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A phase II clinical trial of neoadjuvant sasanlimab and stereotactic body radiation therapy as an in situ vaccine for cisplatin-ineligible MIBC: the RAD VACCINE MIBC trial.
Satkunasivam, Raj; Lim, Kelvin; Teh, Bin S; Guzman, Jonathan; Zhang, Jun; Farach, Andrew; Chen, Shu-Hsia; Wallis, Christopher Jd; Efstathiou, Eleni; Esnaola, Nestor F; Sonpavde, Guru P.
Afiliação
  • Satkunasivam R; Center for Outcomes Research, Houston Methodist Hospital, Houston, TX 77030, USA.
  • Lim K; Department of Urology, Houston Methodist Hospital, Houston, TX 77030, USA.
  • Teh BS; Department of Urology, Houston Methodist Hospital, Houston, TX 77030, USA.
  • Guzman J; Department of Radiation Oncology, Houston Methodist Hospital, Houston, TX 77030, USA.
  • Zhang J; Department of Urology, Houston Methodist Hospital, Houston, TX 77030, USA.
  • Farach A; Department of Urology, Lenox Hill Hospital, New York, NY 10075, USA.
  • Chen SH; Department of Medical Oncology, Houston Methodist Cancer Center, Houston, TX 77030, USA.
  • Wallis CJ; Department of Radiation Oncology, Houston Methodist Hospital, Houston, TX 77030, USA.
  • Efstathiou E; Center for Immunotherapy Research, Houston Methodist Research Institute, Houston, TX 77030, USA.
  • Esnaola NF; Division of Urology, University of Toronto, Toronto, ON M5G 1E2, Canada.
  • Sonpavde GP; Division of Urology, Mount Sinai Hospital, Toronto, ON M5G 1X5, Canada.
Future Oncol ; 18(25): 2771-2781, 2022 Aug.
Article em En | MEDLINE | ID: mdl-35703113
RAD VACCINE MIBC is a phase II clinical trial that aims to determine the safety and effectiveness of a study drug called sasanlimab (an immune checkpoint inhibitor), combined with radiation therapy (stereotactic body radiation therapy) prior to surgery to remove the bladder (known as radical cystectomy [RC]) in muscle-invasive bladder cancer patients. For this type of cancer, patients typically receive chemotherapy followed by RC as the standard of care. However, many patients who have pre-existing medical conditions such as poor kidney function are unable to receive chemotherapy. These patients undergo RC alone at the risk of less optimal cancer control. Bladder cancer is known to inhibit the immune cells (T cells) from attacking it, which is an important way in which the body controls cancer cells. Sasanlimab allows T cells that are specific to the cancer to potentially reactivate. Ongoing studies have shown that drugs similar to sasanlimab can be used to achieve improvement in cancer control in the bladder (as measured by shrinking the cancer or eradicating it) before surgery. The authors are studying the use of the study drug with the addition of stereotactic body radiotherapy (SBRT) as a combined therapy. The role of SBRT as a combined therapy to immune checkpoint inhibition has been well studied to help improve the process of how immune cells recognize cancer cells. By giving both the study drug and SBRT together before RC, the authors aim to demonstrate the safety of this technique and its effectiveness in eradicating all cancer in the bladder. Clinical Trial Registration: NCT05241340 (ClinicalTrials.gov).
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials Limite: Humans Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials Limite: Humans Idioma: En Ano de publicação: 2022 Tipo de documento: Article