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Vinflunine

Phase 3

Bladder Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Aug 1, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment931

FDA Designations

No designations recorded

Clinical trial landscape

Vinflunine · 1 trial · 1 indication

Phase 3 1
NCT02302807A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211]Bladder Cancer
COMPLETED931 Analytics
PHASE3COMPLETED
A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211]
Bladder CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall Survival (OS)
Between randomization and death due to any cause, up to approximately 25 months after first participant enrolled

OS was defined as time from randomization to death from any cause.

Secondary Endpoints

Progression-free Survival (PFS) as Determined by the Investigator With Use of RECIST v1.1
Up to approximately 25 months after first participant enrolled
Unconfirmed Duration of Response (DOR) as Determined by the Investigator With Use of RECIST v1.1
Up to approximately 25 months after first participant enrolled
Percentage of Participants With Adverse Events (AEs)
Up to approximately 46 months after first participant enrolled
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm A: AtezolizumabEXPERIMENTALAtezolizumab will be administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants will receive atezolizumab as long as they continue to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
Arm B: Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)ACTIVE_COMPARATORParticipants randomized to the chemotherapy arm will receive vinflunine, paclitaxel, or docetaxel per the investigator's choice. Vinflunine 320 milligrams per square meter (mg/m\^2), paclitaxel 175 mg/m\^2, or docetaxel 75 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.

Interventions

NameTypeDescription
Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibodyDRUGAtezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
DocetaxelDRUGDocetaxel 75 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle.
PaclitaxelDRUGPaclitaxel 175 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle.
VinflunineDRUGVinflunine 320 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites217

Inclusion Criteria: * Histologically or cytologically documented locally advanced or metastatic UBC (including renal pelvis, ureters, urinary bladder, and urethra). * Representative tumor specimens as specified by the protocol * Disease progression during or following treatment with at least one pl...

Countries:United StatesAustraliaAustriaBelgiumCanadaCzechiaDenmarkFinlandFranceGermanyGreeceHungaryItalyJapanNetherlandsNorwayPolandPortugalRomaniaRussiaSerbiaSloveniaSouth KoreaSpainSwedenSwitzerlandTaiwanTurkey (Türkiye)United Kingdom
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Frequently asked questions about Vinflunine

What is Vinflunine used for in Bladder Cancer?

Vinflunine is an investigational small molecule being studied for the treatment of bladder cancer. It is currently in Phase 3 clinical development. Vinflunine is not approved and remains under investigation for this indication.

Who makes Vinflunine?

Vinflunine is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this small molecule for the treatment of bladder cancer.

What phase is Vinflunine in?

Vinflunine is in Phase 3 clinical development for bladder cancer. It is an investigational drug and has not been approved. One Phase 3 trial has been completed, with a total enrollment of 931 participants.

What clinical trials is Vinflunine in?

Vinflunine was studied in the completed Phase 3 trial NCT02302807, titled 'A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211]'. This trial enrolled 931 participants across multiple countries.

Is Vinflunine the same as Atezolizumab?

No, Vinflunine is not the same as Atezolizumab. Vinflunine is a small molecule, while Atezolizumab is a different drug. In the clinical trial NCT02302807, Vinflunine was used as a chemotherapy comparator against Atezolizumab.