drugset / Trial / NCT03693846

Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors

NCT03693846 ↗

Phase 2 Terminated 11 enrolled Abramson Cancer Center at Penn Medicine
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2019-02-15
Primary completion
2021-03-06
Completion
2021-03-06

Outcome

Outcome not reported

Stopped (Enrollment): “Terminated due to slow enrollment and lack of efficacy”

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 1 mg/kg Intravenous
Subject Nivolumab Monoclonal antibody 480 mg Intravenous