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Be Part of Research - Trial Details - A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
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A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)

Not Recruiting

Open to: ALL

Age: 18.0 - N/A

Northwood Cambridge London

Medical Conditions

Carcinoma, Renal Cell

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The goal of this 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 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 dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Apr 2021 Oct 2026

Publications

"Choueiri TK, Powles T, Voss MH, Plimack ER, Gurney H, Song Y, Perini RF, Rodriguez-Lopez K, Rini BI. LITESPARK-012: pembrolizumab plus lenvatinib with or without belzutifan or quavonlimab for advanced renal cell carcinoma. Future Oncol. 2023 Dec;19(40):2631-2640. doi: 10.2217/fon-2023-0283. Epub 2023 Oct 26."; "37882432"; "Ged Y, Markowski MC, Singla N, Rowe SP. The shifting treatment paradigm of metastatic renal cell carcinoma. Nat Rev Urol. 2022 Nov;19(11):631-632. doi: 10.1038/s41585-022-00651-9."; "36064785"

INTERVENTIONAL

Intervention Type : BIOLOGICAL
Intervention Description : Pembrolizumab 400 mg administered Q6W via IV infusion

Intervention Arm Group : Pembrolizumab + Belzutifan + Lenvatinib;Pembrolizumab + Lenvatinib;

Intervention Type : DRUG
Intervention Description : Belzutifan 120 mg administered QD via oral tablet

Intervention Arm Group : Pembrolizumab + Belzutifan + Lenvatinib;

Intervention Type : BIOLOGICAL
Intervention Description : Pembrolizumab/quavonlimab is a co-formulated product composed of pembrolizumab 400 mg in combination with quavonlimab 25 mg, administered Q6W via IV infusion

Intervention Arm Group : Pembrolizumab/Quavonlimab + Lenvatinib;

Intervention Type : DRUG
Intervention Description : Lenvatinib 20 mg administered QD via oral capsule

Intervention Arm Group : Pembrolizumab + Belzutifan + Lenvatinib;Pembrolizumab + Lenvatinib;Pembrolizumab/Quavonlimab + Lenvatinib;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Mount Vernon Cancer Centre ( Site 3101)
    Northwood
    London, City of
    HA6 2RN
  • Addenbrookes Hospital ( Site 3110)
    Cambridge
    Cambridgeshire
    CB2 2QQ
  • Barts Health NHS Trust - St Bartholomew s Hospital ( Site 3116)
    London
    England
    EC1A 7BE


The study is sponsored by Merck Sharp & Dohme LLC and is in collaboration with Eisai Inc..



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Read full details for Trial ID: NCT04736706
Last updated 14 November 2024

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