Trial · NCT03912818
Durvalumab and Standard Chemotherapy Before Surgery in Treating Patients With Variant Histology Bladder Cancer
NCT03912818, Phase 2, Terminated, Stanford University; results first posted 2023-09-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Durvalumab and Standard Chemotherapy Before Surgery in Treating Patients With Variant Histology Bladder Cancer. Trials, record NCT03912818. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03912818
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Durvalumab and Standard Chemotherapy Before Surgery in Treating Patients With Variant Histology Bladder Cancer
- NCT number
- NCT03912818
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- Stanford University
- Conditions
Bladder Adenocarcinoma, Bladder Mixed Adenocarcinoma, Bladder Squamous Cell Carcinoma, Bladder Urothelial Carcinoma, Infiltrating Bladder Urothelial Carcinoma Sarcomatoid Variant, Infiltrating Bladder Urothelial Carcinoma With Giant Cells, Infiltrating Bladder Urothelial Carcinoma With Glandular Differentiation, Infiltrating Bladder Urothelial Carcinoma With Trophoblastic Differentiation, Infiltrating Bladder Urothelial Carcinoma, Clear Cell Variant, Infiltrating Bladder Urothelial Carcinoma, Micropapillary Variant, Infiltrating Bladder Urothelial Carcinoma, Nested Variant, Infiltrating Bladder Urothelial Carcinoma, Plasmacytoid Variant
- Interventions
- Carboplatin, Cisplatin, Cystectomy, Doxorubicin, Durvalumab, Gemcitabine, Methotrexate, Vinblastine
- First posted
- 2019-04-11
- Last updated
- 2023-09-11
- Results first posted
- 2023-09-11
- Limitations and caveats
- The study did not achieve its planned enrollment size and did not achieve statistical power.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Grade 3-5 Adverse Events | At 120 days | Graded per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The safety and tolerability of durvalumab in combination with chemotherapy in subjects with variant histology bladder cancer who initiate study treatment will be assessed as the number, by treatment cohort, of grade 3, 4, or 5 adverse events, considered probably or definitely related by the investigator. |
| Secondary | Proportion of Subjects Who Initiate Study Treatment and Achieve Tumor Stage of pT2 N0 M0 or Better (e.g., pT0, pT1 N0) at Cystectomy | At 20 weeks | Achievement of tumor staging will be determined by pathologist at cystectomy and reported by treatment cohort. Assessed per National Comprehensive Cancer Network bladder cancer guidelines. * T0 N0 M0 = No evidence of primary tumor * T1 N0 M0 = Tumor staging by pathological assessment detected in lamina propria (T0), with no tumor positive nodes (N0). * T2 N0 M0 = Tumor staging by pathological assessment detected in muscularis propria (pT2), with no tumor positive nodes (N0) or tumor metastases (M0) observed. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Grade 3-5 Adverse Events | At 120 days | events | NUMBER | |
| SECONDARY | Proportion of Subjects Who Initiate Study Treatment and Achieve Tumor Stage of pT2 N0 M0 or Better (e.g., pT0, pT1 N0) at Cystectomy | At 20 weeks | Participants who underwent renal cystectomy are included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Grade 3-5 Adverse Events | Cohort I (Durvalumab, DD MVAC) | Grade 3 | 1 | events | |
| Incidence of Grade 3-5 Adverse Events | Cohort III (Durvalumab, Carbo-gem) | Grade 3 | 2 | events | |
| Incidence of Grade 3-5 Adverse Events | Cohort I (Durvalumab, DD MVAC) | Grade 4 | 0 | events | |
