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)
Sponsor: Merck Sharp & Dohme LLC + Daiichi Sankyo
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Time frame: Up to 21 days in Cycle 1 (Cycle 1 = 21 days)
Number of Participants Who Experience at Least One Adverse Event (AE)
Time frame: Up to approximately 60 months
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Time frame: Up to approximately 60 months
Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
Time frame: Up to approximately 60 months
Secondary Endpoints
Progression-free Survival (PFS) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
Duration of Response (DOR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
Eligibility Criteria
Inclusion 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 ar…
Read full criteria on CT.gov →✦ Analyst Commentary
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