What side effects are associated with this type of intervention?

Common treatments for bladder cancer, such as PD-L1 inhibitors (e.g., Durvalumab) and BCG therapy, have distinct side effect profiles. PD-L1 inhibitors can cause immune-related adverse events including skin reactions, endocrine disorders, and gastrointestinal issues. BCG therapy often leads to local bladder irritation, urinary symptoms, and occasionally systemic infections. Combining these treatments may heighten the risk of immune-related side effects and local bladder toxicity.

What prior FDA approvals exist?

The FDA has approved several treatments for bladder cancer that are similar to the combination of Durvalumab and BCG. Notably, PD-1/PD-L1 inhibitors such as Pembrolizumab and Atezolizumab have been approved for advanced or metastatic urothelial carcinoma. These drugs work by inhibiting the PD-1/PD-L1 pathway, thereby enhancing the immune system's ability to attack cancer cells. Additionally, Bacillus Calmette-Guérin (BCG) has long been used as an intravesical therapy for non-muscle-invasive bladder cancer, leveraging its immune-stimulating properties to prevent cancer recurrence.

What other types of research exist?

Promising novel alternatives to Durvalumab + BCG for bladder cancer patients include: 1) Pembrolizumab (PD-1 inhibitor) which has shown efficacy in various trials for urothelial carcinoma. 2) Atezolizumab (PD-L1 inhibitor) which has been used in combination with chemotherapy for advanced urothelial carcinoma. 3) Nivolumab (PD-1 inhibitor) either alone or in combination with Ipilimumab (CTLA-4 inhibitor), which has shown benefits in other cancers and is being explored for bladder cancer. 4) Enfortumab Vedotin, an antibody-drug conjugate targeting Nectin-4, which has shown promise in patients who have progressed after PD-1/PD-L1 inhibitors.

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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

Must not have

Any concurrent chemotherapy, study intervention, biologic or hormonal therapy for cancer treatment; uncontrolled intercurrent illness

Evidence of muscle-invasive, locally advanced, metastatic, and/or extra-vesical bladder cancer (ie, T2, T3, T4, and / or Stage IV)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 24 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial tests a combination of durvalumab and BCG in adults with high-risk bladder cancer who haven't had previous treatments. Durvalumab helps the immune system fight cancer, while BCG stimulates an immune response in the bladder. BCG has been used for the treatment of bladder cancer for many years and is considered very effective.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

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My bladder cancer is high-risk but hasn't spread beyond the inner layers.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am eligible for BCG therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently on any cancer treatments and do not have any uncontrolled illnesses.

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My bladder cancer has spread beyond the bladder wall.

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I do not have active infections like hepatitis B, C, or HIV.

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I have or had an autoimmune or inflammatory disorder.

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I have been treated with strong immune-boosting drugs.

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Over half of my tumor is made up of specific rare cancer cell types.

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I need surgery to remove my bladder soon.

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I haven't taken immunosuppressive drugs in the last 14 days.

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I am not pregnant, breastfeeding, and willing to use effective birth control.

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My hypothyroidism is under control with medication.

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I cannot receive BCG treatment due to health reasons.

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I have bladder cancer that has not spread into the muscle.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Grade 3 or 4 Possibly related adverse events (PRAEs)

Secondary study objectives

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 more

Awards & Highlights

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.

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

~3750

0 / 18Eligibility criteria met

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.

Gmcsf and Ifnα 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.