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Clinical Trials List

Protocol NumberONO-4538-50/CA209648
Completed

2017-08-10 - 2025-01-09

Phase III

Recruiting12

ICD-10D00.1

Carcinoma in situ of esophagus

ICD-9230.1

Carcinoma in situ of esophagus

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

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 王蒼恩 Digestive System Department
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Huang Chen Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Mo Hou Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 馮盈勳 Division of Hematology & Oncology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蘇裕傑 Division of Hematology & Oncology
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 王全正 Division of Hematology & Oncology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 葉光揚 Division of Hematology & Oncology
Chang Gung Medical Foundation Chang Gung Memorial Hospital, Keelung

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Jui Yen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Hung Hsu Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shau-Hsuan Li Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chen-Yuan Lin Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator I-CHEN WU
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Patients with unresectable, previously untreated advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).

Objectives

‧ To compare overall survival (OS) between nivolumab plus ipilimumab (Group A) and fluorouracil plus cisplatin chemotherapy (Group C) in patients with PD-L1 expression ≥ 1%. ‧ To compare overall survival (OS) between nivolumab combined with fluorouracil and cisplatin (Group B) and fluorouracil plus cisplatin chemotherapy (Group C) in patients with PD-L1 expression ≥ 1%. ‧ To compare progression-free survival (PFS), as assessed by blinded independent central review (BICR), between nivolumab plus ipilimumab (Group A) and fluorouracil plus cisplatin (Group C) in patients with PD-L1 expression ≥ 1%. ‧ To compare progression-free survival (PFS), as assessed by BICR, between nivolumab combined with fluorouracil and cisplatin (Group B) and fluorouracil plus cisplatin (Group C) in patients with PD-L1 expression ≥ 1%.

Test Drug

Injection
Injection

Active Ingredient

Nivolumab
Ipilimumab

Dosage Form

270
270

Dosage

10MG/ML
5MG/ML

Endpoints

Primary Objectives

To compare overall survival (OS) between nivolumab plus ipilimumab (Group A) and fluorouracil plus cisplatin (Group C) in subjects with programmed death-ligand 1 (PD-L1) expression ≥ 1%.

To compare overall survival (OS) between nivolumab combined with fluorouracil and cisplatin (Group B) and fluorouracil plus cisplatin (Group C) in subjects with PD-L1 expression ≥ 1%.

To compare progression-free survival (PFS), as assessed by blinded independent central review (BICR), between nivolumab plus ipilimumab (Group A) and fluorouracil plus cisplatin (Group C) in subjects with PD-L1 expression ≥ 1%.

To compare PFS, as assessed by BICR, between nivolumab combined with fluorouracil and cisplatin (Group B) and fluorouracil plus cisplatin (Group C) in subjects with PD-L1 expression ≥ 1%.

Inclution Criteria

Key Inclusion Criteria:
a) Subjects must have histologically confirmed esophageal squamous cell carcinoma (ESCC) or adenosquamous carcinoma of the esophagus (predominantly squamous differentiation) as defined by AJCC 7th edition (see Appendix 4).
b) Subjects must have unresectable advanced, recurrent, or metastatic ESCC, as defined by AJCC 7th edition, Section 5.1 (see Appendix 4).
c) Subjects must be unsuitable for curative therapy, such as definitive chemoradiotherapy and/or surgery.
d) Subjects must not have received prior systemic anticancer therapy for advanced or metastatic disease as first-line treatment.
i. Prior adjuvant, neoadjuvant, or definitive chemotherapy/radiotherapy/chemoradiotherapy for ESCC is permitted if administered as part of curative intent therapy and completed before enrollment. A recurrence-free interval of at least 24 weeks is required following completion of neoadjuvant/adjuvant therapy or multimodality therapy (chemotherapy and chemoradiotherapy) for locally advanced disease.
e) ECOG performance status must be 0 or 1 (see Appendix 3).
f) Subjects must have at least one measurable lesion, as defined by RECIST version 1.1, determined by CT or MRI. Imaging assessments must be performed within 28 days before randomization.
g) Subjects must provide tumor tissue for biomarker analysis. Before study drug administration, one formalin-fixed paraffin-embedded (FFPE) tumor block or 15 unstained tumor slides along with the corresponding pathology report (if available) must be submitted for biomarker evaluation. The tumor specimen may be newly obtained or archival, provided it was collected within 9 months prior to randomization and no systemic therapy (e.g., adjuvant therapy) was administered after specimen collection. Acceptable samples include core needle biopsies, excisional, or incisional biopsies. Fine-needle aspirates or pleural effusion cell-block specimens are not acceptable for biomarker review and randomization. Bone biopsy specimens without soft tissue components or decalcified bone samples are also not acceptable.
h) To be eligible for randomization, subjects must have a centrally determined PD-L1 expression status of ≥1%, <1%, or indeterminate.

Exclusion Criteria

Key Exclusion Criteria:
a) Subjects must have fully recovered from the effects of major surgery or significant trauma at least 14 days prior to randomization.
b) Subjects with a prior malignancy requiring active treatment within the past 3 years are excluded, except for cancers cured by local therapy and considered cured, such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
c) Subjects with known or suspected autoimmune diseases are excluded. Exceptions include Type 1 diabetes mellitus, hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement, and skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia). In uncertain cases, consultation with the BMS medical monitor prior to informed consent is recommended.
d) Subjects requiring systemic corticosteroid therapy (>10 mg/day prednisone or equivalent) or other immunosuppressive treatment within 14 days before study drug initiation are excluded. Inhaled or topical steroids, and adrenal replacement doses (≤10 mg/day prednisone or equivalent), are allowed in the absence of active autoimmune disease.
e) Subjects who have received prior therapy with antibodies targeting PD-1, PD-L1, PD-L2, CD137, CTLA-4, or any other agents specifically acting on T-cell co-stimulatory or checkpoint pathways are excluded.

The Estimated Number of Participants

  • Taiwan

    80 participants

  • Global

    939 participants

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