Trial · NCT05154994
Tremelimumab + Durvalumab(MEDI4736)+ Belinostat in Urothelial Carcinoma
NCT05154994, Phase 1, Completed, University of Utah
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tremelimumab + Durvalumab(MEDI4736)+ Belinostat in Urothelial Carcinoma. Trials, record NCT05154994. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05154994
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tremelimumab + Durvalumab(MEDI4736)+ Belinostat in Urothelial Carcinoma
- NCT number
- NCT05154994
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 7 participants, actual
- Lead sponsor
- University of Utah
- Conditions
- Infiltrating Urothelial Carcinoma, Sarcomatoid Variant, Locally Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Unresectable Urothelial Carcinoma
- Interventions
- Belinostat, Durvalumab
- First posted
- 2021-12-13
- Last updated
- 2026-10-14
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of dose limiting toxicities (DLTs) (Phase 1A Part 1) | Up to 21 days | Rate of DLTs during the defined DLT period for belinostat dose escalation. The number and proportion of DLTs will be reported for each dose level. An exact 95% confidence interval will be reported for each dose level with more than one patient. |
| Primary | Incidence of DLTs (Phase 1A Part 2) | Up to 21 days | Rate of DLTs during the defined DLT period for confirmation of belinostat for the phased triplet regimen. |
| Primary | Incidence of adverse events (AEs) (Phase 1B) | Up to 3 years | The incidence and frequency of AEs characterized by type, severity (as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0), seriousness, duration, and relationship to study treatment. Will be tabulated by dose level and cohort. Exact 95% binomial confidence intervals. |
| Secondary | Rate of clinical benefit | Up to 3 years | Defined as the proportion of evaluable patients achieving stable disease, a partial response, or a complete response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Will be tabulated by dose level and cohort. Exact 95% binomial confidence intervals. |
| Secondary | Objective response rate | Up to 3 years | Defined as the proportion of evaluable patients achieving a partial response or a complete response per RECIST 1.1 criteria. Will be tabulated by dose level and cohort. Exact 95% binomial confidence intervals. |
| Secondary | Duration of response | Up to 3 years | Defined as the time from documented tumor response to disease progression as defined by RECIST 1.1. Will be analyzed using Kaplan-Meier methodology and associated 95% confidence intervals. |
| Secondary | Progression-free survival | From the initiation of study therapy to disease progression per RECIST 1.1, initiation of alternative therapy, or death from any cause, assessed up to 3 years | Will be analyzed using Kaplan-Meier methodology and associated 95% confidence intervals. |
| Secondary | Overall survival | From the initiation of study therapy until death from any cause, assessed up to 3 years | Will be analyzed using Kaplan-Meier methodology and associated 95% confidence intervals. |
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.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA042014 | Cancer Center Support Grant | ULRICH, CORNELIA M | UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH | NATIONAL CANCER INSTITUTE | 1986 to 2025 |
Source NIH RePORTER
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/NCT05154994
GET https://conductscience.org/api/trials/v1/NCT05154994/registered