drugset / Trial / NCT03693846
Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |