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

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

INTRODUCTION

  • Org Study ID: TAS-120-203
  • Secondary ID: N/A
  • NTC ID: NCT04601857
  • Sponsor: Taiho Oncology, Inc.

BRIEF 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.

  • Overall Status
    Recruiting
  • Start Date
    January 21, 2021
  • Phase
    Phase 2
  • Study Type
    Interventional

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

Facility Status Contact
Facility: UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94158
United States
Status: Recruiting Contact: Contact
Vadim Koshkin

Facility: Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Status: Recruiting Contact: Contact
Guru Sonpavde

Facility: Henry Ford Hospital
Detroit, Michigan 48202
United States
Status: Recruiting Contact: Contact
Clara Hwang

Facility: Comprehensive Care Centers of Nevada
Las Vegas, Nevada 89148
United States
Status: Recruiting Contact: Contact
Oscar Goodman Jr.

Facility: Centre Georges-François Leclerc
Dijon, 21079
France
Status: Recruiting Contact: Contact
Sylvie Zanetta

Facility: Institut Paoli Calmettes - Hôpital de jour
Marseille, 13273
France
Status: Recruiting Contact: Contact
María José Méndez Vidal

Facility: ICANS - Institut de cancérologie de Strasbourg Europe
Strasbourg, 67200
France
Status: Recruiting Contact: Contact
Jesus García-Donás Jiménez

Facility: Centre Regional de Lutte Contre le Cancer de Lorraine
Vandœuvre-lès-Nancy, 54500
France
Status: Recruiting Contact: Contact
Montserrat Domenech

Facility: Institut De Cancerologie Gustave Roussy
Villejuif, 94805
France
Status: Recruiting Contact: Contact
Ignacio Durán Martínez

Facility: Hospital Clinic de Barcelona
Barcelona, 08036
Spain
Status: Recruiting Contact: Contact
Maria Regina Gironés Sarrió

Facility: Hospital de La Santa Creu i Sant Pau
Barcelona, 8025
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Vall d'Hebrón
Barcelona, 8035
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Reina Sofia
Córdoba, 14004
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario HMN Sanchinarro
Madrid, 28050
Spain
Status: Recruiting Contact: N/A
Facility: ALTHAIA, Xarxa Assistencial Universitària de Manresa
Manresa, 8243
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Marqués de Valdecilla
Santander, 39008
Spain
Status: Recruiting Contact: N/A
Facility: Hospital la Fe
Valencia, 46026
Spain
Status: Recruiting Contact: N/A