Trial · NCT03258593
Durvalumab and Vicineum in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG)
NCT03258593, Phase 1, Completed, National Cancer Institute (NCI); results first posted 2023-10-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Durvalumab and Vicineum in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG). Trials, record NCT03258593. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03258593
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Durvalumab and Vicineum in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG)
- NCT number
- NCT03258593
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 15 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Urinary Bladder Neoplasms
- Interventions
- Durvalumab, Vicineum, Acetaminophen, Antihistamine, Bladder Biopsy, TURBT, Cystoscopy, Urine cytology, Electrocardiogram, CT, MRI
- First posted
- 2017-08-23
- Last updated
- 2026-10-27
- Results first posted
- 2023-10-26
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Grades 1-5 Adverse Events | Through study completion, an average of 315 days | Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild, grade 2 is moderate, grade 3 is severe, grade 4 is life-threatening, and grade 5 is death related to adverse event. |
| Secondary | Urinary Epithelial Cell Adhesion Molecule (EpCAM) Compared Between Participants Who Have a Clinical Response to Therapy vs. Those Who Do Not Respond | Baseline, week 1, weeks 2-5, week 6, week 10, week 12 | Urinary EpCAM will be measured and will be compared between participants who have a clinical response to therapy vs. those who do not respond. Although it is expected to have low power, a comparison of the EpCAM levels may be compared between the two response categories using a Wilcoxon rank sum test, with the resulting p-value intended to help describe the differences noted. |
| Secondary | Response Rate | From enrollment until event occurrence (recurrence, progression); twelve weeks. | The response to treatment will be determined for evaluable participants who receive treatment and was measured as follows: Recurrence is suspected and/or determined by urine cytology and/or cystoscopic exam and then confirmed pathologically after a transurethral resection of bladder tumor (TURBT). Complete response rate for carcinoma in situ (CIS) is defined as the absence of CIS upon follow-up biopsies. Disease progression is defined as upstaging from a lower stage to a higher stage (e.g., Ta to T1-T4 or T1 to T2-4; CIS to T1 or CIS to T2-T4; or any N+ or M+ in these high-grade tumors). |
| Secondary | Pharmacokinetic Parameters in Urine Maximum Concentration (Cmax) of Vicineum | Baseline, week 1, week 6, week 12 | Evaluate the pharmacokinetic parameters of Vicineum obtained by urine samples. Urinary Vicineum (in ng/mL). |
| Secondary | Change in Programmed Death-ligand 1 (PD-L1) Levels Between Responders and Non-Responders | Baseline and after treatment with both agents, from enrollment up to 5 weeks | PD-L1 levels will be obtained at baseline and after treatment with both agents. The change in levels will be determined between the two measurements, and these changes will be compared between responders and non-responders. Although it is expected to have low power, in each case the comparisons between the two response categories will be made using a Wilcoxon rank sum test, with the resulting p-value intended to help describe the differences noted. |
| Secondary | Change in Programmed Cell Death Protein 1 (PD-1) Levels Between Responders and Non-Responders | baseline and after treatment with both agents | Programmed Cell Death Protein 1 (PD-1) levels will be obtained at baseline and after treatment with both agents. The change in levels will be determined between the two measurements, and these changes will be compared between responders and non-responders. Although it is expected to have low power, in each case the comparisons between the two response categories will be made using a Wilcoxon rank sum test, with the resulting p-value intended to help describe the differences noted. |
| Secondary | Change in Programmed Death-ligand 1 (PD-L1) Levels Between Participants Who Respond and Have Stable Disease (SD), and Those With Progressive Disease (PD) | Baseline and after treatment, from enrollment up to 5 weeks | PD-L1 levels will be obtained at baseline and after treatment with both agents. The change will be compared between those who respond or have stable disease (SD (clinical benefit=Complete Response (CR)+Partial Response (PR)+SD) and those with progressive disease (PD). Although it is expected to have low power, in each case the comparisons between the two response categories will be made using a Wilcoxon rank sum test, with the resulting p-value intended to help describe the differences noted. |
| Secondary | Change in Programmed Cell Death Protein 1(PD-1) Levels Between Participants Who Respond and Have Stable Disease (SD), and Those With Progressive Disease (PD) | baseline and after treatment | PD-1 levels will be obtained at baseline and after treatment with both agents. The change will be compared between those who respond or have stable disease (SD (clinical benefit=Complete Response (CR)+Partial Response (PR)+SD) and those with progressive disease (PD). Although it is expected to have low power, in each case the comparisons between the two response categories will be made using a Wilcoxon rank sum test, with the resulting p-value intended to help describe the differences noted. |
| Secondary | Changes in the Immune Parameters Obtained From Blood Samples | baseline, 3 weeks, and 5 weeks | All evaluable participants will have determinations of many immune parameters at baseline, 3 months, and 6 months. The changes in the parameters obtained from blood samples will be determined at baseline vs. 3 months, and baseline vs. 6 months. Comparisons of the paired values will be performed using a Wilcoxon signed rank test, and a Hochberg adjustment may be used. |
| Secondary | Changes in the Immune Parameters Obtained From Biopsies | baseline, 3 months, and 6 months | All evaluable participants will have determinations of many immune parameters at baseline, 3 months, and 6 months. The changes in the parameters obtained from biopsies will be obtained from baseline vs. a single second biopsy at 6 months. Comparisons of the paired values will be performed using a Wilcoxon signed rank test, and a Hochberg adjustment may be used. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Grades 1-5 Adverse Events | Through study completion, an average of 315 days | adverse events | NUMBER | |
