A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin

Phase 3

Active, not recruiting

• Conditions: Various Advanced Cancer
• Interventions: Biological: Nivolumab; Drug: Cisplatin; Biological: Ipilimumab; Drug: Fluorouracil

• Registration Number: NCT03143153
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The main purpose of this study is to compare how long subjects with esophageal cancer live overall or live without disease progression after receiving nivolumab and ipilimumab or nivolumab combined with fluorouracil plus cisplatin versus fluorouracil plus cisplatin

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-04
• Study First Submitted QC: 2017-05-04
• Study First Posted: 2017-05-08
• Study Start: 2017-06-29
• Primary Completion: 2021-01-18
• Results First Submitted: 2022-01-11
• Results First Submitted QC: 2022-02-09
• Results First Posted: 2022-03-02
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-04
• Study Completion: 2025-01-13

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 970

Inclusion Criteria

• Must have histologically confirmed squamous cell carcinoma or adenosquamous cell carcinoma of esophagus
• Male or Female at least 18 years of age
• Must have esophageal cancer that cannot be operated on, or treated with definitive chemoradiation with curative intent, that is advanced, reoccurring or has spread out
• Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
• Must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment in this study

Exclusion Criteria

• Presence of tumor cells in the brain or spinal cord which are symptomatic or require treatment
• Active known or suspected autoimmune disease
• Any serious or uncontrolled medical disorder or active infection
• Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
• Any positive test result for hepatitis B or C indicating acute or chronic infection and/or detectable virus

Other protocol defined inclusion/exclusion criteria apply

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nivolumab + Ipilimumab	Nivolumab	-
Nivolumab + Ipilimumab	Ipilimumab	-
Cisplatin + Fluorouracil	Cisplatin	-
Nivolumab + Cisplatin + Fluorouacil	Nivolumab	-
Nivolumab + Cisplatin + Fluorouacil	Fluorouracil	-
Nivolumab + Cisplatin + Fluorouacil	Cisplatin	-
Cisplatin + Fluorouracil	Fluorouracil	-

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS) in Participants With Tumor Cell PD-L1	From the date of randomization to up to the date of death (up to approximately 20 months)	Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the subject was known to be alive.
Progression-free Survival (PFS) as Assessed by BICR in Participants With Tumor Cell PD-L1	From the date of randomization to up to the date of the first documented disease progression or death (up to approximately 9 months)	Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented progressive disease (PD) per Blinded Independent Central Review (BICR) or death due to any cause. Participants who die without a reported prior PD per BICR (and die without start of subsequent therapy) will be considered to have progressed on the date of death. Participants who did not have documented PD per BICR per RECIST1.1 criteria and who did not die, will be censored at the date of the last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy. Participants who did not have any on-study tumor assessments and did not die (or died after initiation of the subsequent anti-cancer therapy) will be censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported PD per BICR will be censored at the last tumor assessment on or prior to initiation of the subsequent anti-cancer therapy.

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS) in All Randomized Participants as Assessed by BICR	From the date of randomization to up to the date of the first documented disease progression or death (up to approximately 7 months)	Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented progressive disease (PD) per Blinded Independent Central Review (BICR) or death due to any cause. Participants who die without a reported prior PD per BICR (and die without start of subsequent therapy) will be considered to have progressed on the date of death. Participants who did not have documented PD per BICR per RECIST1.1 criteria and who did not die, will be censored at the date of the last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy. Participants who did not have any on-study tumor assessments and did not die (or died after initiation of the subsequent anti-cancer therapy) will be censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported PD per BICR will be censored at the last tumor assessment on or prior to initiation of the subsequent anti-cancer therapy.
Overall Survival (OS) in All Randomized Participants	From the date of randomization to up to the date of death (up to approximately 16 months)	Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the subject was known to be alive.
Objective Response Rate (ORR) as Assessed by BICR	From the date of randomization to up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to 40 months)	Objective response rate (ORR) is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Best overall response (BOR) is defined as the best response designation as determined by BICR, recorded between the date of randomization and the date of objectively documented progression (per RECIST 1.1) or the date of subsequent anti-cancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions. Complete response is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to \<10 mm.

