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New drug cocktail shows promise for advanced kidney cancer

NCT ID NCT05899049

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This Phase 3 trial tests whether adding belzutifan or quavonlimab to a standard immunotherapy (pembrolizumab) and targeted therapy (lenvatinib) works better for advanced clear cell kidney cancer. About 249 Chinese patients who haven't had prior treatment will be randomly assigned to one of three drug combinations. The study measures how long patients live without their cancer worsening and overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pembrolizumab, belzutifan, lenvatinib, and quavonlimab
What this could lead to
If successful, this could offer a more effective first-line treatment option for advanced kidney cancer, potentially extending life and delaying disease progression.
What could go wrong
This is an early-stage Phase 3 trial with a small sample size (249 participants) and focuses only on Chinese patients, so results may not apply to other populations. Drug combinations also carry risks of serious side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

251 people

The number who actually took part.

Started

Jul 2022

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 clear cell renal carcinoma renal cell adenocarcinoma renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, renal cell

Contacts and locations

Locations

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

    Beijing, Beijing Municipality, 100142, China

  • Chongqing University Cancer Hospital ( Site 6009)

    Chongqing, Chongqing Municipality, 400030, China

  • Guangzhou First People's Hospital ( Site 6007)

    Guangzhou, Guangdong, 510180, China

  • Henan Cancer Hospital-Urology ( Site 6006)

    Zhengzhou, Henan, 450008, China

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

    Nanjing, Jiangsu, 210000, China

  • Ningbo First Hospital-Urology ( Site 6028)

    Ningbo, Zhejiang, 315010, China

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

    Guangzhou, Guangdong, 510060, China

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

    Guangzhou, Guangdong, 510120, China

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

    Nanchang, Jiangxi, 330006, China

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

    Wenzhou, Zhejiang, 325000, China

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

    Xi'an, Shaanxi, 710061, China

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

    Hangzhou, Zhejiang, 310003, China

  • The First Hospital of Jiaxing ( Site 6033)

    Jiaxing, Zhejiang, 314001, China

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

    Suzhou, Jiangsu, 215004, China

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

    Tianjin, Tianjin Municipality, 300211, China

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

    Chengdu, Sichuan, 610041, China

  • Wuhan Union Hospital ( Site 6002)

    Wuhan, Hubei, 430022, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.