RecruitingPhase 3NCT06022861

A Study to Compare the Efficacy and Safety of LY01015 and Opdivo® Combined Respectively With Chemotherapy in Advanced or Metastatic Esophageal Squamous Cell Carcinoma

A Randomized, Double-blind, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of LY01015 and Opdivo®(Nivolumab Injection)Combined Respectively With Fluorouracil Plus Cisplatin in Participants With Advanced or Metastatic Esophageal Squamous Cell Carcinoma.


Sponsor

Shandong Boan Biotechnology Co., Ltd

Enrollment

510 participants

Start Date

Oct 12, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a randomized, double-blind, multicenter, Phase 3 study to compare the efficacy and safety of LY01015 and Opdivo®(Nivolumab Injection)combined respectively with fluorouracil plus cisplatin in participants with unresectable advanced, recurrent or metastatic previously untreated esophageal squamous cell carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial compares a biosimilar version of nivolumab (LY01015) against the original nivolumab (Opdivo), each combined with chemotherapy, as a first-line treatment for advanced or metastatic esophageal squamous cell carcinoma (a type of esophageal cancer) to confirm they work equally well. **You may be eligible if...** - You are between 18 and 75 with confirmed esophageal squamous cell carcinoma that is advanced or has spread - You have not previously received systemic cancer treatment for metastatic disease - Your tumor tests positive for PD-L1 (TPS 1% or higher) - You are in good physical health (ECOG 0–1) with adequate organ function - You have at least one measurable tumor **You may NOT be eligible if...** - You have symptomatic brain metastases or leptomeningeal disease - Your tumor severely blocks the esophagus or invades nearby organs with high bleeding or fistula risk - You have had prior anti-PD-1/PD-L1 or checkpoint immunotherapy - You have had unstable heart disease, stroke, or severe arrhythmia in the past 6 months - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLY01015

Intravenouslly (IV) 240mg every 2 weeks (Q2W) during the combined chemotherapy period, thereafter, 480mg every 4 weeks(Q4W) during the maintenance treatment period

DRUGFluorouracil

Intravenouslly (IV) l 800mg/m2 every 4 weeks ((on Day 1 through Day 5)during the combined chemotherapy period

DRUGCisplatin

Intravenouslly (IV) 80mg/m2 every 4 weeks (Q4W) during the combined chemotherapy period

DRUGOpdivo®

Intravenouslly (IV) 240mg every 2 weeks (Q2W) during the combined chemotherapy period, 480mg every 4 weeks(Q4W) during the maintenance treatment period within 24 weeks, thereafter converted to LY01015 480mg every 4 weeks(Q4W).


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, China

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NCT06022861


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