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)
Public ClinicalTrials.gov record NCT04938817. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1b/2 Study to Evaluate the Efficacy and Safety of Investigational Agents as Monotherapy or in Combination With Pembrolizumab for the Treatment of Participants With PD-1/L1-refractory Extensive-Stage Small Cell Lung Cancer in Need of Second-Line Therapy (KEYNOTE-B98)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04938817
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 110 participants
Conditions and interventions
Conditions
Interventions
- coformulation pembrolizumab/quavonlimab Biological
- lenvatinib Drug
- MK-4830 Biological
- coformulation favezelimab/pembrolizumab Biological
- R-DXd Biological
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 18, 2021
- Primary completion
- Dec 9, 2029
- Completion
- Dec 9, 2029
- Last update posted
- May 31, 2026
2021 – 2029
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner MD Anderson Cancer Center ( Site 0152) | Gilbert | Arizona | 85234 | — |
| Northside Hospital-Northside Hospital Oncology Network ( Site 0156) | Atlanta | Georgia | 30342 | — |
| Parkview Research Center at Parkview Regional Medical Center ( Site 0180) | Fort Wayne | Indiana | 46845 | — |
| Baptist Health Lexington-Research ( Site 0158) | Lexington | Kentucky | 40503 | — |
| University of Kentucky Chandler Medical Center-Medical Oncology ( Site 0157) | Lexington | Kentucky | 40536 | — |
| MFSMC-HJWCI-Oncology Research ( Site 0178) | Baltimore | Maryland | 21237 | — |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0172) | Omaha | Nebraska | 68130 | — |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0179) | Omaha | Nebraska | 68130 | — |
| Cleveland Clinic-Taussig Cancer Center ( Site 0166) | Cleveland | Ohio | 44195 | — |
| UPMC Hillman Cancer Center ( Site 0177) | Pittsburgh | Pennsylvania | 15232 | — |
| St Francis Cancer Center-Research Office ( Site 0167) | Greenville | South Carolina | 29607 | — |
| Virginia Cancer Institute ( Site 0169) | Richmond | Virginia | 23229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 36 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04938817, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 31, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04938817 live on ClinicalTrials.gov.