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History of Changes for Study: NCT02362594
Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/KEYNOTE-054)
Latest version (submitted July 31, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 9, 2015 None (earliest Version on record)
2 March 12, 2015 Outcome Measures and Study Status
3 June 5, 2015 Study Status
4 July 8, 2015 Study Status
5 August 18, 2015 Recruitment Status, Study Status, Contacts/Locations and Oversight
6 August 21, 2015 Study Status
7 August 26, 2015 Contacts/Locations and Study Status
8 September 11, 2015 Study Status
9 September 28, 2015 Study Status
10 October 7, 2015 Study Status and Contacts/Locations
11 October 13, 2015 Contacts/Locations and Study Status
12 October 29, 2015 Contacts/Locations and Study Status
13 November 10, 2015 Study Status and Contacts/Locations
14 December 11, 2015 Study Status and Contacts/Locations
15 December 31, 2015 Contacts/Locations and Study Status
16 February 2, 2016 Study Status and Contacts/Locations
17 February 11, 2016 Contacts/Locations and Study Status
18 February 24, 2016 Contacts/Locations and Study Status
19 March 3, 2016 Study Status and Contacts/Locations
20 March 9, 2016 Contacts/Locations and Study Status
21 April 1, 2016 Study Status and Contacts/Locations
22 April 7, 2016 Contacts/Locations and Study Status
23 May 20, 2016 Contacts/Locations and Study Status
24 August 10, 2016 Study Status, Contacts/Locations and Study Identification
25 September 13, 2016 Study Status and Contacts/Locations
26 September 28, 2016 Recruitment Status, Study Status and Contacts/Locations
27 November 24, 2016 Study Status
28 February 16, 2017 Study Status
29 April 13, 2017 Study Status
30 August 29, 2017 Study Status
31 November 23, 2017 Oversight, Study Design, Study Status, Eligibility, Outcome Measures, Arms and Interventions, Conditions and Study Description
32 June 11, 2018 Study Status
33 December 10, 2018 Outcome Measures, Study Status, Study Identification, Arms and Interventions, Document Section, Results, IPDSharing, Eligibility, Conditions and Study Description
34 January 10, 2019 Outcome Measures and Study Status
35 January 28, 2019 Study Status
36 September 25, 2020 Study Status and References
37 August 18, 2022 Study Status and More Information
38 July 31, 2023 References, Study Status, Arms and Interventions and Study Description
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Study NCT02362594
Submitted Date:  February 9, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: 3475-054
Brief Title: Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/KEYNOTE-054)
Official Title: Adjuvant Immunotherapy With Anti-PD-1 Monoclonal Antibody Pembrolizumab (MK- 3475) Versus Placebo After Complete Resection of High-risk Stage III Melanoma: A Randomized, Double- Blind Phase 3 Trial of the EORTC Melanoma Group
Secondary IDs: 1325-MG [EORTC study number]
2014-004944-37 [EudraCT Number]
Open or close this module Study Status
Record Verification: February 2015
Overall Status: Not yet recruiting
Study Start: May 2015
Primary Completion: May 2018 [Anticipated]
Study Completion: May 2022 [Anticipated]
First Submitted: February 9, 2015
First Submitted that
Met QC Criteria:
February 9, 2015
First Posted: February 13, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 9, 2015
Last Update Posted: February 13, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Merck Sharp & Dohme LLC
Responsible Party: Sponsor
Collaborators: European Organisation for Research and Treatment of Cancer
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This study will assess whether post-resection adjuvant therapy with pembrolizumab improves recurrence-free survival (RFS) as compared to placebo for high-risk participants with melanoma (Stage IIIA [> 1 mm metastasis], IIIB and IIIC). The study will also assess whether pembrolizumab improves RFS versus placebo in the subgroup of participants with programmed cell death ligand 1 (PD-L1)-positive tumor expression. Participants will be stratified for stage of disease and region and then will be randomly assigned to receive either pembrolizumab or placebo.
Detailed Description:
Open or close this module Conditions
Conditions: Melanoma
Keywords: PD1
PDL1
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 900 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Pembrolizumab
Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 1 year
Biological: pembrolizumab
Placebo Comparator: Placebo
Participants receive placebo IV on Day 1 of each 21-day cycle for up to 1 year
placebo
Locally sourced placebo
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Recurrence-free survival (RFS) for All Participants
[ Time Frame: Up to 3 years ]

2. RFS for Participants with PD-L1-positive Tumor Expression
[ Time Frame: Up to 3 years ]

Secondary Outcome Measures:
1. Distant Metastases-free Survival (DMFS) in All Participants
[ Time Frame: Up to 3 years ]

2. DMFS for Participants with PD-L1-positive Tumor Expression
[ Time Frame: Up to 3 years ]

3. Overall Survival (OS) in All Participants
[ Time Frame: Up to 3 years ]

4. OS in for Participants with PD-L1-positive Tumor Expression
[ Time Frame: Up to 3 years ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion criteria:

  • Completely resected Stage III melanoma
  • Tumor tissue available for evaluation of PD-L1 expression
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function
  • No prior therapy for melanoma except surgery for primary melanoma lesions (or previously treated with interferon for thick primary melanomas without evidence of lymph node involvement are eligible)
  • Female participants of childbearing potential should be willing to use adequate methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication
  • Male participants should agree to use an adequate method of birth control starting with the first dose of study therapy through 120 days after the last dose of study medication

Exclusion criteria:

  • Mucosal or ocular melanoma
  • History of pneumonitis requiring treatment with steroids
  • History of interstitial lung disease
  • History of hematologic or primary solid tumor malignancy, unless no evidence of that disease for 5 years
  • Active autoimmune disease that has required systemic treatment in past 2 years
  • Active infection requiring therapy
  • Unstable hyperthyroidism or hypothyroidism
  • Diagnosis of immunodeficiency
  • Systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
  • Known history of human immunodeficiency virus (HIV), active Hepatitis B or C
  • Treatment with live vaccine within 30 days prior to the first dose of study medication are not eligible
  • Prior treatment with any anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) monoclonal antibody or anti-PD-1, or PD-L1 or PD-L2 agent, or prior participation in any Merck pembrolizumab clinical trial
  • Currently participating and receiving study therapy, or participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks of the first dose of study medication
  • Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of study medication
  • Patient is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or Sponsor staff directly involved with this trial without prospective Institutional Review Board approval (by chair or designee) is given
Open or close this module Contacts/Locations
Study Officials: Medical Director
Study Director
Merck Sharp & Dohme LLC
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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