Trial · NCT02891161
Durvalumab And Radiation Therapy Followed by Adjuvant Durvalumab in Patients With Urothelial Cancer (T2-4 N0-2 M0) of the Bladder
NCT02891161, Phase 1, Phase 2, Terminated, Monika Joshi, MD; results first posted 2024-11-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Durvalumab And Radiation Therapy Followed by Adjuvant Durvalumab in Patients With Urothelial Cancer (T2-4 N0-2 M0) of the Bladder. Trials, record NCT02891161. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02891161
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Durvalumab And Radiation Therapy Followed by Adjuvant Durvalumab in Patients With Urothelial Cancer (T2-4 N0-2 M0) of the Bladder
- NCT number
- NCT02891161
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 26 participants, actual
- Lead sponsor
- Monika Joshi, MD
- Conditions
- Urothelial Cancer
- Interventions
- durvalumab, Radiation Therapy
- First posted
- 2016-09-07
- Last updated
- 2024-11-27
- Results first posted
- 2024-11-27
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase Ib: Safety Assessment - Evaluation of DLT (Dose Limiting Toxicity) Rate | Begin W1 and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 2 years or until unacceptable toxicity. | To assess the safety of combining durvalumab with RT in that DLT rate is lower than than 33% based on CTCAEv4.0 |
| Primary | All Phases: Progression Free Survival Rate at 1 Year | From C1D1 to Progression or until death for 1 year | Progression free survival rate at one year is defined as the probability that a patient remains free of progression of disease (SD+CR+PR) by modified RECIST 1.1 and cystoscopy at 1 year from the start of durvalumab treatment, D1 of durvaRT. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
| Primary | Phase II: Disease Control Rate to Concurrent durvaRT Followed by Durvalumab | From C1D1 until death or up to a maximum of 39 months. | The number of all subjects is reported with stable disease (SD) for 8 weeks, or partial response (PR), or complete response (CR) according to modified RECIST 1.1 and cystoscopy, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease(SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started;Disease Control Rate (DCR) = CR + PR+SD |
| Secondary | All Phases: DCR Post Completion of Concurrent durvaRT | From C1D1 until death or up to a maximum of 39 months | We will be determining the disease control rate, defined as percentage of patients achieving CR, PR, SD post completion of concurrent durvaRT. This will give us some preliminary evidence for efficacy of durvaRT combination. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease(SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started;Disease Control Rate (DCR) = CR + PR+SD |
| Secondary | All Phases : Median Progression Free Survival (PFS) Time | From C1D1 to PD or until death or up to a maximum of 37 months. | Median progression free survival will be determined for all subjects. |
| Secondary | Phase II: Complete Remission | From C1D1 until CR or death or up to a maximum of 39 months. | Estimate the rate of CR is one of the secondary objectives for phase II part of this study. This will help us determine the actual effectiveness of durvaRT approach. CR will be determined with the help of imaging and cystoscopy post completion of durvaRT per modified RECIST 1.1. Number of subjects reporting CR will be reported here. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. |
| Secondary | All Phases: Overall Survival | From C1D1 until death or 39 months. | Estimate the overall survival (OS), defined as time from start of treatment, D1, to the date of death due to any cause. OS is defined, as time from start of treatment to the date of death due to any cause, or to the date of censoring at the last time the subject was known to be alive in intention-to-treat population. OS is one of the secondary objectives of this study. This is an immunotherapy based clinical trial and it is prudent to determine the OS to reflect the long-term benefit from this therapeutic approach. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase Ib: Safety Assessment - Evaluation of DLT (Dose Limiting Toxicity) Rate | Begin W1 and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 2 years or until unacceptable toxicity. | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | All Phases: Progression Free Survival Rate at 1 Year | From C1D1 to Progression or until death for 1 year | All Phase Ib and Phase II subjects were analyzed together. | percentage of participants | NUMBER |
