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

StatusActive, Not Recruiting
PhasePhase 2
Started2022-06-01
View on ClinicalTrials.gov ↗
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

Amendment record

Amended 19 times since 2022-04-07; most recent filed 2025-09-02. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2025-09-02
Amendment Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v19
2025-04-09
Amendment Study Status, Contacts/Locations v18
2024-07-23
Amendment Study Identification, Study Status, Study Description, Conditions, Contacts/Locations v17
2024-06-25
Amendment Study Status, Contacts/Locations v16
2024-05-23
Amendment Study Status, Contacts/Locations v15
2024-04-24
Amendment Study Status, Eligibility, Contacts/Locations v14
2024-04-01
Amendment Study Status, Contacts/Locations v13
2024-03-11
Amendment Study Status, Contacts/Locations v12
2024-03-04
Amendment Study Identification, Study Status v11
2024-02-21
Amendment Study Identification, Study Status, Arms and Interventions v10
2024-02-07
Amendment Study Status, Contacts/Locations v9
2024-01-11
Amendment Study Status, Study Description, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v8
2024-01-10
Amendment Study Status, Contacts/Locations v7
2023-12-04
Amendment Study Status, Contacts/Locations v6
2023-10-24
Amendment Study Status, Contacts/Locations v5
2023-10-12
Amendment Study Status, Contacts/Locations v4
2023-05-25
Amendment Study Status, Contacts/Locations v3
2022-10-19
Amendment Study Status, Contacts/Locations v2
2022-08-03
Amendment Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
2022-04-07
Original filing
Trial Details
NCT Number NCT05318573
Lead Sponsor Fujifilm Pharmaceuticals U.S.A., Inc.
Collaborators: Merck Sharp & Dohme LLC
Conditions Advanced Urothelial Carcinoma, Advanced Non Small Cell Lung Cancer
Enrollment 120 participants
Start Date 2022-06-01
Primary Completion 2029-05 (estimated)
Study Completion 2029-11 (estimated)
Updated on ClinicalTrials.gov 2025-09-04