HelpAcademyLoginJoin us as a Member

Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer

NCT02516241Phase 3Active, not recruiting

Lead sponsor
AstraZeneca (Industry)
Enrollment
1,126 (actual)
Start date
2 Nov 2015
Primary completion
27 Jan 2020 (actual)
Study completion
31 Dec 2026
Last update posted
14 Jul 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
None
Arms
3

Interventions

  • MEDI4736 (Durvalumab) Drug
  • Tremelimumab Drug
  • Cisplatin Drug
  • Carboplatin Drug
  • Gemcitabine Drug

Conditions and primary outcome

  • Urothelial Cancer

Primary outcome

To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Set (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 (From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT02516241 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Set

    Time frame
    From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
    Measure
    Median
    Unit
    Months

    • Combination Therapy vs Standard of CareSuperiority

      Estimate
      0.85Hazard Ratio (HR)
      98.66% CI, two-sided
      0.688 to 1.063
      p-value
      0.0751
      Method
      Log Rank

  2. To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Set

    Time frame
    From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
    Measure
    Median
    Unit
    Months

    • Monotherapy vs Standard of CareSuperiority

      Estimate
      0.89Hazard Ratio (HR)
      96.99% CI, two-sided
      0.695 to 1.139
      p-value
      0.3039
      Method
      Log Rank

Serious adverse events

Time frame: From first administration of study treatment up to 90 days after last dose of study medication or date of initiation of the first subsequent therapy, whichever occurs first, approximately 5 years. All-cause mortality, from screening up to data cut-off date (27JAN2020, approximately 5 years).

Participants with serious adverse events per group for NCT02516241, as posted
GroupAffectedAt risk
Combination Therapy179340
Monotherapy139345
Standard of Care125313

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

1 on PubMed

  1. Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy in previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE): a randomised, open-label, multicentre, phase 3 trial.

    The Lancet. Oncology · 2020 Dec

    PubMed 32971005 (opens in a new tab)DOI 10.1016/S1470-2045(20)30541-6 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

CT-VCA trial quality

About CT-VCA

Loading CT-VCA scores…

Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.