A4061079: Phase 1b dose‐finding study of pembrolizumab + axitinib in
1
st
line mRCC
Phase Ib Study
Dose finding part
Dose expansion part
7‐day lead‐in period with single agent
axitinib prior to cycle 1
-
-
Treatment until confirmed disease progression, unacceptable toxicity, or
withdrawal
Patients with previously
DL1: pembrolizumab 200mg Q3W + axitinib 5mg BID
untreated aRCC, unselected
for PD‐L1 expression
DL1: pembrolizumab 200mg
Q3W + axitinib 5mg BID
DL‐1: (if DL 1 beyond MTD):
pembrolizumab 2mg/kg Q3W + axitinib 3mg
BID
N = 52
NCT02133742
Primary endpoint:
DLTs within the first 6 weeks (2 cycles
of treatment
S f
OR PFS OS TTR DC DR PK
Secondary endpoints:
a ety,
,
,
,
,
,
,
and tumour biomarkers
