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Pembrolizumab in Treating Pat...

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

Last Updated: 2025-12-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-06

Study Completion Date

2026-05-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Desmoplastic Melanoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Biopsy Procedure

Intervention Type PROCEDURE

Undergo tumor biopsy

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Computed Tomography

Intervention Type PROCEDURE

Undergo CT scan

Magnetic Resonance Elastography

Intervention Type PROCEDURE

Undergo MRI

Pembrolizumab

Intervention Type BIOLOGICAL

Given IV

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET scan

Therapeutic Conventional Surgery

Intervention Type PROCEDURE

Undergo surgical resection

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.

Group Type EXPERIMENTAL

Biopsy Procedure

Intervention Type PROCEDURE

Undergo tumor biopsy

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Computed Tomography

Intervention Type PROCEDURE

Undergo CT scan

Pembrolizumab

Intervention Type BIOLOGICAL

Given IV

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET scan

Therapeutic Conventional Surgery

Intervention Type PROCEDURE

Undergo surgical resection

Interventions

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Biopsy Procedure

Undergo tumor biopsy

Intervention Type PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Intervention Type PROCEDURE

Computed Tomography

Undergo CT scan

Intervention Type PROCEDURE

Magnetic Resonance Elastography

Undergo MRI

Intervention Type PROCEDURE

Pembrolizumab

Given IV

Intervention Type BIOLOGICAL

Positron Emission Tomography

Undergo PET scan

Intervention Type PROCEDURE

Therapeutic Conventional Surgery

Undergo surgical resection

Intervention Type PROCEDURE

Other Intervention Names

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Biopsy BIOPSY_TYPE Bx Biological Sample Collection Biospecimen Collected Specimen Collection 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 MRE 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 Medical Imaging, Positron Emission Tomography PET PET Scan Positron emission tomography (procedure) Positron Emission Tomography Scan Positron-Emission Tomography PT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kari L Kendra

Role: PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Locations

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Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Site Status

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

Site Status

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

Site Status

CHI Saint Vincent Cancer Center Hot Springs

Hot Springs, Arkansas, United States

Site Status

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California, United States

Site Status

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status

Epic Care-Dublin

Dublin, California, United States

Site Status

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Site Status

Epic Care Partners in Cancer Care

Emeryville, California, United States

Site Status

Los Angeles General Medical Center

Los Angeles, California, United States

Site Status

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Contra Costa Regional Medical Center

Martinez, California, United States

Site Status

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, United States

Site Status

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Site Status

Bay Area Tumor Institute

Oakland, California, United States

Site Status

Keck Medical Center of USC Pasadena

Pasadena, California, United States

Site Status

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, United States

Site Status

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, United States

Site Status

City of Hope South Pasadena

South Pasadena, California, United States

Site Status

City of Hope Upland

Upland, California, United States

Site Status

Epic Care Cyberknife Center

Walnut Creek, California, United States

Site Status

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

Site Status

The Medical Center of Aurora

Aurora, Colorado, United States

Site Status

Boulder Community Foothills Hospital

Boulder, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Site Status

Rocky Mountain Cancer Centers - Centennial

Centennial, Colorado, United States

Site Status

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Site Status