Study of Pembrolizumab (MK-3475) vs Placebo for Participants With Non-small... | Recruiting
Study of Pembrolizumab (MK-3475) vs... | Recruiting
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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Medical Conditions
  • Non-small Cell Lung Cancer
Primary Contact Details
Toll Free Number
1-888-577-8839
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
NCT02504372
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Biological : pembrolizumab, Other : Placebo

Study Arm Groups : Pembrolizumab, Placebo

Intervention Type
See Interventions above
Primary Outcome Measures
    Disease-free Survival (DFS); Up to 100 months
Secondary Outcome Measures
    Overall Survival (OS); Up to 100 months; Lung Cancer Specific Survival (LCSS); Up to 100 months
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
1380
Participant Inclusion Criteria
    Inclusion Criteria:

    - Pathological diagnosis of NSCLC confirmed at surgery, any histology

    - 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 dose 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 should be willing to use 2 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 treatment

    - Female participants who are breast feeding should discontinue nursing prior to the first dose of study medication and until 120 days after the last study treatment

    - Male participants should agree to use an adequate method of contraception starting with the first dose of study treatment through 120 days after the last dose 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 foreseen neo-adjuvant or adjuvant radiotherapy and/or neo-adjuvant chemotherapy

    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

    - Live vaccine within 30 days prior to the first dose of study treatment

    - Current participation or treatment with an investigational agent or use of an investigational device within 4 weeks of the first dose 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 dose 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 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 dose 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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Merck Sharp & Dohme Ltd.
Hoddesdon
Trial Contact(s)
Primary Trial Contact
Toll Free Number
1-888-577-8839
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Austria, Belgium, Chile, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Latvia, Netherlands, Poland, Portugal, Slovenia, Spain, Switzerland, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific 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)
EudraCT Number
Not available for this trial
Funder(s)
  • ETOP
  • European Organisation for Research and Treatment of Cancer - EORTC
Other Study ID Numbers
3475-091
Sponsor(s)
Merck Sharp & Dohme Corp.
Key Dates

Recruitment Start Date

Nov 2015

Recruitment End Date

Aug 2021

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

20 Jul 2015

Date updated in source

07 Nov 2017