Trial · NCT02516241
Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer
NCT02516241, Phase 3, Active not recruiting, AstraZeneca; results first posted 2021-05-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer. Trials, record NCT02516241. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02516241
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer
- NCT number
- NCT02516241
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 1,126 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Urothelial Cancer
- Interventions
- MEDI4736 (Durvalumab), Tremelimumab, Cisplatin, Carboplatin, Gemcitabine
- First posted
- 2015-08-05
- Last updated
- 2026-07-14
- Other registries' IDs
- eudract:2015-001633-24
- Results first posted
- 2021-05-13
Source ClinicalTrials.gov
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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). | 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. |
| Primary | 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). | 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. |
| Secondary | OS, Full Analysis Set - Durvalumab Monotherapy vs SoC | 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. |
| Secondary | OS, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC | 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. |
| Secondary | OS, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy | 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. |
| Secondary | Alive at 24 Months (OS24), Full Analysis Set | 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. |
| Secondary | Alive at 24 Months (OS24), PD-L1-High Analysis Set | 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. |
| Secondary | Alive at 24 Months (OS24), PD-L1-Low/Negative Analysis Set | 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. |
| Secondary | PFS, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC | 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. |
| Secondary | PFS, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC | 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. |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 registered outcomesOutcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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). | Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis. | Months | MEDIAN |
| PRIMARY | 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). | The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High as defined by an Immunohistochemistry (IHC) assay developed by Ventana as:~≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control | Months | MEDIAN |
| SECONDARY | OS, Full Analysis Set - Durvalumab Monotherapy vs SoC | From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). | Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis. | Months | MEDIAN |
| SECONDARY | OS, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC | From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). | The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High as defined by an Immunohistochemistry (IHC) assay developed by Ventana as:~≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control | Months | MEDIAN |
| SECONDARY | OS, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy | From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). | The PD-L1-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative as defined by an Immunohistochemistry (IHC) assay developed by Ventana as:~\<25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control AND \<25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control. | Months | MEDIAN |
| SECONDARY | Alive at 24 Months (OS24), Full Analysis Set | From randomization date until death due to any cause, assessed up to 24 months or the data cut-off date (27JAN2020). | Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis. | percentage of participants | NUMBER |
| SECONDARY | Alive at 24 Months (OS24), PD-L1-High Analysis Set | From randomization date until death due to any cause, assessed up to 24 months or the data cut-off date (27JAN2020). | The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High as defined by an Immunohistochemistry (IHC) assay developed by Ventana as:~≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control | percentage of participants | NUMBER |
| SECONDARY | Alive at 24 Months (OS24), PD-L1-Low/Negative Analysis Set | From randomization date until death due to any cause, assessed up to 24 months or the data cut-off date (27JAN2020). | The PD-L1-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative as defined by an Immunohistochemistry (IHC) assay developed by Ventana as:~\<25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control AND \<25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control. | percentage of participants | NUMBER |
| SECONDARY | PFS, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC | 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). | Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis. | Months | MEDIAN |
| SECONDARY | PFS, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC | 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). | The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High as defined by an Immunohistochemistry (IHC) assay developed by Ventana as:~≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control | Months | MEDIAN |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 outcomesResults by group183
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Set | Combination Therapy | 15.1 | 95% Confidence Interval 13.1 to 18.0 | Months | |
| To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Set | Standard of Care | 12.1 | 95% Confidence Interval 10.9 to 14 | Months | |
| To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Set | Monotherapy | 14.4 | 95% Confidence Interval 10.4 to 17.3 | Months | |
| To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Set | Standard of Care | 12.1 | 95% Confidence Interval 10.4 to 15.0 | Months | |
| OS, Full Analysis Set - Durvalumab Monotherapy vs SoC | Monotherapy | 13.2 | 95% Confidence Interval 10.3 to 15 | Months | |
| OS, Full Analysis Set - Durvalumab Monotherapy vs SoC | Standard of Care | 12.1 | 95% Confidence Interval 10.9 to 14 | Months | |
| OS, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC | Combination Therapy | 17.9 | 95% Confidence Interval 14.8 to 24.2 | Months | |
| OS, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC | Standard of Care | 12.1 | 95% Confidence Interval 10.4 to 15.0 | Months | |
| OS, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy | Combination Therapy | 11.8 | 95% Confidence Interval 8.9 to 15.8 | Months | |
| OS, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy | Monotherapy | 10.9 | 95% Confidence Interval 8.0 to 14.8 | Months |
1 to 10 of 183Source ClinicalTrials.gov
See all 183 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Combination Therapy | 342 | |
| Overall Study | STARTED | Monotherapy | 346 | |
| Overall Study | STARTED | Standard of Care | 344 | |
| Overall Study | Received Treatment | Combination Therapy | 340 | |
| Overall Study | Received Treatment | Monotherapy | 345 | |
| Overall Study | Received Treatment | Standard of Care | 313 | |
| Overall Study | COMPLETED | Combination Therapy | 0 | |
| Overall Study | COMPLETED | Monotherapy | 0 | |
| Overall Study | COMPLETED | Standard of Care | 0 | |
| Overall Study | NOT COMPLETED | Combination Therapy | 342 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events990
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Combination Therapy | 51 | 340 | 53 |
| other | Anaemia | Blood and lymphatic system disorders | Monotherapy | 58 | 345 | 63 |
| other | Anaemia | Blood and lymphatic system disorders | Standard of Care | 163 | 313 | 222 |
| other | Leukopenia | Blood and lymphatic system disorders | Combination Therapy | 1 | 340 | 1 |
| other | Leukopenia | Blood and lymphatic system disorders | Monotherapy | 1 | 345 | 1 |
| other | Leukopenia | Blood and lymphatic system disorders | Standard of Care | 25 | 313 | 50 |
| other | Neutropenia | Blood and lymphatic system disorders | Combination Therapy | 0 | 340 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Monotherapy | 1 | 345 | 3 |
| other | Neutropenia | Blood and lymphatic system disorders | Standard of Care | 89 | 313 | 187 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Combination Therapy | 1 | 340 | 1 |
1 to 10 of 990Source ClinicalTrials.gov
See all 990 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combination Therapy | 255 | 342 |
| Total, all-cause mortality | Monotherapy | 263 | 346 |
| Total, all-cause mortality | Standard of Care | 270 | 344 |
| Total, other adverse events | Combination Therapy | 306 | 340 |
| Total, other adverse events | Monotherapy | 312 | 345 |
| Total, other adverse events | Standard of Care | 299 | 313 |
| Total, serious adverse events | Combination Therapy | 179 | 340 |
| Total, serious adverse events | Monotherapy | 139 | 345 |
| Total, serious adverse events | Standard of Care | 125 | 313 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32971005 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02516241
GET https://conductscience.org/api/trials/v1/NCT02516241/registered?page=2