Substudy 03A: Phase 1b/2 Umbrella Study of Combination Therapies in RCC
Research type
Research Study
Full title
A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants with RCC (U03): Substudy 03A
IRAS ID
1003373
Contact name
Balaji Venugopal
Contact email
Eudract number
2019-003609-84
Clinicaltrials.gov Identifier
Research summary
Worldwide, 403,262 cases of kidney cancer and 175,098 deaths occurred due to Renal cell carcinoma (RCC) in 2018. RCC comprises
approximately 3.8% of all cancers with a median diagnosis age of 64 years. Despite advances in treatment for advanced RCC, there are still
unmet medical needs.
Pembrolizumab is an immunotherapy that stimulates the body's immune system to fight cancer cells. Pembrolizumab targets and blocks a protein
called PD-1 on the surface of immune cells called T-cells. Blocking PD-1 triggers the T-cells to locate and destroy cancer cells. Pembrolizumab
has an acceptable preclinical safety profile and is in clinical development as an IV immunotherapy for advanced malignancies.
Lenvatinib stops the activity of VEGF receptors which blocks development of blood vessels, preventing tumour growth. Once daily dosing of
lenvatinib combined with pembrolizumab is under development for treating RCC. Interim analysis results from an ongoing study demonstrated the
combination of lenvatinib and pembrolizumab showed promising antitumor activity following disease progression after previous PD-(L)1 Immune
checkpoint inhibitor therapy.
This Phase 1b/2 study includes males and females of at least 18 years with first-line advanced RCC with clear cell component. The study will have
2 or more treatment arms, a reference arm (pembrolizumab + Lenvatinib) and one or more experimental arms, it is expected to last for
approximately 5 years. Investigational agents will be included in the Efficacy Phase after an initial evaluation of safety and tolerability is complete
either in another study, or the safety lead-in phase of this study. Experimental arms will be open for enrolment on a rolling basis to evaluate new
treatment combinations, therefore the total number of participants will depend on the number of investigational arms opened.
The study is sponsored by Merck Sharp & Dohme Limited (MSD) and Eisai. It will take place at 9 study centres in UK.REC name
HSC REC B
REC reference
21/NI/0001
Date of REC Opinion
18 Feb 2021
REC opinion
Further Information Favourable Opinion