Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer
Phase 2
Active, not recruiting
NCT02314169
| Condition | Anal Canal Squamous Cell Carcinoma, Metastatic Anal Canal Carcinoma, Stage IV Anal Cancer AJCC v8 |
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| Phase | Phase 2 |
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| Sponsor | National Cancer Institute (NCI) |
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| Status | Active, not recruiting |
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| Enrollment | 143 participants |
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| Interventions | Biospecimen Collection, Computed Tomography, Ipilimumab, Magnetic Resonance Imaging, Nivolumab |
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| Start date | May 13, 2015 |
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| Completion date | Feb 15, 2025 |
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| Results posted | Aug 7, 2018 |
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Summary
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: Nivolumab | 24 percentage of patients with a response |
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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 |
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| Part B Arm II (Nivolumab, Ipilimumab | 3.7 months |
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Open in BENITIONS
View on ClinicalTrials.gov
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