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Clinical Trials List

Protocol NumberONO-4538-50/CA209648
NCT Number(ClinicalTrials.gov Identfier)NCT03143153

2017-08-10 - 2021-06-30

Phase III

Terminated13

ICD-10D00.1

Carcinoma in situ of esophagus

ICD-10C15

Malignant neoplasm 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

  • Trial Applicant

    PPD DEVELOPMENT (HK) LIMITED

  • Sponsor

    ONO Pharmaceutical Co., Ltd. /Bristol-Myers Squibb Company

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Audit

None

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Audit

None

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

11 Completed

Audit

None

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 王蒼恩 Digestive System Department
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

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 Completed

Principal Investigator
Chang Gung Medical Foundation Chang Gung Memorial Hospital, Keelung

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Chen-Yuan Lin 未分科
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

6 Completed

Audit

CRO

Principal Investigator I-CHEN WU 未分科
Kaohsiung Municipal Gangshan Hospital

Co-Principal Investigator

Audit

CRO

Principal Investigator I-CHEN WU Division of Hematology & Oncology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 王蒼恩 Digestive System Department
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Condition/Disease

Esophageal Squamous Cell Carcinoma

Objectives

Primary Objectives  To compare the OS of nivolumab plus ipilimumab (Arm A) to fluorouracil plus cisplatin chemotherapy (Arm C) in subjects with PD-L1 expression ≥ 1%.  To compare the OS of nivolumab combined with fluorouracil plus cisplatin (Arm B) to fluorouracil plus cisplatin chemotherapy (Arm C) in subjects with PD-L1 expression ≥ 1%.  To compare the PFS of nivolumab plus ipilimumab (Arm A) to fluorouracil and cisplatin combination (Arm C) as assessed by a BICR in subjects with PD-L1expression ≥ 1%.  To compare the PFS of nivolumab combined with fluorouracil plus cisplatin (Arm B) to fluorouracil and cisplatin combination (Arm C) as assessed by a BICR in subjects with PD-L1 expression ≥ 1%.

Test Drug

Nivolumab/Ipilimumab

Active Ingredient

Ipilimumab
Nivolumab

Dosage Form

Solution for Injection
Solution for Injection

Dosage

100 mg (10 mg/mL)
200mg (5mg/mL)

Endpoints

 Overall survival (OS) in subjects with PD-L1 expressing tumors.
 Progression-free Survival (PFS) (as assessed by BICR) in subjects with PD-L1 expressing tumors.
 Overall survival (OS) in All Randomized subjects.
 Progression-free Survival (PFS) (as assessed by BICR) in All Randomized subjects.
 Objective Response Rate (ORR) (as assessed by BICR) in subjects with PD-L1 expressing tumors and All Randomized subjects.

Inclution Criteria

Main inclusion criteria:
a) Subjects must have histologically confirmed squamous cell carcinoma or
adenosquamous cell carcinoma (predominant squamous differentiation) of
esophagus (per AJCC 7th edition, see Appendix 4).
b) Subjects must have unresectable advanced, recurrent or metastatic ESCC (per
AJCC 7th edition 5.1, see Appendix 4).
c) Subjects must not be amenable to curative approaches such as definitive
chemoradiation and/or surgery
d) No prior systemic anticancer therapy given as primary therapy for advanced
or metastatic disease.
i .Prior adjuvant, neoadjuvant, or definitive,
chemotherapy/radiotherapy/chemoradiotherapy for ESCC is permitted if given
as part of curative intent regimen and completed before enrollment.
A recurrence-free period is required for 24 weeks after completion of
neoadjuvant or adjuvant chemotherapies, or after completion of multimodal
therapies (chemotherapies and chemoradiotherapies) for locally advanced diseases
e) ECOG Performance Status of 0 or 1, see Appendix 3
f) Subjects must have at least one measurable lesion by CT or MRI per RECIST 1.1
criteria; radiographic tumor assessment must be performed within 28 days
prior to randomization.
g) Tumor tissue must be provided for biomarker analyses. Either 1 formalin fixed
paraffin embedded (FFPE) tumor tissue block or 15 unstained tumor tissue
slides, with an associated pathology report if available, must be submitted for biomarker evaluation prior to study drug administration. The tumor tissue
sample may be fresh or archival if obtained within 6 months prior to
randomization, and there can have been no systemic therapy (eg, adjuvant)
given after the sample was obtained. Tissue must be a core needle biopsy,
excisional or incisional biopsy. Fine needle biopsies or drainage of pleural
effusions with cytospins are not considered adequate for biomarker review and
randomization. Biopsies of bone lesions that do not have a soft tissue
component or decalcified bone tumor samples are also not acceptable.
h) In order to be randomized, a subject must have a PD-L1 expression
classification ≥ 1% or < 1%, or indeterminate) as determined by the central lab.

Exclusion Criteria

Main exclusion criteria:
a) Subjects must have recovered from the effects of major surgery or significant
traumatic injury at least 14 days before randomization.
b) Prior malignancy requiring active treatment within the previous 3 years except
for locally curable cancers that have been apparently cured, such as basal or
squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of
the prostate, cervix, or breast.
c) Subjects with active, known, or suspected autoimmune disease. Subjects with
Type I diabetes mellitus, residual hypothyroidism due to autoimmune
thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo,
psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll.
For any cases of uncertainty, it is recommended that a BMS medical monitor be
consulted prior to signing informed consent.
d) Subjects with a condition requiring systemic treatment with either
corticosteroids (> 10 mg daily prednisone equivalent) or other
immunosuppressive medications within 14 days of start of study treatment.
Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg
daily prednisone equivalent, are permitted in the absence of active
autoimmune disease.
e) Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or
anti-CTLA-4 antibody, or any other antibody or drug specifically targeting
T-cell co-stimulation or checkpoint pathways.

The Estimated Number of Participants

  • Taiwan

    92 participants

  • Global

    939 participants

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