Durvalumab and Vicineum in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG)

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03258593
Phase
PHASE1
Status
Completed

Conditions

  • Urinary Bladder Neoplasms

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Durvalumab 1500 mg is administered intravenously (IV) once every 4 weeks for 12 months with an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade NMIBC (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost.
  • Vicineum — DRUG
    Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.
  • Acetaminophen — DRUG
    Acetaminophen or equivalent medications per institutional standard may be administered at the discretion of the investigator.
  • Antihistamine — DRUG
    Antihistamine (e.g., diphenhydramine) or equivalent medications per institutional standard may be administered at the discretion of the investigator.
  • Bladder Biopsy — PROCEDURE
    Bladder biopsy at screening and every 3 months before each cystoscopy per schema.
  • TURBT — PROCEDURE
    Transurethral resection of a bladder tumor (TURBT) at screening and every 3 months before each cystoscopy per schema.
  • Cystoscopy — PROCEDURE
    Urine cytology at screening and every 3 months before each cystoscopy per schema.
  • Urine cytology — DIAGNOSTIC_TEST
    Urine cytology at baseline and every 3 months before each cystoscopy per schema.
  • Electrocardiogram — DIAGNOSTIC_TEST
    Electrocardiogram (ECG) at screening, pre-durvalumb infusion and as clinically indicated during the trial.
  • CT — DIAGNOSTIC_TEST
    Computed tomography (CT) at screening and every 12 months while on study.
  • MRI — DIAGNOSTIC_TEST
    Magnetic resonance imaging (MRI) at screening and every 12 months while on study.

Study Details

Background: Non-muscle-invasive bladder cancer is in the early stages. But it usually comes back after treatment. The drugs Vicineum and Durvalumab may help the immune system find and destroy cancer cells. Objective: To test if the drugs Durvalumab and Vicineum together are safe and effective to treat people with bladder cancer that has not spread to the muscle in the bladder. Eligibility: People ages 18 and older who have bladder cancer that has not spread to the muscle in the bladder and was treated unsuccessfully with Bacillus Calmette-Guerin Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Tumor sample from previous surgery. If one is not available, they will have a biopsy: A small piece of tumor is removed. Cystoscopy to examine the inside of the bladder. This may include a biopsy or removing tumors. Computed tomography (CT) or magnetic resonance imaging (MRI): They lie in a machine that takes pictures of the body. Electrocardiogram to test heart function Participants will receive Durvalumab and Vicineum in 2 phases: First phase: Durvalumab every 4 weeks and Vicineum once a week for 3 months Second phase: Durvalumab every 4 weeks and Vicineum once every other week Participants will have tumor samples taken every 3 months. They will have blood and urine tests throughout the study. Participants will continue treatment for up to 2 years. Participants will have a visit about 30 days after their last treatment. This includes blood and urine tests. It may include a cytoscopy or additional biopsies.

Key Dates

Start date
Jun 7, 2018
Status verified
Feb 2026
Primary completion
Aug 1, 2022
Completion
Oct 17, 2022

Study Design

Enrollment
15 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg
    Durvalumab + Vicineum, escalating doses. Up to 2 dose levels will be evaluated in the first 6 - 12 participants.
  • Experimental: Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg
    Durvalumab + Vicineum, at the maximum tolerated dose (MTD). Up to 24 participants.
  • Experimental: Level 1, Durvalumab 1500mg intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 20 mg
    Level 1, Durvalumab 1500mg intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 20 mg
  • Experimental: Arm 2, Durvalumab + Vicineum at the Maximum Tolerated Dose (MTD)
    Arm 2, Durvalumab + Vicineum at the Maximum Tolerated Dose (MTD)

Primary Outcome Measure

Number of Grades 1-5 Adverse Events [ Time Frame: Through study completion, an average of 315 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

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