Rijista: ClinicalTrials.gov
An sabunta: Janairu 25, 2016
Babban ID: NCT02659059
Ranar Rijista: Janairu 15, 2016
Babban mai tallafawa: Bristol-Myers Squibb
Bude batu: Nivolumab da Ipilimumab a matsayin jiyya na farko don mataki na IV mara lafiyar ciwon huhu na 568
Maudu'in kimiyya: Lissafi ne na budewa, nazarin lokaci guda hannu II nazarin Nivolumab hade da Ipilimumab a matsayin maganin layi na farko don mataki na huɗu na ƙananan ƙwayar ƙwayar huhu (NSCLC)
Ranar fara daukar ma'aikata: Fabrairu 2016
Girman samfurin Target: 170
Matsayin daukar ma'aikata: daukar ma'aikata
Nau'in karatu: sa baki
Tsara Nazarin: pointarshen Karshe: Nazarin Tsaro / Ingantawa, Tsarin Tsoma baki: Groupungiyar Singleungiya Guda, Masking: Buɗe Label, Babban Maƙasudi: Jiyya
Tsarin kallo: Lokaci na II
Countriesaukar ƙasashe:
Amurka
Ka'idojin shiga da keɓancewa:
Don ƙarin bayani game da Bristol-Myers Squibb (BMS) halartar gwajin gwaji, don Allah ziyarci www.BMSSstudyConnect.com
Ka'idojin shigarwa:
- Namiji ko mace mai shekaru 18 ko sama da haka
- Ganewar asali na mataki na huɗu ƙananan ƙananan ƙwayoyin cuta
- Gano ganewar sake dawowa mataki IIIB ciwon huhu mara karami da maganin hadewar da ya gabata tare da radiotherapy da chemotherapy sun kasa maganin ba tare da ƙarin zaɓuɓɓukan warkewa ba.
Ka'idodin keɓewa:
- Nazarin batutuwa tare da ƙananan ƙwayoyin CNS waɗanda ba su da magani daga tsarin kulawa na tsakiya an cire su
- Batutuwa masu fama da cutar sankarau
- Maudu'in yana da aiki, sananne, ko kuma waɗanda ake zaton cututtukan autoimmune
- Yi nazarin marasa lafiya tare da cututtukan da ke buƙatar magani na yau da kullun ciki har da buƙatar corticosteroids (> 10 MG daidai da prednisone kowace rana) ko amfani da wasu magungunan rigakafi a cikin kwanaki 14 na farawar farko
- Matan da suke da ciki ko suke shirin yin ciki kafin fara shirin maganin, da / ko kuma an shayar da su nono yayin nazarin.
- Hadawa / cirewa da wasu tsare-tsaren suka ayyana za a iya amfani da shi ta hanyar mizani.
