drugset / Trial / NCT03576963
Guadecitabine and Nivolumab in Treating Refractory Metastatic Colorectal Cancer
Phase 1/2
Withdrawn
University of Southern California
Astex Pharmaceuticals, Inc. · collabBristol-Myers Squibb · collabNational Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment
Summary
This phase Ib/II trial studies the side effects and best dose of guadecitabine when given together with nivolumab and to see how well they work in treating participants with colorectal cancer that does not respond to treatment and has spread to other places in the body. Drugs used in chemotherapy, such as guadecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving guadecitabine and nivolumab may work better in treating participants with colorectal cancer.
Timeline
- Start
- 2020-01-30
- Primary completion
- 2022-01-30
- Completion
- 2023-01-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Guadecitabine | Oligonucleotide (other) | 30 mg/m2 | Subcutaneous |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |