Kunyoresa: ClinicalTrials.gov
Yakagadziriswa: January 25, 2016
Huru ID: NCT02659059
Kunyoresa Zuva: Ndira 15, 2016
Mubatsiri mukuru: Bristol-Myers Squibb
Vhura musoro: Nivolumab pamwe neIpilimumab seyekutanga-mutsara kurapwa kwechikamu IV isiri diki cell cancer yemapapu yekutarisa 568.
Nyaya yesainzi: Rakavhurika chitambi, ruoko-rwechikamu chechipiri II kudzidza Nivolumab yakabatana neIpilimumab senzira yekutanga kurapwa kweiyo nhanho IV isiri-diki kenza yemapapu kenza (NSCLC)
Zuva rekutanga kushandirwa: Kukadzi 2016
Target sampuro saizi: 170
Nzvimbo yekutora: kuunganidza
Rudzi rwekudzidza: kupindira
Yekudzidza Dhizaini: Endpoint Classification: Kudzivirirwa / Kubudirira Kudzidza, Kupindira Muenzaniso: Kamwe Boka Basa, Masking: Vhura Label, Chikuru Chinangwa: Kurapa
Kugadzira: Chikamu II
Kunyorera nyika:
nyika dzakabatana
Kiyi yekupinda uye yekuregedza maitiro:
Kuti uwane rumwe ruzivo nezve Bristol-Myers Squibb (BMS) kiriniki kuyedza kutora chikamu, ndapota shanya www.BMSSstudyConnect.com
Maitiro ekupinda:
- Munhurume kana munhukadzi ane makore gumi nemasere zvichikwira
- Kuongororwa kwedanho IV isiri-diki kenza yemapapu kenza
- Kuongororwa kwechikamu chechitatu chechitatu chegomarara remapapu risiri diki uye kurapa kwakasangana neradiotherapy uye chemotherapy kwakakundikana kurapwa pasina dzimwe nzira dzekurapa.
Kurega maitiro:
- Zvidzidzo zvekudzidza neisingarapike CNS metastases kubva epakati sisitimu system inosarudzika
- Zvidzidzo zvine cancer cancer meningitis
- Musoro unoshanda, unozivikanwa, kana kufungidzirwa autoimmune hosha
- Dzidza varwere vane zvirwere zvinoda systemic kurapwa kusanganisira kudiwa kwecorticosteroids (> 10 mg yakaenzana ne prednisone pazuva) kana kushandisa mimwe mishonga yekuzvidzivirira mukati memazuva gumi nemana ekutanga kurapwa
- Vakadzi vaive nepamuviri kana kuda kubata nhumbu chirongwa chekurapa chisati chatanga, uye / kana kuyamwiswa panguva yechidzidzo.
- Iko kusanganisirwa / kubviswa kunotsanangurwa nezvimwe zvirongwa kunogona kuiswa neyakajairwa.