Trial Locations

Locations (190)

Southern Cancer Center, Inc.; 🇺🇸 Mobile, Alabama, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

Hackensack Meridian Jersey Shore University Medical Center; 🇺🇸 Neptune, New Jersey, United States

Local Institution - 0059; 🇨🇴 Bogota, Colombia

Local Institution - 0232; 🇦🇺 Tamworth, New South Wales, Australia

Local Institution - 0087; 🇦🇷 La Rioja, Argentina

Baylor Charles A. Sammons Cancer Center; 🇺🇸 Dallas, Texas, United States

Local Institution - 0214; 🇨🇱 Santiago, Metropolitana, Chile

Local Institution - 0226; 🇧🇷 Jau, Sao Paulo, Brazil

Oncology Associates Of Oregon, Pc; 🇺🇸 Eugene, Oregon, United States

Local Institution - 0082; 🇨🇦 Montreal, Quebec, Canada

Local Institution - 0095; 🇨🇦 Moncton, New Brunswick, Canada

Local Institution - 0203; 🇺🇸 Morgantown, West Virginia, United States

Local Institution - 0241; 🇦🇹 Salzburg, Austria

Local Institution - 0053; 🇨🇱 Santiago, Metropolitana, Chile

Local Institution - 0058; 🇨🇴 Medellin, Colombia

Local Institution - 0019; 🇧🇷 Barretos, Sao Paulo, Brazil

Local Institution - 0228; 🇧🇷 Rio de Janeiro, Brazil

Local Institution - 0048; 🇦🇷 Buenos Aires, Argentina

Northwest Georgia Oncology Center, P.C.; 🇺🇸 Marietta, Georgia, United States

Local Institution - 0222; 🇨🇦 Montreal, Quebec, Canada

Local Institution - 0094; 🇨🇴 Pereira, Colombia

Local Institution - 0020; 🇧🇷 Sao Paulo, Brazil

Local Institution - 0227; 🇧🇷 Ipatinga, Minas Gerais, Brazil

Local Institution - 0018; 🇧🇷 São José do Rio Preto, São Paulo, Brazil

Local Institution - 0086; 🇦🇷 Rosario, Santa FE, Argentina

Local Institution - 0230; 🇯🇵 Hidaka-shi, Saitama, Japan

Local Institution - 0110; 🇯🇵 Bunkyo-ku, Tokyo, Japan

Local Institution - 0183; 🇨🇳 Xi'an, Shan3xi, China

Local Institution - 0128; 🇯🇵 Chuo-ku, Tokyo, Japan

Local Institution - 0126; 🇯🇵 Koto-ku, Tokyo, Japan

Local Institution - 0178; 🇯🇵 Wakayama-shi, Wakayama, Japan

Local Institution - 0238; 🇯🇵 Ube-shi, Yamaguchi, Japan

Local Institution - 0220; 🇨🇳 Shenyang, China

Local Institution - 0224; 🇨🇴 Monteria, Colombia

Local Institution - 0143; 🇯🇵 Sunto-gun, Shizuoka, Japan

Local Institution - 0175; 🇯🇵 Kitaadachi-gun, Saitama, Japan

Local Institution - 0245; 🇯🇵 Ota-ku, Tokyo, Japan

Local Institution - 0101; 🇯🇵 Chiba, Japan

Local Institution - 0145; 🇯🇵 Kyoto, Japan

Local Institution - 0172; 🇯🇵 Kobe, Hyogo, Japan

