Trial · NCT03732677
Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC
NCT03732677, Phase 3, Active not recruiting, AstraZeneca; results first posted 2025-07-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC. Trials, record NCT03732677. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03732677
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC
- NCT number
- NCT03732677
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 1,063 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Muscle Invasive Bladder Cancer
- Interventions
- Durvalumab, Cisplatin, Gemcitabine
- First posted
- 2018-11-06
- Last updated
- 2026-10-15
- Other registries' IDs
- eudract:2018-001811-59
- Results first posted
- 2025-07-03
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pathologic Complete Response (pCR) Rates at Time of Cystectomy | Up to 6 months | pCR rate is defined as the proportion of patients whose pathological staging was T0N0M0 as assessed per central pathology review using specimens obtained via radical cystectomy following the neoadjuvant treatment. The denominator for pCR will be the number of patients in the FAS. |
| Primary | Event-free Survival (EFS) Per Central Review Defined as Time From Randomization to Event | Up to 48 months | EFS is defined as the time from randomization to the first recurrence of disease post radical cystectomy, time of first documented progression in patients who were medically precluded for radical cystectomy, or time of expected surgery in patients who refuse to undergo a radical cystectomy or failure to undergo a radical cystectomy in participants with residual disease, or the time of death due to any cause, whichever occurs first |
| Secondary | Event-free Survival at 24 Months (EFS24) Per Central Review Defined as Time From Randomization to Event | Up to 24 months | EFS24 is defined as the Kaplan-Meier estimate of EFS at 24 months after randomization, as assessed per blinded independent central review or by central pathology review if a biopsy is required for a suspected new lesion, and per local investigator or local biopsy review if a biopsy is required for a suspected new lesion |
| Secondary | Proportion of Patients Who Undergo Cystectomy | Up to 6 months | The proportion of patients who undergo cystectomy is defined as the proportion patients who undergo radical cystectomy after the neoadjuvant treatment. The denominator will be patients in the FAS. |
| Secondary | Overall Survival | Up to 65 months | OS is defined as the time from the date of randomization until death due to any cause regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy (i.e., date of death or censoring - date of randomization + 1) |
| Secondary | Metastasis-free Survival Per Investigator Assessment or Local Biopsy Review. | Up to 48 months | MFS is defined as the time from date of randomization until the first recognition of distant metastases or death, whichever occurs first |
| Secondary | Disease-specific Survival Per Investigator Assessment or Local Biopsy Review. | Up to 48 months | DSS is defined as the time from the date of randomization until death due to bladder cancer |
| Secondary | Immunogenicity of Durvalumab When Used in Combination With Gemcitabine/Cisplatin as Measured by Presence of Antidrug Antibodies (ADA) | Up to 12 months | Whole blood samples for assessing ADA for durvalumab in serum were collected from patients undergoing durvalumab treatment, following the specified assessment schedule. ADA prevalence is the proportion of patients with a positive ADA result at any time, baseline or post-baseline. Treatment-emergent ADA includes both treatment-induced and treatment-boosted ADA. Its incidence is the proportion of patients with treatment-emergent ADA positivity. Treatment-boosted ADA refers to a baseline-positive ADA titer that increased ≥4-fold during the study. Persistently positive patients have at least two post-baseline ADA-positive readings, with at least 16 weeks between the first and last, or an ADA-positive result at the final assessment. This includes baseline-positive patients meeting these criteria. Transiently positive is defined by at least one post-baseline ADA-positive reading without being persistently positive, including baseline-positive patients meeting these terms. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pathologic Complete Response (pCR) Rates at Time of Cystectomy | Up to 6 months | Full Analysis Set (Intention to Treat): includes all randomized subjects | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Event-free Survival (EFS) Per Central Review Defined as Time From Randomization to Event | Up to 48 months | The full analysis set (FAS) includes all randomized patients | months | MEDIAN |
| SECONDARY | Event-free Survival at 24 Months (EFS24) Per Central Review Defined as Time From Randomization to Event | Up to 24 months | The full analysis set (FAS) Intention to treat included all randomized patients | Percentage of participants | NUMBER |
| SECONDARY | Proportion of Patients Who Undergo Cystectomy | Up to 6 months | The full analysis set (FAS) Intention to treat included all randomized patients. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | Up to 65 months | Months | MEDIAN | |
| SECONDARY | Metastasis-free Survival Per Investigator Assessment or Local Biopsy Review. | Up to 48 months | The full analysis set (FAS) Intention to treat included all randomized patients. | Months | MEDIAN |
