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Cancer Vaccine
BCG + Durvalumab for Bladder Cancer (PATAPSCO Trial)
Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No prior radiotherapy for bladder cancer
Local histological confirmation of high-risk transitional cell carcinoma of the urothelium of the urinary bladder confined to the mucosa or submucosa. A high-risk tumor is defined as one of the following: T1 tumor; High-grade/G3 tumor; CIS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 24 months
Awards & highlights
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.
Who is the study for?
Adults with high-risk non-muscle-invasive bladder cancer (NMIBC) who haven't had systemic therapy for NMIBC or BCG treatment. Participants must have a life expectancy of at least 12 weeks, good organ and marrow function, and no history of immune-mediated therapy or certain autoimmune disorders. Women can't be pregnant or breastfeeding, and all participants must use effective birth control.Check my eligibility
What is being tested?
The trial is testing the combination of Durvalumab (an immunotherapy drug) with BCG (a type of intravesical therapy) to see if it's safe and works well in treating adults with high-risk NMIBC who are new to this kind of treatment.See study design
What are the potential side effects?
Durvalumab may cause immune-related side effects like inflammation in various organs, skin reactions, hormonal gland problems, infusion-related reactions; while BCG can lead to symptoms such as fever, urinary issues, fatigue and possible risk of infection.
PATAPSCO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not had radiation treatment for bladder cancer.
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My bladder cancer is high-risk but hasn't spread beyond the inner layers.
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I have never received immunotherapy for my cancer.
Select...
My bladder cancer is high-risk but hasn't spread beyond the inner layers.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I am eligible for BCG therapy.
PATAPSCO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 12 months and 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months and 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Grade 3 or 4 Possibly related adverse events (PRAEs)
Secondary outcome measures
Best overall response for HRQoL as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Non-Muscle-Invasive Bladder Cancer 24 (EORTC QLQ-NMIBC24)
Best overall response for health-related quality of life (HRQoL) as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (EORTC QLQ-C30)
Complete response rate (CRR)
+4 morePATAPSCO Trial Design
1Treatment groups
Experimental Treatment
Group I: Durvalumab + BCGExperimental Treatment2 Interventions
Participants will receive Durvalumab for 13 cycles every 4 weeks (q4w) for a maximum 12 months. All participants will receive BCG (supplied by the site) intravesically, as induction weekly for 6 weeks. Patients will subsequently receive BCG for maintenance for 3 weekly doses at 3,6,12,18, and up to 24 months, at the physician's discretion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BCG
2015
Completed Phase 4
~3220
Durvalumab
2017
Completed Phase 2
~3840
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for bladder cancer, such as Durvalumab and BCG, work by enhancing the body's immune response against cancer cells. Durvalumab, a PD-L1 inhibitor, blocks the interaction between PD-L1 on tumor cells and PD-1 on T-cells, boosting the immune system's ability to attack the cancer.
BCG therapy involves instilling a live, attenuated strain of Mycobacterium bovis into the bladder, which stimulates a local immune response targeting the cancer cells. Combining these treatments can enhance both systemic and local immune responses, potentially improving treatment efficacy and reducing tumor recurrence for bladder cancer patients.
<i>Gmcsf</i> and <i>Ifnα</i> gene therapy improves the response to BCG immunotherapy in a murine model of bladder cancer.A phase I open label dose-escalation study to evaluate the tolerability, safety and immunological efficacy of sub-urothelial durvalumab injection in adults with muscle-invasive or high-risk non-muscle-invasive bladder cancer (SUBDUE-1, SUB-urothelial DUrvalumab injection-1 study): clinical trial protocol.Durvalumab in cancer medicine: a comprehensive review.
<i>Gmcsf</i> and <i>Ifnα</i> gene therapy improves the response to BCG immunotherapy in a murine model of bladder cancer.A phase I open label dose-escalation study to evaluate the tolerability, safety and immunological efficacy of sub-urothelial durvalumab injection in adults with muscle-invasive or high-risk non-muscle-invasive bladder cancer (SUBDUE-1, SUB-urothelial DUrvalumab injection-1 study): clinical trial protocol.Durvalumab in cancer medicine: a comprehensive review.
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Who is running the clinical trial?
ParexelIndustry Sponsor
305 Previous Clinical Trials
100,989 Total Patients Enrolled
AstraZenecaLead Sponsor
4,293 Previous Clinical Trials
288,620,296 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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).
Research Study Groups:
This trial has the following groups:- Group 1: Durvalumab + BCG
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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.
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