BENITIONSClinical Trial Intelligence

Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer

2상 진행 중(모집 완료) NCT02314169

대상 질환Anal Canal Squamous Cell Carcinoma, Metastatic Anal Canal Carcinoma, Stage IV Anal Cancer AJCC v8
임상 단계2상
스폰서National Cancer Institute (NCI)
상태진행 중(모집 완료)
참여자 수143 명
중재(약물)Biospecimen Collection, Computed Tomography, Ipilimumab, Magnetic Resonance Imaging, Nivolumab
시작일2015년 5월 13일
완료일2025년 2월 15일
결과 공개일2018년 8월 7일

요약

This phase II trial studies how well nivolumab with or without ipilimumab works in treating patients with anal canal cancer that has not responded to previous treatment (refractory) and that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Overall Response Rate: Number of Participants With Response (Part A)

Up to 2 years · percentage of patients with a response

Part A: Nivolumab24 percentage of patients with a response

Progression-free Survival (PFS) (Part B)

Time period from the date of randomization to the date of PD or death whichever occurred first, assessed up to 2 years · months

Part B Arm I (Nivolumab)2.9 months
Part B Arm II (Nivolumab, Ipilimumab3.7 months
p-value0.25

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