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Carcinoma, Renal CellPhase 3NCT05899049

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

A Phase 3 study testing Pembrolizumab, Belzutifan and Pembrolizumab/Quavonlimab in people with Carcinoma, Renal Cell, run by Merck Sharp & Dohme LLC at 17 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Renal Cell
What is being tested?
Pembrolizumab, Belzutifan and Pembrolizumab/Quavonlimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
251 participants
Where
17 sitesChina
Study dates
27 Jul 2022to 22 Apr 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

China17 sites

  • Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 6000)

    Beijing, Beijing Municipality, 100142

  • West China Hospital Sichuan University-Urology Surgery ( Site 6016)

    Chengdu, Sichuan, 610041

  • Chongqing University Cancer Hospital ( Site 6009)

    Chongqing, Chongqing Municipality, 400030

  • SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 6003)

    Guangzhou, Guangdong, 510060

  • The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 6036)

    Guangzhou, Guangdong, 510120

  • Guangzhou First People's Hospital ( Site 6007)

    Guangzhou, Guangdong, 510180

  • The First Affiliated Hospital, Zhejiang University ( Site 6024)

    Hangzhou, Zhejiang, 310003

  • The First Hospital of Jiaxing ( Site 6033)

    Jiaxing, Zhejiang, 314001

  • The First Affiliated Hospital of Nanchang University ( Site 6019)

    Nanchang, Jiangxi, 330006

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S

    Nanjing, Jiangsu, 210000

  • Ningbo First Hospital-Urology ( Site 6028)

    Ningbo, Zhejiang, 315010

  • The Second Affiliated Hospital of Soochow University-Urology ( Site 6025)

    Suzhou, Jiangsu, 215004

  • The Second Hospital of Tianjin Medical University ( Site 6032)

    Tianjin, Tianjin Municipality, 300211

  • The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 6021)

    Wenzhou, Zhejiang, 325000

  • Wuhan Union Hospital ( Site 6002)

    Wuhan, Hubei, 430022

  • The First Affiliated Hospital of Xi'an Jiaotong University ( Site 6014)

    Xi'an, Shaanxi, 710061

  • Henan Cancer Hospital-Urology ( Site 6006)

    Zhengzhou, Henan, 450008

Other trials in China

About this study

Official 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 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.

Read the 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.

Being tested
Pembrolizumab, Belzutifan, Pembrolizumab/Quavonlimab, Lenvatinib
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)
Medical subject headings
Carcinoma, Renal Cell, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabBiological

    Also called MK-3475, KEYTRUDA®

    Pembrolizumab 400 mg administered Q6W via IV infusion

  • BelzutifanDrug

    Also called MK-6482, PT2977, WELIREG™

    Belzutifan 120 mg administered QD via oral tablet

  • Pembrolizumab/QuavonlimabBiological

    Also called MK-1308A

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

  • LenvatinibDrug

    Also called MK-7902, E7080, LENVIMA®

    Lenvatinib 20 mg administered QD via oral capsule

Study groups in NCT05899049
Study groupRoleWhat they receive
Pembrolizumab + Belzutifan + LenvatinibExperimentalParticipants will receive pembrolizumab 400 mg PLUS belzutifan 120 mg PLUS lenvatinib 20 mg. Pembrolizumab will be administered intravenously (IV) once every 6 weeks (Q6W) for up to 18 administrations (up to ~2 years). Belzutifan and lenvatinib will be administered orally once daily (QD) until progressive disease or discontinuation.
Receives: Biological: Pembrolizumab; Drug: Belzutifan; Drug: Lenvatinib
Pembrolizumab/Quavonlimab + LenvatinibExperimentalParticipants will receive pembrolizumab/quavonlimab (co-formulation of pembrolizumab 400 mg and quavonlimab 25 mg) PLUS lenvatinib 20 mg. Pembrolizumab/quavonlimab will be administered IV Q6W for up to 18 administrations (up to ~2 years). Lenvatinib will be administered orally QD until progressive disease or discontinuation.
Receives: Biological: Pembrolizumab/Quavonlimab; Drug: Lenvatinib
Pembrolizumab + LenvatinibActive comparatorParticipants will receive pembrolizumab 400 mg PLUS lenvatinib 20 mg. Pembrolizumab will be administered IV Q6W for up to 18 administrations (up to ~2 years). Lenvatinib will be administered orally QD until progressive disease or discontinuation.
Receives: Biological: Pembrolizumab; Drug: Lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR based on RECIST 1.1 will be presented.

    Measured: Up to approximately 58 months

  2. Overall Survival (OS)

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 58 months

Secondary outcomes (4)

  1. Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR

    ORR is defined as the percentage of participants who have a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by BICR based on RECIST 1.1 will be presented.

    Measured: Up to approximately 58 months

  2. Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR

    For participants who demonstrate a confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by BICR based on RECIST 1.1 will be presented.

    Measured: Up to approximately 58 months

  3. Number of Participants Who Experienced At least One Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience at least one AE will be presented.

    Measured: Up to approximately 58 months

  4. Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be presented.

    Measured: Up to approximately 58 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2023
  2. Study start27 Jul 2022
  3. Primary completion4 Feb 2026
  4. Study completion22 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
251 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05899049
Sponsor's protocol ID
6482-012 China Extension
Other IDs
MK-6482-012 China Extension, jRCT2031210435, PHRR210911-003887
Status last verified
Aug 2026
First submitted
2 Jun 2023
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pembrolizumab, Belzutifan and Pembrolizumab/Quavonlimab in people with Carcinoma, Renal Cell, run by Merck Sharp & Dohme LLC at 17 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) (time frame: Up to approximately 58 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05899049.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.

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