Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003)

  • End date
    Jun 5, 2028
  • participants needed
  • sponsor
    Merck Sharp & Dohme LLC
Updated on 28 July 2022
measurable disease
growth factor
lung cancer
epidermal growth factor receptor
epidermal growth factor
lung carcinoma
proto-oncogene tyrosine-protein kinase ros


The primary hypotheses are that coformulated pembrolizumab/vibostolimab is superior to pembrolizumab alone with respect to (1) overall survival (OS) in participants with programmed cell death 1 ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%, TPS ≥1% and TPS 1% to 49%; and (2) progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR), in participants with PD-L1 TPS ≥1% and TPS ≥50%.

Condition Lung Neoplasms, Non-Small-Cell Lung Carcinoma
Treatment Pembrolizumab, MK-7684A, Pembrolizumab/Vibostolimab
Clinical Study IdentifierNCT04738487
SponsorMerck Sharp & Dohme LLC
Last Modified on28 July 2022


Yes No Not Sure

Inclusion Criteria

Has a histologically or cytologically confirmed diagnosis of Stage IV: M1a, M1b, or M1c non-small cell lung cancer (NSCLC) per the American Joint Committee on Cancer (AJCC) Staging Manual, version 8
Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as determined by the local site assessment
Has confirmation that epidermal growth factor receptor (EGFR)-, anaplastic lymphoma kinase (ALK)-, or reactive oxygen species proto-oncogene 1 (ROS1)-directed therapy is not indicated as primary therapy and absence of ALK and ROS1 gene rearrangements
Has provided tumor tissue that demonstrates Programmed Cell Death 1 Ligand 1 (PD-L1) expression in ≥1% of tumor cells as assessed by immunohistochemistry (IHC) at a central laboratory
Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 assessed within 7 days prior to randomization
Has a life expectancy of at least 3 months
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies
Is not a woman of childbearing potential (WOCBP)
Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 120 days after the last dose of study intervention
Has adequate organ function

Exclusion Criteria

Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy
Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC
Prior treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 6 months before the diagnosis of metastatic NSCLC
Participants must have recovered from all AEs due to previous therapies to Grade ≤1 or baseline. Participants with Grade ≤2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible
Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1)
Has received previous treatment with another agent targeting the T cell immunoreceptor with immunoglobulin (Ig) and immunoreceptor tyrosine-based inhibition motif (ITIM) domains (TIGIT) receptor pathway
anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell
death receptor ligand 2 (PD-L2) agent or with an agent directed to another
stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-
Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Administration of killed vaccines is allowed
associated protein 4 (CTLA-4), OX-40, CD137)
Has known active or untreated CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable for at least 4 weeks by repeat imaging, clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention
Has received radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease
Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
Any licensed COVID-19 vaccine (including for Emergency Use) in a particular country is allowed in the study as long as they are mRNA vaccines, adenoviral vaccines, or inactivated vaccines. These vaccines will be treated just as any other concomitant therapy
Investigational vaccines (i.e., those not licensed or approved for Emergency Use) are not allowed
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Has severe hypersensitivity (≥Grade 3) to pembrolizumab/vibostolimab or pembrolizumab and/or any of its excipients
Has a known history of interstitial lung disease. Lymphangitic spread of the NSCLC is not exclusionary
Is currently participating in or has participated in a study of an investigational
Has an active infection requiring systemic therapy
agent or has used an investigational device within 4 weeks prior to the first
Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority
dose of study intervention
Has a known history of Hepatitis B or known active Hepatitis C virus infection
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
Has a history or current evidence of any condition, therapy, or laboratory abnormality that prevents the participant from receiving platinum-doublet chemotherapy for first line NSCLC, or that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
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