| PRIMARY | Phase II: Disease Control Rate to Concurrent durvaRT Followed by Durvalumab | From C1D1 until death or up to a maximum of 39 months. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | All Phases: DCR Post Completion of Concurrent durvaRT | From C1D1 until death or up to a maximum of 39 months | Phase Ib and Phase II subjects were analyzed together. | percentage of participants | NUMBER |
| SECONDARY | All Phases : Median Progression Free Survival (PFS) Time | From C1D1 to PD or until death or up to a maximum of 37 months. | Phase Ib and Phase II subjects were analyzed together | months | MEDIAN |
| SECONDARY | Phase II: Complete Remission | From C1D1 until CR or death or up to a maximum of 39 months. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | All Phases: Overall Survival | From C1D1 until death or 39 months. | Phase Ib and Phase II subjects were analyzed together. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase Ib: Safety Assessment - Evaluation of DLT (Dose Limiting Toxicity) Rate | Arm Ib: Safety Run In Phase Ib | 0 | Participants | ||
| All Phases: Progression Free Survival Rate at 1 Year | Phase Ib and II | 71.5 | 95% Confidence Interval 55.6 to 91.9 | percentage of participants | |
| Phase II: Disease Control Rate to Concurrent durvaRT Followed by Durvalumab | Arm II: Investigational Treatment Phase II | 13 | Participants | ||
| All Phases: DCR Post Completion of Concurrent durvaRT | Phase Ib and Phase II | 72.7 | 95% Confidence Interval 51.8 to 86.8 | percentage of participants | |
| All Phases : Median Progression Free Survival (PFS) Time | All Phases | 21.8 | 95% Confidence Interval 14.8 to NA | months | |
| Phase II: Complete Remission | Arm II: Investigational Treatment Phase II | 17 | Participants | ||
| All Phases: Overall Survival | All Phases | 30.8 | 95% Confidence Interval 21.8 to NA | months |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Study Treatment | STARTED | Arm Ib: Safety Run In Phase Ib | 6 | |
| Study Treatment | STARTED | Arm II: Investigational Treatment Phase II | 20 | |
| Study Treatment | COMPLETED | Arm Ib: Safety Run In Phase Ib | 2 | |
| Study Treatment | COMPLETED | Arm II: Investigational Treatment Phase II | 7 | |
| Study Treatment | NOT COMPLETED | Arm Ib: Safety Run In Phase Ib | 4 | |
| Study Treatment | NOT COMPLETED | Arm II: Investigational Treatment Phase II | 13 | |
| Follow up | STARTED | Arm Ib: Safety Run In Phase Ib | 6 | |
| Follow up | STARTED | Arm II: Investigational Treatment Phase II | 20 | |
| Follow up | COMPLETED | Arm Ib: Safety Run In Phase Ib | 2 | |
| Follow up | COMPLETED | Arm II: Investigational Treatment Phase II | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events408
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 | Arm Ib: Safety Run In Phase Ib | 3 | 6 | 5 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Arm II: Investigational Treatment Phase II | 4 | 20 | 4 |
| other | ALANINE AMINOTRANSFERASE INCREASED | Investigations | Arm Ib: Safety Run In Phase Ib | 2 | 6 | 2 |
| other | ALANINE AMINOTRANSFERASE INCREASED | Investigations | Arm II: Investigational Treatment Phase II | 2 | 20 | 4 |
| other | ALKALINE PHOSPHATASE INCREASED | Investigations | Arm Ib: Safety Run In Phase Ib | 1 | 6 | 1 |
| other | ALKALINE PHOSPHATASE INCREASED | Investigations | Arm II: Investigational Treatment Phase II | 0 | 20 | 0 |
| other | ALLERGIC REACTION | Immune system disorders | Arm Ib: Safety Run In Phase Ib | 1 | 6 | 1 |
| other | ALLERGIC REACTION | Immune system disorders | Arm II: Investigational Treatment Phase II | 0 | 20 | 0 |
| other | ALLERGIC RHINITIS | Respiratory, thoracic and mediastinal disorders | Arm Ib: Safety Run In Phase Ib | 1 | 6 | 1 |
| other | ALLERGIC RHINITIS | Respiratory, thoracic and mediastinal disorders | Arm II: Investigational Treatment Phase II | 5 | 20 | 5 |
1 to 10 of 408Source ClinicalTrials.gov
See all 408 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm Ib: Safety Run In Phase Ib | 4 | 6 |
| Total, all-cause mortality | Arm II: Investigational Treatment Phase II | 8 | 20 |
| Total, other adverse events | Arm Ib: Safety Run In Phase Ib | 6 | 6 |
| Total, other adverse events | Arm II: Investigational Treatment Phase II | 20 | 20 |
| Total, serious adverse events | Arm Ib: Safety Run In Phase Ib | 4 | 6 |
| Total, serious adverse events | Arm II: Investigational Treatment Phase II | 8 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36822667 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm Ib: Safety Run In Phase Ib vs Arm II: Investigational Treatment Phase II: deaths from any cause | Trial comparisons |
| Arm Ib: Safety Run In Phase Ib vs Arm II: Investigational Treatment Phase II: 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/NCT02891161
GET https://conductscience.org/api/trials/v1/NCT02891161/events?page=2