Safety and Efficacy Study of Pembrolizumab (MK-3475) in Combination With Investigational Agents for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98)

Official Title

A Phase 1b/2 Study to Evaluate the Efficacy and Safety of Pembrolizumab in Combination With Investigational Agents for the Treatment of Participants With PD-1/L1-refractory Extensive-Stage Small Cell Lung Cancer in Need of Second-Line Therapy (KEYNOTE-B98)

Summary:

This study is a rolling arm study of pembrolizumab in combination with investigational agents 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.

Trial Description

Primary Outcome:

• Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
• Number of Participants Who Experience at Least One Adverse Event (AE)
• Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
• Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumours Version 1.1 (RECIST 1.1)

• Progression-free Survival (PFS) Per Response Evaluation Criteria In Solid Tumours Version 1.1 (RECIST 1.1)
• Duration of Response (DOR) Per Response Evaluation Criteria In Solid Tumours Version 1.1 (RECIST 1.1)

View this trial on ClinicalTrials.gov