NCT06099782

A Study of Participant Reported Preference for Subcutaneous Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) Over Intravenous Pembrolizumab (MK-3475) Formulation in Multiple Tumor Types (MK-3475A-F11)

A Phase 2 Study to Evaluate Patient Reported Preference for Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Over Intravenous Pembrolizumab Formulation in Participants With Multiple Tumor Types (MK-3475A-F11)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate participant preference for coformulated hyaluronidase/pembrolizumab pembrolizumab (+) berahyaluronidase alfa \[MK-3475A\] administered subcutaneously (SC) over pembrolizumab \[MK-3475\] administered intravenously (IV) in participants with multiple tumor types. There will be no hypothesis testing in this study.

Conditions

• Non-Small Cell Lung Cancer
• Renal Cell Carcinoma
• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab (+) Berahyaluronidase alfa	Fixed dose coformulated product of hyaluronidase/pembrolizumab adminstered via SC injection.
BIOLOGICAL	Pembrolizumab	Administered via IV infusion

Timeline

• Start date: 2023-12-26
• Primary completion: 2025-04-09
• Completion: 2027-02-15
• First posted: 2023-10-25
• Last updated: 2026-04-08
• Results posted: 2026-04-08

Locations

45 sites across 10 countries: United States, Argentina, Australia, Chile, France, Japan, New Zealand, Poland, South Africa, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study