Ukubhalisa: ClinicalTrials.gov
Kugcine ukubuyekezwa: Januwari 25, 2016
I-ID enkulu: I-NCT02659059
Usuku Lokubhalisa: Januwari 15, 2016
Umxhasi oyinhloko: Bristol-Myers Squibb
Isihloko esivuliwe: I-Nivolumab kanye ne-Ipilimumab njengokwelashwa komugqa wokuqala kwesigaba IV indawo yokuhlola umdlavuza wamaphaphu ongewona omncane weseli 568
Isihloko esingokwesayensi: Ilebuli evulekile, isifundo esisodwa sesigaba sesibili se-Nivolumab esihlanganiswe ne-Ipilimumab njengokwelashwa komugqa wokuqala kwesigaba IV somdlavuza wesifo samangqamuzana ongewona omncane (NSCLC)
Usuku lokuqashwa kokuqala: Februwari 2016
Usayizi wesampula ohlosiwe: 170
Isimo sokuqashwa kabusha: ukuqasha
Uhlobo lokutadisha: ukungenelela
Idizayini Yokufunda: Ukuhlukaniswa Kwendawo Yokugcina: Isifundo Sokuphepha / Sokusebenza Kahle, Imodeli Yokungenela: Umsebenzi Weqembu Elilodwa, Ukufihla: Ilebuli Evulekile, Injongo Eyinhloko: Ukwelashwa
Isiteji: Isigaba II
Ukuqasha amazwe:
I-united states
Indlela yokungena nokhiye wokukhetha:
Ngemininingwane engaphezulu ngokuhlanganyela kwecala lomtholampilo iBristol-Myers Squibb (BMS), sicela uvakashele Www.BMSSstudyConnect.com
Indlela yokungena:
- Owesilisa noma owesifazane oneminyaka engu-18 noma ngaphezulu
- Ukuxilongwa komdlavuza wamaphaphu weseli ongesona omncane
- Ukuxilongwa kwesigaba se-IIIB somdlavuza wamaphaphu ongewona omncane kanye nokwelashwa okuhlanganisiwe kwangaphambilini nge-radiotherapy kanye nokwelashwa ngamakhemikhali kuhlulekile ukwelashwa ngaphandle kwezinketho zokwelashwa ezengeziwe.
Izindlela zokukhishwa:
- Izifundo zokufunda ezine-metastase ze-CNS ezingalapheki ezivela ohlelweni lwezinzwa oluphakathi azifakwanga
- Izihloko ezine-meningitis enomdlavuza
- Isihloko sinezifo ezisebenzayo ezaziwayo, ezaziwayo, noma ezisolwayo
- Cwaninga iziguli ezinezifo ezidinga ukwelashwa okuhlelekile kufaka phakathi isidingo se-corticosteroids (> 10 mg elingana ne-prednisone ngosuku) noma usebenzise ezinye izidakamizwa zokuzivikela ezinsukwini ezingama-14 zokwelashwa kokuqala
- Abesifazane ababekhulelwe noma abasebezokhulelwa ngaphambi kokuqala kohlelo lokwelashwa, kanye / noma banceliswa ngesikhathi socwaningo.
- Ukufakwa / ukukhishwa okuchazwe ezinye izikimu kungasetshenziswa ngezinga.
Umkhawulo wobudala omncane: iminyaka engu-18 ubudala
Umkhawulo weminyaka yobudala: Akukho
Ubulili: ubulili
Ukungenelela:
I-Biologics: INivolumab (Opdivo) + Ipilimumab (Yervoy)
Imiphumela emikhulu:
Isilinganiso Sokuphendula Objective (ORR) [Ibanga Lesikhathi: izinyanga eziyi-6 ngemuva kokwelashwa kokuqala kwesiguli]
Imiphumela yesibili:
Isikhathi sokuphendula (i-DOR) [Isikhathi sesikhathi: isiguli sokugcina izinyanga eziyi-6 ngemuva kokwelashwa kokuqala]
Ukusinda kwe-Progression-free (PFS) [Uhlaka lwesikhathi: isiguli sokugcina izinyanga eziyi-6 ngemva kokwelashwa kokuqala]
Ukusinda okungenazinqubekela phambili kwezinyanga eziyi-6 (PFS) [Uhlaka lwesikhathi: izinyanga eziyi-6 ngemuva komthamo wokuqala]
I-Nivolumab (Opdivo) nivolumab: I-FDA igunyaze i-nivolumab ngoMashi 4, 2015 yokwelapha umdlavuza wamaphaphu we-metastatic squamous non-small cell wamaphaphu nokuqhubekela phambili kwesifo ngesikhathi noma ngemva kwe-chemotherapy esekelwe ku-platinum. Ngaphambilini (ngoZibandlela wezi-2014), i-FDA yasheshisa ukugunyazwa kwe-nivolumab (Opdivo, Bristol-Myers Squibb) yokwelashwa kweziguli ezine-melanoma engasabukeki noma ye-metastatic engazange iphendule kwezinye izidakamizwa. I-Nivolumab iyi-antibody ye-monoclonal ebophezela ku-receptor ye-PD-1 futhi ivimbe ukusebenzisana kwayo ne-PD-L1, PD-L2, ngaleyo ndlela ikhulule ukucindezela kwe-PD-1 endleleni-mediated yokusabela komzimba, kuhlanganise ne-anti-Tumor immune immune. Ucwaningo olubili lusungula ukugunyazwa kwe-FDA. Ukugunyazwa kwe-FDA kusekelwe emiphumeleni yelebula evulekile, emaphakathi, amazwe amaningi, isilingo esingahleliwe esiqhathaniswa nokusebenza kwe-nivolumab ne-docetaxel. Ucwaningo lwaluqondiswe ezigulini ezinomdlavuza wamaphaphu we-metastatic squamous ongewona omncane. Lezi ziguli zabhekana nokukhula kwesifo phakathi noma ngemva kwe-chemotherapy-based chemotherapy. Iziguli zabelwa ngokungahleliwe ukuthola i-nivolumab nge-intravenously 3 mg / kg njalo emavikini e-2 (n = 135), noma i-docetaxel 75 mg / m2 nge-intravenously njalo emavikini e-3 (n = 137). Isiphetho sokuqala socwaningo kwakuyi-OS.
Ukusebenza kweNivolumab kwi-NSCLC ebusayo kuqinisekiswe ngokuqhubekayo ocwaningweni lwengalo eyodwa oluthinta amacala ayi-117 omdlavuza wesifo samaphaphu ongelona omncane. Ababambiqhaza kulolu cwaningo bonke abanolwazi lokuqhubekela phambili kwezifo ngemuva kokwelashwa okwenziwe ngeplathinamu kanye nolunye uhlobo lwemithi elandelwayo. Eqoqweni, iziguli eziyi-15% zibe nempendulo ephelele, okuyi-59% yazo enesikhathi sokuphendula sezinyanga eziyi-6 noma ngaphezulu.
Ukusebenza kwe-Nivolumab ekwelapheni i-NSCLC ene-squamous kwaqinisekiswa ocwaningweni lomtholampilo olungahleliwe olubandakanya iziguli ezingama-272, lapho iziguli eziyi-135 zithole i-nivolumab kanye neziguli eziyi-137 zithole i-docetaxel. Isiphetho esiyinhloko socwaningo kwaba ukusinda kukonke, futhi kwatholakala ukuthi i-nivolumab yelula ukusinda kukonke ngesilinganiso sezinyanga ezingu-3.2 uma kuqhathaniswa ne-docetaxel. Olunye ucwaningo lwengalo eyodwa olubandakanya iziguli eziyi-117 ezelashwa nge-chemotherapy esekelwe ku-platinum kanye okungenani nokwelashwa okuhleliwe okukodwa kweziguli ezinomdlavuza wamaphaphu othuthukisiwe kuphinde kwaqinisekisa ukuphepha nokusebenza kwe-nivolumab. Iziphetho eziyinhloko zocwaningo kwakuyizinga lokuphendula lenhloso (ORR) kanye nenani leziguli ezinamathumba ancishisiwe endaweni noma anyamalele. Imiphumela ibonise ukuthi i-15% yeziguli ikhiqize impendulo ehlosiwe, futhi i-59% yeziguli igcine impendulo ehlosiwe yezinyanga ezingu-6 noma ngaphezulu.
I-Ipilimumab (Yervoy) Ipilimumab: I-CTLA-4 isilawuli esingesihle se-T lymphocyte, esingavimbela ukusebenza kwaso. I-Ipilimumab ibopha i-CTLA-4 futhi ivimbela eyokugcina ekuxhumaneni ne-ligand yayo (CD80 / CD86). Ukuvimba i-CTLA-4 kungakhuphula ukusebenza kwe-T cell nokwanda. Umphumela we-Ipilimumab kwi-melanoma awuqondile, mhlawumbe ngokusebenzisa impendulo yomzimba yokulwa nesimila eqondiswa ngamaseli we-T.
