Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

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.

Official Title

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

Keywords

Advanced and Metastatic Urothelial Cancer, Futibatinib, Pembrolizumab, Urothelial cancer, FGFR, TAS120, MK3475 B04, Transitional Cell Carcinoma, futibatinib and pembrolizumab (KEYTRUDA®))

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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.

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center
    San Francisco California 94158 United States
  • Comprehensive Care Centers of Nevada
    Las Vegas Nevada 89148 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Taiho Oncology, Inc.
ID
NCT04601857
Phase
Phase 2 Transitional Cell Carcinoma Research Study
Study Type
Interventional
Participants
Expecting 46 study participants
Last Updated