Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
1,126actual
Sites
222
Countries
Australia, Austria, Belgium +21
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2015-11-02 | actual | When the study began enrolling |
| Primary completion | 2020-01-27 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2015-08-05 | estimated | When this record first appeared on the registry |
| Results posted | 2021-05-13 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-07-14 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Urothelial Cancer
Interventions
- Drug: MEDI4736 (Durvalumab)
- Drug: Tremelimumab
- Drug: Cisplatin
- Drug: Carboplatin
- Drug: Gemcitabine
Primary outcomes
what the primary-completion date above is the date OFTo Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Set
measured From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Set
measured From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2019-12-03 · 4.4 MB · Prot_000.pdf
Statistical Analysis Planposted 2019-12-04 · 1.3 MB · SAP_001.pdf
Publications
- PMID 32971005 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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