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)

Phase 2 Active not recruiting 147 enrolled Merck Sharp & Dohme LLC

RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start: 2023-12-26
Primary completion: 2025-04-09
Completion: 2027-02-15

Publications

Casarini IA, Kowalski DM, Caglevic C, Karaca Yayla B, Sumbul AT, Yanez Weber P, Yanzi Castilla AN, Bylicki O, Takagi T, McQuarrie K, Saraf S, Arunachalam A, Bhagwati N, Cohen G. Participant-Reported Preference for Pembrolizumab Administered Subcutaneously or Intravenously: A Randomized, Open-Label, Phase II Study. JCO Oncol Pract. 2026 Jun 3:OP2501248. doi: 10.1200/OP-25-01248. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous
Subject	Pembrolizumab (+) Berahyaluronidase Alfa	Unknown	395 mg	Subcutaneous

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)

Summary

Timeline

Publications

Drugs

Indications