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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. MacOS Sierra 10.12.6, macOS High Sierra 10.13.6, and included in macOS Mojave 10.14.5. Numbers 4.0, and Keynote 7.0 for Mac. MacOS 10.12 and later.

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Top of PageStudy DescriptionStudy DesignArms and InterventionsOutcome MeasuresEligibility CriteriaContacts and LocationsMore Information

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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.


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Condition or disease Intervention/treatment Phase
Small Cell Lung CarcinomaBiological: coformulation pembrolizumab/quavonlimabDrug: lenvatinibBiological: MK-4830Biological: coformulation favezelimab/pembrolizumabPhase 1Phase 2

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Top of PageStudy DescriptionStudy DesignArms and InterventionsOutcome MeasuresEligibility CriteriaContacts and LocationsMore Information
Layout table for study information
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
Resource links provided by the National Library of Medicine
Drug Information available for: LenvatinibPembrolizumab
10.12
Genetic and Rare Diseases Information Center resources: Small Cell Lung Cancer

Go to
Top of PageStudy DescriptionStudy DesignArms and InterventionsOutcome MeasuresEligibility CriteriaContacts and LocationsMore Information

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.

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There will be no hypothesis testing in this study.


Condition or disease Intervention/treatment Phase
Small Cell Lung CarcinomaBiological: coformulation pembrolizumab/quavonlimabDrug: lenvatinibBiological: MK-4830Biological: coformulation favezelimab/pembrolizumabPhase 1Phase 2

Keynote 10.12 6 Key

Go to
Top of PageStudy DescriptionStudy DesignArms and InterventionsOutcome MeasuresEligibility CriteriaContacts and LocationsMore Information
Layout table for study information
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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Resource links provided by the National Library of Medicine
Drug Information available for: LenvatinibPembrolizumab
Genetic and Rare Diseases Information Center resources: Small Cell Lung Cancer

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