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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
EU CTIS ID: 2026-525531-16-00
What this study is testing
The primary objective is to determine whether neoadjuvant intravesical Alpha1H administered prior to standard TURBT-based management improves Event-Free Survival (EFS) compared with standard TURBT-based management alone in patients with low- to intermediate-risk NMIBC.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed and dated informed consent.
- Patient with low- to intermediate-risk (in low and intermediate risk subgroup according to IBCG subclassification) non-muscle invasive papillary bladder cancer (NMIBC).
- Male and female subjects, 18 years or older.
- Negative pregnancy test in women of childbearing potential.
- Women of childbearing potential must agree to use appropriate highly effective methods of contraception during the study in compliance with the protocol requirements; fertile men must refrain from donating sperm.
- Patients should be able to keep the content of the bladder for two hours.
You likely can't join if
- Patient with non-papillary tumor appearance at the time of initial cystoscopy
- WHO performance status 3 or 4.
- Any other investigational agent or non-marketed product within one month prior to Visit 1 and during the trial.
- Known active HIV infection, defined as detectable HIV viral load at screening.
- Active hepatitis B virus (HBV) infection, defined as hepatitis B surface antigen (HBsAg) positivity with detectable HBV DNA at screening.
- Active hepatitis C virus (HCV) infection, defined as anti-HCV antibody positivity with detectable HCV RNA at screening in a patient not on stable antiviral treatment.
See the full eligibility criteria
- Signed and dated informed consent.
- Patient with low- to intermediate-risk (in low and intermediate risk subgroup according to IBCG subclassification) non-muscle invasive papillary bladder cancer (NMIBC).
- Male and female subjects, 18 years or older.
- Negative pregnancy test in women of childbearing potential.
- Women of childbearing potential must agree to use appropriate highly effective methods of contraception during the study in compliance with the protocol requirements; fertile men must refrain from donating sperm.
- Patients should be able to keep the content of the bladder for two hours.
- Patient with non-papillary tumor appearance at the time of initial cystoscopy
- WHO performance status 3 or 4.
- Any other investigational agent or non-marketed product within one month prior to Visit 1 and during the trial.
- Known active HIV infection, defined as detectable HIV viral load at screening.
- Active hepatitis B virus (HBV) infection, defined as hepatitis B surface antigen (HBsAg) positivity with detectable HBV DNA at screening.
- Active hepatitis C virus (HCV) infection, defined as anti-HCV antibody positivity with detectable HCV RNA at screening in a patient not on stable antiviral treatment.
- Any concurrent illness that may render a participant ineligible or limit compliance with study requirements.
- Previously enrolled in this trial.
- Previous history of T1 or high-grade disease in recurrent tumors.
- Patient with T1 or high-grade non-muscle invasive papillary bladder cancer (NMIBC).
- Previous intravesical BCG immunotherapy.
- Participants with any other cancer diagnosis within the last 5 years (except for skin basalioma).
- Acute urinary tract infection requiring antibiotic treatment.
- Prior radiotherapy or systemic chemotherapy.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.