Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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

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. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Primary Outcome

DLTs = ≥1 of the following treatment-related toxicities: Grade (G)4 nonhematologic toxicity; G4 hematologic toxicity lasting \>7 days OR G4 platelet count decreased OR G3 platelet count decreased if associated with bleeding; G3 nonhematologic toxicity including G3 fatigue (lasting \>3 days), G3 diarrhea, nausea, vomiting lasting ≥72 hours, G3 rash ≥7 days despite treatment, G3 uncontrolled hypertension; G3/4 nonhematologic laboratory abnormality if requires medical intervention, hospitalization,

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
Merck Sharp & Dohme

558 total trials

What NCT04938817 shows while recruiting

NCT04938817 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 255-participant average among 18 other Small Cell Lung Carcinoma trials with a reported enrollment target (57% lower).

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 names 20 study sites across 17 states, led by 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.

Learn More About Clinical Trials

Similar trials for Small Cell Lung Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04938817's enrollment target sits among peer trials

110 10th of 18 higher than 9 of 18 other Small Cell Lung Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Small Cell Lung Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT01530373 · 110 participants · Phase 2

    Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients

  • NCT02379377 · 110 participants · Phase 1

    18F-FSPG PET in Imaging Patients With Liver Cancer Before Undergoing Surgery or Transplant

  • NCT02411773 · 110 participants · Phase 1

    Sympatholysis in Chronic Kidney Disease

  • NCT03190941 · 110 participants · Phase 1

    Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

More recruiting context for NCT04938817

Source: ClinicalTrials.gov NCT04938817, the US trial registry maintained by the National Library of Medicine. NCT04938817 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.