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About
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.
Full description
The study includes a dose escalation phase (phase Ib) and an expansion phase (phase IIb).
In the phase Ib, patients will be treated with intravesical N-803 in combination with BCG. The purpose of the phase Ib portion of the study is to evaluate the safety, identify the Maximum Tolerated Dose (MTD) of N-803 and determine the Recommended Dose (RD) level of N-803 in combination with BCG for the phase IIb expansion.
In the phase IIb expansion, patients will be randomized to receive either intravesical N-803 in combination with BCG or BCG alone. Patients will be enrolled into one of two study cohorts (Cohort A and Cohort B). These will be two independent study cohorts, evaluated separately for treatment efficacy.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
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).
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:
Laboratory tests performed within 21 days of treatment start:
Adequate pulmonary function without any clinical sign of severe pulmonary dysfunction. PFT > 50% FEV1 if clinically indicated by the investigator.
Negative serum pregnancy test if female and of childbearing potential (non-childbearing is defined as greater than one year postmenopausal or surgically sterilized).
Female participants of childbearing potential must adhere to using a medically accepted method of birth control prior to screening and agree to continue its use during the study or be surgically sterilized (e.g., hysterectomy or tubal ligation) and males must agree to use barrier methods of birth control while on study.
Provide signed informed consent and HIPPA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations.
Exclusion Criteria
Primary purpose
Allocation
Interventional model
Masking
596 participants in 2 patient groups
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Central trial contact
Atessa H Kiani, BS; Paula Bradshaw, MPH, MBA
Data sourced from clinicaltrials.gov
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