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NCT05318573 | RECRUITING | Advanced Urothelial Carcinoma

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

Fujifilm Pharmaceuticals U.S.A., Inc.

Brief Summary:

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

Condition or disease

Advanced Urothelial Carcinoma

Advanced Non Small Cell Lung Cancer

Intervention/treatment

Pembrolizumab

FF-10832

Phase

PHASE2

Detailed Description:

This is a Phase 2a, open label clinical trial evaluating FF-10832 in combination with pembrolizumab and as monotherapy. The trial will begin with a safety run-in phase of 10 patients receiving combination therapy with pembrolizumab; FF 10832 will be dosed at 40 mg/m2 with a fixed dose of pembrolizumab (200 mg). After confirmation of the appropriate FF-10832 dose for use with pembrolizumab, the trial will enroll up to an additional 100 patients in 2 cohorts (urothelial cancer \[UC\] and non-small cell lung cancer \[NSCLC\]) into 4 separate expansion treatment arms (approximately 25 patients in each treatment arm). The disease-defined cohorts will be patients who have progressed on PD-1/PD-L1 therapy who have UC or NSCLC. The UC cohort will be randomized (1:1) to one of two treatment arms (monotherapy or combination therapy) and the NSCLC cohort will be randomized (1:1) to one of two treatment arms (monotherapy or combination therapy), to further establish safety and gain preliminary information on antitumor activity of FF-10832 as monotherapy or in combination with pembrolizumab.

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2022-06-01
Estimated Primary Completion Date : 2029-05
Estimated Study Completion Date : 2029-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Written informed consent is provided by patient or legally acceptable representative;
  • 2. Age ≥ 18 years;
  • 3. Patient populations
    • 1. In the Safety Run-in, patients with histologically or cytologically confirmed advanced or metastatic solid tumors who have disease progression after treatment with standard therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment or refuse standard treatment will be enrolled in therapy
    • 2. In Expansion Phase, patient must have urothelial or NSCLC, and have failed prior anti-PD-1 or anti-PD-L1
    • 4. Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology
    • 5. Eastern Cooperative Oncology Group performance status of 0 to 1
    • 6. Life expectancy of ≥ 3 months
    Exclusion Criteria
    • 1. Positive urine pregnancy test within 72 hours prior to treatment
    • 2. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks (or 5 half-lives, whichever is shorter) prior to treatment;
    • 3. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137), AND was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event;
    • 4. Has received prior radiotherapy within 2 weeks of start of study treatment.
    • 5. For patients with NSCLC
      • 1. Patients who have received radiation therapy to the lung that is \>30 Gy within 6 months of the first dose of trial treatment are excluded;
      • 2. Patients with mutations (e.g., EGFR mutations or ALK gene rearrangements) will be excluded unless they have been previously treated with all specific targeted therapies.
      • 6. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
      • 7. Has had an allogeneic tissue /solid organ transplant.
A Study to Evaluate Safety, Efficacy of FF-10832 in Combo With Pembrolizumab in Urothelial & Non-small Cell Lung Cancer

Location Details

NCT05318573

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Cancer and Blood Speciality Clinic

Long Beach, California, United States, 90806

RECRUITING

United States, California

Sharp Memorial Hospital (Oncology Clinical Research)

San Diego, California, United States, 92123

RECRUITING

United States, District of Columbia

Sibley Memorial Hospital

Washington, District of Columbia, United States, 20016

RECRUITING

United States, Kansas

University of Kansas Cancer Center - Westwood

Westwood, Kansas, United States, 66205

RECRUITING

United States, Kentucky

University of Kentucky Medical Center

Lexington, Kentucky, United States, 40536

RECRUITING

United States, Kentucky

University of Louisville Brown Cancer Center

Louisville, Kentucky, United States, 40202

RECRUITING

United States, Road cancer

Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)

Detroit, Road cancer, United States, 48202

RECRUITING

United States, Missouri

Washington University School of Medicine, Center for Adv Medicine

Saint Louis, Missouri, United States, 63110

RECRUITING

United States, Nebraska

Nebraska Cancer Specialists - Legacy

Omaha, Nebraska, United States, 68130

RECRUITING

United States, Nevada

Comprehensive Cancer Centers of Nevada - Southern Hills

Las Vegas, Nevada, United States, 89148

COMPLETED

United States, New Jersey

Atlantic Health System / Morristown Medical Center

Morristown, New Jersey, United States, 07960

RECRUITING

United States, New York

NYU Langone Health

New York, New York, United States, 10016

RECRUITING

United States, New York

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

RECRUITING

United States, Ohio

TriHealth Cancer Institute; Good Samaritan Hospital

Cincinnati, Ohio, United States, 45220

RECRUITING

United States, Oregon

Providence Cancer Institute Franz Clinic

Portland, Oregon, United States, 97213

RECRUITING

United States, Pennsylvania

Hospital of the Univ of Pennsylvania Perlman Center

Philadelphia, Pennsylvania, United States, 19104

RECRUITING

United States, Pennsylvania

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232

RECRUITING

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

RECRUITING

United States, South Dakota

Avera Cancer Institute

Sioux Falls, South Dakota, United States, 57105

COMPLETED

United States, Tennessee

Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75235

RECRUITING

United States, Virginia

Virginia Cancer Specialists, PC

Fairfax, Virginia, United States, 22031

RECRUITING

United States, Wisconsin

University of Wisconsin Clinical Science Center

Madison, Wisconsin, United States, 53792