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Study Summary
This trial is testing a new treatment for patients with NMIBC who have failed BCG therapy or who are BCG-naïve. The trial has two phases: a dose-escalation phase to establish safety and a Phase 2 efficacy study. Eligible patients will be enrolled in either Phase 1 or Phase 2.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I have had issues with urine flowing backward or needed a tube in my urinary tract that hasn't been resolved.I haven't had cancer treatment or experimental drugs in the last 30 days (or 3 months for certain drugs).I was treated with a checkpoint inhibitor and it didn't work, but it's been 30 days (Phase 1) or 3 months (Phase 2) since then.I have ongoing kidney swelling due to a blockage in my urinary tract.I do not have any ongoing serious infections requiring treatment.I have HIV, Hepatitis B, or Hepatitis C.I have had part of my bladder surgically removed.I have had lung inflammation or disease after treatment with PD-1 or PD-L1 inhibitors.I have a history of bladder pain syndrome.My biopsy for a small tumor was thorough and included the muscle layer.I can take care of myself but may not be able to do heavy physical work.I am an adult over 18 and not pregnant or breastfeeding.I have had radiation to my pelvis or seed implant radiation to my prostate in the last year.I have ongoing kidney problems.My cancer has spread to other parts of my body.I have not been diagnosed with any cancer other than skin or noninvasive cervical cancer in the past year.I am currently not on any chemotherapy treatments.I have not taken pembrolizumab in the last 30 days (Phase 1) or 3 months (Phase 2).I have had a recent heart attack or coronary stenting.I have bladder cancer that hasn't responded to BCG treatment and I can't or won't have bladder removal surgery.I have bladder cancer, haven't had much BCG treatment, and can't or won't have surgery.My blood counts meet the required levels for treatment.
- Group 1: Phase 2
- Group 2: Phase 1
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Can people with the relevant medical condition participate in this trial now?
"Yes, this clinical trial is still recruiting patients. The most recent update on the progress of the trial was posted on 5/11/2022, and recruitment began on 4/22/2021."
How many people can potentially enroll in this research project?
"That is accurate. The clinical trial, which was first announced on April 22nd 2021, is still recruiting patients as of May 11th 2022. They are looking for a total of 222 people to participate at 8 different locations."
What are the primary goals of this clinical trial?
"The primary goal of this study, which will last approximately 48 weeks, is to Phase 1: Nature, incidence, relatedness, and severity of all AEs and SAEs according to the CTCAE v5.0.. Additionally, researchers are looking at secondary outcomes including Phase 2: Progression-free survival (PFS), Phase 1: The number of patients who experience a DLT through the end of Cycle 1 , andPhase 2: Duration of response of the responding patients."
Are there different research hospitals participating in this clinical trial across Canada?
"In addition to Laura & Isaac Perlmutter Cancer Center at NYU Langone Health in New york, this trial is also running out of New jersey Urology, LLC in Voorhees and UT Southwestern Medical Center in Dallas. There are a total of 8 different locations for this study."
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