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Gemcitabine 38 mg/ml Concentrate for Solution for Infusion

DRUG8 trials

Sponsors

Bristol-Myers Squibb International Corporation, Bristol Myers Squibb International Corporation, Gilead Sciences Inc., F. Hoffmann-La Roche AG, Janssen Cilag International

Conditions

Cohort 1 and 2: High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) with FGFR Mutations or Fusions Cohort 3 Intermediate Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) with FGFR Mutations or FusionsEarly Stage Non-Small Cell Lung Cancer (NSCLC)Early-Stage Resectable Non-small cell lung cancer (NSCLC)Metastatic Urothelial CarcinomaPD-L1 Positive Metastatic Triple-Negative Breast CancerPD-L1-negative metastatic triple-negative breast cancer or PD-L1-positive metastatic triple-negative breast cancer previously treated with an anti-PD-(L)1 agent in the curative settingRelapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)Untreated Unresectable or Metastatic Urothelial Cancer

Phase 2

Phase 3

Randomized, Open-Label, Phase 3 Trial of Nivolumab plus Ipilimumab or Nivolumab plus Platinum-Doublet Chemotherapy versus Platinum-Doublet Chemotherapy in Early Stage NSCLC
CompletedCTIS2022-501360-18-00
Bristol-Myers Squibb International CorporationEarly Stage Non-Small Cell Lung Cancer (NSCLC)
Start: 2017-03-15End: 2024-12-03Target: 194Updated: 2024-12-03
A Phase III, Double-Blinded, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Neoadjuvant Treatment with Atezolizumab or Placebo in Combination with Platinum-Based Chemotherapy in Patients With resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer
CompletedCTIS2023-504209-35-00
F. Hoffmann-La Roche AGEarly-Stage Resectable Non-small cell lung cancer (NSCLC)
Start: 2018-04-04End: 2025-12-31Target: 207Updated: 2026-01-13
A Phase 3, Open-label, Randomized Study of Nivolumab Combined with Ipilimumab, or with Standard of Care Chemotherapy, versus Standard of Care Chemotherapy in Participants with Previously Untreated Unresectable or Metastatic Urothelial Cancer
Active, not recruitingCTIS2022-501784-40-00
Bristol Myers Squibb International CorporationUntreated Unresectable or Metastatic Urothelial Cancer
Start: 2017-05-26Target: 701Updated: 2026-01-26
A Phase 3, Multicenter, Randomized, Open-Label Study of Epcoritamab Plus Lenalidomide Compared to Rituximab Plus Gemcitabine and Oxaliplatin in Participants with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
RecruitingCTIS2024-510965-41-00
AbbVie Deutschland GmbH & Co. KGRelapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
Start: 2024-09-03Target: 116Updated: 2025-12-15
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician’s Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1
Active, not recruitingCTIS2023-504194-21-00
Gilead Sciences Inc.PD-L1 Positive Metastatic Triple-Negative Breast Cancer
Start: 2022-09-13Target: 114Updated: 2026-01-12
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1
Active, not recruitingCTIS2023-504195-14-00
Gilead Sciences Inc.PD-L1-negative metastatic triple-negative breast cancer or PD-L1-positive metastatic triple-negative breast cancer previously treated with an anti-PD-(L)1 agent in the curative setting
Start: 2022-08-31Target: 167Updated: 2025-12-12