Therapeutic Plasma Exchange With Enfortumab Vedotin and Pembrolizumab for Treatment of Bladder Cancers

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07087860
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Bladder Urothelial Carcinoma
  • Metastatic Renal Pelvis and Ureter Urothelial Carcinoma
  • Refractory Bladder Urothelial Carcinoma
  • Refractory Renal Pelvis and Ureter Urothelial Carcinoma
  • Stage IV Bladder Cancer AJCC v7
  • Stage IV Renal Pelvis and Ureter Cancer AJCC v7

Eligibility Criteria

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

Interventions

  • Best Practice — OTHER
    Receive standard of care
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood and urine samples
  • Central Venous Cannula Insertion — PROCEDURE
    Undergo central line placement
  • Computed Tomography — PROCEDURE
    Undergo CT or PET/CT
  • Enfortumab Vedotin — DRUG
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Plasmapheresis — PROCEDURE
    Undergo TPE
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Antibody-Drug Conjugate Therapy — BIOLOGICAL
    Given IV

Study Details

This phase II trial compares therapeutic plasma exchange followed by enfortumab vedotin and pembrolizumab to standard of care next-line therapy for the treatment of patients with bladder or upper urinary tract cancers that have spread from where they first started (primary site) to other places in the body (metastatic) and that have not responded to previous treatment (refractory). TPE is a process that slowly removes a patient's blood through an intravenous or central line. The blood is sent through a machine that separates the plasma (the liquid part of blood) from other blood components (red cells, white cells, platelets). The plasma is then removed. The remaining blood components are combined with replacement fluid and returned to the patient's bloodstream through the intravenous or central line. 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. Treatment with enfortumab vedotin and pembrolizumab is already approved by the Food and Drug Administration for the treatment of bladder cancer, but TPE is not. Combining TPE with enfortumab vedotin and pembrolizumab may work better than standard of care options for treating metastatic and refractory bladder and urinary tract cancers. This study also evaluates the effect of TPE with standard of care antibody drug conjugates (ADCs) in treating patients with refractory metastatic bladder cancer. ADC therapy is treatment with a monoclonal antibody linked to a chemotherapy drug. It is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, and delivers chemotherapy to kill them. Giving TPE with standard of care ADC therapy may be effective in treating patients with refractory metastatic bladder cancer.

Key Dates

Start date
Aug 1, 2025
Status verified
May 2026
Primary completion
Aug 7, 2028
Completion
Aug 7, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A (TPE, EV, pembrolizumab)
    Patients undergo TPE via venous access or central line on days 1-3 of cycles 1-3 and receive enfortumab vedotin IV over 30 minutes on days 3 and 10 of cycles 1-3 and on days 1 and 8 of cycle 4 and beyond and pembrolizumab IV over 30 minutes on day 3 of cycles 1-3 and day 1 of cycles 4 and beyond. Cycles repeat every 21 days in the absence of disease progression of unacceptable toxicity. Patients also undergo CT, PET/CT, or MRI and collection of blood and urine samples throughout the study. Patients may undergo central line placement prior to TPE.
  • Active Comparator: Group B (standard of care)
    Patients receive physician's choice of standard of care next-line therapy. Patients also undergo CT, PET/CT, or MRI and collection of blood and urine samples throughout the study.
  • Experimental: Cohort C (TPE, ADC)
    Patients undergo TPE via venous access or central line on days 1-3 of cycles 1-3 only and receive physician's choice of standard of care ADC IV on day 3 of cycles 1-3 and on day 1 of cycles 4 and beyond. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT, or MRI and collection of blood and urine samples throughout the study.

Primary Outcome Measure

Overall response rate (ORR) (Groups A and B) [ Time Frame: Up to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Jacob J. Orme, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rochester, MN

By research site
Mayo Clinic in Rochester· Rochester, MN

Related Studies