| Incidence of Grade 3-5 Adverse Events | Cohort III (Durvalumab, Carbo-gem) | Grade 4 | 0 | events | |
| Incidence of Grade 3-5 Adverse Events | Cohort I (Durvalumab, DD MVAC) | Grade 5 | 0 | events | |
| Incidence of Grade 3-5 Adverse Events | Cohort III (Durvalumab, Carbo-gem) | Grade 5 | 0 | events | |
| Proportion of Subjects Who Initiate Study Treatment and Achieve Tumor Stage of pT2 N0 M0 or Better (e.g., pT0, pT1 N0) at Cystectomy | Cohort I (Durvalumab, DD MVAC) | 1 | Participants | ||
| Proportion of Subjects Who Initiate Study Treatment and Achieve Tumor Stage of pT2 N0 M0 or Better (e.g., pT0, pT1 N0) at Cystectomy | Cohort III (Durvalumab, Carbo-gem) | 1 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort I (Durvalumab, DD MVAC) | 3 | |
| Overall Study | STARTED | Cohort II (Durvalumab, Cis-gem) | 0 | |
| Overall Study | STARTED | Cohort III (Durvalumab, Carbo-gem) | 3 | |
| Overall Study | COMPLETED | Cohort I (Durvalumab, DD MVAC) | 3 | |
| Overall Study | COMPLETED | Cohort II (Durvalumab, Cis-gem) | 0 | |
| Overall Study | COMPLETED | Cohort III (Durvalumab, Carbo-gem) | 3 | |
| Overall Study | NOT COMPLETED | Cohort I (Durvalumab, DD MVAC) | 0 | |
| Overall Study | NOT COMPLETED | Cohort II (Durvalumab, Cis-gem) | 0 | |
| Overall Study | NOT COMPLETED | Cohort III (Durvalumab, Carbo-gem) | 0 |
Source ClinicalTrials.gov
Adverse events76
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 | Abdominal Pain | Gastrointestinal disorders | Cohort I (Durvalumab, DD MVAC) | 1 | 3 | |
| other | Abdominal Pain | Gastrointestinal disorders | Cohort III (Durvalumab, Carbo-gem) | 0 | 3 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort I (Durvalumab, DD MVAC) | 1 | 3 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort III (Durvalumab, Carbo-gem) | 1 | 3 | |
| other | Anorexia | Psychiatric disorders | Cohort I (Durvalumab, DD MVAC) | 1 | 3 | |
| other | Anorexia | Psychiatric disorders | Cohort III (Durvalumab, Carbo-gem) | 0 | 3 | |
| other | Constipation | Gastrointestinal disorders | Cohort I (Durvalumab, DD MVAC) | 0 | 3 | |
| other | Constipation | Gastrointestinal disorders | Cohort III (Durvalumab, Carbo-gem) | 1 | 3 | |
| other | Diarrhea | Gastrointestinal disorders | Cohort I (Durvalumab, DD MVAC) | 0 | 3 | |
| other | Diarrhea | Gastrointestinal disorders | Cohort III (Durvalumab, Carbo-gem) | 1 | 3 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort I (Durvalumab, DD MVAC) | 0 | 3 |
| Total, all-cause mortality | Cohort III (Durvalumab, Carbo-gem) | 0 | 3 |
| Total, other adverse events | Cohort I (Durvalumab, DD MVAC) | 3 | 3 |
| Total, other adverse events | Cohort III (Durvalumab, Carbo-gem) | 3 | 3 |
| Total, serious adverse events | Cohort I (Durvalumab, DD MVAC) | 2 | 3 |
| Total, serious adverse events | Cohort III (Durvalumab, Carbo-gem) | 3 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Cohort I (Durvalumab, DD MVAC) vs Cohort III (Durvalumab, Carbo-gem): Proportion of Subjects Who Initiate Study Treatment and Achieve Tumor Stage of pT2 N0 M0 or Better (e.g., pT0, pT1 N0) at Cystectomy | Trial comparisons |
| Cohort I (Durvalumab, DD MVAC) vs Cohort III (Durvalumab, Carbo-gem): deaths from any cause | Trial comparisons |
| Cohort I (Durvalumab, DD MVAC) vs Cohort III (Durvalumab, Carbo-gem): 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/NCT03912818
GET https://conductscience.org/api/trials/v1/NCT03912818/events?page=2