drugset / Trial / NCT04879368
RegoNivo vs Standard of Care Chemotherapy in AGOC
Phase 3
Completed
462 enrolled
Australasian Gastro-Intestinal Trials Group
Academic and Community Cancer Research United · collabBayer · collabBristol-Myers Squibb · collabInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · collabNational Cancer Center Hospital East · collabSyneos Health · collabTaiwanese Cooperative Oncology Group · collabUniversity of Sydney · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
To determine if the regorafenib and nivolumab combination (RegoNivo) improves overall survival compared with current standard chemotherapy options in refractory AGOC.
Timeline
- Start
- 2021-05-05
- Primary completion
- 2025-01-14
- Completion
- 2025-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Docetaxel | Small molecule | — | — |
| Comparator | Irinotecan | Small molecule | — | — |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |
| Comparator | Paclitaxel | Small molecule | — | — |
| Subject | Regorafenib | Small molecule | 90 mg | Oral |
| Comparator | Tipiracil | Small molecule | — | Oral |
| Comparator | Trifluridine | Small molecule | — | Oral |