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Active, not recruitingNCT02775851Updated Jul 7, 2026Results posted

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

A Phase 2 interventional study of Biopsy Procedure and Biospecimen Collection in Desmoplastic Melanoma, sponsored by National Cancer Institute (NCI). Active, not recruiting at 280 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
57
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Desmoplastic Melanoma
03

In context

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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, 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
57 participants (actual)

Study arms

  • 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.

    Procedure: Biopsy Procedure · Procedure: Biospecimen Collection · Procedure: Computed Tomography · Procedure: Magnetic Resonance Elastography · Biological: Pembrolizumab · Procedure: Positron Emission Tomography · Procedure: Therapeutic Conventional Surgery

  • 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.

    Procedure: Biopsy Procedure · Procedure: Biospecimen Collection · Procedure: Computed Tomography · Biological: Pembrolizumab · Procedure: Positron Emission Tomography · Procedure: Therapeutic Conventional Surgery

Interventions

  • ProcedureBiopsy Procedure

    Undergo tumor biopsy

    Also known as: Biopsy, BIOPSY_TYPE, Bx

  • ProcedureBiospecimen Collection

    Undergo blood sample collection

    Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

  • ProcedureComputed Tomography

    Undergo CT scan

    Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

  • ProcedureMagnetic Resonance Elastography

    Undergo MRI

    Also known as: MRE

  • BiologicalPembrolizumab

    Given IV

    Also known as: BCD-201, GME 751, GME751, Keytruda, Lambrolizumab, MK 3475, MK-3475, MK3475, Pembrolizumab Biosimilar BCD-201, Pembrolizumab Biosimilar GME751, Pembrolizumab Biosimilar QL2107, Pembrolizumab Biosimilar RPH-075, Pembrolizumab Biosimilar SB27, QL2107, RPH 075, RPH-075, RPH075, SB 27, SB-27, SB27, SCH 900475, SCH-900475, SCH900475

  • ProcedurePositron Emission Tomography

    Undergo PET scan

    Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

  • ProcedureTherapeutic Conventional Surgery

    Undergo surgical resection

06

What researchers measure

Primary outcomes

  1. Pathologic Complete Response (pCR) Rate (Cohort A)

    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.

    Time frame: Up to 5 years

  2. Complete Response (CR) Rate (Cohort B)

    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.

    Time frame: Up to 5 years

Secondary outcomes

  1. 9 Week Response Rate (Cohort A)

    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.

    Time frame: Up to 3 months

  2. Overall Survival (Cohort A and B)

    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.

    Time frame: Up to 5 years

  3. Progression Free Survival (Cohort B)

    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

    Time frame: Up to 5 years

  4. Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

    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.

    Time frame: Duration of treatment and follow-up until death or 5 years post registration.

Other outcomes

  1. Baseline Mutational Load (Cohort A and B)

    Will assess the association between per megabase mutation rate and pCR or CR status.

    Time frame: Up to 5 years

  2. Change in T-cell Infiltration (Cohort A and B)

    Will compare change in CD8 expression following treatment between responders and non-responders.

    Time frame: Up to 5 years

  3. ctDNA Fraction

    Will assess the association between response and ctDNA fraction.

    Time frame: Up to 5 years

  4. Clonality of Tumor Infiltrating T Cells (Cohort A and B)

    Will compare change from baseline in TCR clonality metric between responders and non-responders.

    Time frame: Up to 5 years

  5. Adaptive Immune Resistant Mechanism (Cohort A and B)

    Will compare change in PD-L1 expression between responders and non-responders.

    Time frame: Up to 5 years

07

Results

Posted Apr 23, 2024

Participant flow

Participant flow — Overall Study
MilestoneCohort A: Resectable - Pembrolizumab, SurgeryCohort B: Unresectable - Pembrolizumab
Started3027
Completed285
Not completed222
Withdrew: Adverse event110
Withdrew: Refusal unrelated to adverse event01
Withdrew: Progression/relapse04
Withdrew: Other - not protocol specified07
Withdrew: Withdrawal by subject10

Outcome measures

PrimaryPathologic Complete Response (pCR) Rate (Cohort A)

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.

Time frame:
Up to 5 years
Reported as:
Number · percentage of participants
Pathologic Complete Response (pCR) Rate (Cohort A)
percentage of participantsCohort A: Resectable - Pembrolizumab, Surgery
Pathologic Complete Response (pCR) Rate (Cohort A)55 (36 to 74)
Statistical analysis
  • Cohort A: Resectable - Pembrolizumab, Surgery · One-sided Exact Binomial · p = <0.001
PrimaryComplete Response (CR) Rate (Cohort B)

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.

