BCG + Durvalumab for Bladder Cancer
(PATAPSCO Trial)
Recruiting in Palo Alto (17 mi)
+20 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: AstraZeneca
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?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.
Do I need to stop my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use immunosuppressive medication within 14 days before the first dose of durvalumab, and you cannot have any concurrent chemotherapy, biologic, or hormonal therapy for cancer treatment.
What data supports the idea that BCG + Durvalumab for Bladder Cancer is an effective treatment?
The available research does not provide direct data on the effectiveness of BCG combined with Durvalumab for bladder cancer. However, it does highlight the effectiveness of BCG alone as a treatment for high-grade non-muscle-invasive bladder cancer, with a substantial cure rate in selected patients. Additionally, a study on Durvalumab alone shows promise for treating BCG-unresponsive bladder cancer. While these studies suggest that both BCG and Durvalumab have potential benefits individually, there is no specific data provided on their combined use for bladder cancer in the available research.
12345What safety data is available for BCG and Durvalumab treatment in bladder cancer?
The safety data for BCG and Durvalumab treatment in bladder cancer includes studies on adverse drug reactions from BCG instillation, safety and efficacy of Durvalumab in BCG-unresponsive bladder cancer, and adverse reactions during BCG maintenance therapy. Additionally, a systematic review protocol aims to assess the safety of BCG for bladder cancer, and a Phase I trial evaluated the safety of BCG combined with pembrolizumab, which is another immune checkpoint inhibitor similar to Durvalumab.
15678Is the treatment BCG and Durvalumab a promising treatment for bladder cancer?
Yes, BCG and Durvalumab show promise as a treatment for bladder cancer. BCG is a well-known treatment that helps the immune system fight cancer cells in the bladder. Durvalumab, a type of drug called an immune checkpoint inhibitor, helps the immune system attack cancer more effectively. Together, they could improve the body's ability to control and fight bladder cancer.
358910Eligibility Criteria
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.Inclusion Criteria
I have not had radiation treatment for bladder cancer.
I had surgery to remove all visible bladder cancer less than 4 months ago.
My bladder cancer is high-risk but hasn't spread beyond the inner layers.
+7 more
Exclusion Criteria
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.
+13 more
Participant Groups
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.
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.
BCG is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Bacillus Calmette-Guérin for:
- Non-muscle invasive bladder cancer
🇪🇺 Approved in European Union as Bacillus Calmette-Guérin for:
- Non-muscle invasive bladder cancer
🇨🇦 Approved in Canada as Bacillus Calmette-Guérin for:
- Non-muscle invasive bladder cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Research SiteSyracuse, NY
Research SiteLittle Rock, AR
Research SiteHanover, MD
Research SiteJacksonville, FL
More Trial Locations
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Who Is Running the Clinical Trial?
AstraZenecaLead Sponsor
ParexelIndustry Sponsor
References
Phase I trial of intravesical Bacillus Calmette-Guérin combined with intravenous pembrolizumab in recurrent or persistent high-grade non-muscle-invasive bladder cancer after previous Bacillus Calmette-Guérin treatment. [2022]We conducted the first phase I dose-escalation trial (NCT02324582) of intravesical Bacillus Calmette-Guérin (BCG) in combination with systemic pembrolizumab in patients with high-grade non-muscle-invasive bladder cancer (HGNMIBC) who had persistent or recurrent disease after prior intravesical therapy with BCG. The primary endpoint was the safety of this combination. The secondary endpoint was clinical activity at three months following BCG treatment.
Immunotherapeutic strategies for high-risk bladder cancer. [2018]Transitional cell carcinoma (TCC), which is the pathological diagnosis for the majority of bladder cancers, is a solid tumor entity that is responsive to immunotherapy as evidenced by a substantial cure rate documented with the use of intravesical bacillus Calmette-Guérin (BCG) therapy in selected patients with high-grade superficial disease. The nonspecific immune modulation that occurs as a result of BCG therapy is not well understood; however, the success of BCG therapy provides a basis for the exploration of mechanisms related to immune responses and the development of novel immunotherapeutic agents for the treatment of high-risk disease. In this review, we discuss the complexity of the immune system and therapies that are considered capable of manipulating it to potentially benefit patients with bladder cancer.
Intravesical bacillus Calmette-Guerin (BCG) in treating non-muscle invasive bladder cancer-analysis of adverse effects and effectiveness of two strains of BCG (Danish 1331 and Moscow-I). [2022]To compare the differences in adverse effects and efficacy profile between bacillus Calmette-Guerin (BCG) Danish 1331 and BCG Moscow-I strain in management of non-muscle invasive bladder cancer.
Lenalidomide augments the efficacy of bacillus Calmette-Guerin (BCG) immunotherapy in vivo. [2022]Intravesical bacillus Calmette-Guerin (BCG) is the gold standard for high-grade non-muscle-invasive bladder cancer (NMIBC); however, some patients do not respond to initial therapy while others relapse and/or progress. Therefore, combination strategies that can enhance the efficacy and sustainability of BCG are needed. Herein, we explore the efficacy of lenalidomide, a thalidomide derivative with immunomodulatory effects, in combination with BCG, both in vitro and in vivo.
A Phase II Study of Durvalumab for Bacillus Calmette-Guerin (BCG) Unresponsive Urothelial Carcinoma In Situ of the Bladder. [2023]Immune checkpoint blockade holds promise for treating bacillus Calmette-Guerin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC). In this phase II study, we investigated the safety and efficacy of durvalumab, a human IgG1 monoclonal antibody, against BCG-unresponsive carcinoma in situ (CIS).
Adverse reactions related to treatment compliance during BCG maintenance therapy for non-muscle-invasive bladder cancer. [2013]The aim of the study was to investigate the factor of adverse reactions related to compliance with Mycobacterium bovis bacillus Calmette-Guérin maintenance therapy in patients with high-risk non-muscle-invasive bladder cancer.
Adverse drug reactions of intravesical bacillus Calmette-Guerin instillation and risk factors of the development of adverse drug reactions in superficial cancer and carcinoma in situ of the bladder. [2006]We examined the incidence and severity of adverse drug reactions following intravesical bacillus Calmette-Guerin (BCG) instillation for superficial bladder cancer including carcinoma in situ. We investigated the relationship between adverse drug reactions and patient background to clarify risk factors for the development of adverse drug reactions.
Efficacy and safety of Bacillus Calmette-Guerin for bladder cancer: A protocol of systematic review. [2023]This study will systematically assess the efficacy and safety of Bacillus Calmette-Guerin (BCG) for patients with bladder cancer (BC).
High grade superficial (G3t1) transitional cell carcinoma of the bladder treated with intravesical Bacillus Calmette-Guerin (BCG). [2006]Immunotherapy with Bacillus Calmette Guerin (BCG) has been widely used recently as primary option for treatment of high grade superficial (G3T1) carcinoma of the bladder. We describe our long term experience of therapy of G3T1 bladder cancer.
Novel sequential treatment strategy for patients with muscle-invasive bladder cancer (MIBC): intravesical recombinant BCG, followed by neoadjuvant chemoimmunotherapy, radical cystectomy plus pelvic lymphadenectomy and adjuvant immunotherapy - protocol of a multicentre, single arm phase 2 trial (SAKK 06/19). [2023]The combination of checkpoint inhibition and cisplatin-based chemotherapy is investigated in muscle invasive bladder cancer (MIBC) and results from phase 2 trials have been presented. Intravesical BCG has been used for non-MIBC (NMIBC) in patients with carcinoma in situ and high-grade Ta/T1 tumours. BCG induces innate and adapted immune response and upregulation of PD-L1 in preclinical models. The proposed trial is intended to implement a new immuno-immuno-chemotherapy induction therapy for MIBC. The combination of BCG and checkpoint inhibition with chemotherapy aims at higher intravesical responses and better local and systemic control of disease.