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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

• Advanced and Metastatic Urothelial Cancer

ELIGIBILITY

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

- 2. Age ≥ 18 years of age

- 3. Histologically confirmed advanced or metastatic urothelial carcinoma who have not received systemic treatment for advanced metastatic disease.
1. Cohort A: must have an FGFR3 mutation or FGFR1-4 fusion/rearrangement.

- 2. 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)

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

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

- 6. Adequate organ function.

- 7. Have a measurable disease per RECIST 1.1
Exclusion Criteria:
1. Have received prior therapy with anti-PD-1, anti-PD-L1/L2 agent or FGFR inhibitor.

- 2. History and/or current evidence of any of the following disorders:
1. Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the Investigator.

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

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

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

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

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

- 6. Have had an allogenic tissue/ organ transplant.

- 7. 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.

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

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

- 10. 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: Taiho Oncology, INC

Phone: 1-609-250-7336

Email: clinicaltrialinfo@taihooncology.com

LOCATION