Brief Title: Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Objective response rate (ORR)

Primary Outcome 1 - Timeframe: Approximately 12 months

CONDITION

• Advanced and Metastatic Urothelial Cancer

ELIGIBILITY

Inclusion Criteria:
Willing and able to provide written informed consent for the trial.

- Age ≥ 18 years of age
Histologically confirmed advanced or metastatic urothelial carcinoma who have not received systemic treatment for advanced metastatic disease.
Cohort A: must have an FGFR3 mutation or FGFR1-4 fusion/rearrangement.

- Cohort B: all other patients with UC (including patients with other FGFR or non-FGFR genetic aberrations and patients with wild-type [non-mutated] tumors)

- Unfit for or intolerant to standard platinum-based chemotherapy.

- Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.

- Adequate organ function.

- Have a measurable disease per RECIST 1.1
Exclusion Criteria:
Have received prior therapy with anti-PD-1, anti-PD-L1/L2 agent or FGFR inhibitor.
History and/or current evidence of any of the following disorders:
Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the Investigator.

- Ectopic mineralization/calcification considered clinically significant in the opinion of the Investigator.

- Retinal or corneal disorder considered clinically significant in the opinion of the Investigator.

- Has received a live vaccine within 30 days prior to the first dose of study drug.

- Have an active autoimmune disease that has required systemic treatment in the past 2 years.

- Have a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.

- Have had an allogenic tissue/ organ transplant.

- Has known human immunodeficiency virus (HIV) and/or history of Hepatitis B or C infections, or known to be positive for Hepatitis B antigen (HBsAg)/ Hepatitis B virus (HBV) DNA or Hepatitis C Antibody or RNA.

- Have known active central nervous system metastases and/or carcinomatous meningitis.

- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.

- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 1-609-250-7336

Email: clinicaltrialinfo@taihooncology.com

LOCATION