An Open-label, Randomized, Phase 3 Study of MK-6482 in Combination With Lenvatinib (MK-7902) vs Cabozantinib in Participants With Advanced Renal Cell Carcinoma Who Have Progressed After Prior Anti-PD-1/L1 Therapy

  • STATUS
    Recruiting
  • End date
    Dec 23, 2024
  • participants needed
    708
  • sponsor
    Merck Sharp & Dohme LLC
Updated on 21 October 2022
measurable disease
carcinoma
karnofsky performance status
cabozantinib
programmed cell death 1 ligand 1
lenvatinib
advanced renal cell carcinoma
clear cell renal cell carcinoma

Summary

This study will compare the efficacy and safety of belzutifan + lenvatinib versus cabozantinib in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy.

The primary hypothesis is that belzutifan + lenvatinib is superior to cabozantinib in terms of progression-free survival or overall survival.

Details
Condition Carcinoma, Renal Cell
Treatment Cabozantinib, Lenvatinib, Belzutifan
Clinical Study IdentifierNCT04586231
SponsorMerck Sharp & Dohme LLC
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Unresectable, locally advanced or metastatic clear cell renal cell carcinoma (RCC)
Disease progression on or after an anti-programmed cell death-1/ligand 1 (PD-1/L1) therapy as either first or second-line treatment for locally advanced/metastatic RCC or as adjuvant treatment or neoadjuvant/adjuvant with progression on or within 6 months of last dose
Measurable disease per RECIST 1.1 criteria as assessed by local study investigator
Karnofsky performance status (KPS) score of at least 70% assessed within 10 days before randomization
Received no more than 2 prior systemic regimens including: one anti-PD-1/L1 containing adjuvant or neoadjuvant/adjuvant regimens with progression on or within 6 months from the last dose of that regimen OR one or 2 regimens for locoregional/advanced disease
Received only 1 prior antiPD-1/L1 therapy for adjuvant, neoadjuvant/adjuvant or locally advanced/metastatic RCC
A male participant is eligible to participate if he is abstinent from heterosexual intercourse or agrees to use contraception during the intervention period and for at least 7 days after the last dose of belzutifan or lenvatinib in the belzutifan+lenvatinib arm, whichever occurs last, and 23 days after the last dose of cabozantinib
A female participant is eligible to participate if they are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 30 days after the last dose of study intervention in the belzutifan+ lenvatinib arm, or 120 days after the last dose of study intervention in the cabozantinib arm
Adequately controlled blood pressure
Adequate organ function

Exclusion Criteria

A pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
Known central nervous system (CNS) metastases and/or carcinomatous meningitis
Known additional malignancy that is progressing or has required active treatment within the past 3 years except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy
Pre-existing ≥Grade 3 gastrointestinal or nongastrointestinal fistula
Symptomatic pleural effusion (e.g.,cough, dyspnea, pleuritic chest pain) that is not clinically stable
Clinically significant cardiac disease within 6 months of first dose of study intervention
Prolongation of QTc interval to >480 ms
Moderate to severe hepatic impairment
History of significant bleeding within 3 months before randomization
Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study
Unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption)
History of solid organ transplantation
Known hypersensitivity or allergy to the active pharmaceutical ingredients or any component of the study intervention formulations
Prior treatment with belzutifan or another hypoxia-inducible factor (HIF)-2α inhibitor
Prior treatment with lenvatinib
Prior treatment with cabozantinib
Received colony-stimulating factors [eg, granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GMCSF) or recombinant erythropoietin (EPO)] within 28 days before randomization
Currently participating in a study of an investigational agent or using an investigational device
Active infection requiring systemic therapy
History of hepatitis B or known active hepatitis C infection
History of human immunodeficiency virus (HIV) infection
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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