Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma
NCT03473756 · View on ClinicalTrials.gov ↗
Study Summary
FORT-2 is designed to evaluate safety, efficacy, RP2D and PK of rogaratinib in combination with atezolizumab in patients with untreated FGFR-positive urothelial carcinoma. The study originally comprised two separate parts: Phase 1b (Part A) and Phase 2 (Part B). The study parts differ in design, objectives, and treatment. The primary objectives of this Phase 1b study (Part A) are to determine the safety, tolerability, RP2D and pharmacokinetics of rogaratinib in combination with atezolizumab in these patients. The primary objective of the Part B is to compare progression-free survival (PFS) according to RECIST v1.1 of rogaratinib in combination with atezolizumab over placebo in combination with atezolizumab in untreated patients with FGFR-positive locally advanced or metastatic urothelial carcinoma. Of note, patients who participate in Part A are not allowed to participate in Part B. Part B will be initiated once the data from Part A supports continuation of the study, even if this occurs prior to primary completion of Part A. The sponsor may decide not to continue the study as a whole after completion of Part A if the data do not support further development. Part B of the study will no longer be conducted.
Conditions Studied
Interventions
- DRUG Atezolizumab
- DRUG Rogaratinib (BAY1163877)
Study Locations (20)
Other
- Uniklinikum Salzburg - Landeskrankenhaus — Salzburg
- Universitätsklinikum AKH Wien — Vienna
- Institut Bergonie - Unicancer Nouvelle Aquitaine — Bordeaux
- Centre Oscar Lambret - Lille — Lille
- Institut de Cancérologie de l'Ouest - Saint Herblain — Saint-Herblain
North Rhine-Westphalia
- Universitätsklinikum Köln — Cologne
- Universitätsklinikum Essen — Essen
Lombardy
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan
- Istituto Europeo di Oncologia s.r.l - Sviluppo di nuovi farmaci per Terapie Innovative — Milan
Veneto
- Istituto Oncologico Veneto — Padua
- A.O.U.I. Verona — Verona
Arizona
- University of Arizona Cancer Center — Tucson
Illinois
- UChicago Medicine Comprehensive Cancer Center - Hyde Park — Chicago
Michigan
- Barbara Ann Karmanos Cancer Institute - Detroit Headquarters — Detroit
New York
- Memorial Sloan-Kettering Cancer Center — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2018-05-15 |
| Est. Completion | 2024-07-10 |
| Phase | Phase 1 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03473756
The ClinicalTrials.gov registry entry for NCT03473756 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Urothelial Carcinoma appearing as the primary indexed condition, and to 2 interventions — of which Atezolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03473756 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, North Rhine-Westphalia, Lombardy. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03473756 about?
NCT03473756 is a clinical study titled "Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma". FORT-2 is designed to evaluate safety, efficacy, RP2D and PK of rogaratinib in combination with atezolizumab in patients with untreated FGFR-positive urothelial carcinoma. The study originally comprised two separate parts: Phase 1b (Part A) and Phase 2 (Part B). The study parts differ in design, obj...
What is the current status of trial NCT03473756?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2018-05-15. Estimated completion is 2024-07-10.
What conditions does trial NCT03473756 study?
This clinical trial studies the following conditions: Urothelial Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03473756?
The interventions under investigation include: Atezolizumab (DRUG), Rogaratinib (BAY1163877) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03473756?
This trial is sponsored by Bayer, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03473756 being conducted?
This trial has 20 study locations across Arizona, Illinois, Michigan, New York, Upper Austria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.