INCYTE_INCB54828-205_Urothelial Carcinoma
Research type
Research Study
Full title
A Phase 2, Open-Label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Plus Pembrolizumab Versus Pemigatinib Alone Versus Standard of Care as First-Line Treatment for Metastatic or Unresectable Urothelial Carcinoma in Cisplatin-Ineligible Participants Whose Tumors Express FGFR3 Mutation or Rearrangement (FIGHT-205)
IRAS ID
272371
Contact name
Thomas Powles
Contact email
Sponsor organisation
Incyte
Eudract number
2019-000721-50
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 2 months, 28 days
Research summary
This is a phase 2 study which means that the study doctor knows that the treatment is safe to use, the first side effects are known and that the study drug has an effect on cancer cells. It is open label so both the study doctor and participant know the treatment for the participant. It is randomised which means the participants are divided by chance into separate groups to compare the different treatments and it is a multicentre study which means it is carried out at numerous hospitals. This study is for participant over 18 years, and it's purpose is to evaluate the efficacy and safety of Pemigatinib (the study drug).
The planned study will evaluate the safety of Pemigatinib alone or in combination with Pembrolizumab versus Standard of Care as a first-line treatment for patients with Urothelial Carcinoma (bladder cancer) that has spread to different areas of the body or that cannot be removed completely through surgery. The participants must be ineligible for Cisplatin (chemotherapy drug) and it is required that the tumours show FGFR3 (Fibroblast Growth Factor Receptor, a human protein) mutation or Rearrangement.
This study will be considered to have met its primary objective if Pembrolizumab plus Pemigatinib or Pemigatinib alone is superior to Standard Of Care treatment. Randomisation will occur after the patient has completed screening to make sure that the study is suitable for them. Approximately 372 patients will be randomised in equal numbers to 1 of the following 3 treatment groups: 1- Pemigatinib Plus Pembrolizumab, 2-Pemigatinib Alone or 3-Standard of Care.
The study duration will allow up to 35 days for screening followed by continuous treatment in consecutive 21-day cycles as long as participants are receiving benefit and have not met any criteria for study withdrawal, and at least 30 days after the last dose of study treatment for follow-up.
Participants who receive Pembrolizumab may receive up to 35 administrations (approximately 2 years). Participants who receive Pemigatinib may receive treatment until disease progression. The safety follow-up visit is 30 days after the last dose of study treatment. It is estimated that an individual will participate for approximately 18 months.REC name
London - West London & GTAC Research Ethics Committee
REC reference
20/LO/0051
Date of REC Opinion
18 Mar 2020
REC opinion
Further Information Favourable Opinion