A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin
Summary
The main purpose of this study is to compare how long subjects with esophageal cancer live overall or live without disease progression after receiving nivolumab and ipilimumab or nivolumab combined with fluorouracil plus cisplatin versus fluorouracil plus cisplatin
Timeline
- Start
- 2017-06-29
- Primary completion
- 2021-01-18
- Completion
- 2025-01-13
Outcome
Mixed primary results
registry analysis (superiority test); Arm A: Nivolumab + Ipilimumab vs Arm C: Chemotherapy; p = 0.0010; Hazard Ratio (HR) 0.64 (98.6% CI 0.46 to 0.90) NCT03143153 ↗
registry analysis (superiority test); Arm B: Nivolumab + Chemotherapy vs Arm C: Chemotherapy; p <0.0001; Hazard Ratio (HR) 0.54 (99.5% CI 0.37 to 0.80) NCT03143153 ↗
registry analysis (superiority test); Arm A: Nivolumab + Ipilimumab vs Arm C: Chemotherapy; p = 0.8958; Hazard Ratio (HR) 1.02 (98.5% CI 0.73 to 1.43) NCT03143153 ↗
registry analysis (superiority test); Arm B: Nivolumab + Chemotherapy vs Arm C: Chemotherapy; p = 0.0023; Hazard Ratio (HR) 0.65 (98.5% CI 0.46 to 0.92) NCT03143153 ↗
Publications
- Zhang Y, Li C, Du K, Pengkhun N, Huang Z, Gong M, Li Y, Liu X, Li L, Wang D, Wang C, Chen F, Li J. Comparative analysis of immune checkpoint inhibitors in first-line treatment of esophageal squamous cell carcinoma: a network meta-analysis. Immunotherapy. 2023 Jul;15(10):737-750. doi: 10.2217/imt-2022-0236. Epub 2023 May 4.
- Kato K, Doki Y, Ogata T, Motoyama S, Kawakami H, Ueno M, Kojima T, Shirakawa Y, Okada M, Ishihara R, Kubota Y, Amaya-Chanaga C, Chen T, Matsumura Y, Kitagawa Y. First-line nivolumab plus ipilimumab or chemotherapy versus chemotherapy alone in advanced esophageal squamous cell carcinoma: a Japanese subgroup analysis of open-label, phase 3 trial (CheckMate 648/ONO-4538-50). Esophagus. 2023 Apr;20(2):291-301. doi: 10.1007/s10388-022-00970-1. Epub 2022 Nov 19.
- Doki Y, Ajani JA, Kato K, Xu J, Wyrwicz L, Motoyama S, Ogata T, Kawakami H, Hsu CH, Adenis A, El Hajbi F, Di Bartolomeo M, Braghiroli MI, Holtved E, Ostoich SA, Kim HR, Ueno M, Mansoor W, Yang WC, Liu T, Bridgewater J, Makino T, Xynos I, Liu X, Lei M, Kondo K, Patel A, Gricar J, Chau I, Kitagawa Y; CheckMate 648 Trial Investigators. Nivolumab Combination Therapy in Advanced Esophageal Squamous-Cell Carcinoma. N Engl J Med. 2022 Feb 3;386(5):449-462. doi: 10.1056/NEJMoa2111380.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | — | — |
| Subject | Ipilimumab | Monoclonal antibody | — | — |
| Subject | Nivolumab | Monoclonal antibody | — | — |
| Subject | fluorouracil | Small molecule | — | — |