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NCT03698019 · CITED IN SOURCE DOCUMENTS

A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2026-08-04

This phase II trial studies how pembrolizumab works before and after surgery in treating patients with stage III-IV high-risk melanoma. 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. Giving pembrolizumab before and after surgery may work better compared to after surgery alone in treating melanoma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

Who could take part
eligibility Criteria
Inclusion Criteria: * STEP 1 REGISTRATION (RANDOMIZATION): Patients must have clinically detectable stage III (clinically detectable N1b, N1c, N2b, N2c, N3b and N3c) or stage IV resectable melanoma. Patients with melanoma of mucosal or acral origin are eligible. Patients with melanoma of uveal origin are not eligible. Patients with a history of brain metastases are not eligible. Clinically detectable is defined as disease that is apparent and measurable via physical examination or radiographic imaging. * STEP 1 REGISTRATION (RANDOMIZATION): Patients are eligible for this trial either at initial presentation of their melanoma or at the time of the first detected nodal, satellite/in-transit, distant metastases, or recurrent disease in prior lymphadenectomy basin or distant site. Nodal, satellite/in-transit metastasis, distant metastases or disease in a prior complete lymphadenectomy basin must have been confirmed histologically by hematoxylin (H) \& eosin (E) stained slides. * STEP 1 REGISTRATION (RANDOMIZATION): Patients with multiple regional nodal basin involvement are eligible. Gross or microscopic extracapsular nodal extension is permitted. * STEP 1 REGISTRATION (RANDOMIZATION): Patients must have histologically proven stage IIIB or higher. This would entail pathologic confirmation beyond the primary or initial diagnosis of melanoma involving fine needle aspiration cytology or biopsy confirmation of any N-category or M-category resectable site. * STEP 1 REGISTRATION (RANDOMIZATION): Patients must not have received previous neoadjuvant treatment for their melanoma. Patients may have received prior non-immunotherapy adjuvant therapy. Patients must not have had prior immunotherapy including, but not limited to ipilimumab, interferon alfa-2b, high dose interleukin (IL)-2, pegylated-interferon (PEG-IFN), anti-PD-1, anti-PD-L1 intra-tumoral, or vaccine therapies. Patients must not be planning to receive any of the prohibited therapies during treatment phases on the study. * STEP 1 REGISTRATION (RANDOMIZATION): Patients must not be planning to receive concomitant other biologic therapy, hormonal therapy, other chemotherapy, surgery, while on protocol therapy. * STEP 1 REGISTRATION (RANDOMIZATION): Patients may have received prior radiation therapy, including after prior surgical resection. All adverse events associated with prior surgery and radiation therapy must have resolved to =\< grade 1 prior to randomization. * STEP 1 REGISTRATION (RANDOMIZATION): Patients must be \>= 18 years of age * STEP 1 REGISTRATION (RANDOMIZATION): All patients must have disease status documented by a complete physical examination and imaging studies within 42 days prior to randomization. Imaging studies must include a CT of the chest, abdomen and pelvis with intravenous contrast (unless contraindicated). For patients with melanoma arising from the head and neck, dedicated neck imaging (CT with intravenous contrast is required. If the patient has unknown primary with disease in the axilla, neck imaging is required CT imaging must be done with intravenous contrast if there are no contraindications for it. Extremity melanomas must be imaged using CT with intravenous contrast or MRI with and without gadolinium * Note: PET-CT scans are NOT acceptable to establish eligibility. Non-iodinated CT scans that are part of common PET-CT imaging protocols do not provide contrast for difficult to ascertain areas such as the neck and liver, and do not provide enough CT detail to perform appropriate RECIST 1.1 measurements. As such, a PET-CT with non-contrast CT or non-diagnostic quality CT images is considered insufficient for the detection of melanoma. * STEP 1 REGISTRATION (RANDOMIZATION): All patients must have a CT or magnetic resonance imaging (MRI) of the brain within 42 days prior to randomization. The brain CT or MRI should be performed with intravenous contrast (unless contraindicated). * STEP 1 REGISTRATION (RANDOMIZATION): Absolute neutrophil count (ANC) \>= 1,500/microliter (mcL) (within 42 days prior to randomization). * STEP 1 REGISTRATION (RANDOMIZATION): Platelets \>= 100,000/mcL (within 42 days prior to randomization). * STEP 1 REGISTRATION (RANDOMIZATION): Hemoglobin \>= 10 g/dL (within 42 days prior to randomization). * STEP 1 REGISTRATION (RANDOMIZATION): Total bilirubin =\< 1.5 x institutional upper limit