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BCG + Durvalumab for Bladder Cancer (PATAPSCO Trial)
PATAPSCO Trial Summary
This trial assesses the safety, tolerability, and efficacy of a new therapy for adults with bladder cancer who have not been treated yet.
PATAPSCO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPATAPSCO Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PATAPSCO Trial Design
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Who is running the clinical trial?
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- I have not had radiation treatment for bladder cancer.I had surgery to remove all visible bladder cancer less than 4 months ago.I am not currently on any cancer treatments and do not have any uncontrolled illnesses.My bladder cancer has spread beyond the bladder wall.I do not have active infections like hepatitis B, C, or HIV.I have or had an autoimmune or inflammatory disorder.I have been treated with strong immune-boosting drugs.I need surgery to remove my bladder soon.My bladder cancer is high-risk but hasn't spread beyond the inner layers.I haven't taken immunosuppressive drugs in the last 14 days.I am not pregnant, breastfeeding, and willing to use effective birth control.My bladder cancer is high-risk but hasn't spread beyond the inner layers.I am fully active or restricted in physically strenuous activity but can do light work.I have never received immunotherapy for my cancer.I have never had BCG therapy or stopped it over 3 years ago.Over half of my tumor is made up of specific rare cancer cell types.You have received an organ or stem cell transplant from someone else.My hypothyroidism is under control with medication.My bladder cancer has spread to lymph or blood vessels, but BCG is the only treatment option for me.I had cancer before, but it was treated, and I've been cancer-free for over 2 years, or it was a minor skin cancer or early-stage prostate cancer without worsening.I am eligible for BCG therapy.My organs and bone marrow are working well.You have a history of a current immune system disorder.I cannot receive BCG treatment due to health reasons.I have bladder cancer that has not spread into the muscle.You are expected to live for at least 12 weeks (90 days).
- Group 1: Durvalumab + BCG
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Are individuals above the age of thirty five eligible to partake in this research study?
"Per the requirements of this trial, individuals aged 18 to 130 can apply. Additionally, 10 studies for younger participants and 315 for those over 65 are available."
Has the combination of Durvalumab + BCG been given sanction by the FDA?
"Our team at Power assigned durvalumab + BCG a score of 3 since it has reached Phase 3 and there are numerous clinical indications that both its safety and efficacy have been established."
Is enrollment for this investigation still open?
"Correct. The clinical trial's information on ClinicalTrials.gov shows that it is currently enrolling, having been posted on the 11th of August 2023 and most recently updated on 23rd of August. This investigation seeks to recruit 100 individuals from 13 different centres."
How many facilities are engaged in this trial's proceedings?
"At this time, prospective participants may enroll in the clinical trial at 13 different sites. These include Conway, San Diego and Greenwood as well as other locations; thus, it is recommended to choose a nearby site to abate any travelling necessities."
How many individuals have enrolled in this research project?
"Indeed, clinicaltrials.gov displays that this medical trial is presently recruiting participants. This study was first published on August 11th 2023 and has been recently updated on the 23rd of the same month. Approximately 100 volunteers are needed from 13 different locations to complete this research project."
Who would be an appropriate candidate for participation in this experiment?
"This trial is seeking 100 individuals between 18 and 130 years old who have been diagnosed with bladder cancer, provided that they satisfy further demands. Candidates must be BCG-naive, possess a confirmed histological report of high risk transitional cell carcinoma limited to the mucosa or submucosa; undergone complete resection of all Ta/T1 papillary disease prior to enrollment (with TURBT not more than 4 months before enrollment); never had radiotherapy for their condition; have at least 12 weeks life expectancy as well as adequate organ and marrow function; hold a World Health Organization/Eastern Cooperative Oncology Group performance status"
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