| SECONDARY | Disease-specific Survival Per Investigator Assessment or Local Biopsy Review. | Up to 48 months | The full analysis set (FAS) Intention to treat included all randomized patients. | months | MEDIAN |
| SECONDARY | Immunogenicity of Durvalumab When Used in Combination With Gemcitabine/Cisplatin as Measured by Presence of Antidrug Antibodies (ADA) | Up to 12 months | The ADA analysis set includes all participants who had non-missing baseline ADA and at least one non-missing post-baseline ADA result. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group23
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pathologic Complete Response (pCR) Rates at Time of Cystectomy | Durvalumab + Gemcitabine + Cisplatin | 199 | Participants | ||
| Pathologic Complete Response (pCR) Rates at Time of Cystectomy | Gemcitabine + Cisplatin | 146 | Participants | ||
| Event-free Survival (EFS) Per Central Review Defined as Time From Randomization to Event | Durvalumab + Gemcitabine + Cisplatin | NA | Inter-Quartile Range 13.4 to NA | months | |
| Event-free Survival (EFS) Per Central Review Defined as Time From Randomization to Event | Gemcitabine + Cisplatin | 46.1 | Inter-Quartile Range 8.6 to NA | months | |
| Event-free Survival at 24 Months (EFS24) Per Central Review Defined as Time From Randomization to Event | Durvalumab + Gemcitabine + Cisplatin | 67.8 | 95% Confidence Interval 63.6 to 71.7 | Percentage of participants | |
| Event-free Survival at 24 Months (EFS24) Per Central Review Defined as Time From Randomization to Event | Gemcitabine + Cisplatin | 59.8 | 95% Confidence Interval 55.4 to 64 | Percentage of participants | |
| Proportion of Patients Who Undergo Cystectomy | Durvalumab + Gemcitabine + Cisplatin | 469 | Participants | ||
| Proportion of Patients Who Undergo Cystectomy | Gemcitabine + Cisplatin | 441 | Participants | ||
| Overall Survival | Durvalumab+Gemcitabine+Cisplatin | NA | Inter-Quartile Range 41.9 to NA | Months | |
| Overall Survival | Gemcitabine+Cisplatin | NA | Inter-Quartile Range 24.1 to NA | Months |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Durvalumab + Gemcitabine + Cisplatin | 533 | |
| Overall Study | STARTED | Gemcitabine + Cisplatin | 530 | |
| Overall Study | Started Neoadjuvant Treatment | Durvalumab + Gemcitabine + Cisplatin | 530 | |
| Overall Study | Started Neoadjuvant Treatment | Gemcitabine + Cisplatin | 526 | |
| Overall Study | Completed Neoadjuvant Treatment | Durvalumab + Gemcitabine + Cisplatin | 417 | |
| Overall Study | Completed Neoadjuvant Treatment | Gemcitabine + Cisplatin | 389 | |
| Overall Study | Completed Radical Cystectomy | Durvalumab + Gemcitabine + Cisplatin | 469 | |
| Overall Study | Completed Radical Cystectomy | Gemcitabine + Cisplatin | 441 | |
| Overall Study | Started Adjuvant Treatment | Durvalumab + Gemcitabine + Cisplatin | 383 | |
| Overall Study | Started Adjuvant Treatment | Gemcitabine + Cisplatin | 0 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events718
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 | Urinary tract infection | Infections and infestations | Durvalumab + Gemcitabine + Cisplatin | 124 | 530 | 181 |
| other | Urinary tract infection | Infections and infestations | Gemcitabine + Cisplatin | 108 | 526 | 158 |
| other | Procedural pain | Injury, poisoning and procedural complications | Durvalumab + Gemcitabine + Cisplatin | 46 | 530 | 49 |
| other | Procedural pain | Injury, poisoning and procedural complications | Gemcitabine + Cisplatin | 38 | 526 | 43 |
| other | Alanine aminotransferase increased | Investigations | Durvalumab + Gemcitabine + Cisplatin | 46 | 530 | 65 |
| other | Alanine aminotransferase increased | Investigations | Gemcitabine + Cisplatin | 38 | 526 | 48 |
| other | Amylase increased | Investigations | Durvalumab + Gemcitabine + Cisplatin | 34 | 530 | 43 |
| other | Amylase increased | Investigations | Gemcitabine + Cisplatin | 19 | 526 | 26 |
| other | Blood creatinine increased | Investigations | Durvalumab + Gemcitabine + Cisplatin | 94 | 530 | 131 |
| other | Blood creatinine increased | Investigations | Gemcitabine + Cisplatin | 76 | 526 | 97 |
1 to 10 of 718Source ClinicalTrials.gov
See all 718 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Durvalumab + Gemcitabine + Cisplatin | 27 | 533 |
| Total, all-cause mortality | Gemcitabine + Cisplatin | 29 | 526 |
| Total, other adverse events | Durvalumab + Gemcitabine + Cisplatin | 522 | 530 |
| Total, other adverse events | Gemcitabine + Cisplatin | 511 | 526 |
| Total, serious adverse events | Durvalumab + Gemcitabine + Cisplatin | 326 | 530 |
| Total, serious adverse events | Gemcitabine + Cisplatin | 287 | 526 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39282910 | 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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Durvalumab + Gemcitabine + Cisplatin vs Gemcitabine + Cisplatin: Proportion of Patients Who Undergo Cystectomy | Trial comparisons |
| Durvalumab + Gemcitabine + Cisplatin vs Gemcitabine + Cisplatin: Pathologic Complete Response (pCR) Rates at Time of Cystectomy | Trial comparisons |
| Durvalumab + Gemcitabine + Cisplatin vs Gemcitabine + Cisplatin: deaths from any cause | Trial comparisons |
| Durvalumab + Gemcitabine + Cisplatin vs Gemcitabine + Cisplatin: serious adverse events | Trial comparisons |
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/NCT03732677
GET https://conductscience.org/api/trials/v1/NCT03732677/results?page=2