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

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Updated on 21 October 2022

See if I qualify

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 Identifier	NCT04586231
Sponsor	Merck Sharp & Dohme LLC
Last Modified on	21 October 2022

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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

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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