| Trial name or title | KEYNOTE‐426 ‐ Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK‐3475) in Combination with Axitinib versus Sunitinib Monotherapy in Participants with Renal Cell Carcinoma. |
| Methods |
Study design: parallel‐arm, open‐label
RCT. Setting: multicentre, international phase III. Countries: Japan, Hungary, Spain, Korea, Russia, US. |
| Participants |
Main inclusion criteria: aged ≥ 18
years, either gender, histologically or cytologically confirmed advanced or
mRCC (stage IV) with clear‐cell component with or without sarcomatoid
features, availability of an archival tumour tissue sample or fresh biopsy,
measurable disease (RECIST 1.1), no previously systemic therapy, KPS
≥ 70%. Main exclusion criteria: prior treatment with VEGF receptor or mTOR targeting agents; prior treatment with anti‐PD‐1, anti‐PD‐L1, anti‐PD‐L2 or other immunotherapy; known severe hypersensitivity reactions; active autoimmune disease; active infection; major surgery within 4 weeks prior to randomization; heart failure NYHA III or IV. Sample size planned: 840. |
| Interventions |
Group 1: pembrolizumab and axitinib. Group 0: sunitinib. |
| Outcomes |
Primary outcome: PFS, OS. Secondary outcomes: ORR, safety. |
| Starting date | September 2016. |
| Contact information | Merck Sharp & Dohme Corp. |
| Notes | Estimated primary completion date: December 2019; EudraCT: 2016‐000588‐17. |
AE: adverse event; AJCC: American Joint Committee on Cancer; CT: computer tomography; CTLA‐4: cytotoxic T‐lymphocyte antigen 4; ECOG: Eastern Cooperative Oncology Group; IL: interleukin; IFN‐α: interferon‐α; KPS: Karnovsky Performance Status; LLN: lower limit of normal; mRCC: metastatic renal cell carcinoma; MRI: magnetic resonance imaging; MSKCC: Memorial Sloan‐Kettering Cancer Center; mTOR: mammalian target of rapamycin; NCI‐CTC: National Cancer Institute Common Terminology Criteria; NCI CTCAE: National Cancer Institute Common Terminology Criteria for Adverse Events; NYHA: New York Heart Association; ORR: objective response rate; PD: programmed death; PD‐1: programmed death‐1; PFS: progression‐free survival; PSA: prostate‐specific antigen; QoL: quality of life; RCC: renal cell carcinoma; RCT: randomized controlled trial; RECIST: Response Evaluation Criteria In Solid tumours; SOC: standard of care; ULN: upper limit of normal; VEGF: vascular endothelial growth factor.