Acronym:
Keynote 564
ACTRN/NCT /ethics:
NCT03142334
Scientific title:
A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564)
Summary of trial and patient characteristics
| Cancer Type | Kidney | ||
|---|---|---|---|
| Trial Type | Treatment | ||
| Phase | Phase III | Tumour Stream | Kidney |
| Age Range | 18 years and older | Cancer Stage | All stages |
| Sex | Both | Anticipated Start Date | 2017-06-09 |
| Molecular Target | Anticipated End Date | 2022-11-12 | |
| Cancer Type | Kidney |
|---|---|
| Trial Type | Treatment |
| Phase | Phase III |
| Age Range | 18 years and older |
| Sex | Both |
| Molecular Target | |
| Tumour Stream | Kidney |
| Cancer Stage | All stages |
| Anticipated Start Date | 2017-06-09 |
| Anticipated End Date | 2022-11-12 |
Trial Summary
The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in the adjuvant treatment of adult participants who have undergone nephrectomy and have intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) renal cell carcinoma (RCC) with clear cell component. The primary study hypothesis is that pembrolizumab is superior to placebo with respect to Disease-free Survival (DFS) as assessed by the Investigator in male and female participants with intermediate-high risk, high risk and M1 NED RCC.
Lay Summary
A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564)
Sponsor / Cooperative group
Merck Sharp & Dohme Corp
Participating Hospitals
| Hospital | Clinical Trial Coordinator | Phone | Principal Investigator | Recruitment Status | |
|---|---|---|---|---|---|
| Ashford Cancer Centre Research | Helen Daykin | hdaykin@adelaidecancercentre.com.au | 08 8292 2240 | Recruiting |