Mafi qarancin shekarun iyaka: shekara 18
Matsakaicin iyakar iyakar: Babu
Jinsi: jinsi
Tsarin baki:
Ilimin ilimin halittu: Nivolumab (Opdivo) + Ipilimumab (Yervoy)
Babban sakamakon:
Respimar Amfani da Maƙasudin (ORR) [Range Lokaci: watanni 6 bayan magani na farko na haƙuri]
Sakamakon Secondary:
Tsawan lokaci na amsawa (DOR) [Tsarin lokaci: ƙarshe mai haƙuri na watanni 6 bayan jiyya na farko]
Rayuwa marar ci gaba (PFS) [Tsarin lokaci: haƙuri na ƙarshe watanni 6 bayan jiyya na farko]
6-wata na ci gaba-free rayuwa (PFS) [Lokaci frame: 6 watanni bayan na farko kashi]
Nivolumab (Opdivo) nivolumab: FDA ta amince da nivolumab a ranar 4 ga Maris, 2015 don maganin ciwon daji na huhu mara ƙananan ƙwayar cuta tare da ci gaba da cututtuka a lokacin ko bayan ilimin chemotherapy na tushen platinum. A baya can (a cikin Disamba 2014), FDA ta haɓaka amincewar nivolumab (Opdivo, Bristol-Myers Squibb) don kula da marasa lafiya tare da melanoma marasa lafiya ko metastatic melanoma waɗanda basu amsa ga wasu kwayoyi ba. Nivolumab wani maganin rigakafi ne na monoclonal wanda ke ɗaure ga mai karɓar PD-1 kuma yana toshe hulɗar sa tare da PD-L1, PD-L2, don haka yana sakin hanyar PD-1-matsakaici-matsakaici na maganin rigakafi, gami da amsawar rigakafin Tumor. Nazarin biyu sun tabbatar da amincewar FDA. Amincewar FDA ta dogara ne akan sakamakon buɗaɗɗen lakabin, cibiyoyi da yawa, gwajin bazuwar ƙasashe da yawa waɗanda ke kwatanta ingancin nivolumab da docetaxel. Binciken ya yi niyya ga marasa lafiya da ke fama da ciwon huhu na huhu na metastatic. Wadannan marasa lafiya sun sami ci gaban cututtuka a lokacin ko bayan ilimin chemotherapy na tushen platinum. An ba marasa lafiya ba da izini ba don karɓar nivolumab na cikin jini na 3 mg / kg kowane mako 2 (n = 135), ko docetaxel 75 mg / m2 a cikin jini kowane mako 3 (n = 137). Babban ƙarshen binciken shine OS.
An sake inganta tasirin Nivolumab akan NSCLC mai rikitarwa a gwajin hannu daya wanda ya shafi shari'oi 117 na ƙananan ƙwayoyin cuta na huhu. Masu shiga cikin wannan binciken duk sun sami ci gaban cutar bayan shan magani na platinum kuma aƙalla wani tsarin kula da tsarin. A cikin ƙungiyar, 15% na marasa lafiya suna da cikakkiyar amsa, wanda 59% yana da lokacin amsawa na watanni 6 ko fiye.
An tabbatar da ingancin Nivolumab a cikin maganin squamous NSCLC a cikin binciken bincike na asibiti wanda ya shafi marasa lafiya 272, wanda marasa lafiya 135 suka karbi nivolumab kuma marasa lafiya 137 sun karbi docetaxel. Babban ƙarshen binciken shine rayuwa gabaɗaya, kuma an gano cewa nivolumab ya tsawaita rayuwar gabaɗaya ta matsakaicin watanni 3.2 idan aka kwatanta da docetaxel. Wani bincike na hannu daya wanda ya shafi marasa lafiya 117 da ke jurewa maganin chemotherapy na tushen platinum kuma aƙalla tsarin tsarin jiyya ga marasa lafiya da ciwon huhu da ya ci gaba ya tabbatar da aminci da ingancin nivolumab. Maƙasudin ƙarshen binciken shine ƙimar amsawar haƙiƙa (ORR) da kuma adadin marasa lafiya tare da raguwar ciwace-ciwacen gida ko bace. Sakamakon ya nuna cewa 15% na marasa lafiya sun samar da amsa mai ma'ana, kuma 59% na marasa lafiya sun ci gaba da mayar da martani ga watanni 6 ko fiye.
Ipilimumab (Yervoy) Ipilimumab: CTLA-4 mara kyau ne mai kula da kwayar T lymphocytes, wanda zai iya hana aikinta aiki. Ipilimumab yana ɗaure ga CTLA-4 kuma yana hana ƙarshen yin ma'amala tare da ligand (CD80 / CD86). Toshewar CTLA-4 na iya haɓaka haɓakar T da haɓaka. Tasirin Ipilimumab akan melanoma kaikaitacce ne, mai yiwuwa ne ta hanyar maganin rigakafin ƙwayar ƙwayar cuta wanda aka daidaita tsakanin ƙwayoyin T.
