Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer
Active, enrolledPhase 3Results postedLast updated 28 January 2026
What this trial tests
Phase 3 trial testing MEDI4736 (Durvalumab) in Urothelial Cancer in 1,126 participants. Participants enrolled and being followed up; not accepting new ones.
Adults 18 to 130, any sex, with Urothelial Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis SetPrimary· From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
Group
Value
95% CI
Combination Therapy
15.1
13.1 – 18.0
Standard of Care
12.1
10.9 – 14
To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis SetPrimary· From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
Group
Value
95% CI
Monotherapy
14.4
10.4 – 17.3
Standard of Care
12.1
10.4 – 15.0
OS, Full Analysis Set - Durvalumab Monotherapy vs SoCSecondary· From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
Group
Value
95% CI
Monotherapy
13.2
10.3 – 15
Standard of Care
12.1
10.9 – 14
OS, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoCSecondary· From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
Group
Value
95% CI
Combination Therapy
17.9
14.8 – 24.2
Standard of Care
12.1
10.4 – 15.0
OS, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab MonotherapySecondary· From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
Group
Value
95% CI
Combination Therapy
11.8
8.9 – 15.8
Monotherapy
10.9
8.0 – 14.8
Standard of Care
12.2
10.4 – 14
Alive at 24 Months (OS24), Full Analysis SetSecondary· From randomization date until death due to any cause, assessed up to 24 months or the data cut-off date (27JAN2020).
Alive at 24 months (OS24) is defined as the Kaplan-Meier estimate of OS at 24 months.
Group
Value
95% CI
Combination Therapy
39.0
33.8 – 44.2
Monotherapy
31.5
26.6 – 36.4
Standard of Care
29.0
24.2 – 34.0
Alive at 24 Months (OS24), PD-L1-High Analysis SetSecondary· From randomization date until death due to any cause, assessed up to 24 months or the data cut-off date (27JAN2020).
Alive at 24 months (OS24) is defined as the Kaplan-Meier estimate of OS at 24 months.
Group
Value
95% CI
Combination Therapy
43.7
36.8 – 50.3
Monotherapy
36.0
29.5 – 42.6
Standard of Care
29.3
23.1 – 35.7
Alive at 24 Months (OS24), PD-L1-Low/Negative Analysis SetSecondary· From randomization date until death due to any cause, assessed up to 24 months or the data cut-off date (27JAN2020).
Alive at 24 months (OS24) is defined as the Kaplan-Meier estimate of OS at 24 months.
Group
Value
95% CI
Combination Therapy
32.1
24.5 – 40.0
Monotherapy
24.5
17.6 – 32.0
Standard of Care
28.6
21.2 – 36.4
PFS, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoCSecondary· Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
Progression free survival (PFS) (per RECIST 1.1, as assessed by investigator) was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomized therapy or receives another anticancer therapy prior to progression.
Median PFS was calculated using the Kaplan-Meier technique.
Group
Value
95% CI
Combination Therapy
3.7
3.4 – 3.8
Monotherapy
2.3
1.9 – 3.5
Standard of Care
6.7
5.7 – 7.3
PFS, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoCSecondary· Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
Progression free survival (PFS) (per RECIST 1.1, as assessed by investigator) was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomized therapy or receives another anticancer therapy prior to progression.
Median PFS was calculated using the Kaplan-Meier technique.
Group
Value
95% CI
Combination Therapy
4.1
3.6 – 5.7
Monotherapy
2.4
1.9 – 3.7
Standard of Care
5.8
5.6 – 7.2
PFS, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab MonotherapySecondary· Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
Progression free survival (PFS) (per RECIST 1.1, as assessed by investigator) was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomized therapy or receives another anticancer therapy prior to progression.
Median PFS was calculated using the Kaplan-Meier technique.
Group
Value
95% CI
Combination Therapy
2.0
1.9 – 3.6
Monotherapy
2.0
1.9 – 3.5
Standard of Care
7.2
5.7 – 7.5
Alive and Progression-free at 12 Months (APF12), Full Analysis SetSecondary· Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020).
Alive and progression-free at 12 months (APF12) was defined as the Kaplan-Meier estimate of PFS (per RECIST 1.1 as assessed by investigator) at 12 months.
Group
Value
95% CI
Combination Therapy
21.4
17.2 – 26.0
Monotherapy
16.8
13.1 – 21.1
Standard of Care
15.3
11.4 – 19.7
Adverse events — posted to ClinicalTrials.gov
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)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination with Tremelimumab Versus Standard of Care Chemotherapy in Patients with Stage IV Urothelial Cancer
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03084471 — An Open-Label, Multi-Centre, Study to Assess the Safety of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or D
· Phase 3
· completed
NCT02453282 — Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non S
· Phase 3
· active not recruiting
NCT02301130 — Study of Mogamulizumab + MEDI4736 (Durvalumab) and Mogamulizumab + Tremelimumab in Subjects w/ Advanced Solid Tumors
· Phase 1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 28 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02516241.