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)

  • STATUS
    Recruiting
  • End date
    Apr 29, 2027
  • participants needed
    598
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 25 July 2021
cancer
measurable disease
growth factor
lung cancer
pembrolizumab
epidermal growth factor receptor
ROS1
EGFR
epidermal growth factor
mk-3475
lung carcinoma
proto-oncogene tyrosine-protein kinase ros

Summary

The primary hypotheses are that coformulated pembrolizumab/vibostolimab is superior to pembrolizumab alone with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR), and with respect to overall survival (OS), in participants with non-small cell lung cancer.

Details
Condition Non-Small Cell Lung Cancer, Pulmonary Disease, Lung Neoplasm, Lung Cancer, Lung Disease, nsclc, lung tumor
Treatment Pembrolizumab, MK-7684A, Pembrolizumab/Vibostolimab
Clinical Study IdentifierNCT04738487
SponsorMerck Sharp & Dohme Corp.
Last Modified on25 July 2021

Eligibility

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), 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-associated protein 4 (CTLA-4), OX-40, CD137)
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
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 received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Administration of killed vaccines is allowed
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
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 severe hypersensitivity (Grade 3) to pembrolizumab/vibostolimab or pembrolizumab and/or any of its excipients
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
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Has a known history of interstitial lung disease. Lymphangitic spread of the NSCLC is not exclusionary
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note