Erdafitinib compared with Vinflunine or Docetaxel or Pembrolizumab
Research type
Research Study
Full title
A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects with Advanced Urothelial Cancer and Selected FGFR Gene Aberrations
IRAS ID
238051
Contact name
Anna Sandell
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2017-002932-18
Clinicaltrials.gov Identifier
not applicable , not applicable
Duration of Study in the UK
3 years, 1 months, 23 days
Research summary
This study is being carried out to compare the effects of a new investigational drug called erdafitinib with those of docetaxel, vinflunine and pembrolizumab, which are treatments already used to treat urothelial cancer.
Erdafitinib targets a group of proteins called fibroblast growth factor receptors (FGFRs). FGFRs play an important role in normal cell development, but genetic changes can produce abnormal proteins and cause cells to become cancerous.
Erdafitinib specifically targets FGFRs, and in early clinical studies has been shown to be effective in some patients with specific FGFR alterations.
Patients in this study will be assigned to either of the following 2 cohorts based on their previous treatment;
Cohort 1 – erdafitinib OR chemotherapy (vinflunine or docetaxel)
Cohort 2- erdafitinib OR immunotherapy (pembrolizumab)If patients have already received immunotherapy treatment agents, called “PD(L)1 inhibitors” for their urothelial cancer, they will receive erdafitinib or vinflunine or docetaxel. The choice of which chemotherapy drug used will be down to the principal investigator at each study site. If patients have not already received immunotherapy treatment, they will receive erdafitinib or pembrolizumab.
Within the relevant patient cohort, patients will have a 50% chance to be assigned to either erdafitinib or one of the other agents, chemotherapy or pembrolizumab.
There will be 4 parts;• Molecular Screening– Tumour tissue samples will be tested to determine if the patient has the required FGFR alterations that make them eligible for the study.
• Screening – The patient will be assessed to see if they can take part in the study based on their fitness, clinical status, blood tests and medical history.
• Treatment – Most patients will receive treatment for an amount of time estimated to be approximately 7-8 months although this time can be longer or shorter; patients can remain on treatment until their cancer worsens or they are no longer receiving benefit. Various procedures will be performed during treatment to monitor the effects of the patient’s treatment.
• Follow-up - Patients will return to hospital or be contacted by phone every 12 weeks to assess how well they are.About 6000 patients will be pre-screened and about 630 patients will be enrolled on to the study worldwide.
This study is being sponsored by Janssen-Cilag International NV
REC name
Scotland B REC
REC reference
18/SS/0010
Date of REC Opinion
8 Feb 2018
REC opinion
Favourable Opinion