๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-09-02

A Study to Evaluate Safety, Efficacy of FF-10832 in Combo With Pembrolizumab in Urothelial & Non-small Cell Lung Cancer (NCT05318573)

A Phase 2a Study With Safety Run-in to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FF-10832 Monotherapy or in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

๐Ÿ”ต Active, Not Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

To confirm a recommended Phase 2 dose (RP2D) of FF-10832 (Gemcitabine Liposome Injection) given intravenously Day 1 of a 21-day cycle, in combination with 200 mg pembrolizumab given intravenously Day 1 of the same 21-day cycle, for treatment of advanced urothelial and non-small cell lung cancer

Who can join: Review the eligibility criteria below.

Location: Cancer and Blood Speciality Clinic โ€” Long Beach, California

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (23 Sites)

  • Cancer and Blood Speciality Clinic โ€” Long Beach, California
  • Sharp Memorial Hospital (Oncology Clinical Research) โ€” San Diego, California
  • Sibley Memorial Hospital โ€” Washington D.C., District of Columbia
  • University of Kansas Cancer Center - Westwood โ€” Westwood, Kansas
  • University of Kentucky Medical Center โ€” Lexington, Kentucky
  • University of Louisville Brown Cancer Center โ€” Louisville, Kentucky
  • Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion) โ€” Detroit, Michigan
  • Washington University School of Medicine, Center for Adv Medicine โ€” St Louis, Missouri
  • Nebraska Cancer Specialists - Legacy โ€” Omaha, Nebraska
  • Comprehensive Cancer Centers of Nevada - Southern Hills โ€” Las Vegas, Nevada
  • Atlantic Health System / Morristown Medical Center โ€” Morristown, New Jersey
  • NYU Langone Health โ€” New York, New York
  • Icahn School of Medicine at Mount Sinai โ€” New York, New York
  • TriHealth Cancer Institute; Good Samaritan Hospital โ€” Cincinnati, Ohio
  • Providence Cancer Institute Franz Clinic โ€” Portland, Oregon
  • Hospital of the Univ of Pennsylvania Perlman Center โ€” Philadelphia, Pennsylvania
  • UPMC Hillman Cancer Center โ€” Pittsburgh, Pennsylvania
  • Medical University of South Carolina โ€” Charleston, South Carolina
  • Avera Cancer Institute โ€” Sioux Falls, South Dakota
  • Sarah Cannon Research Institute โ€” Nashville, Tennessee
  • University of Texas Southwestern Medical Center โ€” Dallas, Texas
  • Virginia Cancer Specialists, PC โ€” Fairfax, Virginia
  • University of Wisconsin Clinical Science Center โ€” Madison, Wisconsin

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—