التفاصيل البيبلوغرافية
| العنوان: |
Nivolumab with or without ipilimumab in patients with recurrent or metastatic cervical cancer (CheckMate 358): a phase 1-2, open-label, multicohort trial |
| المؤلفون: |
Oaknin, Ana, Moore, Kathleen, Meyer, Tim, López-Picazo González, José, Devriese, Lot A, Amin, Asim, Lao, Christopher D, Boni, Valentina, Sharfman, William H, Park, Jong Chul, Tahara, Makoto, Topalian, Suzanne L, Magallanes, Manuel, Molina Alavez, Alejandro, Khan, Tariq Aziz, Copigneaux, Catherine, Lee, Michelle, Garnett-Benson, Charlie, Wang, Xuya, Naumann, R Wendel |
| المساهمون: |
MS Medische Oncologie, Cancer |
| سنة النشر: |
2024 |
| مصطلحات موضوعية: |
Oncology, Journal Article |
| الوصف: |
BACKGROUND: In preliminary findings from the recurrent or metastatic cervical cancer cohort of CheckMate 358, nivolumab showed durable anti-tumour responses, and the combination of nivolumab plus ipilimumab showed promising clinical activity. Here, we report long-term outcomes from this cohort. METHODS: CheckMate 358 was a phase 1-2, open-label, multicohort trial. The metastatic cervical cancer cohort enrolled patients from 30 hospitals and cancer centres across ten countries. Female patients aged 18 years or older with a histologically confirmed diagnosis of squamous cell carcinoma of the cervix with recurrent or metastatic disease, an Eastern Cooperative Oncology Group performance status of 0 or 1, and up to two previous systemic therapies were enrolled into the nivolumab 240 mg every 2 weeks group, the randomised groups (nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks [NIVO3 plus IPI1] or nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 3 weeks for four cycles then nivolumab 240 mg every 2 weeks [NIVO1 plus IPI3]), or the NIVO1 plus IPI3 expansion group. All doses were given intravenously. Patients were randomly assigned (1:1) to NIVO3 plus IPI1 or NIVO1 plus IPI3 via an interactive voice response system. Treatment continued until disease progression, unacceptable toxicity, or consent withdrawal, or for up to 24 months. The primary endpoint was investigator-assessed objective response rate. Anti-tumour activity and safety were analysed in all treated patients. This study is registered with ClinicalTrials.gov (NCT02488759) and is now completed. FINDINGS: Between October, 2015, and March, 2020, 193 patients were recruited in the recurrent or metastatic cervical cancer cohort of CheckMate 358, of whom 176 were treated. 19 patients received nivolumab monotherapy, 45 received NIVO3 plus IPI1, and 112 received NIVO1 plus IPI3 (45 in the randomised group and 67 in the expansion group). Median follow-up times were 19·9 months (IQR 8·2-44·8) with nivolumab, 12·6 months (7·8-37·1) ... |
| نوع الوثيقة: |
article in journal/newspaper |
| وصف الملف: |
application/pdf |
| اللغة: |
English |
| تدمد: |
1470-2045 |
| Relation: |
https://dspace.library.uu.nl/handle/1874/452541 |
| الاتاحة: |
https://dspace.library.uu.nl/handle/1874/452541 |
| Rights: |
info:eu-repo/semantics/ClosedAccess |
| رقم الانضمام: |
edsbas.4E001CE0 |
| قاعدة البيانات: |
BASE |