Pembrolizumab + Lenvatinib in Participants with nccRCC
Research type
Research Study
Full title
A Phase 2, Single-arm, Open-label Clinical Trial of Pembrolizumab Plus Lenvatinib in Participants with First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (nccRCC) (KEYNOTE-B61)
IRAS ID
1003510
Contact name
Tom Waddell
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp
Eudract number
2020-004087-26
Clinicaltrials.gov Identifier
Research summary
This is a Phase 2, non-randomised, single-arm, multi-site, open label study of pembrolizumab in combination with lenvatinib in
participants who have advanced or metastatic non-clear cell renal cell carcinoma (nccRCC).
Renal cell carcinoma (RCC) accounts for the sixth most common cancer in men and the eight most common cancer in women.
Currently there is no globally accepted standard of care in nccRCC and clinical trials have predominantly focused on patients
with clear cell histology due to the higher prevalence of clear cell renal cell carcinoma (ccRCC) compared to nccRCC.
Pembrolizumab and Lenvatinib are approved to treat other types of cancers, but are not approved to treat nccRCC.
Approximately 152 male and female participants, aged 18 years and over, with previously untreated nccRCC will be enrolled
from approximately 15 countries. The study will be conducted at 3 trial sites in the UK.
The trial will run for approximately 4 years and 7 months consisting of screening, initial treatment, end of treatment and post
treatment phase. All participants will be allocated to receive treatment with pembrolizumab intravenously every 6 weeks and
lenvatinib orally every day. Participants may be treated with pembrolizumab for up to 2 years (18 cycles) or until a discontinuation
criterion is met. Participants may be treated with lenvatinib for longer than 2 years or until a discontinuation criterion is met.
If the patient’s cancer comes back or gets worse after they have stopped study treatment, participants have an optional second
course treatment where they may be able to receive about 1 additional year (9 cycles) of pembrolizumab and may also be able to
continue lenvatinib treatment during this phase.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
21/NW/0001
Date of REC Opinion
16 Feb 2021
REC opinion
Further Information Favourable Opinion