Minimum zera muganho: makore gumi nemasere
Zera repamusoro muganhu: Hapana
Gender: murume kana mukadzi
Kupindira:
Biologics: Nivolumab (Opdivo) + Ipilimumab (Yervoy)
Mhedzisiro huru:
Chinangwa Chekupindura Rate (ORR) [Nguva Range: 6 mwedzi mushure mekutanga kurapwa kwemurwere wekupedzisira]
Mibairo yechipiri:
Nguva yekupindura (DOR) [Nguva yakatarwa: murwere wekupedzisira mwedzi mitanhatu mushure mekutanga kurapwa]
Kufambira mberi-pasina kupona (PFS) [Nguva yenguva: murwere wekupedzisira 6 mwedzi mushure mekutanga kurapwa]
Mwedzi-mitanhatu yekufambira mberi-kwemahara kupona (PFS) [Nguva yakatarwa: mwedzi mitanhatu mushure mekutanga dosi]
Nivolumab (Opdivo) nivolumab: Iyo FDA yakabvumidza nivolumab musi waKurume 4, 2015 yekurapa metastatic squamous isiri diki kenza yemapapu nekukura kwechirwere panguva kana mushure meplatinum-based chemotherapy. Kare (muna Zvita 2014), iyo FDA yakakurumidza kubvumidza nivolumab (Opdivo, Bristol-Myers Squibb) kurapwa kwevarwere vane unresectable kana metastatic melanoma vasina kupindura kune mamwe madhiragi. Nivolumab inonzi monoclonal antibody inosungirirana nePD-1 receptor uye inovhara kusangana kwayo nePD-L1, PD-L2, nokudaro ichisunungura PD-1 nzira-yakagadziriswa kudzvinyirirwa kwemhinduro yekudzivirira, kusanganisira anti-Tumor immune response. Zvidzidzo zviviri zvinogadza mvumo yeFDA. Mvumo yeFDA yakavakirwa pamibairo yeakavhurika-label, multi-center, multi-nyika randomized muyedzo uchienzanisa kushanda kwe nivolumab uye docetaxel. Chidzidzo ichi chakanangana nevarwere vane metastatic squamous isiri diki cell kenza yemapapu. Varwere ava vakawana kufambira mberi kwechirwere panguva kana mushure meplatinum-based chemotherapy. Varwere vakagoverwa kuti vagamuchire nivolumab intravenously 3 mg / kg masvondo ose e2 (n = 135), kana docetaxel 75 mg / m2 intravenously mavhiki e3 (n = 137). Mhedziso yekutanga yekudzidza yaive OS.
Kubudirira kweNivolumab pane squamous NSCLC kwakasimbiswa mune imwechete-ruoko kutongwa kunosanganisira 117 makesi e squamous asiri madiki maseru kenza yemapapu. Vatori vechikamu muchidzidzo ichi vese vane ruzivo rwekuwedzera kwehurwere mushure mekurapwa kweplatinamu-uye imwezve systemic yekurapa regimen. Mune cohort, 15% yevarwere vaive nemhinduro yakazara, yeiyo 59% yaive nenguva yekupindura yemwedzi mitanhatu kana kudarika.
Kushanda kweNivolumab mukurapa squamous NSCLC kwakasimbiswa mune imwe nzira yekliniki yekuongorora inosanganisira varwere ve272, avo 135 varwere vakagamuchira nivolumab uye 137 varwere vakagamuchira docetaxel. Mhedziso yekutanga yechidzidzo yaive kupona kwese, uye zvakaonekwa kuti nivolumab yakawedzera kupona kwese neavhareji yemwedzi 3.2 zvichienzaniswa nedocetaxel. Imwe ongororo yeruoko rumwe yaisanganisira varwere zana negumi nevanomwe vari kurapwa neplatinum-based chemotherapy uye inokwana imwe systemic therapy yevarwere vane cancer yemapapu yakawedzera kusimbisa kuchengetedzeka uye kushanda kwenivolumab. Mhedziso dzekutanga dzechidzidzo chaive chinangwa chekupindura mwero (ORR) uye chikamu chevarwere vane mamota akaderedzwa kana akanyangarika munharaunda. Zvigumisiro zvakaratidza kuti 117% yevarwere vakabudisa mhinduro yechinangwa, uye 15% yevarwere vakachengetedza mhinduro yechinangwa kwemwedzi ye59 kana kupfuura.
Ipilimumab (Yervoy) Ipilimumab: CTLA-4 isiri yakasarudzika yeT lymphocyte, iyo inogona kudzivisa kushanda kwayo. Ipilimumab inosunga kuCTLA-4 uye inodzivirira iyo yekupedzisira kubva mukudyidzana neiyo ligand (CD80 / CD86). Kuvhara CTLA-4 kunogona kuwedzera T cell activation uye kuwanda. Mhedzisiro yeIpilimumab pane melanoma haina kunangana, pamwe kuburikidza neanorwisa-bundu immune mhinduro inopindirana neT masero.
