Ph3 of MK6482 with Lenvatinib vs Cabozantinib for Advanced RCC
An Open-label, Randomized, Phase 3 Study of MK-6482 in Combination with Lenvatinib (MK-7902) vs Cabozantinib for Treatment in Participants with Advanced Renal Cell Carcinoma Who Have Progressed After Prior Anti- PD-1/L1 Therapy
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Clinical Trial Information
Trial Contact: Djuro, Victor; Frankos, Marie; Walton, Sherri
Trial Phone: 321.841.7477 ; 321.841.7303 ; 321.841.1907
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IRB No: WIRB 20202886
Protocol Abbrev: MK6482-011
Principal Investigator:
Phase: Drug: Phase III
Age Group: Adult
Secondary Protocol No: MK6482-011
Treatment: Participants will be randomly assigned in a 1:1 ratio to receive either MK-6482+lenvatinib or cabozantinib.
Therapies Involved: Medication
ClinicalTrials.gov ID: NCT04586231
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Objective
The primary objective is to compare MK-6482+lenvatinib to cabozantinib with respect to PFS per Response Criteria in
Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR). -
Key Eligibility
Inclusion Criteria:
• Unresectable, locally advanced or metastatic clear cell renal cell carcinoma (RCC).
• Disease progression on or after having received systemic treatment for locally advanced or metastatic RCC with programmed cell death 1 ligand 1 (PD-1/L1).
• 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 prior to the first dose of study intervention.
• 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.
• 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 5 days after the last dose of study intervention.
• 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 MK-6482+ lenvatinib arm, or 120 days after the last dose of study intervention in the cabozantinib arm.
• 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 prior to randomization.
• Hypoxia (a pulse oximeter reading <92% at rest), requires intermittent supplemental oxygen, or requires chronic supplemental oxygen.
• 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 [e.g., breast carcinoma, cervical cancer in situ] that have undergone potentially curative therapy.
• Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Clinically significant cardiac disease within 12 months of first dose of study intervention.
• Symptomatic pleural effusion (e.g.,cough, dyspnea, pleuritic chest pain) that is not clinically stable.
• 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).
• Known hypersensitivity or allergy to the active pharmaceutical ingredients or any component of the study intervention formulations.
• Prior treatment with MK-6482 or another hypoxia-inducible factor (HIF)-2α inhibitor.
• Prior treatment with lenvatinib.
• Prior treatment with cabozantinib.
• Currently participating in a study of an investigational agent or using an investigational device.
• Active infection requiring systemic therapy.
• History of Human Immunodeficiency Virus (HIV) infection.
• 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.
