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Get access to a Mac with macOS 10.12 Sierra installed. Create a guest account with your Apple ID and use it to login to the Mac App Store. “Purchase” Keynote, Pages and Numbers. Now if you go back to your older Mac, these products will be associated with your Apple ID, and the Mac App Store will offer to install the latest compatible version. Tumor mutational burden (TMB), defined as the number of somatic mutations per megabase of interrogated genomic sequence, varies across malignancies. Panel sequencing-based estimates of TMB have largely replaced whole-exome sequencing-derived TMB in the clinic.
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.
| 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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Keynote 10.12 6 Update
| 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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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.
| 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 |