of normal (IULN) (except patients with Gilbert's syndrome, who must have a total bilirubin \< 3.0 mg/dL) (within 42 days prior to randomization). * STEP 1 REGISTRATION (RANDOMIZATION): Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 2 x IULN (within 42 days prior to randomization). * STEP 1 REGISTRATION (RANDOMIZATION): Alkaline phosphatase =\< 2 x IULN (within 42 days prior to randomization). * STEP 1 REGISTRATION (RANDOMIZATION): Patients must have lactate dehydrogenase (LDH) performed within 42 days prior to randomization. * STEP 1 REGISTRATION (RANDOMIZATION): Patients must have adequate renal function as evidenced by calculated creatinine clearance \> 30 mL/min. The creatinine level (mg/dL) used in the calculation must be obtained within 42 days prior to randomization. * STEP 1 REGISTRATION (RANDOMIZATION): Patients must have Zubrod performance status =\< 2. * STEP 1 REGISTRATION (RANDOMIZATION): Patients must not have a history of (non-infectious) pneumonitis that required steroids or current pneumonitis. * STEP 1 REGISTRATION (RANDOMIZATION): Patients must not have an active infection requiring systemic therapy. * STEP 1 REGISTRATION (RANDOMIZATION): 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. * STEP 1 REGISTRATION (RANDOMIZATION): Patients must not have received live vaccines within 42 days prior to randomization. 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. * NOTE: The COVID-19 vaccines (currently available and those in the pipeline for FDA emergency use authorization or FDA approval) do not contain live virus, and therefore, COVID-19 vaccination does not affect or preclude eligibility for the S1801 trial. For patients who have undergone lymphadenectomy, vaccines should be delivered to a limb with an intact lymph node basin (Sentinel lymph node biopsy in a limb is acceptable). The vaccine should not be administered in a limb that has undergone lymphadenectomy. * STEP 1 REGISTRATION (RANDOMIZATION): Patients known to be human immunodeficiency virus (HIV) positive are eligible if they meet the following criteria within 30 days prior to randomization: stable and adequate CD4 counts (\>= 350 mm\^3), and serum HIV viral load of \< 25,000 IU/ml. Patients may be on or off anti-viral therapy so long as they meet the CD4 count criteria. * STEP 1 REGISTRATION (RANDOMIZATION): Patients must not have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection prior to randomization. Note: No testing for hepatitis B and hepatitis C is required unless mandated by local health authority. * STEP 1 REGISTRATION (RANDOMIZATION): Prior malignancy is allowed providing it does not require concurrent therapy. * STEP 1 REGISTRATION (RANDOMIZATION): Women of childbearing potential must have a negative urine or serum pregnancy test within 28 days prior to randomization. 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. * STEP 1 REGISTRATION (RANDOMIZATION): Patients must be deemed medically fit to undergo surgery by the treating medical/surgical team. * STEP 1 REGISTRATION (RANDOMIZATION): Patients must be willing to submit the following surgical specimens: either all tissue blocks from the surgical specimen or two slides per block (\[1\] hematoxylin and eosin \[H\&E\] slide and \[1\] unstained slide OR \[2\] unstained slides if H\&E stained slides cannot be provided). * STEP 1 REGISTRATION (RANDOMIZATION): Patients must be offered the opportunity to participate in specimen banking. * STEP 1 REGISTRATION (RANDOMIZATION): Patients must be informed of the investigational nature of this study and must sign and give written informed consent for this protocol in accordance with institutional and federal guidelines. * STEP 1 REGISTRATION (RANDOMIZATION): As a part of the Oncology Patient Enrollment Network (OPEN) randomization 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. * STEP 2 REGISTRATION (SURGERY): Patients randomized to arm 2 (neoadjuvant arm) must be willing to submit tissue to determine pathologic response regardless of number of pre-operative doses of pembrolizumab (MK-3475) received. Determination of pathologic response cannot be done on less than the full surgical specimen. * STEP 2 REGISTRATION (SURGERY): Patients must have disease assessments by CT chest/abdomen/pelvis with IV contrast, and neck CT with IV contrast if primary head and neck melanoma, performed within 42 days (and no more than 49 days) before the planned date of surgery. MRI combined with non-contrast CT is an acceptable alternative for patients with CT contrast allergy, but imaging must encompass total body. * STEP 2 REGISTRATION (SURGERY): Patients must register to step 2 within 17 days prior to planned date of surgery. * STEP 3 REGISTRATION (ADJUVANT THERAPY): Patients must have undergone surgery prior to Step 3 registration. The Step 2 surgery must have completely resected their melanoma. * Patients with gross positive residual disease