A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84)

Part of paid clinical trials in Fullerton, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06698042
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab (+) Berahyaluronidase alfa — BIOLOGICAL
    Administered subcutaneously on Day 1 of each cycle
  • Pembrolizumab — BIOLOGICAL
    Administered intravenously on Day 1 of each cycle

Study Details

Researchers are looking for new ways to treat non-small cell lung cancer (NSCLC) that is metastatic, which means cancer has spread to other parts of the body. Some people with metastatic NSCLC are treated with pembrolizumab, an immunotherapy treatment that is given into a vein as an intravenous (IV) infusion. Pembrolizumab (+) Berahyaluronidase alfa is pembrolizumab that is given under the skin as a subcutaneous (SC) injection. The goal of this study is to learn what happens to pembrolizumab in a person's body over time when it is given as an IV infusion or SC injection.

Key Dates

Start date
Nov 21, 2024
Status verified
Mar 2026
Primary completion
Mar 12, 2026
Completion
Feb 11, 2030

Study Design

Enrollment
67 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab (+) Berahyaluronidase alfa
    Pembrolizumab (+) Berahyaluronidase alfa SC will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may be eligible for second course.
  • Active Comparator: Pembrolizumab
    "Pembrolizumab by IV Infusion will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may be eligible for second course,

Primary Outcome Measure

Area Under the Curve (AUC) of Pembrolizumab Measured After the First Dose [ Time Frame: At designated time points (up to approximately 14 months) ]

Locations (4)

FacilityCityStateZIPSite coordinators
Providence Medical Foundation ( Site 0117)FullertonCalifornia92835-
Illinois Cancer Care ( Site 0101)PeoriaIllinois61615-
Montefiore Medical Center ( Site 0104)The BronxNew York10461-
University of Cincinnati Medical Center ( Site 0112)CincinnatiOhio45219-

Related coverage on Hipa.ai

Find similar trials in Fullerton, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Providence Medical Foundation· Fullerton, CAIllinois Cancer Care· Peoria, ILMontefiore Medical Center· The Bronx, NYUniversity of Cincinnati Medical Center· Cincinnati, OH

Related Studies