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COMPLETED Phase 3

Study of Lenvatinib (MK-7902/E7080) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care in Participants With Metastatic Colorectal Cancer (MK-7902-017/E7080-G000-325/LEAP-017)

NCT04776148 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to assess the safety and efficacy of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in participants with metastatic colorectal cancer. The study will also compare lenvatinib plus pembrolizumab with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil hydrochloride). The primary study hypothesis is that lenvatinib plus pembrolizumab is superior to standard of care with respect to overall survival.

Conditions Studied

Interventions

  • DRUG pembrolizumab
  • DRUG lenvatinib
  • DRUG regorafenib
  • DRUG TAS-102 (trifluridine and tipiracil)

Study Locations (20)

Maryland

  • MFSMC-HJWCI-Oncology Research ( Site 0012) — Baltimore
  • MedStar Good Samaritan Hospital-Oncology Research ( Site 0038) — Baltimore

Virginia

  • Inova Schar Cancer Institute ( Site 0022) — Fairfax
  • Blue Ridge Cancer Care ( Site 0036) — Roanoke

Other

  • Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0303) — Buenos Aires
  • IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0300) — Buenos Aires

Queensland

  • Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si — Brisbane
  • Gallipoli Medical Research Foundation-GMRF CTU ( Site 1500) — Greenslopes

California

  • Pacific Cancer Care ( Site 0031) — Monterey

Georgia

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0021) — Marietta

Illinois

  • University of Chicago Medical Center-Medicine - Section of Hematology/Oncology - Gastrointestinal P — Chicago

Michigan

  • Henry Ford Hospital ( Site 0024) — Detroit

Trial Details

FieldValue
Enrollment Target 563 participants
Start Date 2021-03-29
Est. Completion 2024-09-27
Phase Phase 3

Sponsor

Merck Sharp & Dohme

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04776148

The ClinicalTrials.gov registry entry for NCT04776148 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 563 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Colorectal Neoplasms appearing as the primary indexed condition, and to 4 interventions — of which pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04776148 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Maryland, Virginia, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04776148 about?

NCT04776148 is a clinical study titled "Study of Lenvatinib (MK-7902/E7080) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care in Participants With Metastatic Colorectal Cancer (MK-7902-017/E7080-G000-325/LEAP-017)". The purpose of this study is to assess the safety and efficacy of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in participants with metastatic colorectal cancer. The study will also compare lenvatinib plus pembrolizumab with the standard of care treatment of regorafenib and...

What is the current status of trial NCT04776148?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 563 participants. The study started on 2021-03-29. Estimated completion is 2024-09-27.

What conditions does trial NCT04776148 study?

This clinical trial studies the following conditions: Colorectal Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04776148?

The interventions under investigation include: pembrolizumab (DRUG), lenvatinib (DRUG), regorafenib (DRUG), TAS-102 (trifluridine and tipiracil) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04776148?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04776148 being conducted?

This trial has 20 study locations across California, Georgia, Illinois, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial