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Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205)

NCT04003610 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-11-04

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of pemigatinib plus pembrolizumab or pemigatinib alone versus the standard of care for participants with metastatic or unresectable urothelial carcinoma who are not eligible to receive cisplatin, are harboring FGFR3 mutation or rearrangement, and who have not received prior treatment.

Conditions

  • Metastatic Urothelial Carcinoma
  • Unresectable Urothelial Carcinoma

Interventions

DRUG

Pemigatinib

13.5 mg once a day orally

DRUG

Pembrolizumab

200 mg Q3W intravenously

DRUG

Gemcitabine

1000 mg/m\^2 IV over 30 minutes on Days 1 and 8 of each 3-week cycle

DRUG

Carboplatin

Dosed to target AUC of 5 mg/mL/min or 4.5 mg/mL/min if required per local guidelines on Day 1 or 2 of each 3-week cycle

Sponsors & Collaborators

Principal Investigators

  • Luis Feliz Vinas, MD · Incyte Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-14
Primary Completion
2021-04-18
Completion
2021-04-18
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Finland
  • France
  • Germany
  • Ireland
  • Italy
  • Japan
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04003610 on ClinicalTrials.gov