This is a single-arm phase II study of twenty-one subjects with mucinous adenocarcinoma of the colon, rectum, or appendix with prior systemic therapy with a fluoropyrimidine, oxaliplatin, and irinotecan. Treatment will consist of nivolumab 480mg every 4 weeks and ipilimumab 1mg/kg every 8 weeks until disease progression, unacceptable toxicity, or 2 years of therapy.
Treatment will consist of nivolumab 480mg every 4 weeks and ipilimumab 1mg/kg every 8 weeks (within a 56-day cycle, (Nivolumab administered on days 1 and 29, and Ipilimumab administered on day 1 of each cycle). Imaging assessments will be conducted every 8 weeks (+/-2 weeks) for the first 24 weeks then every 8-12 weeks (+/-2 weeks). If progression is noted on imaging in the setting of clinical stability, subjects may remain on study and have confirmatory imaging in 4-8 weeks per iRECIST criteria
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
IV infusion per institutional guidelines and the Package Insert
IV infusion per institutional guidelines and the Package Insert
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Number of Participants With Progression-Free Survival at 6 Months
To determine six-month progression-free survival by iRECIST from start of study treatment until 6 months
Time frame: Start of treatment until 6 months later
Progression-Free Survival
to determine Progression-Free survival from start of study treatment until time of documented disease progression or death assessed up to 2 years
Time frame: start of treatment until disease progression or death, assessed up to 2 years
Overall Survival
Overall survival (OS) is defined as the duration of time from start of treatment to death
Time frame: From start of treatment until death assessed up to 2 years
Objective Response Rate
The objective response rate is determined by the percentage of individuals on study attaining a complete or partial response as noted by by iRECIST and RECIST v1.1 Criteria
Time frame: From start of treatment until progression or death assessed up to 2 years
Duration of Response
Time from the first recorded partial or complete response using RECIST v.1.1 criteria until disease progression or death
Time frame: From the first recorded partial or complete response until progressive disease or death, whichever came first, assessed up to 2 years
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