| Study name |
KEYNOTE‐679/ECHO‐302 |
| Methods |
Study type: RCT, phase III
Blinding: no, open‐label
Accrual period: December 7, 2017 ‐ February 8, 2022 (estimated study completion date)
Countries: multicentre (140 study locations)
Cross‐over study: no
Status: Active, not recruiting (as of February 28, 2022) |
| Participants |
Estimated enrolment: N = 129
Inclusion criteria:
histologic confirmation of locally advanced or metastatic RCC with a clear‐cell component with or without sarcomatoid features must not have received any prior systemic therapy for their mRCC measurable disease based on RECIST v1.1 archival tumour tissue sample or newly obtained core or excisional biopsy of a tumour lesion as required Karnofsky performance status ≥ 70% adequate organ function per protocol‐defined criteria
Exclusion criteria:
use of protocol‐defined prior/concomitant therapy currently receiving or has received an investigational treatment as part of a study of an investigational agent or has used an investigational device within 4 weeks before randomisation history of severe hypersensitivity reaction to study treatments or their excipients active autoimmune disease that has required systemic treatment in past 2 years known additional malignancy that has progressed or has required active treatment in the last 3 years known active central nervous system metastases and/or carcinomatous meningitis history of (noninfectious) pneumonitis that required steroids or current pneumonitis history or presence of an abnormal electrocardiogram that, in the investigator's opinion, is clinically meaningful significant cardiac event within 12 months before Cycle 1 Day 1
|
| Interventions |
Experimental arm: pembrolizumab + epacadostat
Control arm: sunitinib or Pazopanib |
| Outcomes |
Primary outcome(s):
Secondary outcome(s):
Relevant to this review but not reported: SAEs, OS, PFS, QoL, TFST, number of patients who discontinued treatment
Other outcomes (not relevant to this review): ORR |
| Starting date |
07.12.2017 |
| Contact information |
Mark Jones, MD |
| Notes |
Funding sources: Incyte Corporation, Merck Sharp & Dohme Corp. |
