A Phase II/III Study of Peri-operative Nivolumab and Ipilimumab in Patients with Locoregional Esophageal and Gastroesophageal Junction Adenocarcinoma
Categories (click each to see list of all clinical trials associated with that category): GI (ONC)
Current Status: Open
Phase: II/III
Principal Investigator: Klute, Kelsey
Eligibility: https://clinicaltrials.gov/ct2/show/study/NCT03604991?term=03604991&draw=2&rank=1#eligibility
Summary
Primary Outcome Measures :
(1) Pathologic complete response (Step I) [ Time Frame: Up to 5 weeks ]
The study with compare the pathologic complete response of Arm A and Arm B using a one-sided 0.10 level chi-squared test for proportions.
(2) Disease-free survival (DFS) (Step 2) [ Time Frame: From the adjuvant treatment randomization assessed for up to 7 years ]
DFS measured from the adjuvant treatment randomization will be the endpoint of the adjuvant portion of the study and to achieve the desired power it is expected that patients will be followed for an additional year post completion of accrual to the adjuvant portion. The DFS comparison will be between patients randomized to Arm C (nivolumab) versus Arm D (nivolumab plus ipilimumab) using a one-sided 0.10 level stratified log rank test.
Secondary Outcome Measures :
(1) Incidence of adverse events [ Time Frame: Up to 7 years ]
Graded according to Common Terminology Criteria for Adverse Events version 5.0. Toxicity will be evaluated among all treated patients regardless of eligibility and interim analyses of toxicity are performed twice yearly. The study will have sufficient precision to provide 95% confidence intervals on toxicity
(2) Overall survival [ Time Frame: From the time of first randomization up to 7 years ]
Analyses will be descriptive in nature and will not follow any formal interim monitoring.
(3) DFS [ Time Frame: From the time of first randomization up to 7 years ]
The DFS comparison will be between patients randomized to Arm C (nivolumab) versus Arm D (nivolumab plus ipilimumab) using a one-sided 0.10 level stratified log rank test.
Other Outcome Measures:
(1) Percent change in mean volumetric apparent diffusion coefficient (ADC) [ Time Frame: Baseline to mid-treatment ]
The study will assess the area under the receiver operating characteristic curve of the changes of ADC value.