A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Blad… (NCT02138734) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer
United States369 participantsStarted 2014-07-21
Plain-language summary
This is a Phase Ib/IIb, randomized, two-cohort, open-label, multicenter study of intravesical N-803 plus BCG versus BCG alone, in BCG naïve patients with high-grade NMIBC.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell carcinoma high-grade subtype (mixed histology tumors allowed if transitional cell histology is predominant histology).
✓. Cohort A: Histologically confirmed CIS (with or without Ta/T1 disease); Cohort B: Histologically confirmed high-grade papillary disease (Ta/T1 only).
✓. Patients are eligible if the diagnostic biopsy was done within 3 months of treatment start and a cystoscopy demonstrating no resectable disease was done within 6 calendar weeks (inclusive of 48 days) of treatment start (residual CIS is acceptable; patients with T1 disease must undergo repeat resection if muscularis propria is not present in each biopsy sample). Patients with high-grade Ta and/or T1 disease should have complete resection before study treatment.
✓. Upper tract imaging within 6 months prior to study entry must not be suspicious for upper tract malignancy.
✓. Currently eligible for intravesical BCG therapy.
✓. Age ≥ 18 years.
✓. Performance status: ECOG performance status of 0, 1, or 2.
✓. BCG-naive disease as defined as either of the following:
Exclusion criteria
✕. Prior BCG treatment or known hypersensitivity to BCG. Patients who have received more than a single-dose post-operative treatment of mitomycin-C or gemcitabine following the most recent screening TURBT/biopsy are excluded.
✕. Concurrent use of other investigational agents (not including FDA-authorized drugs for the prevention and treatment of COVID-19).
✕. History of or evidence of muscle-invasive, locally advanced, metastatic and/or extravesical bladder cancer or any other cancer within the past 5 years, except: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage 1 or 2 cancer from which the patient is currently in complete remission, or stable prostate cancer (under active surveillance or hormone control).
✕. Symptomatic congestive heart failure (CHF), NYHA (New York Heart Association) Class III or IV or other clinical signs of severe cardiac dysfunction.
✕. Severe/unstable angina pectoris, or myocardial infarction within 6 months prior to study entry.
✕. History or evidence of uncontrollable CNS disease.
✕. Known HIV-positive.
✕. Active systemic infection requiring parenteral antibiotic therapy. All prior infections must have resolved following optimal therapy.