The purpose of this study is to determine the safety and tolerability of neoadjuvant/adjuvant Nivolumab or Nivolumab plus Relatlimab in patients with HCC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Nivolumab 480mg will be administered as a 30 minute IV infusion (-/+15min) at cycle 1 day 1 and at cycle 2 day 1 (28 days) then every month for up to 12 months. Intravenous administration of Nivolumab (480 mg) will occur on Cycle 1 and 2 of the study then every 28 days up to a year. Nivolumab will be administered on Day 1 of each cycle for 10 doses/ months (whichever occurs first) for adjuvant.
Patients will receive 480 mg Relatlimab intravenously (-/+15min) on cycle 1 day 1 and at cycle 2 day 1 (every 28 days) for up to 1 year co-administered with Nivolumab.
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
The Ohio State University, Wexner Medical Center
Columbus, Ohio, United States
Number of patients who complete pre-op treatment and proceed to surgery
Time frame: 4 years
Number of participants experiencing study drug-related toxicities
Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0.
Time frame: 4 years
Percentage of participants who obtain R0 resection
Time frame: 8 weeks
Percentage of evaluable patients who obtain a pathologic complete response (pCR) or major pathologic response (MPR)
Time frame: 8 weeks
Objective response rate (ORR) at 8 weeks
ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \>20% increase in sum of diameters of target lesions, stable disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.
Time frame: 8 weeks
Overall survival (OS) at 12 months
OS will be measured from date of first dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.
Time frame: 12 months
Overall survival (OS) at 18 months
OS will be measured from date of first dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.
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Time frame: 18 months
Overall survival (OS) at 3 years
OS will be measured from date of first dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.
Time frame: 3 years
Overall survival (OS) at 5 years
OS will be measured from date of first dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.
Time frame: 5 years
Disease free survival (DFS) at 12 months
Number of months from the date of first treatment until disease recurrence at 12 months. Estimation based on the Kaplan-Meier curve.
Time frame: 12 months
Disease free survival (DFS) at 18 months
Number of months from the date of first treatment until disease recurrence at 18 months. Estimation based on the Kaplan-Meier curve.
Time frame: 18 months
Disease free survival (DFS) at 3 years
Number of months from the date of first treatment until disease recurrence at 3 years. Estimation based on the Kaplan-Meier curve.
Time frame: 3 years
Disease free survival (DFS) at 5 years
Number of months from the date of first treatment until disease recurrence at 5 years. Estimation based on the Kaplan-Meier curve.
Time frame: 5 years