NCT04938817

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 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)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Small Cell Lung Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	coformulation pembrolizumab/quavonlimab	Intravenous (IV) infusion
DRUG	lenvatinib	Oral administration
BIOLOGICAL	MK-4830	IV infusion
BIOLOGICAL	coformulation favezelimab/pembrolizumab	IV infusion
BIOLOGICAL	R-DXd	IV Infusion

Timeline

• Start date: 2021-08-19
• Primary completion: 2029-12-10
• Completion: 2029-12-10
• First posted: 2021-06-24
• Last updated: 2026-04-13

Locations

48 sites across 12 countries: United States, Australia, Austria, Canada, Hungary, Israel, Italy, Poland, Russia, South Korea, Spain, Switzerland

Regulatory

• FDA-regulated drug study