Enfortumab Vedotin, Pembrolizumab and Quemliclustat for the Treatment of Unresectable Locally Advanced and Metastatic Urothelial Cancer

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT07667335
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Locally Advanced Bladder Urothelial Carcinoma
  • Locally Advanced Renal Pelvis Urothelial Carcinoma
  • Locally Advanced Ureter Urothelial Carcinoma
  • Metastatic Bladder Giant Cell Urothelial Carcinoma
  • Metastatic Renal Pelvis Urothelial Carcinoma
  • Metastatic Ureter Urothelial Carcinoma
  • Stage IIIB Bladder Cancer AJCC v8
  • Stage IV Bladder Cancer AJCC v8
  • Stage IV Renal Pelvis Cancer AJCC v8
  • Stage IV Ureter Cancer AJCC v8
  • Unresectable Bladder Urothelial Carcinoma
  • Unresectable Renal Pelvis Urothelial Carcinoma
  • Unresectable Ureter Urothelial Carcinoma

Eligibility Criteria

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

Interventions

  • Quemliclustat — DRUG
    Given IV
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Enfortumab Vedotin — DRUG
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Biopsy Procedure — PROCEDURE
    Undergo tumor biopsy

Study Details

This phase Ib/II trial tests the safety, side effects, and best dose of quemliclustat in combination with enfortumab vedotin and pembrolizumab, and to see how well the combination works for the treatment of bladder, renal pelvis, or ureter urothelial cancer that cannot be removed by surgery (unresectable), that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of cancer cells. Enfortumab attaches to a protein called nectin-4 on cancer cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Quemliclustat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving quemliclustat in combination with enfortumab vedotin and pembrolizumab and may be safe, tolerable and/or effective in treating patients with unresectable locally advanced and metastatic urothelial cancer.

Key Dates

Start date
Dec 1, 2026
Status verified
Jun 2026
Primary completion
Jul 16, 2029
Completion
Jul 16, 2029

Study Design

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

Arms

  • Experimental: Treatment (enfortumab vedotin, pembrolizumab, quemliclustat)
    Patients receive quemliclustat IV on day 1, enfortumab vedotin IV on days 1 and 8 and pembrolizumab IV on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients may undergo tumor biopsy during screening and optionally undergo throughout the study. Patients also undergo CT/MRI and blood sample collection throughout the study.

Primary Outcome Measure

Incidence of treatment related adverse events (Phase Ib) [ Time Frame: From baseline, up to 21 days after last dose of investigational product ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Rosa Nadal Rios, MD, PhD
[email protected]
206-598-3300
Rosa Nadal Rios, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Seattle, WA

By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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