What is clinical trial NCT03486873 studying?

NCT03486873 is a Phase 3 clinical trial evaluating Pembrolizumab for Solid Tumors. The trial is sponsored by Merck Sharp & Dohme LLC and is currently recruiting.

What phase is the NCT03486873 clinical trial?

NCT03486873 is a Phase 3 clinical trial. Phase 3 trials are pivotal studies required before FDA approval, typically enrolling hundreds to thousands of participants to prove efficacy and safety.

Is NCT03486873 still recruiting participants?

The current enrollment status of NCT03486873 is: RECRUITING. The trial is actively enrolling — check ClinicalTrials.gov for eligibility criteria.

Who is the sponsor of clinical trial NCT03486873?

NCT03486873 is sponsored by Merck Sharp & Dohme LLC (MRK). BiotechSign currently grades the sponsor a F (35/100) based on its composite pipeline strength and catalyst outlook.

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NCT03486873Phase 3RECRUITING

Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)

Study Summary

The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.

Conditions

Solid Tumors Hematologic Malignancies

Interventions / Drugs

Pembrolizumab Standard of Care (SOC)Lenvatinib Olaparib MK-4280 MK-4280A Pembrolizumab (+) Berahyaluronidase alfa

View on ClinicalTrials.gov ↗

Sponsor

Study Details

Enrollment3500 participants

Primary Completion—

Lead SponsorMerck Sharp & Dohme LLC

Data Retrieved2026-04-11 02:55:36.205412+00:00

What This Trial Means for Biotech Investors

Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 3,500 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.

MRK Full Pipeline →All Companies →

Not financial advice. BiotechSign data is sourced from ClinicalTrials.gov, SEC EDGAR, and other public databases for research and informational purposes only. It does not constitute investment recommendations. Always do your own due diligence before making investment decisions.