Academic Journal
A non-inferiority randomized phase III trial of standard immunotherapy by checkpoint inhibitors vs. reduced dose intensity in responding patients with metastatic cancer: the MOIO protocol study
| العنوان: | A non-inferiority randomized phase III trial of standard immunotherapy by checkpoint inhibitors vs. reduced dose intensity in responding patients with metastatic cancer: the MOIO protocol study |
|---|---|
| المؤلفون: | Gwenaelle Gravis, Patricia Marino, Daniel Olive, Frederique Penault-LLorca, Jean-Pierre Delord, Clotilde Simon, Assia Lamrani-Ghaouti, Renaud Sabatier, Joseph Ciccolini, Jean-Marie Boher |
| المصدر: | BMC Cancer, Vol 23, Iss 1, Pp 1-10 (2023) |
| بيانات النشر: | BMC |
| سنة النشر: | 2023 |
| المجموعة: | Directory of Open Access Journals: DOAJ Articles |
| مصطلحات موضوعية: | Metastatic cancer, Immunotherapy, Checkpoint inhibitors, Health Economics, Quality of life, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282 |
| الوصف: | Background Immunotherapy (IO) has become a standard of care for treating various types of metastatic cancers and has significantly improved clinical outcome. With the exception of metastatic melanoma in complete response for which treatment can be stopped at 6 months, these treatments are currently administered until either disease progression for some IO, 2 years for others, or unacceptable toxicity. However, a growing number of studies are reporting maintenance of response despite discontinuation of therapy. There is currently no evidence of a dose effect of IO in pharmacokinetic studies. Maintaining efficacy despite a reduction in treatment intensity by decreasing the frequency of administration in patients with highly selected metastatic cancer, is the hypothesis evaluated in the MOIO study. Method/design This non-inferiority, randomized phase III study aims to compare the standard regimen to a 3 monthly regimen of variousIO drugs in adult patients with metastatic cancer in partial (PR) or complete response (CR) after 6 months of standard IO dosing (except melanoma in CR). This is a French national study conducted in 36 centers. The main objective is to demonstrate that the efficacy of a three-monthly administration is not unacceptably less efficacious than a standard administration. Secondary objectives are cost-effectiveness, quality of life (QOL), anxiety, fear of relapse, response rate, overall survival and toxicity. After 6 months of standard IO, patients with partial or complete response will be randomized 1:1 between standard IO or a reduced intensity dose of IO, administered every 3 months. The randomization will be stratified on therapy line,, tumor type, IO type and response status. The primary endpoint is the hazard ratio of progression-free survival. With a planned study duration of 6 years, including 36 months enrolment time, 646 patients are planned to demonstrate with a statistical level of evidence of 5% that the reduced IO regimen is non-inferior to the standard IO regimen, with a ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 1471-2407 |
| Relation: | https://doi.org/10.1186/s12885-023-10881-8; https://doaj.org/toc/1471-2407; https://doaj.org/article/f6dbb0d0357042c1b1776de60f441d38 |
| DOI: | 10.1186/s12885-023-10881-8 |
| الاتاحة: | https://doi.org/10.1186/s12885-023-10881-8 https://doaj.org/article/f6dbb0d0357042c1b1776de60f441d38 |
| رقم الانضمام: | edsbas.E7082FFE |
| قاعدة البيانات: | BASE |
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