A Phase IB/II Study of Rogaratinib and Atezolizumab as Initial Treatment in Patients with FGFR-Positive Advanced or Metastatic Urothelial Carcinoma Who Cannot Receive Cisplatin

Full Title

An International, Multicenter, Phase 1b/2 Study of Rogaratinib (BAY 1163877) in Combination with Atezolizumab as First-Line Treatment in Cisplatin-Ineligible Patients with FGFR-Positive Locally Advanced or Metastatic Urothelial Carcinoma

Purpose

The purpose of this study is to assess the safety of the investigational drug rogaratinib when given in combination with atezolizumab immunotherapy in patients with locally advanced or metastatic urothelial cancer that has high amounts of proteins called fibroblast growth factor receptor 1 (FGFR1) and FGFR3. Rogaratinib is designed to inhibit cancer growth by blocking FGFR, which some cancers need to grow.

Atezolizumab is an immunotherapy drug that boosts the power of the immune system to find and kill cancer cells. It is used to treat urothelial cancers, but in some patients the cancer continues to grow. It is hoped that combining atezolizumab with rogaratinib will be more effective than atezolizumab alone.

Rogaratinib is taken orally (by mouth) and atezolizumab is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable or metastatic urothelial cancer that cannot be treated with cisplatin therapy.
  • Patients’ tumors must contain FGFR1 or FGFR3.
  • Patients may not have previously received chemotherapy for advanced urothelial cancer or immunotherapy, although prior treatment with BCG is allowed if completed at least 4 weeks before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Jonathan Rosenberg at 646-888-4741.

Protocol

18-394

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators