Results of a Phase 1 Dose Escalation Study of Intravesical TMX-101 in Patients with Nonmuscle Invasive Bladder Cancer

Falke, J.; Lammers, Rianne J.M.; Arentsen, H.C.; Ravic, Miroslav; Pozzi, Raffaella; Cornel, Erik B.; Vergunst, H.; Reijke, Theo M. de; Witjes, J. Alfred

doi:10.1016/j.juro.2012.11.150

Cited by 34 publications

(20 citation statements)

References 31 publications

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“…[22] Its administration via intravesical instillation has also been found to be safe and tolerable. [23] In the recently completed phase 2 trial involving patients with carcinoma in situ (CIS), 2 out of 12 patients demonstrated negative cytology and biopsy results at 6 weeks following treatment. [24]…”

Section: Bcg-naïvementioning

confidence: 99%

Current clinical trials in non–muscle invasive bladder cancer

Siddiqui

Grant

Sanford

et al. 2017

Urologic Oncology: Seminars and Original Investigations

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Background The treatment options for non-muscle invasive bladder cancer (NMIBC) remain limited. BCG was the last major breakthrough in bladder cancer therapy almost 4 decades ago. There have been improvements in the understanding of immune therapies and cancer biology, leading to the development of novel agents. This has led to many clinical trials that are currently underway to find the next generation of therapies for NMIBC. Method We reviewed clinicaltrials.org and pubmed.gov to find the recently completed and ongoing clinical trials in NIMBC. Included in this review are clinical trials that are currently active and trials that were completed in and after 2014. Result Many trials with BCG naïve and BCG unresponsive/recurrent/refractory/failure NMIBC patients are either currently underway or have been recently completed. A wide variety of novel therapeutic agents are being investigated that range from cytotoxic agents to immunomodulatory agents to targeted molecular therapies. Other approaches include cancer vaccines, gene therapies, and chemoradiation potentiation agents. Novel drug delivery methods are also being tested. Conclusion This comprehensive update of current trials provides researchers an overview of the current clinical trial landscape for patients with NMIBC.

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Section: Bcg-naïvementioning

confidence: 99%

Current clinical trials in non–muscle invasive bladder cancer

Siddiqui

Grant

Sanford

et al. 2017

Urologic Oncology: Seminars and Original Investigations

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“…139 A multicentre phase 1 study was reported the safeness of TMX-101 (liquid formulation of imiquimod) intravesical administration for NMIBC patients. 140…”

Section: Tlr7 Agonistsmentioning

confidence: 99%

Toll‐like receptors: The role in bladder cancer development, progression and immunotherapy

Moghadam

Nowroozi

2019

Scand J Immunol

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Bladder cancer is one of the leading causes of death worldwide. The main immune mechanisms which lead to bladder cancer development or treatment outcomes have yet to be elucidated. Toll‐like receptors (TLRs) play key roles against cancer. TLRs are expressed both on immune cells and on tumour cells and drive immune responses in progression as well as treatment of cancer. Identification of signalling pathways via TLRs could revolutionize further improvement of therapeutic strategies against cancers in the future. According to the recent studies, TLRs agonists are effective immunostimulants and have important role in induction of immune responses with immunotherapeutic potential against several diseases including cancer. They play an important role in the bladder urothelium as a part of immune defence against uropathogens. On the other hand, decreased TLRs expression was found in bladder tumours, particularly in non‐muscle‐invasive ones. Bacillus Calmette‐Guerin (BCG) (agonist of TLR2 and TLR4) is approved by US FDA for immunotherapy of bladder cancer. Despite high efficiency, immunotherapy with BCG may cause toxicity and adverse effects. Nowadays, in vitro and in vivo studies have been conducted to find alternative options for non‐responder patients. Studies on TLR agonists for bladder cancer treatment have shown promising results. In this review, we discuss recent data about mechanisms played by TLRs in bladder cancer developments as well as therapeutic application of TLR agonists in cancer treatment.

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“…45,46 In the clinical setting, TMX-101, a variant formulation of imiquimod, was tested in a phase 1 trial demonstrating safety in 16 patients. 47 A phase 2 trial (NCT01731652) has been developed. 19 …”

Section: Lenalidomidementioning

confidence: 99%