following surgery do not qualify as having disease-free status, and, therefore, such patients are not eligible to register for adjuvant therapy. * Patients with microscopic residual disease (i.e., positive margins) can be treated with re-excision or radiation, per site discretion, to render the patient disease-free prior to registration of adjuvant therapy. * Disease-free status must be documented by a complete physical examination and radiographic imaging studies within 42 days prior to Step 3 registration. Imaging studies must include a CT of the chest, abdomen, and pelvis (unless contraindicated). Extremity melanomas must be imaged using CT with intravenous contrast or MRI with and without gadolinium. CT imaging must be done with intravenous contrast if there are no contraindications for it. * For patients with melanoma arising from the head and neck, dedicated neck imaging (CT with IV contrast, unless contraindicated) is required. * If the patient has had unknown primary with disease in the axilla, neck imaging is required to assure the region is clear of cancer. * Any other clinically indicated imaging studies if performed (e.g., bone scan) must show no evidence of disease. * STEP 3 REGISTRATION (ADJUVANT THERAPY): Patients must be registered to step 3 no more than 84 days after date of surgery. * STEP 3 REGISTRATION (ADJUVANT THERAPY): Patients with R0 or R1 resections must have disease-free status documented by a complete physical examination and imaging studies within 42 days prior to step 3 registration. These patients must have disease assessments by CT chest/abdomen/pelvis with IV contrast, and neck CT with IV contrast if primary head and neck melanoma. MRI combined with non-contrast CT is an acceptable alternative for patients with CT contrast allergy, but imaging must encompass total body. * STEP 3 REGISTRATION (ADJUVANT THERAPY): Patients with R2 resections are not eligible for step 3 and must be removed from study treatment
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Within 17 days (preferably within 14 days) days after IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study.
    intervention Names
    1. Procedure: Biospecimen Collection
    2. Procedure: Computed Tomography
    3. Procedure: Magnetic Resonance Imaging
    4. Biological: Pembrolizumab
    5. Procedure: Therapeutic Conventional Surgery
    label
    Arm I (adjuvant pembrolizumab)
    type
    EXPERIMENTAL
  2. description
    Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks for 3 cycles, then undergo surgery within 3 weeks. Within 84 days, patients receive pembrolizumab IV over 30 minutes every 3 weeks for 15 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study.
    intervention Names
    1. Procedure: Biospecimen Collection
    2. Procedure: Computed Tomography
    3. Procedure: Magnetic Resonance Imaging
    4. Biological: Pembrolizumab
    5. Procedure: Therapeutic Conventional Surgery
    label
    Arm II (adjuvant and neoadjuvant pembrolizumab)
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Arm I (adjuvant pembrolizumab)
    2. Arm II (adjuvant and neoadjuvant pembrolizumab)
    description
    Undergo collection of blood
    name
    Biospecimen Collection
    other Names
    1. Biological Sample Collection
    2. Biospecimen Collected
    3. Sample Collection
    4. Specimen Collection
    type
    PROCEDURE
  2. arm Group Labels
    1. Arm I (adjuvant pembrolizumab)
    2. Arm II (adjuvant and neoadjuvant pembrolizumab)
    description
    Undergo CT
    name
    Computed Tomography
    other Names
    1. CAT
    2. CAT Scan
    3. Computed Axial Tomography
    4. Computerized Axial Tomography
    5. Computerized axial tomography (procedure)
    6. Computerized Tomography
    7. Computerized Tomography (CT) scan
    8. CT
    9. CT Scan
    10. Diagnostic CAT Scan
    11. Diagnostic CAT Scan Service Type
    12. tomography
    type
    PROCEDURE
  3. arm Group Labels
    1. Arm I (adjuvant pembrolizumab)
    2. Arm II (adjuvant and neoadjuvant pembrolizumab)
    description
    Undergo MRI
    name
    Magnetic Resonance Imaging
    other Names
    1. Magnetic Resonance
    2. Magnetic Resonance Imaging (MRI)
    3. Magnetic resonance imaging (procedure)
    4. Magnetic Resonance Imaging Scan
    5. Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    6. MR
    7. MR Imaging
    8. MRI
    9. MRI Scan
    10. MRIs
    11. NMR Imaging
    12. NMRI
    type
    PROCEDURE
  4. arm Group Labels
    1. Arm I (adjuvant pembrolizumab)
    2. Arm II (adjuvant and neoadjuvant pembrolizumab)
    description
    Given IV
    name
    Pembrolizumab
    other Names
    1. BCD-201
    2. GME 751
    3. GME751
    4. Keytruda
    5. Lambrolizumab
    6. MK 3475
    7. MK-3475
    8. MK3475
    9. Pembrolizumab Biosimilar BCD-201
    10. Pembrolizumab Biosimilar GME751
    11. Pembrolizumab Biosimilar QL2107
    12. Pembrolizumab Biosimilar RPH-075
