Trial · NCT02901548
Phase 2 Durvalumab (Medi4736) for Bacillus Calmette-Guérin (BCG) Refactory Urothelial Carcinoma in Situ of the Bladder
NCT02901548, Phase 2, Terminated, H. Lee Moffitt Cancer Center and Research Institute; results first posted 2021-06-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2 Durvalumab (Medi4736) for Bacillus Calmette-Guérin (BCG) Refactory Urothelial Carcinoma in Situ of the Bladder. Trials, record NCT02901548. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02901548
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Durvalumab (Medi4736) for Bacillus Calmette-Guérin (BCG) Refactory Urothelial Carcinoma in Situ of the Bladder
- NCT number
- NCT02901548
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Conditions
- Carcinoma in Situ of Bladder, Bladder Cancer
- Interventions
- Durvalumab, Cystoscopy with Biopsy
- First posted
- 2016-09-15
- Last updated
- 2022-07-29
- Results first posted
- 2021-06-11
- Limitations and caveats
- All reported deaths were on post study treatment survival follow up.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response Rate at 6 Months | 6 Months | Complete Response Rate at month six based on the week 26 mapping biopsy in BCG refractory CIS urothelial bladder cancer. The absence of CIS of bladder on the mapping biopsies after pathological review would be considered complete response to treatment. |
| Secondary | Complete Response Rate at 24 Months | 24 Months | Complete Response Rate at month 24 based on the week 104 mapping biopsy in BCG refractory CIS urothelial bladder cancer. The absence of CIS of bladder on the mapping biopsies after pathological review would be considered complete response to treatment. |
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 | Complete Response Rate at 6 Months | 6 Months | Evaluable participants | percentage of participants | NUMBER |
| SECONDARY | Complete Response Rate at 24 Months | 24 Months | Evaluable participants. Study was closed early due to futility. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Response Rate at 6 Months | Durvalumab Plus Cystoscopy | 23.1 | 95% Confidence Interval 5 to 53.8 | percentage of participants | |
| Complete Response Rate at 24 Months | Durvalumab Plus Cystoscopy | 0 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Durvalumab Plus Cystoscopy | 17 | |
| Overall Study | COMPLETED | Durvalumab Plus Cystoscopy | 13 | |
| Overall Study | NOT COMPLETED | Durvalumab Plus Cystoscopy | 4 |
Source ClinicalTrials.gov
Adverse events78
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 | Investigations- Other | Investigations | Durvalumab Plus Cystoscopy | 9 | 17 | 12 |
| other | INR increased | Investigations | Durvalumab Plus Cystoscopy | 3 | 17 | 5 |
| other | Serum amylase increased | Investigations | Durvalumab Plus Cystoscopy | 3 | 17 | 4 |
| other | Alanine aminotransferase increased | Investigations | Durvalumab Plus Cystoscopy | 1 | 17 | 1 |
| other | Alkaline phosphatase increased | Investigations | Durvalumab Plus Cystoscopy | 1 | 17 | 1 |
| other | Aspartate aminotransferase increased | Investigations | Durvalumab Plus Cystoscopy | 1 | 17 | 1 |
| other | Creatinine increased | Investigations | Durvalumab Plus Cystoscopy | 1 | 17 | 1 |
| other | Electrocardiogram QT corrected interval prolonged | Investigations | Durvalumab Plus Cystoscopy | 1 | 17 | 1 |
| other | GGT increased | Investigations | Durvalumab Plus Cystoscopy | 1 | 17 | 1 |
| other | Lipase increased | Investigations | Durvalumab Plus Cystoscopy | 1 | 17 | 2 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Durvalumab Plus Cystoscopy | 3 | 17 |
| Total, other adverse events | Durvalumab Plus Cystoscopy | 17 | 17 |
| Total, serious adverse events | Durvalumab Plus Cystoscopy | 5 | 17 |
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 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/NCT02901548
GET https://conductscience.org/api/trials/v1/NCT02901548/events?page=2