Harbor Medical Park Gig Harbor Washington United States 98335
    269 Saint Clare Hospital Lakewood Washington United States 98499
    270 Jefferson Healthcare Port Townsend Washington United States 98368
    271 Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo Washington United States 98370
    272 MultiCare Good Samaritan Hospital Puyallup Washington United States 98372
    273 MultiCare Deaconess Cancer and Blood Specialty Center - Valley Spokane Valley Washington United States 99216
    274 MultiCare Deaconess Cancer and Blood Specialty Center - Downtown Spokane Washington United States 99204
    275 MultiCare Deaconess Cancer and Blood Specialty Center - North Spokane Washington United States 99218
    276 Franciscan Research Center-Northwest Medical Plaza Tacoma Washington United States 98405
    277 Mary Bridge Children's Hospital and Health Center Tacoma Washington United States 98405
    278 MultiCare Tacoma General Hospital Tacoma Washington United States 98405
    279 Northwest Medical Specialties PLLC Tacoma Washington United States 98405
    280 Cancer Center of Western Wisconsin New Richmond Wisconsin United States 54017
    281 Cheyenne Regional Medical Center-West Cheyenne Wyoming United States 82001
    282 Billings Clinic-Cody Cody Wyoming United States 82414
    283 Welch Cancer Center Sheridan Wyoming United States 82801

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Kari L Kendra, Southwest Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT02775851
    Other Study ID Numbers:
    • NCI-2016-00666
    • NCI-2016-00666
    • S1512
    • S1512
    • S1512
    • U10CA180888
    First Posted:
    May 18, 2016
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Apr 1, 2022
    Additional relevant MeSH terms:
    Melanoma
    Pembrolizumab

    Study Results

    No Results Posted as of Jun 30, 2022