An Open-label, Randomized Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or MK-1308A in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, as First-Line Treatment in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)

The goal of this China extension study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in Chinese participants with advanced clear cell renal cell carcinoma (ccRCC).
The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall survival (OS), in advanced ccRCC participants; and (2) pembrolizumab/quavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants.

Start Date27 Jul 2022

Sponsor / Collaborator

Merck Sharp & Dohme LLC

[+1]

CTR20220530 / Active, not recruitingPhase 3

在晚期肾透明细胞癌（ccRCC）患者中开展的一项开放标签、随机III期研究，旨在评估帕博利珠单抗（MK-3475）联合Belzutifan（MK-6482）及仑伐替尼（MK-7902），或MK-1308A联合仑伐替尼，相比于帕博利珠单抗联合仑伐替尼作为一线治疗的有效性和安全性

[Translation] An open-label, randomized, phase III study evaluating the efficacy and safety of pembrolizumab (MK-3475) plus Belzutifan (MK-6482) and lenvatinib (MK-7902), or MK-1308A plus lenvatinib, compared with pembrolizumab plus lenvatinib as first-line treatment in patients with advanced clear cell renal cell carcinoma (ccRCC)

在晚期ccRCC受试者一线治疗中比较帕博利珠单抗联合Belzutifan（MK-6482）及仑伐替尼，或MK-1308A联合仑伐替尼，相比于帕博利珠单抗联合仑伐替尼作为一线治疗的有效性和安全性

[Translation]

To compare the efficacy and safety of pembrolizumab plus Belzutifan (MK-6482) and lenvatinib, or MK-1308A plus lenvatinib, compared with pembrolizumab plus lenvatinib as first-line treatment in participants with advanced ccRCC

Start Date27 Jul 2022

Sponsor / Collaborator

MSD R&D (China) Co. Ltd.

[+2]

CTR20211819 / Active, not recruitingPhase 2

一项在晚期肝细胞癌受试者中评价MK-1308A（MK-1308/MK-3475复方）联合仑伐替尼（E7080/MK-7902）用于一线治疗的安全性和有效性的II期、多中心临床研究

[Translation] A phase II, multicenter clinical study evaluating the safety and efficacy of MK-1308A (MK-1308/MK-3475 combination) combined with lenvatinib (E7080/MK-7902) as first-line treatment in subjects with advanced hepatocellular carcinoma

评估MK-1308A/仑伐替尼研究干预在既往未接受过全身治疗的晚期肝细胞癌受试者中的安全性和有效性

[Translation]

To evaluate the safety and efficacy of the MK-1308A/lenvatinib study intervention in subjects with advanced hepatocellular carcinoma who have not received prior systemic therapy

Start Date01 Nov 2021

Sponsor / Collaborator

MSD R&D (China) Co. Ltd.

[+2]

100 Clinical Results associated with Pembrolizumab/Quavonlimab

100 Translational Medicine associated with Pembrolizumab/Quavonlimab

100 Patents (Medical) associated with Pembrolizumab/Quavonlimab

100 Deals associated with Pembrolizumab/Quavonlimab

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Clear Cell Renal Cell Carcinoma	Phase 3	CN	Merck Sharp & Dohme LLC	27 Jul 2022
Renal Cell Carcinoma	Phase 3	US	Merck Sharp & Dohme Corp.	14 Apr 2021
Renal Cell Carcinoma	Phase 3	CN	Merck Sharp & Dohme Corp.	14 Apr 2021
Renal Cell Carcinoma	Phase 3	JP	Merck Sharp & Dohme Corp.	14 Apr 2021
Renal Cell Carcinoma	Phase 3	AU	Merck Sharp & Dohme Corp.	14 Apr 2021
Renal Cell Carcinoma	Phase 3	BR	Merck Sharp & Dohme Corp.	14 Apr 2021
Renal Cell Carcinoma	Phase 3	CA	Merck Sharp & Dohme Corp.	14 Apr 2021
Renal Cell Carcinoma	Phase 3	CL	Merck Sharp & Dohme Corp.	14 Apr 2021
Renal Cell Carcinoma	Phase 3	CO	Merck Sharp & Dohme Corp.	14 Apr 2021
Renal Cell Carcinoma	Phase 3	HR	Merck Sharp & Dohme Corp.	14 Apr 2021

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