Trial · NCT04315155
Evaluating Safety & Efficacy Belinostat Combo w Nivo Alone & w Ipi in Patients w Treated Metastatic/Advanced Carcinomas w ARID1A Lof Mutation
NCT04315155, Phase 1, Withdrawn, University of Utah
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluating Safety & Efficacy Belinostat Combo w Nivo Alone & w Ipi in Patients w Treated Metastatic/Advanced Carcinomas w ARID1A Lof Mutation. Trials, record NCT04315155. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04315155
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating Safety & Efficacy Belinostat Combo w Nivo Alone & w Ipi in Patients w Treated Metastatic/Advanced Carcinomas w ARID1A Lof Mutation
- NCT number
- NCT04315155
- Status
- Withdrawn
- Phases
- Phase 1
- Enrollment
- 0 participants, actual
- Lead sponsor
- University of Utah
- Conditions
- Metastatic Adenocarcinoma
- Interventions
- Belinostat, nivolumab, ipilimumab, nivolumab, Belinostat
- First posted
- 2020-03-19
- Last updated
- 2020-10-28
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | rate of dose limiting toxicities (DLTs) during defined DLT period | 9-12 months | assess the recommended phase 2 dose of belinostat in combination with nivolumab in patients with advanced solid tumors harboring ARID1A mutations. |
| Primary | rate of intolerable refractory immune mediated adverse events assessed during the defined DLT evaluation period | 12-18 months | assess the safety and tolerability of belinostat in combination with nivolumab with and without ipilimumab in patients with advanced solid tumors. |
| Secondary | frequency and characterization of Adverse Events (AE) | up to 5 years | assess the safety of belinostat in combination with nivolumab with or without ipilimumab in patients with advanced solid tumors |
| Secondary | • The rate of clinical benefit defined as the proportion of evaluable patients achieving stable disease, a partial response, or a complete response per RECIST 1.1 criteria | up to 5 years | assess the efficacy of belinostat in combination with nivolumab with or without ipilimumab in patients with advanced solid tumors |
| Secondary | • Objective response rate (ORR) as defined as the proportion of evaluable patients achieving a partial response or a complete response per RECIST 1.1 criteria. | up to 5 years | assess the efficacy of belinostat in combination with nivolumab with or without ipilimumab in patients with advanced solid tumors |
| Secondary | • Duration of response (DoR) as defined as the time from documented tumor response to disease progression as defined by RECIST 1.1. | up to 5 years | assess the efficacy of belinostat in combination with nivolumab with or without ipilimumab in patients with advanced solid tumors |
| Secondary | • Progression-free survival (PFS) as defined as the time from the initiation of study therapy to disease progression per RECIST 1.1, initiation of alternative therapy, or death from any cause. | up to 5 years | assess the efficacy of belinostat in combination with nivolumab with or without ipilimumab in patients with advanced solid tumors |
| Secondary | Overall survival (OS) | up to 5 years | assess the efficacy of belinostat in combination with nivolumab with or without ipilimumab in patients with advanced solid tumors |
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.
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/NCT04315155
GET https://conductscience.org/api/trials/v1/NCT04315155/registered