Time frame:
Up to 5 years
Reported as:
Number · percentage of participants
Complete Response (CR) Rate (Cohort B)
percentage of participantsCohort B: Unresectable - Pembrolizumab
Complete Response (CR) Rate (Cohort B)37 (19 to 58)
Statistical analysis
  • Cohort B: Unresectable - Pembrolizumab · One-sided Exact Binomial · p = <0.001
Secondary9 Week Response Rate (Cohort A)

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.

Time frame:
Up to 3 months
Reported as:
Number · percentage of participants
9 Week Response Rate (Cohort A)
percentage of participantsCohort A: Resectable - Pembrolizumab, Surgery
9 Week Response Rate (Cohort A)46 (27 to 67)
SecondaryOverall Survival (Cohort A and B)

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.

Time frame:
Up to 5 years
Reported as:
Median · months
Overall Survival (Cohort A and B)
monthsCohort A: Resectable - Pembrolizumab, SurgeryCohort B: Unresectable - Pembrolizumab
Overall Survival (Cohort A and B)NA (37.0 to NA)50.6 (42.4 to NA)
SecondaryProgression Free Survival (Cohort B)

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

Time frame:
Up to 5 years
Reported as:
Median · months
Progression Free Survival (Cohort B)
monthsCohort B: Unresectable - Pembrolizumab
Progression Free Survival (Cohort B)49.2 (33.3 to NA)
SecondaryNumber of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

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.

Time frame:
Duration of treatment and follow-up until death or 5 years post registration.
Reported as:
Number · Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
ParticipantsCohort A: MK-3475 (Pembrolizumab)Cohort B: MK-3475 (Pembrolizumab)
Abdominal pain01
Adrenal insufficiency01
Back pain01
CPK increased01
Colitis12
Diarrhea02
Dyspnea01
Hypokalemia01
Hypoxia01
Immune system disorders - Other, specify01
Lipase increased01
Lung infection01
Mucositis oral10
Musculoskeletal and connective tiss disorder - Other01
Myositis01
Pancreatitis02
Rash maculo-papular02
Sepsis01
Skin and subcutaneous tissue disorders - Other01
Upper gastrointestinal hemorrhage01
Other pre-specifiedBaseline Mutational Load (Cohort A and B)

Will assess the association between per megabase mutation rate and pCR or CR status.

Time frame:
Up to 5 years

Results for this outcome have not been posted.

Other pre-specifiedChange in T-cell Infiltration (Cohort A and B)

Will compare change in CD8 expression following treatment between responders and non-responders.

Time frame:
Up to 5 years

Results for this outcome have not been posted.

Other pre-specifiedctDNA Fraction

Will assess the association between response and ctDNA fraction.

Time frame:
Up to 5 years

Results for this outcome have not been posted.

Other pre-specifiedClonality of Tumor Infiltrating T Cells (Cohort A and B)

Will compare change from baseline in TCR clonality metric between responders and non-responders.

Time frame:
Up to 5 years

Results for this outcome have not been posted.

Other pre-specifiedAdaptive Immune Resistant Mechanism (Cohort A and B)

Will compare change in PD-L1 expression between responders and non-responders.

Time frame:
Up to 5 years

Results for this outcome have not been posted.

Adverse events

Collected over Duration of treatment and follow up until death or 5 years post registration.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort A: MK-3475 (Pembrolizumab)5/29 (17.2%)1/29 (3.4%)23/29 (79.3%)
Cohort B: MK-3475 (Pembrolizumab)10/27 (37%)14/27 (51.9%)25/27 (92.6%)
Most frequent serious events
Showing 10 of 29
Most frequent serious events
EventCohort A: MK-3475 (Pembrolizumab)Cohort B: MK-3475 (Pembrolizumab)
DyspneaRespiratory, thoracic and mediastinal disorders0/293/27
Adrenal insufficiencyEndocrine disorders0/292/27
ColitisGastrointestinal disorders0/292/27
DiarrheaGastrointestinal disorders0/292/27
PancreatitisGastrointestinal disorders0/292/27
Lung infectionInfections and infestations0/292/27
AnemiaBlood and lymphatic system disorders0/291/27
Febrile neutropeniaBlood and lymphatic system disorders0/291/27
Atrial fibrillationCardiac disorders0/291/27
Heart failureCardiac disorders0/291/27
Most frequent other events
Showing 10 of 70
Most frequent other events
EventCohort A: MK-3475 (Pembrolizumab)Cohort B: MK-3475 (Pembrolizumab)
FatigueGeneral disorders16/2920/27
AnemiaBlood and lymphatic system disorders4/2911/27
DiarrheaGastrointestinal disorders8/299/27
Rash maculo-papularSkin and subcutaneous tissue disorders6/298/27
Skin and subcutaneous tissue disorders - OtherSkin and subcutaneous tissue disorders2/298/27
Lymphocyte count decreasedInvestigations2/297/27
HyperglycemiaMetabolism and nutrition disorders0/297/27
CoughRespiratory, thoracic and mediastinal disorders2/297/27
ConstipationGastrointestinal disorders4/296/27
PainGeneral disorders4/296/27

