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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06022861
Recruitment Status : Recruiting
First Posted : September 5, 2023
Last Update Posted : March 15, 2024
Sponsor:
Information provided by (Responsible Party):
Shandong Boan Biotechnology Co., Ltd

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Drug: LY01015 Drug: Fluorouracil Drug: Cisplatin Drug: Opdivo® Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : October 12, 2023
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: LY01015+ Fluorouracil + Cisplatin Drug: LY01015
Intravenouslly (IV) 240mg every 2 weeks (Q2W) during the combined chemotherapy period, thereafter, 480mg every 4 weeks(Q4W) during the maintenance treatment period

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

Drug: Cisplatin
Intravenouslly (IV) 80mg/m2 every 4 weeks (Q4W) during the combined chemotherapy period
Active Comparator: Opdivo® + Fluorouracil + Cisplatin Drug: Fluorouracil
Intravenouslly (IV) l 800mg/m2 every 4 weeks (（on Day 1 through Day 5)during the combined chemotherapy period

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

Drug: Opdivo®
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).


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate(ORR) as assessed by IRC [ Time Frame: from baseline to week 16 ]

Secondary Outcome Measures :
  1. Objective Response Rate(ORR) as assessed by IRC and investigator [ Time Frame: from baseline to week 24 ]
  2. Disease Control Rate (DCR) [ Time Frame: up to 2 years ]
  3. Duration of Response (DOR) [ Time Frame: up to 2 years ]
  4. Progression-Free Survival (PFS) [ Time Frame: up to 2 years ]
  5. 16-week Progression-Free Survival Rate [ Time Frame: from baseline to week 16 ]
  6. 24-week Progression-Free Survival Rate [ Time Frame: from baseline to week 16 ]
  7. Overall Survival (OS) [ Time Frame: up to 2 years ]
  8. Incidence and severity of adverse effects (AEs) [ Time Frame: up to 2 years ]
  9. Incidence of Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (Nab) [ Time Frame: up to 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing to sign the informed consent form.
  2. Male or female aged 18 to 75 years patients.
  3. Histopathologically confirmed esophagus squamous cell carcinoma.
  4. Diagnosed with advanced or metastatic ESCC per AJCC 8th edition, not be amenable to curative approaches( such as definitive chemoradiation/surgery), not received prior systemic anti-cancer therapy for progressive or metastatic disease. Prior neoadjuvant, adjuvant or definitive radiotherapy/chemoradiotherapy/chemotherapy for locally advanced diseases is permitted if time from the last dose to recurrence> 24 weeks.
  5. Must have at least one measurable lesion assessed by investigator per RECIST 1.1 criteria .
  6. ECOG performance status of 0 to 1.
  7. Prior to the first dose, the tumor tissue samples must be provided for PD-L1 expression analysis, and PD-L1 TPS≥1%.
  8. Expected survival ≥6 months.
  9. Adequate organ function at screening.

Exclusion Criteria:

  1. Presence of symptomatic brain metastasis or spinal compression, or history of meningeal metastasis. Patients with asymptomatic brain metastases who have received prior treatment are permitted to enroll if the disease is stable, and corticosteroids have not been required for at least 4 weeks prior to screening. Patients with carcinomatous meningitis are ineligible, regardless of whether the disease is clinically stable or not.
  2. With high risks of bleeding or fistula due to apparent tumor invasion to esophagus or adjacent organs.
  3. Known endoscopy-confirmed near-complete obstruction requiring interventional therapy or with risk of perforation post stent implantation in the esophagus or trachea.
  4. Unstable disease within 6 months prior to signing informed consent form, including but not limited to unstable angina, myocardial infarction, NYHA Class II or higher cardiac failure, severe arrhythmia or cerebrovascular accident (including transient ischemic attacks) requiring treatment, or any other poorly-controlled systemic disease, for example, uncontrolled hypertension (systolic pressure ≥160 mmHg or diastolic pressure≥100 mmHg) despite standard treatment.
  5. Received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 agent or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
  6. Prior cumulative exposure dose of cisplatin>300 mg/m2 and time from the last dose of cisplatin to randomization ≤12 month.
  7. Received a live vaccine within 4 weeks prior to the first dose, or be scheduled to receive a live vaccine during the entire course of the study.
  8. Received systemic chemotherapy, targeted therapy, immunosuppressants, immunostimulants, biological agents, Chinese herbal medicines for anti-tumor indications (prescription or medical record required), Chinese patent drug or any other investigational agents or participated in interventional clinical study within 4 weeks (or five half-lives, whichever is longer) prior to the first dose.
  9. Other conditions, as determined by the investigator, for example, severe deep vein thrombosis, arterial embolism, hepatic encephalopathy, Child-Pugh grade B or more severe cirrhosis, or other acute or chronic disease, mental illnesses or laboratory abnormalities, which may lead to the following consequences: increase the risks associated with study participation or study drug administration, or interfere with the interpretation of study results.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06022861


Locations
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China
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, China
Contact: Ruihua Xu    020-87343795    rhuaxu@163.com   
Sponsors and Collaborators
Shandong Boan Biotechnology Co., Ltd
More Information
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Responsible Party: Shandong Boan Biotechnology Co., Ltd
ClinicalTrials.gov Identifier: NCT06022861    
Other Study ID Numbers: LY01015/CT-CHN-302
First Posted: September 5, 2023    Key Record Dates
Last Update Posted: March 15, 2024
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
 Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Fluorouracil
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs