Trial Profile
A Randomized Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin in Subjects With Unresectable Advanced, Recurrent or Metastatic Previously Untreated Esophageal Squamous Cell Carcinoma
Status:
Active, no longer recruiting
Phase of Trial:
Phase III
Latest Information Update: 27 Feb 2024
Price :
$35
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At a glance
- Drugs Ipilimumab (Primary) ; Nivolumab (Primary) ; Cisplatin; Fluorouracil
- Indications Adenocarcinoma; Oesophageal cancer; Squamous cell cancer
- Focus Registrational; Therapeutic Use
- Acronyms CheckMate 648
- Sponsors Bristol-Myers Squibb
- 20 Jan 2024 Results of exploratory biomarker analysis (n=191) of Nivolumab (NIVO) plus chemotherapy or ipilimumab vs chemo as 1L treatment for advanced esophageal squamous cell carcinoma presented at the 2024 Gastrointestinal Cancers Symposium
- 20 Jan 2024 Results assessing quality-adjusted time without symptoms and toxicity (Q-TWiST) analysis comparing nivolumab plus ipilimumab or nivolumab plus chemotherapy versus CT in patients with advanced esophageal squamous cell carcinoma presented at the 2024 Gastrointestinal Cancers Symposium
- 23 Mar 2023 According to an Ono Pharmaceutical media release, the company announced that Ono Pharma Korea Co received the additional approval of Opdivo on March 22, 2023 from the Ministry of Food and Drug Safety (MFDS) in South Korea, for the first-line treatment of patients with unresectable advanced or metastatic esophageal squamous cell carcinoma with tumor cell PD-L1 expression greater than or equal 1%, in the following two combination treatments: Opdivo + Yervoy and Opdivo + chemotherapy.