BENITIONSClinical Trial Intelligence

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

Phase 2 Active, not recruiting NCT02314169

ConditionAnal Canal Squamous Cell Carcinoma, Metastatic Anal Canal Carcinoma, Stage IV Anal Cancer AJCC v8
PhasePhase 2
SponsorNational Cancer Institute (NCI)
StatusActive, not recruiting
Enrollment143 participants
InterventionsBiospecimen Collection, Computed Tomography, Ipilimumab, Magnetic Resonance Imaging, Nivolumab
Start dateMay 13, 2015
Completion dateFeb 15, 2025
Results postedAug 7, 2018

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: 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

Open in BENITIONS View on ClinicalTrials.gov

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