A Phase 2 Study Evaluating Futibatinib (TAS-120) Plus Pembrolizumab in the Treatment of Advanced or Metastatic Urothelial Carcinoma

NOT ENROLLING
Protocol # :
20-549
Conditions
Advanced and Metastatic Urothelial Cancer
Phase
II
Disease Sites
Urinary Bladder
Other Urinary
Principal Investigator
Wei, Xiao, Xiao
Site Research Nurses
Bretta, Katherine, v.
Lagerstedt, Elizabeth
Leisner, Claire
Mingrino, Sage
Pace, Amanda
Prisby, Judith
Theodore, Catherine
Walsh, Meghara

Trial Description

The purpose of the trial is to evaluate the antitumor activity and confirm the safety for the
combination of Fibroblast Growth Factor Receptor (FGFR) inhibitor futibatinib and
anti-programmed cell death-1 (PD-1) antibody pembrolizumab in patients with advanced or
metastatic urothelial cancer who are not candidates to receive a platinum-based treatment
regimens.

Eligibility Requirements

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.

20-549