Pembrolizumab in Treating Patients With Desmoplastic Melanoma That Can or Cannot Be Removed by Surgery
Launched by NATIONAL CANCER INSTITUTE (NCI) · May 16, 2016
Trial Information
Current as of August 02, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a drug called pembrolizumab to see how well it works for patients with desmoplastic melanoma, a type of skin cancer that can either be surgically removed or not. The trial is designed for two groups of patients: one group has melanoma that doctors believe they can completely remove with surgery, while the other group has melanoma that cannot be removed by surgery. Pembrolizumab is a type of treatment known as immunotherapy, which helps the body’s immune system fight cancer.
To participate in this trial, patients need to be at least 18 years old and have a confirmed diagnosis of desmoplastic melanoma. They should not have received any previous treatment for this cancer, and certain health criteria must be met, such as having stable blood counts and no active infections or other serious health issues. Participants will receive pembrolizumab and will be closely monitored for their health and response to the treatment. This trial is currently active but not recruiting new participants. If you or a loved one is considering getting involved, it’s important to discuss all details with your healthcare provider.
Gender
ALL
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
About National Cancer Institute (Nci)
The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
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Nampa, Idaho, United States
Danville, Illinois, United States
Los Angeles, California, United States
Clive, Iowa, United States
Loveland, Colorado, United States
Hays, Kansas, United States
Silverdale, Washington, United States
Sandpoint, Idaho, United States
Baker City, Oregon, United States
Ontario, Oregon, United States
Wheat Ridge, Colorado, United States
Lafayette, Colorado, United States
Denver, Colorado, United States
Olathe, Kansas, United States
Mount Vernon, Illinois, United States
Clive, Iowa, United States
Des Moines, Iowa, United States
Denver, Colorado, United States
Rolla, Missouri, United States
Pittsburg, Kansas, United States
Littleton, Colorado, United States
Parker, Colorado, United States
Ballwin, Missouri, United States
Saint Louis, Missouri, United States
Patients applied
Trial Officials
Kari L Kendra
Principal Investigator
SWOG Cancer Research Network
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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