NORSE - 42756493BLC2002
Research type
Research Study
Full title
A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Erdafitinib plus JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Subjects with Metastatic or Surgically Unresectable Urothelial Cancer with Selected FGFR Gene Alterations
IRAS ID
258654
Contact name
Santhanam Sundar
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2017-001980-19
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Bladder cancer is the most common malignancy involving the urinary system. Urothelial (formerly called transitional cell) carcinoma is the 4th most common cancer in males and 11th most common in females. Although treatment for the early disease stages of the disease has significantly improved, once the cancer has spread to elsewhere in the body (metastasised), the overall survival (OS) dramatically decreases. Potential treatments for metastasised have high level of toxicity and nearly half of patients are ineligible leading to very poor survival rates in this unfit patient population. The options for further treatment are limited and outcomes dismal.
The purpose of this study is to research the effects of two investigational drugs called erdafitinib and JNJ-63723283 for patients with metastatic or surgically unresectable (unable to be removed with surgery) urothelial cancer. Erdafitinib is a drug that targets a group of proteins called fibroblast growth factor receptors or FGFRs. Erdafitinib has shown benefit in cancer patients with certain genetic changes affecting this group of proteins. JNJ-63723283 is an antibody (protein produced by the immune system that targets certain proteins) that targets and blocks a specific protein to improve anti-cancer activity.
Participants will be randomly assigned to different cohorts and will receive a combination of the study drugs (or erdafitinib on its own). This is a Phase 1b/2 study, and some participants in Phase 2 of the study will undertake a dosing schedule informed by data gathered from the initial Phase 1b period. The study consists of a Screening period (including molecular pre-screening), a Treatment phase and a Follow-up phase. Participants will remain in the Treatment period for until they either withdraw or meet the discontinuation criteria (e.g. disease progression), although it is expected most participants will receive treatment for around 6-7 months.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
19/YH/0008
Date of REC Opinion
4 Jun 2019
REC opinion
Further Information Favourable Opinion