    type
    BIOLOGICAL
  5. arm Group Labels
    1. Arm I (adjuvant pembrolizumab)
    2. Arm II (adjuvant and neoadjuvant pembrolizumab)
    description
    Undergo surgery
    name
    Therapeutic Conventional Surgery
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
313
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Event-free survival (EFS) is measured from date of randomization to date of first: documentation of progression that render participant unable to receive planned protocol surgery, off protocol therapy for any reason without subsequent protocol surgery, failure to begin adjuvant therapy within 84 days after surgery, relapse after surgery or death due to any cause. Participants last known to be alive and event-free are censored at date of last contact. All events that occurred before the start of adjuvant therapy were assigned an event date of 84 days.
    measure
    Two-Year Event-Free Survival Rate
    time Frame
    2 years
secondary Outcomes
  1. description
    Only adverse events that are possibly, probably or definitely related to study drug are reported.
    measure
    Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
    time Frame
    Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization.
  2. description
    Overall survival (OS) is measured from date of randomization to date of death due to any cause. Participants known to be alive are censored at date of last contact.
    measure
    Two-Year Overall Survival Rate
    time Frame
    2 years
  3. description
    On the neoadjuvant arm, the response rate was assessed after neoadjuvant therapy and before surgical resection. The response rate includes both complete response (CR) and partial response (PR). CR is defined as complete disappearance of all target and non-target lesions, no new lesions, and no disease related symptoms. PR is defined as greater than or equal to 30% decrease under baseline of the sum of all appropriate diameters of all target measurable lesions, no unequivocal progression or non-measurable disease, and no new lesions. The best response rate is calculated from the sequence of objective statuses. CR is defined as two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. PR is defined as two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration, but not qualifying as CR.
    measure
    Response Rate
    time Frame
    2 years
  4. description
    To determine the number of participants on each arm who received the surgery planned at randomization.
    measure
    Number of Participants Receiving Surgery
    time Frame
    2.5 years
Full study description
brief Summary
This phase II trial studies how pembrolizumab works before and after surgery in treating patients with stage III-IV high-risk melanoma. 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. Giving pembrolizumab before and after surgery may work better compared to after surgery alone in treating melanoma.
detailed Description
PRIMARY OBJECTIVE: I. To compare event-free survival (EFS) in participants with high-risk resectable melanoma randomized to neoadjuvant pembrolizumab (MK-3475) with participants randomized to adjuvant pembrolizumab (MK-3475). SECONDARY OBJECTIVES: I. To assess the frequency and severity of toxicities on each of the arms. II. To compare between arms overall survival (OS), disease control at 24 weeks, locoregional control in the surgical site(s), and total number of pembrolizumab (MK-3475) doses received. III. On the neoadjuvant arm, to estimate the pathologic response rate, the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 response rate (confirmed and unconfirmed complete response \[CR\] and partial response \[PR\]), and the immune-related (i)RECIST response rate (confirmed and unconfirmed CR and PR), before surgical resection; to compare definitions of pathologic partial response; and to evaluate the association between pathologic response and EFS and OS. IV. To describe the proportion of participants on each arm who received the surgery planned at randomization. ADDITIONAL OBJECTIVE: I. To bank tumor tissue and whole blood in anticipation of future correlative studies in this participant population. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Within 17 days (preferably within 14 days) days after surgical resection, patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study, and magnetic resonance imaging (MRI) or computers tomography (CT) on study. ARM II: Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks for 3 cycles, then undergo surgical resection within 3 weeks. Within 84 days, patients receive pembrolizumab IV over 30 minutes every 3 weeks for 15 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. After completion of study treatment, patients are followed up at 3 and 12 weeks, then every 3 months for 2 years, every 6 months for 3 years, then every 12 months for up to 10 years.
