MK-6482-012: Phase 3 Study of Immune and Targeted Combination Therapies for ccRCC
Research type
Research Study
Full title
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 Firstline Treatment in Participants with Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
IRAS ID
1003832
Contact name
Vivienne Liddle
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2020-002216-52
Clinicaltrials.gov Identifier
Research summary
Renal cancers will be diagnosed in an estimated 400,000 patients worldwide each year. Despite a wide variety of treatment options, there are no evidence-based optimal recommended treatment options for participants with advanced cancers including clear cell renal cell carcinoma (ccRCC).
This is a Phase 3 trial testing the safety and efficacy of Arm A (MK-6482, pembrolizumab (pembro) + lenvatinib) and Arm B (MK-1308A (a coformulation of pembro + MK-1308) + lenvatinib) compared to Arm C (pembro and lenvatinib). The trial will last approximately 6years and will recruit about 1431 male and female, aged 18 years with advanced ccRcc.Pembro and lenvatinib have been approved to treat people with different types of cancers but not for ccRcc. MK-6482 and MK-1308A are still being researched.
The trial has 3 parts:
Screening: To see if participants can join the trial with this lasting about one month.Eligible participants will be randomly assigned in a 1 in 3 chance to Arm A, Arm B or Arm C.
Treatment: Participants will visit the trial site 5 times during the first cycle (each cycle is 6 weeks) and 2 times (every 3 weeks) during each cycle after that. This is up to a maximum of 2 years. Depending on the assigned group, participants will receive MK-6482/Lenvatinib until their cancer gets worse or until they leave the trial, and MK-1308A/Pembro up to 18 cycles, until their cancer gets worse, or until they leave the trial (whichever comes first). During the study, participants will undergo procedures such as physical examinations, ECGs, blood/urine samples and scans.
Follow-up: After participants stop taking the trial drug, they will enter the follow-up phase.
The trial is sponsored by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (MSD), and a collaboration with Eisai.REC name
South Central - Oxford C Research Ethics Committee
REC reference
21/SC/0336
Date of REC Opinion
9 Dec 2021
REC opinion
Further Information Favourable Opinion