NCT03693846

Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors

A Phase II Study of Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Mucinous Adenocarcinoma of the Colon
• Mucinous Adenocarcinoma of the Rectum

Interventions

Type	Name	Description
DRUG	Nivolumab	IV infusion per institutional guidelines and the Package Insert
DRUG	Ipilimumab	IV infusion per institutional guidelines and the Package Insert

Timeline

• Start date: 2019-02-15
• Primary completion: 2021-03-06
• Completion: 2021-03-06
• First posted: 2018-10-03
• Last updated: 2022-10-20
• Results posted: 2022-10-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study