Trial Title:
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, vs Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)-China Extension Study
NCT ID:
NCT05899049
Condition:
Carcinoma, Renal Cell
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Pembrolizumab
Lenvatinib
Belzutifan
Conditions: Keywords:
Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Hypoxia inducible factor (HIF)
Hypoxia inducible factor 1B (HIF-1B)
Hypoxia inducible factor 2 alpha (HIF-2 alpha)
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Pembrolizumab
Description:
Pembrolizumab 400 mg administered Q6W via IV infusion
Arm group label:
Pembrolizumab + Belzutifan + Lenvatinib
Arm group label:
Pembrolizumab + Lenvatinib
Other name:
MK-3475
Other name:
KEYTRUDA®
Intervention type:
Drug
Intervention name:
Belzutifan
Description:
Belzutifan 120 mg administered QD via oral tablet
Arm group label:
Pembrolizumab + Belzutifan + Lenvatinib
Other name:
MK-6482
Other name:
PT2977
Other name:
WELIREG™
Intervention type:
Biological
Intervention name:
Pembrolizumab/Quavonlimab
Description:
Pembrolizumab/quavonlimab is a co-formulated product composed of pembrolizumab 400 mg in
combination with quavonlimab 25 mg, administered Q6W via IV infusion
Arm group label:
Pembrolizumab/Quavonlimab + Lenvatinib
Other name:
MK-1308A
Intervention type:
Drug
Intervention name:
Lenvatinib
Description:
Lenvatinib 20 mg administered QD via oral capsule
Arm group label:
Pembrolizumab + Belzutifan + Lenvatinib
Arm group label:
Pembrolizumab + Lenvatinib
Arm group label:
Pembrolizumab/Quavonlimab + Lenvatinib
Other name:
MK-7902
Other name:
E7080
Other name:
LENVIMA®
Summary:
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.
Detailed description:
The China extension study will include participants previously enrolled in China in the
global study for MK-6482-012 (NCT04736706) plus those enrolled during the China extension
enrollment period. A total of approximately 249 Chinese participants will be enrolled.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Has histologically confirmed diagnosis of RCC with clear cell component.
- Has received no prior systemic therapy for advanced ccRCC
- Male participants are abstinent from heterosexual intercourse or agree to use
contraception during and for at least 7 days after last dose of study intervention
with belzutifan and lenvatinib.
- Female participants are not pregnant or breastfeeding and are either not a woman of
child-bearing potential (WOCBP) or use a contraceptive method that is highly
effective or are abstinent from heterosexual intercourse during the intervention
period and for at least 120 days after pembrolizumab or pembrolizumab/quavonlimab or
for at least 30 days after last dose of lenvatinib or belzutifan, whichever occurs
last
- Has adequately controlled blood pressure with or without antihypertensive
medications
- Has adequate organ function.
- Participants receiving bone resorptive therapy must have therapy initiated at least
2 weeks prior to randomization/allocation
Exclusion Criteria:
- Has a known additional malignancy that is progressing or has required active
treatment within the past 3 years
- Has had major surgery, other than nephrectomy within 4 weeks prior to randomization
- Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has received prior radiotherapy within 2 weeks prior to first dose of study
intervention
- Has hypoxia or requires intermittent supplemental oxygen or requires chronic
supplemental oxygen
- Has clinically significant cardiac disease within 12 months from first dose of study
intervention
- Has a history of interstitial lung disease
- Has symptomatic pleural effusion; a participant who is clinically stable following
treatment of this condition is eligible
- Has preexisting gastrointestinal or non-gastrointestinal fistula
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
or any other form of immunosuppressive therapy within 7 days prior to the first dose
of study treatment
- Has a known psychiatric or substance abuse disorder that would interfere with
requirements of the study
- Has received a live or live-attenuated vaccine within 30 days before the first dose
of study drug; killed vaccines are allowed
- Has an active autoimmune disease that has required systemic treatment in the past 2
years
- Has a history of noninfectious pneumonitis that required steroids or has current
pneumonitis
- Has an active infection requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection
- Has a known history of Hepatitis B
- Has radiographic evidence of intratumoral cavitation, encasement or invasion of a
major blood vessel
- Has clinically significant history of bleeding within 3 months prior to
randomization
- Has had an allogenic tissue/solid organ transplant
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 6000)
Address:
City:
Beijing
Zip:
100142
Country:
China
Facility:
Name:
Chongqing University Cancer Hospital ( Site 6009)
Address:
City:
Chongqing
Zip:
400030
Country:
China
Facility:
Name:
SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 6003)
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Facility:
Name:
The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 6036)
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Facility:
Name:
Guangzhou First People's Hospital ( Site 6007)
Address:
City:
Guangzhou
Zip:
510180
Country:
China
Facility:
Name:
Henan Cancer Hospital-Urology ( Site 6006)
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Facility:
Name:
Wuhan Union Hospital ( Site 6002)
Address:
City:
Wuhan
Zip:
430022
Country:
China
Facility:
Name:
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S
Address:
City:
Nanjing
Zip:
210000
Country:
China
Facility:
Name:
The Second Affiliated Hospital of Soochow University-Urology ( Site 6025)
Address:
City:
Suzhou
Zip:
215004
Country:
China
Facility:
Name:
The First Affiliated Hospital of Nanchang University ( Site 6019)
Address:
City:
Nanchang
Zip:
330006
Country:
China
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 6014)
Address:
City:
Xi'an
Zip:
710061
Country:
China
Facility:
Name:
West China Hospital Sichuan University-Urology Surgery ( Site 6016)
Address:
City:
Cheng Du
Zip:
610041
Country:
China
Facility:
Name:
The Second Hospital of Tianjin Medical University ( Site 6032)
Address:
City:
Tianjin
Zip:
300211
Country:
China
Facility:
Name:
The First Affiliated Hospital, Zhejiang University ( Site 6024)
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Facility:
Name:
The First Hospital of Jiaxing ( Site 6033)
Address:
City:
Jiaxing
Zip:
314001
Country:
China
Facility:
Name:
Ningbo First Hospital-Urology ( Site 6028)
Address:
City:
Ningbo
Zip:
315010
Country:
China
Facility:
Name:
The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 6021)
Address:
City:
Wenzhou
Zip:
325000
Country:
China
Start date:
July 27, 2022
Completion date:
December 1, 2026
Lead sponsor:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Collaborator:
Agency:
Eisai Inc.
Agency class:
Industry
Source:
Merck Sharp & Dohme LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05899049
https://merckclinicaltrials.com/
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=6482-012&&kw=6482-012