| SECONDARY | Urinary Epithelial Cell Adhesion Molecule (EpCAM) Compared Between Participants Who Have a Clinical Response to Therapy vs. Those Who do Not Respond | Baseline, week 1, weeks 2-5, week 6, week 10 and week 12 | |||
| SECONDARY | Response Rate | From enrollment until event occurrence (recurrence, progression); twelve weeks. | percentage of participants | NUMBER | |
| SECONDARY | Pharmacokinetic Parameters in Urine Maximum Concentration (Cmax) of Vicineum | Baseline, week 1, week 6, week 12 | ng/mL | MEDIAN | |
| SECONDARY | Change in Programmed Death-ligand 1 (PD-L1) Levels Between Responders and Non-Responders | Baseline and after treatment with both agents, from enrollment up to 5 weeks | Number of responders and non-responders in the rows below = overall number of participants analyzed for each group. | pg/mL | MEDIAN |
| SECONDARY | Change in Programmed Cell Death Protein 1 (PD-1) Levels Between Responders and Non-Responders | baseline and after treatment with both agents | |||
| SECONDARY | Change in Programmed Death-ligand 1 (PD-L1) Levels Between Participants Who Respond and Have Stable Disease (SD), and Those With Progressive Disease (PD) | Baseline and after treatment, from enrollment up to 5 weeks | Number of participants with SD and participants with PD in the rows below = overall number of participants analyzed for each group. | pg/mL | MEDIAN |
| SECONDARY | Change in Programmed Cell Death Protein 1(PD-1) Levels Between Participants Who Respond and Have Stable Disease (SD), and Those With Progressive Disease (PD) | baseline and after treatment | |||
| SECONDARY | Changes in the Immune Parameters Obtained From Blood Samples | baseline, 3 weeks, and 5 weeks | pg/mL | MEDIAN | |
| SECONDARY | Changes in the Immune Parameters Obtained From Biopsies | baseline, 3 months, and 6 months |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group94
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Grades 1-5 Adverse Events | Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | Grade 1 | 12 | adverse events | |
| Number of Grades 1-5 Adverse Events | Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | Grade 1 | 3 | adverse events | |
| Number of Grades 1-5 Adverse Events | Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | Grade 1 | 15 | adverse events | |
| Number of Grades 1-5 Adverse Events | Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | Grade 2 | 9 | adverse events | |
| Number of Grades 1-5 Adverse Events | Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | Grade 2 | 3 | adverse events | |
| Number of Grades 1-5 Adverse Events | Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | Grade 2 | 12 | adverse events | |
| Number of Grades 1-5 Adverse Events | Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | Grade 3 | 4 | adverse events | |
| Number of Grades 1-5 Adverse Events | Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | Grade 3 | 0 | adverse events | |
| Number of Grades 1-5 Adverse Events | Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | Grade 3 | 4 | adverse events | |
| Number of Grades 1-5 Adverse Events | Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | Grade 4 | 0 | adverse events |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Run-In Induction Phase | STARTED | Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | 12 | |
| Run-In Induction Phase | STARTED | Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | 0 | |
| Run-In Induction Phase | STARTED | Level 1, Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 20 mg | 0 | |
| Run-In Induction Phase | STARTED | Arm 2, Durvalumab + Vicineum at the Maximum Tolerated Dose (MTD) | 0 | |
| Run-In Induction Phase | COMPLETED | Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | 12 | |
| Run-In Induction Phase | COMPLETED | Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | 0 | |
| Run-In Induction Phase | COMPLETED | Level 1, Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 20 mg | 0 | |
| Run-In Induction Phase | COMPLETED | Arm 2, Durvalumab + Vicineum at the Maximum Tolerated Dose (MTD) | 0 | |
| Run-In Induction Phase | NOT COMPLETED | Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | 0 | |
| Run-In Induction Phase | NOT COMPLETED | Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | 0 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events261
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 | Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | 1 | 12 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | 0 | 3 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | 1 | 15 | 1 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | 2 | 12 | 2 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | 0 | 3 | 0 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | 2 | 15 | 2 |
| other | Anxiety | Psychiatric disorders | Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | 1 | 12 | 1 |
| other | Anxiety | Psychiatric disorders | Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | 0 | 3 | 0 |
| other | Anxiety | Psychiatric disorders | Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | 1 | 15 | 1 |
| other | Atrial fibrillation | Cardiac disorders | Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | 2 | 12 | 3 |
1 to 10 of 261Source ClinicalTrials.gov
See all 261 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | 0 | 12 |
| Total, all-cause mortality | Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | 0 | 3 |
| Total, all-cause mortality | Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | 0 | 15 |
| Total, other adverse events | Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | 12 | 12 |
| Total, other adverse events | Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | 3 | 3 |
| Total, other adverse events | Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | 15 | 15 |
| Total, serious adverse events | Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | 4 | 12 |
| Total, serious adverse events | Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | 0 | 3 |
| Total, serious adverse events | Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg | 4 | 15 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg vs Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) |
Source 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/NCT03258593
GET https://conductscience.org/api/trials/v1/NCT03258593/results?page=2