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NCT04938817 · ClinicalTrials.gov registry record · 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)

A Phase 1 study of Small Cell Lung Carcinoma, sponsored by Merck Sharp & Dohme.

Recruiting
Registry status
Phase 1
Development phase
110
Enrollment target
20
Study locations

NCT04938817 is a Phase 1 study of Small Cell Lung Carcinoma that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 110 participants, below the 255-participant average among 18 other Small Cell Lung Carcinoma trials with a reported enrollment target (57% lower). The trial reports 20 study locations across 17 states.

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The verdict

NCT04938817, a Phase 1 study of Small Cell Lung Carcinoma, is actively recruiting participants, sponsored by Merck Sharp & Dohme.

RECRUITING
Registry status
Phase 1
Development phase
110 participants
Enrollment target
20
Study locations

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

Small Cell Lung Carcinoma

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

558 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, categorized as Phase 1. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 255-participant average among 18 other Small Cell Lung Carcinoma trials with a reported enrollment target (57% lower). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

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.

NCT04938817 reports 20 study locations spanning 17 distinct geographic areas - top geographies include Kentucky, Nebraska, Other.

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.

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).

Who is sponsoring clinical trial NCT04938817?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.