Baseline characteristics

Age, Customized
Age, Customized(years)Cohort A: Resectable - Pembrolizumab, SurgeryCohort B: Unresectable - PembrolizumabTotal
Age74.7 (37.3 to 91.1)75.2 (58.7 to 89.6)74.9 (37.3 to 91.1)
Sex: Female, Male
Sex: Female, Male(Participants)Cohort A: Resectable - Pembrolizumab, SurgeryCohort B: Unresectable - PembrolizumabTotal
Female729
Male222547
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Cohort A: Resectable - Pembrolizumab, SurgeryCohort B: Unresectable - PembrolizumabTotal
Hispanic or Latino101
Not Hispanic or Latino262652
Unknown or Not Reported213
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Cohort A: Resectable - Pembrolizumab, SurgeryCohort B: Unresectable - PembrolizumabTotal
Race — White282755
Race — Unknown101
Performance Status
Performance Status(Participants)Cohort A: Resectable - Pembrolizumab, SurgeryCohort B: Unresectable - PembrolizumabTotal
0221941
17815
T Stage
T Stage(Participants)Cohort A: Resectable - Pembrolizumab, SurgeryCohort B: Unresectable - PembrolizumabTotal
Tis011
T0022
T1a112
T1b202
T2a617
T2b112
T3a7411
T3b123
T4a8816
T4b257
Tx101
Unknown022
N Stage
N Stage(Participants)Cohort A: Resectable - Pembrolizumab, SurgeryCohort B: Unresectable - PembrolizumabTotal
N0241236
N1b224
N2a011
N2b022
N2c314
N3022
NX044
Unknown033
M Stage
M Stage(Participants)Cohort A: Resectable - Pembrolizumab, SurgeryCohort B: Unresectable - PembrolizumabTotal
M029837
M1a011
M1b01111
M1c077
08

