HomeTrialNCT05017012
NCT05017012Phase 1ACTIVE NOT RECRUITING

A Study to Evaluate the Bioavailability of Pembrolizumab (MK-3475) Via Subcutaneous (SC) Injection of Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180) [MK-3475A] In Advanced Solid Tumors (MK-3475A-C18)

Study Summary

This is a study to assess the pharmacokinetics, safety, and tolerability of pembrolizumab formulated with berahyaluronidase when administered as a SC injection to participants with advanced solid tumors. Participants will receive SC injections of pembrolizumab (+) berahyaluronidase alfa containing one of 2 different concentrations (Conc) of pembrolizumab, Conc1 and Conc2, corresponding to a pembrolizumab dose level of dose 1 for Arms 1, 2, and 3 and dose 2 for Arm 4.

View on ClinicalTrials.gov ↗
Study Details
Enrollment72 participants
Primary Completion
Lead SponsorMerck Sharp & Dohme LLC
Data Retrieved2026-04-11 02:55:36.205423+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 1 trials primarily test safety and dosing in a small number of participants (typically 20–100). Results do not yet speak to efficacy. FDA approval is typically many years away from this stage.

Status & Expected Data

Enrollment is complete. The trial is in its follow-up or data collection phase — a readout may occur on or near the primary completion date.

Enrolled: 72 participants
Sponsor Catalyst Profile

Merck & Co (MRK) is the sponsoring company for this trial. BiotechSign currently grades this company F (35/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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