Renal cell carcinoma
Conditions
Interventions
Experimental:Pembrolizumab + Axitinib Combination Therapy
Participants receive pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.
Active Comparator:Sunitinib Mono
Sponsors
MSD K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Has histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features. -Has locally advanced/metastatic disease (i.e., newly diagnosed Stage IV RCC per American Joint Committee on Cancer) or has recurrent disease. -Has measurable disease per RECIST 1.1 as assessed by the investigator/site radiologist. -Has received no prior systemic therapy for advanced RCC. -Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion. Lesions must not be previously irradiated. -Has Karnofsky performance status (KPS) >= 70% as assessed within 10 days prior to randomization. -If receiving bone resorptive therapy (including but not limited to bisphosphonate or RANK-L inhibitor) must have therapy initiated at least 2 weeks prior to randomization. -Demonstrates adequate organ function. -Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug. -Male participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study drug through 120 days after the last dose of study drug.
Exclusion criteria
Exclusion criteria: -Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization. -Has had major surgery within 4 weeks, received radiation therapy within 2 weeks prior to randomization, or has not recovered (i.e., =480 msec. -Has a history of any of the following cardiovascular conditions within 12 months of randomization: -Myocardial C1nfarction -Unstable angina pectoris -Cardiac angioplasty or stenting -Coronary/peripheral artery bypass graft -Class III or IV congestive heart failure per New York Heart Association -Cerebrovascular accident or transient ischemic attack -Has a history of deep vein thrombosis or pulmonary embolism within 6 months of screening. -Has poorly controlled hypertension defined as systolic blood pressure (SBP) >=150 mm Hg and/or diastolic blood pressure (DBP) >=90 mm Hg. -Has evidence of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Progression-free survival (PFS), as assessed by blinded independent central imaging review (BICR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), comparing pembrolizumab in combination with axitinib versus sunitinib monotherapy over approximately 2 years. -Overall survival (OS), comparing pembrolizumab in combination with axitinib versus sunitinib monotherapy over approximately 39 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Objective response rate (ORR), disease control rate (DCR), and duration of response (DOR), comparing pembrolizumab in combination with axitinib versus sunitinib monotherapy over approximately 39 months. -Safety and tolerability of pembrolizumab in combination with axitinib versus sunitinib monotherapy over approximately 39 months. -Number of participants experiencing adverse events over approximately 39 months. -Number of participants who discontinued study treatment due to adverse events over approximately 39 months. | — |
Countries
Brazil, Canada, Czech Republic, France, Germany, Hungary, Ireland, Italy, Poland, Russia, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States
Contacts
Public ContactMSDJRCT inquiry mailbox
MSD K.K.
Outcome results
None listed