A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)

  • STATUS
    Recruiting
  • End date
    Dec 23, 2024
  • participants needed
    708
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 11 April 2021

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 Renal Cell Carcinoma, Renal Cell Cancer
Treatment Cabozantinib, Lenvatinib, Belzutifan
Clinical Study IdentifierNCT04586231
SponsorMerck Sharp & Dohme Corp.
Last Modified on11 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Renal Cell Cancer or Renal Cell Carcinoma?
Do you have any of these conditions: Renal Cell Carcinoma or Renal Cell Cancer?
Do you have any of these conditions: Renal Cell Cancer or Renal Cell Carcinoma?
Do you have any of these conditions: Renal Cell Cancer or Renal Cell Carcinoma?
Do you have any of these conditions: Renal Cell Cancer or Renal Cell Carcinoma?
Do you have any of these conditions: Renal Cell Carcinoma or Renal Cell Cancer?
Do you have any of these conditions: Renal Cell Carcinoma or Renal Cell Cancer?
Do you have any of these conditions: Renal Cell Cancer or Renal Cell Carcinoma?
Do you have any of these conditions: Renal Cell Carcinoma or Renal Cell Cancer?
Do you have any of these conditions: Renal Cell Carcinoma or Renal Cell Cancer?
Do you have any of these conditions: Renal Cell Cancer or Renal Cell Carcinoma?
Do you have any of these conditions: Renal Cell Cancer or Renal Cell Carcinoma?
Do you have any of these conditions: Renal Cell Cancer or Renal Cell Carcinoma?
Do you have any of these conditions: Renal Cell Cancer or Renal Cell Carcinoma?
Unresectable, locally advanced or metastatic clear cell renal cell carcinoma (RCC)
Disease progression on or after having received systemic treatment with anti-programmed cell death-1/ligand 1 (PD-1/L1) for locally advanced or metastatic RCC
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
Can submit an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
Received no more than 2 prior systemic regimens for locally advanced or metastatic RCC
Received only 1 prior antiPD-1/L1 therapy for locally advanced or metastatic RCC
A female participant is eligible to participate if she is 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
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 WOCBP must have a negative highly sensitive pregnancy test (urine or serum) within 24 hours before the first dose of study intervention
Adequately controlled blood pressure
Adequate organ function

Exclusion Criteria

Is a WOCBP who has a positive urine pregnancy test within 24 hours before the first dose of study intervention
Hypoxia (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
Clinically significant cardiac disease within 6 months of first dose of study intervention
Symptomatic pleural effusion (e.g.,cough, dyspnea, pleuritic chest pain) that is not clinically stable
Prolongation of QTc interval to >480 ms
Pre-existing Grade 3 gastrointestinal or nongastrointestinal fistula
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)-2 inhibitor
Prior treatment with lenvatinib
Prior treatment with cabozantinib
Currently participating in a study of an investigational agent or using an investigational device
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
Active infection requiring systemic therapy
History of hepatitis B or known active hepatitis C infection
History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
History of human immunodeficiency virus (HIV) infection
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