Tremelimumab + Durvalumab(MEDI4736)+ Belinostat in Urothelial Carcinoma

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT05154994
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Infiltrating Urothelial Carcinoma, Sarcomatoid Variant
  • Locally Advanced Urothelial Carcinoma
  • Metastatic Urothelial Carcinoma
  • Unresectable Urothelial Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belinostat — DRUG
    Given IV
  • Durvalumab — BIOLOGICAL
    Given IV

Study Details

This phase I trial studies the side effects and best dose of belinostat when given together with durvalumab in treating patients with urothelial cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable) and has spread to nearby tissue or lymph nodes (locally advanced). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Belinostat is a potential anti-cancer drug, known as a histone deacetylase (HDAC) inhibitor, which means that belinostat stops the activity of HDAC enzymes (an enzyme is a protein that in small amounts can speed up a biological reaction). HDAC enzymes play an important role in cell growth and cell death. Giving durvalumab and belinostat may improve the body's ability to fight cancer.

Key Dates

Start date
Jan 14, 2022
Status verified
Jan 2026
Primary completion
Aug 31, 2026
Completion
Feb 29, 2028

Study Design

Enrollment
9 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (durvalumab, belinostat)
    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.

Primary Outcome Measure

Incidence of dose limiting toxicities (DLTs) (Phase 1A Part 1) [ Time Frame: Up to 21 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112-

Find similar trials in Salt Lake City, UT

By research site
Huntsman Cancer Institute/University of Utah· Salt Lake City, UT

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