Bladder Cancer Clinical Trial

Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion criteria:

Existence of archival or fresh tumor biopsy specimen for FGFR1/3 mRNA expression testing
High FGFR1 or 3 mRNA expression levels (RNAscope score of 3+ or 4+) in archival or fresh tumor biopsy specimen
Documented locally advanced (T4, any N; or any T, N2-3) or metastatic urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra, meeting all of the following criteria:
No prior systemic treatment for locally advanced or metastatic urothelial carcinoma. For patients who received prior adjuvant/neoadjuvant chemotherapy or chemo-radiation for urothelial carcinoma, a treatment-free interval > 12 months between the last treatment administration and the date of recurrence is required in order to be considered treatment-naïve in the metastatic setting. Prior local intra-vesical chemotherapy or prior local immunotherapy is allowed if completed at least 4 weeks before the first study drug administration. Regionally available standard of care options must be considered for all patients.

Ineligibility for cisplatin-based chemotherapy as defined by any one of the following criteria:

Impaired renal function (GFR > 30 but < 60 mL/min/1.73 m2) according to the modification of diet in renal disease (MDRD) abbreviated formula
A Hearing loss (measured by audiometry) of > 25 dB at two contiguous test frequencies in at least one ear.
Grade ≥ 2 peripheral neuropathy (i.e. sensory alteration or paresthesia including tingling)
Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1.

Exlusion criteria:

Active symptomatic or untreated brain metastases as determined by CT or MRI evaluation during screening and prior radiographic assessment.
History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, granulomatosis with polyangiitis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.

History or current condition of an uncontrolled cardiovascular disease including any of the following conditions:

Congestive heart failure (CHF) NYHA Class 2 or greater, unstable angina (symptoms of angina at rest) or
New-onset angina (within last 3 months before the first study drug administration)
Myocardial infarction (MI) within past 6 months before the first study drug administration
Unstable cardiac arrhythmias requiring anti-arrhythmic therapy.
Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or known left ventricular ejection fraction < 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate.
Current diagnosis of any retinal disorders including retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion.
Current evidence of endocrine alteration of calcium phosphate homeostasis (e.g. parathyroid disorder, history of parathyroidectomy, tumor lysis, tumoral calcinosis, paraneoplastic hypercalcemia).
Concomitant therapies that are known to increase serum calcium or phosphate levels (i.e. antacids, phosphate-containing laxatives oral/rectal, potassium phosphate) and that cannot be discontinued or switched to a different medication before the first study drug administration
Treatment with systemic corticosteroids or other systemic immunosuppressant medications within 2 weeks before the first study drug administration, or anticipated requirement for systemic immunosuppressive medications during the trial.

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

37

Study ID:

NCT03473756

Recruitment Status:

Active, not recruiting

Sponsor:

Bayer

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There are 30 Locations for this study

See Locations Near You

University of Arizona Cancer Center
Tucson Arizona, 85724, United States
Comprehensive Cancer Center
Chicago Illinois, 60637, United States
Barbara Ann Karmanos Cancer Institute - Detroit
Detroit Michigan, 48201, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States
Ordensklinikum Linz GmbH Elisabethinen
Linz Oberösterreich, 4020, Austria
Uniklinikum Salzburg - Landeskrankenhaus
Salzburg , 5020, Austria
Krankenhaus der Barmherzigen Brüder
Wien , 1020, Austria
Universitätsklinikum AKH Wien
Wien , 1090, Austria
Institut Bergonié - Unicancer Nouvelle Aquitaine
Bordeaux Cedex , 33076, France
Centre Oscar Lambret - Lille
Lille Cedex , 59020, France
Institut de Cancérologie de l'Ouest - Saint Herblain
Nantes , 44805, France
Universitätsklinikum Essen
Essen Nordrhein-Westfalen, 45122, Germany
Universitätsklinikum Köln
Köln Nordrhein-Westfalen, 50937, Germany
Universitätsmedizin der Johannes Gutenberg Universität Mainz
Mainz Rheinland-Pfalz, 55131, Germany
A.O.U. di Modena - Policlinico
Modena Emilia-Romagna, 41124, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano Lombardia, 20133, Italy
IRCCS Istituto Europeo di Oncologia s.r.l. (IEO)
Milano Lombardia, 20141, Italy
Istituto Oncologico Veneto IRCCS (IOV)
Padova Veneto, 35128, Italy
A.O.U.I. Verona
Verona Veneto, 37134, Italy
National Cancer Center Hospital East
Kashiwa Chiba, 277-8, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama Ehime, 791-0, Japan
University of Tsukuba Hospital
Tsukuba Ibaraki, 305-8, Japan
The Cancer Institute Hospital of JFCR
Koto-ku Tokyo, 135-8, Japan
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Ciutat Sanitària i Universitaria de la Vall d'Hebron
Barcelona , 08035, Spain
Hospital Clínic i Provincial de Barcelona
Barcelona , 08036, Spain
Hospital Ramón y Cajal | Oncología
Madrid , 28034, Spain
Hospital General Universitario de Valencia
Valencia , 46014, Spain

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

37

Study ID:

NCT03473756

Recruitment Status:

Active, not recruiting

Sponsor:


Bayer

How clear is this clinincal trial information?

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