- 3475-B98 2020-005628-12 ( EudraCT Number ) MK-3475-B98 ( Other Identifier: Merck ) KEYNOTE-B98 ( Other Identifier: Merck ) First Posted: June 24, 2021 Key Record Dates: Last Update Posted: August 6, 2021 Last Verified: August 2021 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: Yes.
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Go toThis 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.
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Small Cell Lung Carcinoma | Biological: coformulation pembrolizumab/quavonlimabDrug: lenvatinibBiological: MK-4830Biological: coformulation favezelimab/pembrolizumab | Phase 1Phase 2 |
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| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 80 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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) |
| Estimated Study Start Date : | August 6, 2021 |
| Estimated Primary Completion Date : | November 2, 2026 |
| Estimated Study Completion Date : | November 2, 2026 |
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