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RECRUITING Phase 1

Safety and Efficacy Study of Investigational Agents as Monotherapy or in Combination With Pembrolizumab (MK-3475) for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98)

NCT04938817 · View on ClinicalTrials.gov ↗

Study Summary

This study is a rolling arm study of investigational agents as monotherapy or in combination with pembrolizumab in participants with anti-programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) refractory ES-SCLC in need of second-line treatment. This study will have 2 parts: an initial safety lead-in to determine safety and tolerability for experimental combinations of investigational agents without an established recommended phase 2 dose (RP2D) followed by an efficacy evaluation. Investigational agents will initiate directly in or be added to the efficacy evaluation after an initial evaluation of safety and tolerability of the investigational agent has been completed in a separate study or in the safety lead-in of this study. If an RP2D for a combination being evaluated in the safety lead-in is established from another study, then the efficacy evaluation may begin at the determined RP2D. There will be no hypothesis testing in this study.

Conditions Studied

Interventions

  • BIOLOGICAL MK-4830
  • BIOLOGICAL coformulation pembrolizumab/quavonlimab
  • DRUG lenvatinib
  • BIOLOGICAL coformulation favezelimab/pembrolizumab
  • BIOLOGICAL R-DXd

Study Locations (20)

Kentucky

  • Baptist Health Lexington-Research ( Site 0158) — Lexington
  • University of Kentucky Chandler Medical Center-Medical Oncology ( Site 0157) — Lexington

Nebraska

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0172) — Omaha
  • Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0179) — Omaha

Other

  • Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 3101) — Vienna
  • Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 3100) — Vienna

Arizona

  • Banner MD Anderson Cancer Center ( Site 0152) — Gilbert

Georgia

  • Northside Hospital-Northside Hospital Oncology Network ( Site 0156) — Atlanta

Indiana

  • Parkview Research Center at Parkview Regional Medical Center ( Site 0180) — Fort Wayne

Maryland

  • MFSMC-HJWCI-Oncology Research ( Site 0178) — Baltimore

Ohio

  • Cleveland Clinic-Taussig Cancer Center ( Site 0166) — Cleveland

Trial Details

FieldValue
Enrollment Target 110 participants
Start Date 2021-08-19
Est. Completion 2029-12-10
Phase Phase 1

Sponsor

Merck Sharp & Dohme

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04938817

The ClinicalTrials.gov registry entry for NCT04938817 describes a study currently listed as recruiting. It is categorized as Phase 1, 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 110 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 Small Cell Lung Carcinoma appearing as the primary indexed condition, and to 5 interventions — of which MK-4830 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: NCT04938817 reports 20 study locations spanning 17 distinct geographic areas — top geographies include Kentucky, Nebraska, 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 NCT04938817 about?

NCT04938817 is a clinical study titled "Safety and Efficacy Study of Investigational Agents as Monotherapy or in Combination With Pembrolizumab (MK-3475) for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98)". This study is a rolling arm study of investigational agents as monotherapy or in combination with pembrolizumab in participants with anti-programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) refractory ES-SCLC in need of second-line treatment. This study will have 2 parts: an initi...

What is the current status of trial NCT04938817?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 110 participants. The study started on 2021-08-19. Estimated completion is 2029-12-10.

What conditions does trial NCT04938817 study?

This clinical trial studies the following conditions: Small Cell Lung Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04938817?

The interventions under investigation include: MK-4830 (BIOLOGICAL), coformulation pembrolizumab/quavonlimab (BIOLOGICAL), lenvatinib (DRUG), coformulation favezelimab/pembrolizumab (BIOLOGICAL), R-DXd (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04938817?

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 NCT04938817 being conducted?

This trial has 20 study locations across Arizona, Georgia, Indiana, Kentucky, Maryland. 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