Study locations

280 sites
  • Fairbanks Memorial Hospital
    Fairbanks, Alaska 99701, United States
  • Cancer Center at Saint Joseph's
    Phoenix, Arizona 85004, United States
  • Mercy Hospital Fort Smith
    Fort Smith, Arkansas 72903, United States
  • CHI Saint Vincent Cancer Center Hot Springs
    Hot Springs, Arkansas 71913, United States
  • Mission Hope Medical Oncology - Arroyo Grande
    Arroyo Grande, California 93420, United States
  • City of Hope Comprehensive Cancer Center
    Duarte, California 91010, United States
  • Epic Care-Dublin
    Dublin, California 94568, United States
  • Bay Area Breast Surgeons Inc
    Emeryville, California 94608, United States
  • Epic Care Partners in Cancer Care
    Emeryville, California 94608, United States
  • Los Angeles General Medical Center
    Los Angeles, California 90033, United States
  • USC / Norris Comprehensive Cancer Center
    Los Angeles, California 90033, United States
  • UCLA / Jonsson Comprehensive Cancer Center
    Los Angeles, California 90095, United States
  • Contra Costa Regional Medical Center
    Martinez, California 94553-3156, United States
  • USC Norris Oncology/Hematology-Newport Beach
    Newport Beach, California 92663, United States
  • Alta Bates Summit Medical Center - Summit Campus
    Oakland, California 94609, United States
  • Bay Area Tumor Institute
    Oakland, California 94609, United States
  • Keck Medical Center of USC Pasadena
    Pasadena, California 91105, United States
  • Pacific Central Coast Health Center-San Luis Obispo
    San Luis Obispo, California 93401, United States
  • Mission Hope Medical Oncology - Santa Maria
    Santa Maria, California 93444, United States
  • City of Hope South Pasadena
    South Pasadena, California 91030, United States
  • City of Hope Upland
    Upland, California 91786, United States
  • Epic Care Cyberknife Center
    Walnut Creek, California 94597, United States
  • Rocky Mountain Cancer Centers-Aurora
    Aurora, Colorado 80012, United States
  • The Medical Center of Aurora
    Aurora, Colorado 80012, United States
  • Boulder Community Foothills Hospital
    Boulder, Colorado 80303, United States
  • Rocky Mountain Cancer Centers-Boulder
    Boulder, Colorado 80304, United States
  • Rocky Mountain Cancer Centers - Centennial
    Centennial, Colorado 80112, United States
  • Penrose-Saint Francis Healthcare
    Colorado Springs, Colorado 80907, United States
  • Rocky Mountain Cancer Centers-Penrose
    Colorado Springs, Colorado 80907, United States
  • Cancer Center of Colorado at Sloan's Lake
    Denver, Colorado 80204, United States
  • National Jewish Health-Main Campus
    Denver, Colorado 80206, United States
  • The Women's Imaging Center
    Denver, Colorado 80209, United States
  • AdventHealth Porter
    Denver, Colorado 80210, United States
  • Colorado Blood Cancer Institute
    Denver, Colorado 80218, United States
  • Presbyterian - Saint Lukes Medical Center - Health One
    Denver, Colorado 80218, United States
  • Rocky Mountain Cancer Centers-Midtown
    Denver, Colorado 80218, United States
  • Saint Joseph Hospital - Cancer Centers of Colorado
    Denver, Colorado 80218, United States
  • Rocky Mountain Cancer Centers-Rose
    Denver, Colorado 80220, United States
  • Rose Medical Center
    Denver, Colorado 80220, United States
  • Western Surgical Care
    Denver, Colorado 80220, United States
  • CommonSpirit Cancer Center Mercy
    Durango, Colorado 81301, United States
  • Mercy Medical Center
    Durango, Colorado 81301, United States
  • Mountain Blue Cancer Care Center - Swedish
    Englewood, Colorado 80113, United States
  • Swedish Medical Center
    Englewood, Colorado 80113, United States
  • National Jewish Health-Western Hematology Oncology
    Golden, Colorado 80401, United States
  • Saint Mary's Hospital and Regional Medical Center
    Grand Junction, Colorado 81501, United States
  • Grand Valley Oncology
    Grand Junction, Colorado 81505, United States
  • Banner North Colorado Medical Center
    Greeley, Colorado 80631, United States
  • Good Samaritan Hospital - Cancer Centers of Colorado
    Lafayette, Colorado 80026, United States
  • CommonSpirit Saint Anthony Hospital Cancer Center
    Lakewood, Colorado 80228, United States
  • Rocky Mountain Cancer Centers-Littleton
    Littleton, Colorado 80120, United States
  • AdventHealth Littleton
    Littleton, Colorado 80122, United States
  • Rocky Mountain Cancer Centers-Sky Ridge
    Lone Tree, Colorado 80124, United States
  • Sky Ridge Medical Center
    Lone Tree, Colorado 80124, United States
  • Longmont United Hospital
    Longmont, Colorado 80501, United States
  • Rocky Mountain Cancer Centers-Longmont
    Longmont, Colorado 80501, United States
  • Banner North Colorado Medical Center - Loveland Campus
    Loveland, Colorado 80539, United States
  • AdventHealth Parker
    Parker, Colorado 80138, United States
  • Saint Mary Corwin Medical Center
    Pueblo, Colorado 81004, United States
  • National Jewish Health-Northern Hematology Oncology
    Thornton, Colorado 80260, United States
  • Intermountain Health Lutheran Hospital
    Wheat Ridge, Colorado 80401, United States
  • Hartford Hospital
    Hartford, Connecticut 06102, United States
  • Mount Sinai Comprehensive Cancer Center at Aventura
    Aventura, Florida 33180, United States
  • Holy Cross Hospital
    Fort Lauderdale, Florida 33308, United States
  • Mount Sinai Medical Center
    Miami Beach, Florida 33140, United States
  • Moffitt Cancer Center-International Plaza
    Tampa, Florida 33607, United States
  • Moffitt Cancer Center - McKinley Campus
    Tampa, Florida 33612, United States
  • Moffitt Cancer Center
    Tampa, Florida 33612, United States
  • Low Country Cancer Care
    Savannah, Georgia 31404, United States
  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
    Savannah, Georgia 31405, United States
  • Summit Cancer Care-Candler
    Savannah, Georgia 31405, United States
  • Saint Alphonsus Cancer Care Center-Boise
    Boise, Idaho 83706, United States
  • Saint Alphonsus Cancer Care Center-Caldwell
    Caldwell, Idaho 83605, United States
  • Kootenai Health - Coeur d'Alene
    Coeur d'Alene, Idaho 83814, United States
  • Walter Knox Memorial Hospital
    Emmett, Idaho 83617, United States
  • Idaho Urologic Institute-Meridian
    Meridian, Idaho 83642, United States
  • Saint Alphonsus Cancer Care Center-Nampa
    Nampa, Idaho 83687, United States
  • Kootenai Clinic Cancer Services - Post Falls
    Post Falls, Idaho 83854, United States
  • Kootenai Clinic Cancer Services - Sandpoint
    Sandpoint, Idaho 83864, United States
  • OSF Saint Anthony's Health Center
    Alton, Illinois 62002, United States
  • Rush-Copley Medical Center
    Aurora, Illinois 60504, United States
  • Northwestern University
    Chicago, Illinois 60611, United States
  • Carle at The Riverfront
    Danville, Illinois 61832, United States
  • Carle Physician Group-Effingham
    Effingham, Illinois 62401, United States
  • Northwestern Medicine Cancer Center Delnor
    Geneva, Illinois 60134, United States
  • Northwestern Medicine Lake Forest Hospital
    Lake Forest, Illinois 60045, United States
  • Carle Physician Group-Mattoon/Charleston
    Mattoon, Illinois 61938, United States
  • SSM Health Good Samaritan
    Mount Vernon, Illinois 62864, United States
  • Carle Cancer Center
    Urbana, Illinois 61801, United States
  • The Carle Foundation Hospital
    Urbana, Illinois 61801, United States
  • Northwestern Medicine Cancer Center Warrenville
    Warrenville, Illinois 60555, United States
  • Rush-Copley Healthcare Center
    Yorkville, Illinois 60560, United States
  • Deaconess Clinic Downtown
    Evansville, Indiana 47713, United States
  • Chancellor Center for Oncology
    Newburgh, Indiana 47630, United States
  • Mercy Cancer Center-West Lakes
    Clive, Iowa 50325, United States
  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
    Clive, Iowa 50325, United States
  • Alegent Health Mercy Hospital
    Council Bluffs, Iowa 51503, United States
  • Greater Regional Medical Center
    Creston, Iowa 50801, United States
  • Mercy Medical Center - Des Moines
    Des Moines, Iowa 50314, United States
  • UI Health Care Mission Cancer and Blood - Laurel Clinic
    Des Moines, Iowa 50314, United States

