A Randomized Phase III Study of Immune Checkpoint Inhibition with Chemotherapy in Treatment-Naïve Metastatic Anal Cancer Patients
Categories (click each to see list of all clinical trials associated with that category): GI (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Tenner, Laura
Eligibility: https://clinicaltrials.gov/study/NCT04444921?cond=NCT04444921&rank=1
Summary
Primary Outcome Measures :
1) Progression-free survival [ Time Frame: Up to 2 years ]
Defined as the first of progressive disease or death due to any cause. Analyzed using a stratified two-sided overall 0.05 level log-rank test. Will utilize standard Eastern Cooperative Oncology Group -American College of Radiology Imaging Network interim monitoring for efficacy evaluation.
Secondary Outcome Measures :
1) Objective response rate (ORR) [ Time Frame: Up to 2 years ]
ORR is the ratio of the number of patients with a complete response or partial response, as defined by Response Evaluation Criteria in Solid Tumors version 1.1, to the total number of treated patients.
2) Overall survival [ Time Frame: Time between treatment randomization and death by any cause, assessed up to 2 years ]
Evaluated by a stratified log-rank test, and using a two-sided 0.05 level Cochran Mantel-Haenzel.
3) Incidence of adverse events [ Time Frame: Up to 2 years ]
Analyses of toxicity will be via frequency tabulations and percentages by worst degree of toxicity and comparisons will be done via chi-square or Fisher's exact tests as appropriate.