Trial · NCT07579195
Consolidative Therapy After EV + Pembrolizumab in Muscle Invasive Bladder Cancer, REINFORCE Trial
NCT07579195, Phase 1, Phase 2, Recruiting, University of Washington
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Consolidative Therapy After EV + Pembrolizumab in Muscle Invasive Bladder Cancer, REINFORCE Trial. Trials, record NCT07579195. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07579195
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Consolidative Therapy After EV + Pembrolizumab in Muscle Invasive Bladder Cancer, REINFORCE Trial
- NCT number
- NCT07579195
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 12 participants, estimated
- Lead sponsor
- University of Washington
- Conditions
- Muscle Invasive Bladder Carcinoma, Stage III Bladder Cancer AJCC v8, Stage IV Bladder Cancer AJCC v8
- Interventions
Intensity-Modulated Radiation Therapy, Volume Modulated Arc Therapy, Radiosensitizing Agent, Radical Cystectomy, Pelvic Lymphadenectomy, Stereotactic Body Radiation Therapy, Computed Tomography, Positron Emission Tomography, Magnetic Resonance Imaging, Transurethral Resection of Bladder Tumor, Cystoscopy, Biospecimen Collection, Questionnaire Administration
- First posted
- 2026-05-12
- Last updated
- 2026-08-25
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Completion rate of protocol-defined treatment (feasibility) | 12 months since eligibility determination | Feasibility will be assessed through the completion rate of protocol-defined treatment. Primary endpoint is met if the completion rate of protocol-defined treatment is \> 70%. Descriptive statistics will be provided. |
| Secondary | Progression-free survival | From date of enfortumab vedotin (EV) + pembrolizumab start to date of first documentation of progression assessed by local review, or death due to any cause, assessed up to 12 months | The Kaplan-Meier method will be used. |
| Secondary | Incidence of treatment-related grade 3 or higher adverse events | Up to 12 months after the completion of consolidative therapy | Safety of consolidative radiation therapy will be assessed by the incidence of treatment-related grade 3 or higher toxicities per Common Terminology Criteria for Adverse Events version 6 that is possibly, probably, or definitely related to radiation treatment or chemoradiation therapy. Descriptive statistics will be provided. |
| Secondary | Change in patient-reported quality of life | From baseline to each follow-up assessment (every 3 months up to 12 months after completion of consolidative therapy) | Changes in patient-reported quality of life will be measured by the Functional Assessment of Cancer Therapy-Bladder (FACT-Bl) assessment. Will measure change in total FACT-Bl score from baseline to each follow-up assessment as well as changes in individual domain subscale scores (physical, social/family, emotional, functional well-being, and bladder-specific concerns). Each question is scored 0-4 and higher score indicates better quality of life (for negatively worded items \[e.g., symptoms, distress\], scores are reversed). Clinically meaningful deterioration or improvement will be defined using established minimally important difference thresholds for FACT-Bl. |
| Secondary | Time to progression in the bladder (local control) | 12 months since the start of EV + pembrolizumab | The Kaplan-Meier method will be used. |
| Secondary | Time to progression in the pelvis (pelvic control) | 12 months since the start of EV + pembrolizumab | The Kaplan-Meier method will be used. |
| Secondary | Overall survival | From first date of EV + pembrolizumab to death from any cause, assessed up to 12 months since the start of EV + pembrolizumab | The Kaplan-Meier method will be used. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT07579195
GET https://conductscience.org/api/trials/v1/NCT07579195/registered