Active Not RecruitingPhase 1 / Phase 2NCT04938817
Official study title

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)

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedcoformulation pembrolizumab/quavonlimab and lenvatinib

Plus 3 other study approaches.

Who it may be forSmall cell lung cancer (SCLC) · PD-L1 · Resistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 1, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?48 U.S. locations

Locations may change over time.

Who runs it?Merck Sharp & Dohme LLC

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Merck Sharp & Dohme LLC
Interventions being studied
Biological: coformulation pembrolizumab/quavonlimab; Drug: lenvatinib; Biological: MK-4830; Biological: coformulation favezelimab/pembrolizumab; Biological: R-DXd
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • The main inclusion criteria include but are not limited to the following:
  • Arms A-E:
  • Has histologically or cytologically confirmed diagnosis of ES-SCLC in need of second-line therapy
  • Has progressed on or after treatment with an anti-programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) monoclonal antibody (mAb) administered as part of first-line platinum-based systemic therapy for ES-SCLC
  • Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition
  • Has received 1 prior line of systemic therapy for small cell lung cancer (SCLC)
  • If a woman of childbearing potential (WOCBP), participant must have a negative highly sensitive pregnancy test within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study treatment
  • Has measurable disease per RECIST 1.1 as assessed by local site investigator/radiology and verified by BICR
  • Has submitted an archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before allocation/randomization
  • Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
  • Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
  • Has a predicted life expectancy of \>3 months
  • Arms A-D:
  • Male participants must be abstinent from heterosexual intercourse or agree to use contraception during treatment for at least 7 days after the last dose of lenvatinib. No contraception is required if the participant is receiving pembrolizumab, pembrolizumab/quavonlimab, MK-4830, or favezelimab/pembrolizumab
  • Female participants are not pregnant or breastfeeding and are not a WOCBP or if are a WOCBP, are abstinent from heterosexual intercourse or are using contraception during the intervention period and for at least 120 days after the last dose of pembrolizumab, pembrolizumab/quavonlimab, MK-4830, or favezelimab/pembrolizumab or 30 days after the last dose of lenvatinib, whichever occurs last
  • Female participants must abstain from breastfeeding during the intervention period and for at least 120 days after the last dose of pembrolizumab, pembrolizumab/quavonlimab, MK-4830, or favezelimab/pembrolizumab or 7 days after the last dose of lenvatinib, whichever occurs last
  • Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 millimeters of mercury (mm Hg) with no change in antihypertensive medications within 1 week before allocation/randomization
  • Arm E:
  • If capable of producing sperm, the participant agrees to refrain from donating sperm and abstain from penile-vaginal intercourse or use a penile/external condom when having penile-vaginal intercourse with a nonparticipant of childbearing potential who is not currently pregnant. The length of time required to continue contraception for the study intervention R-Dx-d is 150 days
  • If a person of childbearing potential (POCBP) must use a contraceptive method that is highly effective (with a failure rate of \<1% per year), with low user dependency, or if they adhere to penile-vaginal intercourse abstinence as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least the time needed to eliminate the study intervention after the last dose of study intervention. In addition, the participant agrees not to donate eggs (ova, oocytes) to others or freeze/store eggs during this period for the purpose of reproduction. The length of time required to continue contraception for the study intervention R-Dx-d is 210 days after the last dose
Reasons someone may not be able to joinExclusion criteria

The main

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Banner MD Anderson Cancer Center ( Site 0152)Gilbert, Arizona
  • Northside Hospital-Northside Hospital Oncology Network ( Site 0156)Atlanta, Georgia
  • Parkview Research Center at Parkview Regional Medical Center ( Site 0180)Fort Wayne, Indiana
  • Baptist Health Lexington-Research ( Site 0158)Lexington, Kentucky
  • University of Kentucky Chandler Medical Center-Medical Oncology ( Site 0157)Lexington, Kentucky
  • MFSMC-HJWCI-Oncology Research ( Site 0178)Baltimore, Maryland
  • Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0172)Omaha, Nebraska
  • Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0179)Omaha, Nebraska
  • Cleveland Clinic-Taussig Cancer Center ( Site 0166)Cleveland, Ohio
  • UPMC Hillman Cancer Center ( Site 0177)Pittsburgh, Pennsylvania
  • St Francis Cancer Center-Research Office ( Site 0167)Greenville, South Carolina
  • Virginia Cancer Institute ( Site 0169)Richmond, Virginia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 1, 2026. Always confirm current availability with the study team.

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