Source references
references
  1. citation
    Mangana J, Ozdemir BC, Mihic-Probst D, Siano M, Metaxas Y, Maul LV, Hunger RE, Lindenblatt N, Olariu R, Von Moos R, Balermpas P, Schiappacase L, Mangas C, Michielin O, Dummer R. The updated Swiss guidelines for the treatment and follow-up of cutaneous melanoma. Swiss Med Wkly. 2025 Jul 8;155:4210. doi: 10.57187/s.4210.
    pmid
    40811146
    type
    DERIVED
  2. citation
    Long GV, Menzies AM, Scolyer RA. Neoadjuvant Checkpoint Immunotherapy and Melanoma: The Time Is Now. J Clin Oncol. 2023 Jun 10;41(17):3236-3248. doi: 10.1200/JCO.22.02575. Epub 2023 Apr 27.
    pmid
    37104746
    type
    DERIVED
  3. citation
    Patel SP, Othus M, Chen Y, Wright GP Jr, Yost KJ, Hyngstrom JR, Hu-Lieskovan S, Lao CD, Fecher LA, Truong TG, Eisenstein JL, Chandra S, Sosman JA, Kendra KL, Wu RC, Devoe CE, Deutsch GB, Hegde A, Khalil M, Mangla A, Reese AM, Ross MI, Poklepovic AS, Phan GQ, Onitilo AA, Yasar DG, Powers BC, Doolittle GC, In GK, Kokot N, Gibney GT, Atkins MB, Shaheen M, Warneke JA, Ikeguchi A, Najera JE, Chmielowski B, Crompton JG, Floyd JD, Hsueh E, Margolin KA, Chow WA, Grossmann KF, Dietrich E, Prieto VG, Lowe MC, Buchbinder EI, Kirkwood JM, Korde L, Moon J, Sharon E, Sondak VK, Ribas A. Neoadjuvant-Adjuvant or Adjuvant-Only Pembrolizumab in Advanced Melanoma. N Engl J Med. 2023 Mar 2;388(9):813-823. doi: 10.1056/NEJMoa2211437.
    pmid
    36856617
    type
    DERIVED
  4. citation
    Gorry C, McCullagh L, O'Donnell H, Barrett S, Schmitz S, Barry M, Curtin K, Beausang E, Barry R, Coyne I. Neoadjuvant treatment for stage III and IV cutaneous melanoma. Cochrane Database Syst Rev. 2023 Jan 17;1(1):CD012974. doi: 10.1002/14651858.CD012974.pub2.
    pmid
    36648215
    type
    DERIVED
Source notices and limitations
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        onsidered for patients with high-risk node-positive disease or resectable metastatic disease based on the results of a phase II trial (<a href="/clinicaltrials/NCT03698019">SWOG S1801</a> [NCT03698019]). In the trial, patients who received 1 year of neoadjuvant and adjuvant pembrolizumab had improved event-free survival (EFS) com
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        igh-risk node-positive disease or resectable metastatic disease based on the results of a phase II trial (<a href="/clinicaltrials/NCT03698019">SWOG S1801</a> [NCT03698019]). In the trial, patients who received 1 year of neoadjuvant and adjuvant pembrolizumab had improved event-free survival (EFS) compared with those who underwen
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        bindex="-1">Evidence (pembrolizumab):</p> <div class="pdq-content-list"><ol id="_1455"><li>An open-label phase II study (<a href="/clinicaltrials/NCT03698019">SWOG S1801</a> [NCT03698019]) conducted at 90 sites in the United States enrolled 313 patients with resectable macroscopic stage IIIB to stage IV melanoma. Pa
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        izumab):</p> <div class="pdq-content-list"><ol id="_1455"><li>An open-label phase II study (<a href="/clinicaltrials/NCT03698019">SWOG S1801</a> [NCT03698019]) conducted at 90 sites in the United States enrolled 313 patients with resectable macroscopic stage IIIB to stage IV melanoma. Patients were randomly assigned
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      1. context
        Updated: May 2, 2025
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    Preserved source evidence · Not medical advice