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Substudy 03C: A Study of Combination Therapies in Participants With Renal Cell Carcinoma With Recurrent Disease During or After Anti-PD-(L)1 Therapy (MK-3475-03C/KEYMAKER-U03)
140 patients around the world
Available in Chile, United States
Merck Sharp & Dohme LLC
2Research sites
140Patients around the world
This study is for people with
Kidney cancer
Renal cell carcinoma
Requirements for the patient
To 120 Years
All Gender
Medical requirements
- Has a histologically confirmed diagnosis of unresectable locally advanced/metastatic renal cell carcinoma (RCC) with clear cell component.Has received no other prior systemic therapy for treatment of advanced/metastatic clear cell renal cell carcinoma (ccRCC) except for adjuvant programmed cell death ligand 1 (PD-(L)1) therapy.Has disease recurrence during adjuvant anti- PD-(L)1 therapy or ≤24 months following the last dose of adjuvant anti-PD-(L)1 therapy.Is able to swallow oral medication.Submits an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.Participants receiving bone resorptive therapy must have therapy initiated at least 2 weeks before allocation/randomization.Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤140/90 mm Hg with no change in antihypertensive medications within 1 week before allocation/randomization.Has adequate organ function.
- Has clinically significant hematuria, hematemesis, or hemoptysis of (>2.5 mL) of red blood, or other history of significant bleeding.Has clinically significant cardiovascular disease within 12 months from first dose of study intervention.Has deep vein thrombosis within 3 months before allocation/randomization unless stable, asymptomatic, and treated with therapeutic anticoagulation for at least 4 weeks before allocation/randomization.Has history of idiopathic pulmonary fibrosis, organizing pneumonia, or evidence of active pneumonitis.Has serious wound, ulcer or bone fracture or has had major surgery within 8 weeks before first dose of study intervention.Has symptomatic pleural effusion for example cough, dyspnea, pleuritic chest pain, ascites, or pericardial fluid requiring drainage in the last 4 weeks before allocation/randomization.Has gastrointestinal (GI) disorders, including those associated with a high risk of perforation or fistula formation.Has malabsorption due to prior GI surgery or GI disease.Has moderate to severe hepatic impairment.Has received colony-stimulating factors within 28 days prior to intervention allocation/randomization.Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids.Is currently receiving strong inhibitors of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study.Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention.Is currently receiving anticoagulants or platelet inhibitors that cannot be discontinued for the duration of the study.Have been previously allocated/randomized to study intervention in any sub study of protocol MK-3475-U03.Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.Has active autoimmune disease that has required systemic treatment in the past 2 years.Has an active infection requiring systemic therapy.Has history of human immunodeficiency virus (HIV) infection.Has hepatitis B or hepatitis C virus infection.
Sites
Centro de Investigación Clínica Bradford Hill - Santiago, Región Metropolitana
Recruiting
Centro de Estudios Clínicos SAGA - CECSAGA
Recruiting
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Renal cell carcinoma
Requirements
To 120 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07049926
