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Study of Pembrolizumab (MK-3475) vs Placebo for Participants With Non-small Cell Lung Cancer After Resection With or Without Standard Adjuvant Therapy (MK-3475-091/KEYNOTE-091) (PEARLS)

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ClinicalTrials.gov Identifier: NCT02504372
Recruitment Status : Recruiting
First Posted : July 21, 2015
Last Update Posted : November 26, 2018
Sponsor:
Collaborators:
ETOP
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
In this study, participants with Stage IB/II-IIIA non-small cell lung cancer (NSCLC) who have undergone surgical resection (lobectomy or pneumonectomy) with or without adjuvant chemotherapy will be treated with pembrolizumab or placebo. The primary study hypothesis is that pembrolizumab will provide improved disease-free survival (DFS) versus placebo.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Biological: pembrolizumab Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1080 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Phase 3 Trial With Anti-PD-1 Monoclonal Antibody Pembrolizumab (MK-3475) Versus Placebo for Patients With Early Stage NSCLC After Resection and Completion of Standard Adjuvant Therapy (PEARLS)
Actual Study Start Date : November 6, 2015
Estimated Primary Completion Date : August 19, 2021
Estimated Study Completion Date : February 2, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Pembrolizumab
Participants receive pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year (expected maximum 18 doses).
Biological: pembrolizumab
Other Name: MK-3475

Placebo Comparator: Placebo
Participants receive placebo, IV, every 3 weeks, for one year (expected maximum 18 doses).
Other: Placebo



Primary Outcome Measures :
  1. Disease-free Survival (DFS) [ Time Frame: Up to 77 months ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 110 months ]
  2. Lung Cancer Specific Survival (LCSS) [ Time Frame: Up to 110 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathological diagnosis of NSCLC confirmed at surgery, any histology. Participants with two synchronous primary non-small cell lung cancers are excluded from the study
  • Union for International Cancer Control (UICC) v7 Stage IB with T ≥ 4 cm, II-IIIA NSCLC after complete surgical resection with resection margins proved microscopically free of disease (R0). Carcinoma in situ can be present at the bronchial margin
  • Available tumor sample obtained at surgical resection for programmed cell death ligand-1 (PD-L1) Immunohistochemistry (IHC) expression assessment
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  • Adequate organ function performed within 10 days of treatment initiation
  • Female participants of childbearing potential must have a negative urine or serum pregnancy test at screening (within 72 hours of first infusion of study medication). If the urine test cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the participant to be eligible
  • Female participants of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity starting with the first infusion of study treatment through 120 days after the last infusion of study treatment
  • Female participants who are breast feeding must discontinue nursing prior to the first infusion of study medication and until 120 days after the last infusion study treatment
  • Male participants must agree to use an adequate method of contraception starting with the first infusion of study treatment through 120 days after the last infusion of study treatment
  • Absence of severe comorbidities that in the opinion of the Investigator might hamper the participation to the study and/or the treatment administration
  • No prior or planned neo-adjuvant or adjuvant radiotherapy and/or neo-adjuvant chemotherapy for the current malignancy is allowed

Exclusion Criteria:

  • Evidence of disease at clinical examination and/or baseline radiological assessment as documented by contrast enhanced chest/upper abdomen CT scan, brain CT/MRI and clinical examination
  • More than 4 cycles of adjuvant therapy
  • Prior treatment with anti-programmed cell death (anti-PD)-1, anti-PD ligand-1/2, anti-CD137, or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) modulators or any other immune-modulating agents
  • Live vaccine within 30 days prior to the first infusion of study treatment
  • Current participation or treatment with an investigational agent or use of an investigational device within 4 weeks of the first infusion of study treatment
  • History of Human Immunodeficiency Virus (HIV) (known HIV 1/2 antibodies positive). No known active Hepatitis B or C
  • Chronic use of immunosuppressive agents and/or systemic corticosteroids or any use in the last 3 days prior to the first infusion of study treatment
  • History of interstitial lung disease or (non-infectious) pneumonitis that required oral or IV steroids (other than COPD exacerbation) or current pneumonitis
  • Active autoimmune disease that has required systemic treatment in past 2 years
  • History of a hematologic or primary solid tumor malignancy, unless in remission for at least 5 years with the exception of pT1-2 prostatic cancer Gleason score < 6, superficial bladder cancer, non melanomatous skin cancer or carcinoma in situ of the cervix
  • Previous allogeneic tissue/solid organ transplant
  • Active infection requiring therapy
  • Surgery- or chemotherapy-related toxicity (non-hematological) not resolved to Grade 1 with the exception of alopecia, fatigue, neuropathy and lack of appetite /nausea
  • 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 infusion of study treatment
  • Participant will not be eligible if the participant 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, unless prospective site Review Board approval is given allowing exception to this criterion for a specific participant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02504372


Contacts
Contact: Toll Free Number 1-888-577-8839

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Sponsors and Collaborators
Merck Sharp & Dohme Corp.
ETOP
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02504372     History of Changes
Other Study ID Numbers: 3475-091
2015-000575-27 ( EudraCT Number )
EORTC-1416-LCG ( Other Identifier: EORTC )
163457 ( Registry Identifier: JAPIC-CTI )
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018

Keywords provided by Merck Sharp & Dohme Corp.:
NSCLC
PDL1
PD-L1
PDL

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pembrolizumab
Antineoplastic Agents