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Histone Deacetylase Inhibitor

Triple Therapy for Bladder Cancer (RESOLVE Trial)

Phase 1
Recruiting
Led By Sumati V Gupta
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Estimated creatinine clearance >= 30 mL/min by Cockcroft-Gault formula
Malignancy harboring ARID1A loss of function (lof) genomic alterations as determined by the standard of care next-generation sequencing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

RESOLVE Trial Summary

This trial is testing the combination of tremelimumab, durvalumab, and belinostat to see if it is effective and has minimal side effects in treating patients with urothelial cancer.

Who is the study for?
Adults (18+) with advanced urothelial carcinoma that's spread or can't be surgically removed, who've tried at least one therapy or declined/aren't suitable for standard treatments. They must have ARID1A gene alterations, measurable disease, good organ function and blood counts, and a life expectancy of over 12 weeks. Women must not be pregnant and use effective contraception.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs: Belinostat (an HDAC inhibitor that may stop cancer cells from growing) and Durvalumab (a monoclonal antibody designed to help the immune system attack cancer). It aims to find the safest dose with acceptable side effects for patients with specific genetic changes in their tumors.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system attacking normal organs, infusion-related reactions like fever or chills, fatigue, nausea, liver enzyme changes indicating liver damage, low blood cell counts increasing infection risk or bleeding tendency.

RESOLVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidneys are working well enough, with a creatinine clearance of at least 30 mL/min.
Select...
My cancer has a specific genetic change called ARID1A loss of function.
Select...
My liver enzymes are within acceptable limits despite having liver metastases.
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My body weight is over 30 kg.
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I am post-menopausal or not pregnant if pre-menopausal.
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I am fully active and can carry on all pre-disease activities without restriction.
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My bladder cancer has spread or cannot be surgically removed, and may include rare types.

RESOLVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of DLTs (Phase 1A Part 2)
Incidence of adverse events (AEs) (Phase 1B)
Incidence of dose limiting toxicities (DLTs) (Phase 1A Part 1)
Secondary outcome measures
Duration of response
Objective response rate
Overall survival
+2 more

Side effects data

From 2012 Phase 2 trial • 32 Patients • NCT00301756
88%
Fatigue
81%
Nausea
75%
Lymphocyte count decreased
72%
Constipation
3%
Abdominal pain
3%
Urinary tract infection
3%
Lower gastrointestinal hemorrhage
3%
Dyspnea
3%
Pleural infection
3%
Upper gastrointestinal hemorrhage
3%
Activated partial thromboplastin time prolonged
3%
Dehydration
3%
Pneumonitis
3%
Cytokine release syndrome
3%
Small intestinal obstruction
3%
Arthralgia
3%
Non-cardiac chest pain
3%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Enzyme Inhibitor Therapy)

RESOLVE Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (durvalumab, belinostat)Experimental Treatment2 Interventions
Phased Doublet Therapy Eligible patients enrolled will be administered durvalumab 1120 mg every 3 weeks C1 through C7 followed by durvalumab 1500 mg every four weeks C8 through C15 (T300+D). Belinostat administration will begin with Cycle 2 for 6 cycles. From cycle 8 on, durvalumab will be administered in 28-day cycles to complete up to a total of 15 cycles of treatment or until treatment discontinuation criteria is met. Belinostat will be administered at the assigned dose level on days one through five of every applicable cycle. Belinostat administration on five consecutive days is preferred. Administration within seven days of Day 1 is allowed as needed to accommodate holidays and infusion schedules. Durvalumab will be infused over 60 minutes (±10 minutes). For Cycles 2-7, belinostat will be infused over 30 minutes (-5 minutes/+15 minutes) and will be administered after durvalumab. Separate infusion bags and filters must be used for each infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belinostat
2006
Completed Phase 2
~430
Durvalumab
2017
Completed Phase 2
~3870

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,680 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,997 Total Patients Enrolled
Sumati V GuptaPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide information on past studies that have employed Belinostat?

"Presently, there are 347 Belinostat trials actively collecting data with 52 of those studies reaching Phase 3. Most research is happening in Cordoba, Texas; however, many clinical sites around the world have joined this effort and are now running Belinostat trials."

Answered by AI

What is the current regulatory status of Belinostat?

"Belinostat's safety has been assessed to be a 1 due to the fact that it is currently undergoing Phase 1 clinical trials. This means there is limited evidence which suggests the drug can be both safe and effective."

Answered by AI

Are there vacancies for participants in this trial?

"Affirmative. Information gleaned from clinicaltrials.gov reveals that this experiment has been recruiting since January 14th 2022 and the most updated post was on May 3rd 2022. The trial is in need of 9 volunteers at a single location."

Answered by AI

What medical conditions have been most effectively treated through Belinostat?

"Belinostat has been approved to treat the following conditions: relapse peripheral t-cell lymphoma, disease and unresectable stage iii non-small cell lung cancer."

Answered by AI

Are there any antecedent investigations of this kind?

"Currently, there are 347 active studies related to Belinostat across 1327 cities and 58 nations. The initial clinical trial for this drug, sponsored by AstraZeneca in 2007, involved 37 patients and was successfully approved during Phase 2 of the study. In the 14 years that have followed, 151 trials exploring its efficacy have been conducted worldwide."

Answered by AI

What is the targeted outcome of this research endeavor?

"The primary goal of this 21-day clinical trial is to measure the incidence of dose limiting toxicities. Secondary objectives include overall survival, which will be assessed using Kaplan-Meier methodology with 95% confidence intervals, objective response rate (proportion of evaluable patients achieving a partial or complete response according to RECIST 1.1 criteria), and rate of clinical benefit (measured as proportion of evaluable patients achieving stable disease, partial response, or complete response per RECIST 1.1)."

Answered by AI

How many participants have enrolled in this medical experiment?

"Affirmative, the information released on clinicaltrials.gov states that this investigation is actively recruiting participants. Initially posted on January 14th 2022 and recently updated on May 3rd 2022, 9 individuals are needed to be recruited from one medical facility."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Tremelimumab + Durvalumab(MEDI4736)+ Belinostat in ARID1A Mutated Cancer Focus on Urothelial Carcinoma
2022. "Tremelimumab + Durvalumab(MEDI4736)+ Belinostat in ARID1A Mutated Cancer Focus on Urothelial Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05154994.
~2 spots leftby Nov 2024
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