RegoNivo vs Standard of Care Chemotherapy in AGOC

Phase 3 Completed 462 enrolled Australasian Gastro-Intestinal Trials Group Academic and Community Cancer Research United · collab Bayer · collab Bristol-Myers Squibb · collab Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · collab National Cancer Center Hospital East · collab Syneos Health · collab Taiwanese Cooperative Oncology Group · collab University 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

Outcome

Missed primary endpoint

registry analysis (other test); RegoNivo vs Standard of Care; p = 0.23; Hazard Ratio (HR) 0.88 (95% CI 0.71 to 1.09) NCT04879368 ↗

Publications

Lam LL, Pavlakis N, Shitara K, Sjoquist KM, Martin AJ, Yip S, Kang YK, Bang YJ, Chen LT, Moehler M, Bekaii-Saab T, Alcindor T, O'Callaghan CJ, Tebbutt NC, Hague W, Chan H, Rha SY, Lee KW, Gebski V, Jaworski A, Zalcberg J, Price T, Simes J, Goldstein D. INTEGRATE II: randomised phase III controlled trials of regorafenib containing regimens versus standard of care in refractory Advanced Gastro-Oesophageal Cancer (AGOC): a study by the Australasian Gastro-Intestinal Trials Group (AGITG). BMC Cancer. 2023 Feb 22;23(1):180. doi: 10.1186/s12885-023-10642-7.

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