Local Institution - 0106; 🇯🇵 Bunkyo-ku, Tokyo, Japan

Local Institution - 0196; 🇯🇵 Shinjuku-Ku, Tokyo, Japan

Local Institution - 0155; 🇯🇵 Shinjuku-ku, Tokyo, Japan

Local Institution - 0076; 🇷🇴 Craiova, Romania

Local Institution - 0066; 🇬🇧 London, Greater London, United Kingdom

Local Institution - 0090; 🇲🇽 Tuxtla Gutierrez, Chiapas, Mexico

Local Institution - 0161; 🇨🇳 Tainan, TNN, Taiwan

Local Institution - 0031; 🇬🇧 Manchester, Greater Manchester, United Kingdom

Local Institution - 0157; 🇰🇷 Ulsan, Korea, Republic of

Local Institution - 0063; 🇪🇸 Barcelona, Spain

Local Institution - 0033; 🇸🇬 Singapore, Central Singapore, Singapore

Local Institution - 0163; 🇨🇳 Kaohsiung County, Taiwan

Local Institution - 0069; 🇬🇧 London, Greater London, United Kingdom

Local Institution - 0089; 🇷🇺 Moscow, Russian Federation

Local Institution - 0125; 🇹🇷 Diyarbakır, Turkey

Local Institution - 0237; 🇬🇧 London, United Kingdom

Local Institution - 0088; 🇷🇺 St Petersburg, Russian Federation

Local Institution - 0133; 🇨🇳 Kaohsiung, Taiwan

Local Institution - 0159; 🇨🇳 Taoyuan, Taiwan

Local Institution - 0096; 🇹🇷 Ankara, Turkey

Local Institution - 0029; 🇬🇧 Surrey, United Kingdom

Local Institution - 0062; 🇪🇸 Madrid, Spain

University Of Miami Sylvester Comprehensive Cancer Center; 🇺🇸 Miami, Florida, United States

Miami Cancer Institute at Baptist Health, Inc.; 🇺🇸 Miami, Florida, United States

Local Institution - 0028; 🇺🇸 Houston, Texas, United States

Local Institution - 0217; 🇨🇳 Fuzhou, Fujian, China

Local Institution - 0199; 🇨🇳 Shantou, Guangdong, China

Local Institution - 0195; 🇨🇳 Zhengzhou, Henan, China

Local Institution - 0249; 🇨🇳 Changsha, Hunan, China

Local Institution - 0179; 🇨🇳 Beijing, Beijing, China

Local Institution - 0212; 🇨🇳 Changsha, Hunan, China

Local Institution - 0201; 🇨🇳 Nanjing, Jiangsu, China

Local Institution - 0180; 🇨🇳 Changchun, Jilin, China

Local Institution - 0215; 🇨🇳 Shanghai, Shanghai, China

Local Institution - 0200; 🇨🇳 Shanghai, Shanghai, China

Local Institution - 0184; 🇨🇳 Hangzhou, Zhejiang, China

Local Institution - 0247; 🇨🇳 Linhai, Zhejiang, China

Local Institution - 0248; 🇨🇳 Xi'An, China

Usc/Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States

Oncology & Hematology Associates Of Southwest Virginia, Inc.; 🇺🇸 Roanoke, Virginia, United States

Local Institution - 0011; 🇦🇺 Douglas, Queensland, Australia

Local Institution - 0197; 🇨🇳 Hefei, Anhui, China

Local Institution - 0207; 🇨🇳 Hefei, Anhui, China

Local Institution - 0216; 🇨🇳 Beijing, Beijing, China

Local Institution - 0219; 🇨🇳 Fuzhou, Fujian, China

Local Institution - 0185; 🇨🇳 Harbin, Heilongjiang, China

Local Institution - 0193; 🇨🇳 Zhengzhou, Henan, China

Local Institution - 0194; 🇨🇳 Zhengzhou, Henan, China

Local Institution - 0083; 🇨🇿 Brno, Czechia

Local Institution - 0008; 🇨🇿 Brno, Czechia

Local Institution - 0116; 🇫🇷 Lille, Nord, France

Local Institution - 0006; 🇨🇿 Novy Jicin, Czechia

Local Institution - 0114; 🇫🇷 Caen, France

Local Institution - 0112; 🇫🇷 Montpellier, France

Local Institution - 0113; 🇫🇷 Rennes Cedex, France

Local Institution - 0242; 🇫🇷 Toulouse, France

Local Institution - 0115; 🇫🇷 Villejuif, France

Local Institution - 0070; 🇭🇰 Kowloon, Hong Kong

Local Institution - 0039; 🇮🇹 Milano, Italy

Local Institution - 0152; 🇯🇵 Akita-shi, Akita, Japan

Local Institution - 0169; 🇯🇵 Matsuyama-shi, Ehime, Japan

Local Institution - 0104; 🇯🇵 Hirosaki-shi, Aomori, Japan

Local Institution - 0173; 🇯🇵 Kashiwa-shi, Chiba, Japan

Local Institution - 0119; 🇯🇵 Matsuyama-shi, Ehime, Japan

Local Institution - 0142; 🇯🇵 Fukuoka-shi, Fukuoka, Japan

Local Institution - 0103; 🇯🇵 Fukushima-shi, Fukushima, Japan

Local Institution - 0100; 🇯🇵 Hiroshima-Shi, Hiroshima, Japan

Local Institution - 0176; 🇯🇵 Ota, Gunma, Japan

Local Institution - 0111; 🇯🇵 Sapporo-shi, Hokkaido, Japan

Local Institution - 0170; 🇯🇵 Akashi-shi, Hyogo, Japan

Local Institution - 0118; 🇯🇵 Kobe-shi, Hyogo, Japan

Local Institution - 0171; 🇯🇵 Kanazawa, Ishikawa, Japan

Local Institution - 0127; 🇯🇵 Isehara, Kanagawa, Japan

Local Institution - 0229; 🇯🇵 Kagoshima-shi, Kagoshima, Japan

Local Institution - 0109; 🇯🇵 Kawasaki-shi, Kanagawa, Japan

Local Institution - 0105; 🇯🇵 Sagamihara-shi, Kanagawa, Japan

Local Institution - 0117; 🇯🇵 Yokohama-shi, Kanagawa, Japan

Local Institution - 0141; 🇯🇵 Kumamoto-shi, Kumamoto, Japan

Local Institution - 0120; 🇯🇵 Kamigyo-ku, Kyoto, Japan

Local Institution - 0144; 🇯🇵 Sendai, Miyagi, Japan

Local Institution - 0146; 🇯🇵 Niigata-shi, Niigata, Japan

Local Institution - 0137; 🇯🇵 Okayama-shi, Okayama, Japan

Local Institution - 0135; 🇯🇵 Kurashiki-shi, Okayama, Japan

Local Institution - 0221; 🇯🇵 Hirakata, Osaka, Japan

Local Institution - 0138; 🇯🇵 Osaka-shi, Osaka, Japan

Local Institution - 0098; 🇯🇵 Osakasayama, Osaka, Japan

Local Institution - 0139; 🇯🇵 Takatsuki City, Osaka, Japan

Local Institution - 0107; 🇯🇵 Suita, Osaka, Japan

Local Institution - 0156; 🇯🇵 Minato-ku, Tokyo, Japan

Local Institution - 0231; 🇯🇵 Toyama-shi, Toyama, Japan

Local Institution - 0108; 🇯🇵 Shizuoka, Japan

Local Institution - 0129; 🇰🇷 Seongnam-si, Kyǒnggi-do, Korea, Republic of

Local Institution - 0165; 🇰🇷 Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of

Local Institution - 0166; 🇰🇷 Busan, Korea, Republic of

Local Institution - 0150; 🇰🇷 Daegu, Korea, Republic of

Local Institution - 0149; 🇰🇷 Daejeon, Korea, Republic of

Local Institution - 0236; 🇰🇷 Jeonju-si, Korea, Republic of

Local Institution - 0235; 🇰🇷 Seoul, Korea, Republic of

Local Institution - 0130; 🇰🇷 Seoul, Korea, Republic of

Local Institution - 0177; 🇰🇷 Seoul, Korea, Republic of

Local Institution - 0168; 🇰🇷 Seoul, Korea, Republic of

Local Institution - 0131; 🇰🇷 Seoul, Korea, Republic of

Local Institution - 0123; 🇰🇷 Seoul, Korea, Republic of

Local Institution - 0234; 🇲🇽 San Luis Potosi, Mexico

Local Institution - 0092; 🇵🇪 Callao, Peru

Local Institution - 0060; 🇵🇪 Lima, Peru

Local Institution - 0093; 🇵🇪 Lima, Peru

Local Institution - 0022; 🇵🇱 Warszawa, Poland

Local Institution - 0243; 🇵🇹 Porto, Portugal

Local Institution - 0021; 🇧🇷 Ijui, RIO Grande DO SUL, Brazil

Local Institution - 0010; 🇦🇺 Murdoch, Western Australia, Australia

Local Institution - 0017; 🇧🇷 Salvador, Bahia, Brazil

Local Institution - 0016; 🇧🇷 Porto Alegre, RIO Grande DO SUL, Brazil

Local Institution - 0085; 🇮🇹 Bergamo, Italy

Local Institution - 0084; 🇮🇹 Padova, Italy

Local Institution - 0240; 🇮🇹 Pisa, Italy

Local Institution - 0099; 🇩🇰 Odense, Denmark

Local Institution - 0151; 🇰🇷 Seoul, Korea, Republic of

Local Institution - 0140; 🇯🇵 Shinagawa-ku, Tokyo, Japan

Local Institution - 0164; 🇨🇳 Keelung, Taiwan

Local Institution - 0132; 🇨🇳 Taichung, Taiwan

Local Institution - 0162; 🇨🇳 Taipei, Taiwan

Local Institution - 0134; 🇨🇳 Taipei, Taiwan

Local Institution - 0024; 🇵🇱 Lublin, Poland

Local Institution - 0034; 🇸🇬 Singapore, Singapore

Local Institution - 0071; 🇲🇽 Merida, Yucatan, Mexico

Local Institution - 0081; 🇷🇴 Bucuresti, Romania

Local Institution - 0080; 🇷🇴 Suceava, Romania

Local Institution - 0136; 🇯🇵 Chuo-ku, Tokyo, Japan

Local Institution - 0158; 🇨🇳 Changhua, Taiwan

Local Institution - 0160; 🇨🇳 Tainan, Taiwan

Local Institution - 0122; 🇹🇷 Edrine, Turkey

Local Institution - 0147; 🇯🇵 Yokohama-shi, Kanagawa, Japan

Local Institution - 0102; 🇲🇽 Mexico, Distrito Federal, Mexico

Local Institution - 0079; 🇷🇴 Cluj-Napoca, Romania

Local Institution - 0050; 🇦🇷 Capital Federal, Buenos Aires, Argentina

Local Institution - 0124; 🇨🇳 Taipei, Taiwan

Local Institution - 0167; 🇨🇳 Kaohsiung, Taiwan

Local Institution - 0174; 🇯🇵 Fukuoka-shi, Fukuoka, Japan

Local Institution - 0154; 🇯🇵 Gifu City, Gifu, Japan

Local Institution - 0148; 🇯🇵 Shimotsuga-gun, Tochigi, Japan

Local Institution - 0153; 🇯🇵 Chiba, Japan

Rocky Mountain Cancer Centers; 🇺🇸 Denver, Colorado, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Northwest Cancer Specialists, P.C.; 🇺🇸 Portland, Oregon, United States

Local Institution - 0037; 🇨🇦 Trois-Rivieres, Quebec, Canada

Local Institution - 0182; 🇨🇳 Beijing, Beijing, China

Local Institution - 0035; 🇭🇰 Hong Kong, Hong Kong