Showing the first 100 of 280 sites.

09

References and documents

Publications

  • Kendra KL, Bellasea SL, Eroglu Z, Hu-Lieskovan S, Campbell KM, Carson WE 3rd, Wada DA, Plaza JA, In GK, Ikeguchi A, Hyngstrom J, Brohl AS, Chmielowski B, Khushalani NI, Markowitz J, Monroe M, Contreras CM, Bowles T, Norman K, Medina E, Gonzalez CR, Baselga-Carretero I, Garcilazo IP, Vega-Crespo A, Chen JM, Deen NNA, Patel SP, Grossmann KF, Sondak VK, Sharon E, Moon J, Wu MC, Ribas A. Neoadjuvant PD-1 blockade in surgically resectable desmoplastic melanoma: cohort A of the phase 2 SWOG S1512 trial. Nat Cancer. 2026 Feb;7(2):272-282. doi: 10.1038/s43018-025-01113-y. Epub 2026 Jan 29. PubMed 41611998 ↗
  • Kendra KL, Bellasea SL, Eroglu Z, Hu-Lieskovan S, Campbell KM, Carson WE 3rd, Wada DA, Plaza JA, Sosman JA, In GK, Ikeguchi A, Hyngstrom J, Brohl AS, Khushalani NI, Markowitz J, Negrea G, Kasbari S, Doolittle GC, Swami U, Roberts T, Mathew BN, Medina E, Baselga-Carretero I, Gonzalez CR, Garcilazo IP, Vega-Crespo A, Chen JM, Naser Al-Deen N, Patel SP, Sharon E, Moon J, Wu MC, Ribas A. Anti-PD-1 therapy in unresectable desmoplastic melanoma: the phase 2 SWOG S1512 trial. Nat Med. 2025 Nov;31(11):3668-3674. doi: 10.1038/s41591-025-03875-5. Epub 2025 Aug 14. PubMed 40813711 ↗

Study documents

  • Protocol and statistical analysis plan · Jan 30, 2023

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02775851
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
May 18, 2016
Start date
Feb 6, 2017
Primary completion
Apr 14, 2023
Completion
May 15, 2027 (estimated)
Results posted
Apr 23, 2024
Last update
Jul 7, 2026

Study contacts

Kari L Kendra
principal investigator · SWOG Cancer Research Network

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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