Delving into the Latest Updates on Pembrolizumab/Quavonlimab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

quavonlimab/pembro, MK 1308A, MK-1308A

Target

CTLA4 x PD-1

Action

inhibitors

Mechanism

CTLA4 inhibitors(Cytotoxic T-Lymphocyte-Associated Antigen 4 inhibitors), PD-1 inhibitors(Programmed cell death protein 1 inhibitors)

Therapeutic Areas

NeoplasmsUrogenital DiseasesDigestive System Disorders+ [2]

Active Indication

Renal Cell CarcinomaLocally Advanced Clear Cell Renal Cell CarcinomaMicrosatellite instability-high colorectal cancer+ [4]

Inactive Indication

Metastatic Colorectal Carcinoma

Originator Organization

Merck Sharp & Dohme Corp.

Active Organization

Merck Sharp & Dohme Corp.Merck Sharp & Dohme LLC

MSD R&D (China) Co. Ltd.

Inactive Organization

Merck & Co., Inc.

License Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 93660H

The sequence is quoted from: *****

Sequence Code 93670L

The sequence is quoted from: *****

Sequence Code 432609798H

The sequence is quoted from: *****

Sequence Code 432609800L

The sequence is quoted from: *****

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

Start Date19 Aug 2021

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

[+1]

NCT04895722

/ Active, not recruitingPhase 2

A Phase 2, Multicenter, Multi Arm, Study to Evaluate MK-1308A (Co-formulated Quavonlimab (MK-1308)/Pembrolizumab) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer: (MK-1308A-008)

The purpose of this study is to assess the efficacy and safety of co-formulated pembrolizumab/quavonlimab versus other treatments in participants with MSI-H or dMMR Metastatic Stage IV Colorectal Cancer.

Start Date25 Jun 2021

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

NCT04700072

/ CompletedPhase 1/2

A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02D

Substudy 02D is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study.
The goal of substudy 02D is to evaluate the safety and efficacy of investigational treatment arms in programmed cell-death 1 (PD-1) naïve or PD-1 exposed participants with melanoma brain metastasis (MBM) and to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available.
As of amendment 2 (effective 01DEC2022) enrollment into the treatment arm of pembrolizumab and lenvatinib has been discontinued.

Start Date03 May 2021

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

100 Clinical Results associated with Pembrolizumab/Quavonlimab

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100 Translational Medicine associated with Pembrolizumab/Quavonlimab

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100 Patents (Medical) associated with Pembrolizumab/Quavonlimab

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100 Deals associated with Pembrolizumab/Quavonlimab

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Renal Cell Carcinoma	Phase 3	United States	Merck Sharp & Dohme LLC	11 May 2021
Renal Cell Carcinoma	Phase 3	China	Merck Sharp & Dohme LLC	11 May 2021
Renal Cell Carcinoma	Phase 3	Japan	Merck Sharp & Dohme LLC	11 May 2021
Renal Cell Carcinoma	Phase 3	Australia	Merck Sharp & Dohme LLC	11 May 2021
Renal Cell Carcinoma	Phase 3	Brazil	Merck Sharp & Dohme LLC	11 May 2021
Renal Cell Carcinoma	Phase 3	Canada	Merck Sharp & Dohme LLC	11 May 2021
Renal Cell Carcinoma	Phase 3	Chile	Merck Sharp & Dohme LLC	11 May 2021
Renal Cell Carcinoma	Phase 3	Colombia	Merck Sharp & Dohme LLC	11 May 2021
Renal Cell Carcinoma	Phase 3	Croatia	Merck Sharp & Dohme LLC	11 May 2021
Renal Cell Carcinoma	Phase 3	Czechia	Merck Sharp & Dohme LLC	11 May 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04740307 (KEYSTEP-004, ASCO_GI2024) Manual	Phase 2	Advanced Hepatocellular Carcinoma First line	115	coformulation of quavonlimab and pembro plus lenva (advanced hepatocellular carcinoma (HCC))	izaoqvadjq \| cigkscoktb(twwjfjshxr) = nnjzvisxqp faqxedwcdu (fyirgylsuq, 28.5 - 46.9) View more	Positive	18 Jan 2024

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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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