A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma
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ClinicalTrials.gov Identifier: NCT03698019 |
Recruitment Status :
Recruiting
First Posted : October 5, 2018
Last Update Posted : March 2, 2021
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Tracking Information | |||||
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First Submitted Date ICMJE | October 4, 2018 | ||||
First Posted Date ICMJE | October 5, 2018 | ||||
Last Update Posted Date | March 2, 2021 | ||||
Actual Study Start Date ICMJE | December 6, 2018 | ||||
Estimated Primary Completion Date | September 1, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Event-free survival (EFS) in patients with high-risk resectable melanoma randomized to neoadjuvant pembrolizumab with patients randomized to adjuvant pembrolizumab [ Time Frame: Date of randomization to date of first progression or death, assessed up to 10 years ] We will use exponential-mixture cure models to describe EFS patterns in the arms.
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Original Primary Outcome Measures ICMJE |
Event-free survival (EFS) in patients with high-risk resectable melanoma randomized to neoadjuvant pembrolizumab with patients randomized to adjuvant pembrolizumab [ Time Frame: Date of randomization to date of first progression or death assessed up to 10 years ] We will use exponential-mixture cure models to describe EFS patterns in the arms.
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma | ||||
Official Title ICMJE | A Phase II Randomized Study of Adjuvant Versus NeoAdjuvant Pembrolizumab (MK-3475) for Clinically Detectable Stage III-IV High-Risk Melanoma | ||||
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 patients with high-risk resectable melanoma randomized to neoadjuvant MK-3475 (pembrolizumab) with patients randomized to adjuvant MK-3475 (pembrolizumab). 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 MK-3475 (pembrolizumab) 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 patients 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 patient population. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Within 84 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. 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. 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 a total of 10 years. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
500 | ||||
Original Estimated Enrollment ICMJE |
556 | ||||
Estimated Study Completion Date ICMJE | September 1, 2022 | ||||
Estimated Primary Completion Date | September 1, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | |||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03698019 | ||||
Other Study ID Numbers ICMJE | NCI-2018-02107 NCI-2018-02107 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) S1801 ( Other Identifier: SWOG ) S1801 ( Other Identifier: CTEP ) U10CA180888 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | National Cancer Institute (NCI) | ||||
Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | National Cancer Institute (NCI) | ||||
Verification Date | September 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |