scholarly journals 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

2021 ◽  
Author(s):  
Andrew Moe ◽  
Elizabeth Liow ◽  
Andrew Redfern ◽  
Nicole Swarbrick ◽  
Tom Ferguson ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Bladder Cancer ◽  
High Risk ◽  
Phase I ◽  
Trial Protocol ◽  
Open Label ◽  
Muscle Invasive Bladder Cancer ◽  
Dose Escalation Study ◽  
Label Dose ◽  
Muscle Invasive

scholarly journals Phase I Clinical Trial of Everolimus Combined with Trimodality Therapy in Patients with Muscle-Invasive Bladder Cancer

2017 ◽  
Vol 3 (2) ◽  
pp. 105-112 ◽  
Author(s):  
Bassel G. Bachir ◽  
Luis Souhami ◽  
Jose João Mansure ◽  
Fabio Cury ◽  
Marie Vanhuyse ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Bladder Cancer ◽  
Phase I ◽  
Phase I Clinical Trial ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
Trimodality Therapy ◽  
Muscle Invasive

scholarly journals Intravesical nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer: a single-arm, open-label, repeat-dose clinical trial

2021 ◽  
Vol 22 (1) ◽  
pp. 107-117 ◽  
Author(s):  
Stephen A Boorjian ◽  
Mehrdad Alemozaffar ◽  
Badrinath R Konety ◽  
Neal D Shore ◽  
Leonard G Gomella ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Gene Therapy ◽  
Bladder Cancer ◽  
Invasive Bladder Cancer ◽  
Repeat Dose ◽  
Open Label ◽  
Muscle Invasive Bladder Cancer ◽  
Muscle Invasive

scholarly journals Protocol for phase I study of pembrolizumab in combination with Bacillus Calmette-Guérin for patients with high-risk non-muscle invasive bladder cancer

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e028287 ◽  
Author(s):  
Marcus L Jamil ◽  
Mustafa Deebajah ◽  
Akshay Sood ◽  
Kathy Robinson ◽  
Krishna Rao ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Phase I ◽  
Radical Cystectomy ◽  
Endoscopic Resection ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
Safety And Efficacy ◽  
Bcg Therapy ◽  
Muscle Invasive

IntroductionThe initial treatment for high-risk non-muscle invasive bladder cancer (NMIBC) is endoscopic resection of the tumour followed by BCG therapy. In those who develop recurrence, the standard treatment is radical cystectomy. Despite the advancement in surgical technique and postoperative care, the degree of morbidity associated with radical cystectomy remains high, therefore less invasive treatment modalities are desirable. Therapies targeting the programmed death (PD) pathway have shown promise in urothelial carcinoma. We undertook the current study to determine the safety and efficacy of administering pembrolizumab (a monoclonal antibody targeting the interaction between PD-1 and its ligand) in combination with BCG in high-risk NMIBC.MethodsThis is a single-centre phase I safety and efficacy study of pembrolizumab used in combination with intravesicular BCG treatment for subjects with pathologically documented high-risk NMIBC despite having received two courses of induction therapy or BCG treatment followed by maintenance BCG. Fifteen subjects will be enrolled, patients will receive treatment with 200 mg of pembrolizumab every 21 days, starting 2 weeks from the initial endoscopic resection and continuing for 6 weeks after the final dose of BCG. The primary objective is to determine the safety of administering pembrolizumab at a fixed dose of 200 mg every 3 weeks in conjunction with intravesicular BCG treatment in patients with high-risk NMIBC who have failed previous treatment. Secondary objectives are to determine the 19 weeks and the 3, 12 and 24 months post-treatment completion complete response rate with combined pembrolizumab and intravesicular BCG therapy in the aforementioned patients.Ethics and disseminationThe study has been approved by the Institutional Review Board of the Henry Ford Hospital. The results of this study will be published in a peer-reviewed journal and presented at a scientific conference.Trial registration numberNCT02324582.

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