Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors

Mucinous Adenocarcinoma of the Rectum Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma, Mucinous
• Appendiceal Neoplasms
• Cystadenocarcinoma
• Mucinous Adenocarcinoma of the Colon
• Mucinous Adenocarcinoma of the Rectum

• NCT number: NCT03693846
• Study type: Interventional
• Source: Abramson Cancer Center of the University of Pennsylvania
• Status: Terminated
• Phase: Phase 2
• Start date: February 15, 2019
• Completion date: March 6, 2021