A Randomized Phase III Study to Investigate the Efficacy and Safety of Alpha1H as a Neoadjuvant Therapy in Participants with Low- to Intermediate-Risk/Low-Grade Papillary Non-Muscle Invasive Bladder Cancer

Conditions

Non-Muscle Invasive Papillary Bladder Cancer

Brief summary

Event-Free Survival is defined as the time from randomization to the earliest occurrence of: i) Recurrence of NMIBC (any grade or stage), ii) Progression to muscle-invasive bladder cancer (MIBC), iii) Development of metastatic bladder cancer, iv) Death from any cause

Detailed description

CR rate in the Alpha1H arm compared to SOC., Overall Survival in Alpha1H arm compared to SOC., Tumor response to Alpha1H based on change in tumor size, cell numbers in urine, properties of shed tumor cells and induction of apoptosis., Tumor response defined by cancer-related gene expression in tissue samples and urine RNA., Protein biomarkers/immune response to Alpha1H in the urine of patients pre- and post-Alpha1H treatment., Correlation between tumor cell shedding and recurrence or CR failure in study population., Tissue accumulation of Alpha1H., Safety and tolerability of Alpha1H., Incidence and severity of treatment-emergent adverse events (AEs) and complications attributable to intravesical instillation of Alpha 1H (dysuria, urinary frequency/urgency, urinary retention, hematuria)., Quality of Life (QOL) changes based on Patient-Reported-Outcomes (QLQ-NMIBC24]) from baseline to follow-up visit.

Related papers

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Interventions

DRUGalpha 1H

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Event-Free Survival is defined as the time from randomization to the earliest occurrence of: i) Recurrence of NMIBC (any grade or stage), ii) Progression to muscle-invasive bladder cancer (MIBC), iii) Development of metastatic bladder cancer, iv) Death from any cause	—

Secondary

Measure	Time frame
CR rate in the Alpha1H arm compared to SOC., Overall Survival in Alpha1H arm compared to SOC., Tumor response to Alpha1H based on change in tumor size, cell numbers in urine, properties of shed tumor cells and induction of apoptosis., Tumor response defined by cancer-related gene expression in tissue samples and urine RNA., Protein biomarkers/immune response to Alpha1H in the urine of patients pre- and post-Alpha1H treatment., Correlation between tumor cell shedding and recurrence or CR failure in study population., Tissue accumulation of Alpha1H., Safety and tolerability of Alpha1H., Incidence and severity of treatment-emergent adverse events (AEs) and complications attributable to intravesical instillation of Alpha 1H (dysuria, urinary frequency/urgency, urinary retention, hematuria)., Quality of Life (QOL) changes based on Patient-Reported-Outcomes (QLQ-NMIBC24]) from baseline to follow-up visit.	—

Measure

Time frame

CR rate in the Alpha1H arm compared to SOC., Overall Survival in Alpha1H arm compared to SOC., Tumor response to Alpha1H based on change in tumor size, cell numbers in urine, properties of shed tumor cells and induction of apoptosis., Tumor response defined by cancer-related gene expression in tissue samples and urine RNA., Protein biomarkers/immune response to Alpha1H in the urine of patients pre- and post-Alpha1H treatment., Correlation between tumor cell shedding and recurrence or CR failure in study population., Tissue accumulation of Alpha1H., Safety and tolerability of Alpha1H., Incidence and severity of treatment-emergent adverse events (AEs) and complications attributable to intravesical instillation of Alpha 1H (dysuria, urinary frequency/urgency, urinary retention, hematuria)., Quality of Life (QOL) changes based on Patient-Reported-Outcomes (QLQ-NMIBC24]) from baseline to follow-up visit.

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Outcome results

None listed