An Immuno-therapy Study of Nivolumab in Combination With Experimental Medication BMS-986205 Compared to Standard of Care EXTREME Regimen in First-line Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck

Last updated: April 16, 2019
Sponsor: Bristol-Myers Squibb
Overall Status: Trial Not Available

Phase

3

Condition

Lung Cancer

Nasopharyngeal Cancer

Head And Neck Cancer

Treatment

N/A

Clinical Study ID

NCT03386838
CA017-063
2017-003059-46
  • Ages > 18
  • All Genders

Study Summary

This is a study of Nivolumab in combination with experimental medication BMS-986205 compared to the standard of care EXTREME regimen in head and neck cancer that has come back after initial treatment, or is widespread when first diagnosed.

Eligibility Criteria

Inclusion

For more information regarding Bristol-Myers Squibb Clinical Trial participation, pleasevisit www.BMSStudyConnect.com Inclusion Criteria:

  • Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN), fromany of the following primary sites only: oral cavity, oropharynx, hypopharynx, andlarynx.

  • Recurrent or metastatic disease that is not amenable to therapy with curative intent (surgery or radiation therapy with or without chemotherapy)

  • No prior treatment with systemic anti-cancer therapy for SCCHN, unless protocolspecified criteria are met

  • ECOG Performance Status of 0-1

  • Measurable disease by CT or MRI per RECIST 1.1 criteria

Exclusion

Exclusion Criteria:

  • Women who are pregnant or breastfeeding

  • Recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma ofunknown primary, squamous cell carcinoma that originated from the skin and salivarygland or paranasal sinus, non-squamous histologies (eg, mucosal melanoma)

  • Participants with untreated CNS metastases are excluded

  • Participants with carcinomatous meningitis

  • Prior malignancy active within the previous 3 years except for locally curable cancersthat 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 Other protocol defined inclusion/exclusion criteria could apply

Study Design

Study Start date:
March 28, 2018
Estimated Completion Date:
April 19, 2018

Connect with a study center

  • Local Institution

    Caba, Buenos Aires 1118
    Argentina

    Site Not Available

  • Local Institution

    Pergamino, Buenos Aires
    Argentina

    Site Not Available

  • Local Institution

    Viedma, RIO Negro 8500
    Argentina

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  • Local Institution

    Liverpool, New South Wales 2010
    Australia

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  • Local Institution

    North Sydney, New South Wales 2060
    Australia

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    Sydney, New South Wales 2065
    Australia

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    Brisbane, Queensland 4102
    Australia

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    South Brisbane, Queensland 4101
    Australia

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    Elizabeth Vale, South Australia 5112
    Australia

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    East Melbourne, Victoria 3165
    Australia

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  • Local Institution

    Heidelberg, Victoria 3084
    Australia

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  • Local Institution

    Nedlands, Western Australia 6009
    Australia

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  • Local Institution

    Edegem, 2650
    Belgium

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    Leuven, B-300
    Belgium

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  • Local Institution

    Goiacnia, Goias 74605-040
    Brazil

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    Recife, Pernambuco 50040-000
    Brazil

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  • Local Institution

    Ijui, RIO Grande DO SUL 98700-000
    Brazil

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  • Local Institution

    Porto Alegre, RIO Grande DO SUL 90020-090
    Brazil

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  • Local Institution

    Barretos, SAO Paulo 14784-400
    Brazil

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    Sao Jose Do Rio Preto, SAO Paulo 15090-000
    Brazil

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  • Local Institution

    Rio de Janeiro, 22793-080
    Brazil

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  • Local Institution

    Edmonton, Alberta T6G 1Z2
    Canada

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    Halifax, Nova Scotia B3H 2Y9
    Canada

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    Montreal, Quebec H4A 3J1
    Canada

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    Quebec, G1J 1Z4
    Canada

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  • Local Institution

    Vina del Mar, Valparaiso 2540364
    Chile

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    Monteria, Cordoba
    Colombia

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    Bogota,
    Colombia

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    Medellin,
    Colombia

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  • Local Institution

    Brno, 656 53
    Czechia

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    Hradec Kralove, 500 05
    Czechia

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    Olomouc, 779 00
    Czechia

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  • Local Institution

    Bielefeld, 33604
    Germany

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    Essen, 45147
    Germany

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    Gera, 07548
    Germany

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    Hamburg, 22763
    Germany

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    Heilbronn, 74078
    Germany

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    Koblenz, 56068
    Germany

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    Luebeck, 23562
    Germany

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    Munich, 81675
    Germany

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    Brescia, 25123
    Italy

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    Modena, 41124
    Italy

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    Napoli, 80131
    Italy

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    Padova, 35128
    Italy

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    Palermo, 90100
    Italy

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    Savona, 17100
    Italy

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    Nagoya, Aichi 4648681
    Japan

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    Kashiwa-shi, Chiba 2778577
    Japan

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    Matsuyama-shi, Ehime 7910280
    Japan

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    Sapporo-shi, Hokkaido 0608648
    Japan

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    Akashi-shi, Hyogo 6738558
    Japan

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    Kobe-shi, Hyogo 6500017
    Japan

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    Yokohama-shi, Kanagawa 2360004
    Japan

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    Natori, Miyagi 9811293
    Japan

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    Natori-shi, Miyagi 9811293
    Japan

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    Sendai, Miyagi 9808575
    Japan

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    Hidaka-shi, Saitama 3501298
    Japan

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    Chuo-ku, Tokyo 1040045
    Japan

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    Koto-ku, Tokyo 1358550
    Japan

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    Fukuoka, 8111395
    Japan

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    Busan, 602-739
    Korea, Republic of

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    Seoul, 120-752
    Korea, Republic of

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    Mexico, Distrito Federal 14000
    Mexico

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    Monterrey, Nuevo LEON 64320
    Mexico

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    Oaxaca de Juarez, Oaxaca 68040
    Mexico

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    Merida, Yucatan 97070
    Mexico

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    Chihuahua, 31000
    Mexico

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    Bydgoszcz, 85-796
    Poland

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    Gdansk, 80-952
    Poland

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    Gliwice, 44-101
    Poland

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    Krakow, 31-826
    Poland

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    Warszawa, 02-781
    Poland

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  • Local Institution

    Bucharest, 020122
    Romania

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    Bucuresti, 021389
    Romania

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    Cluj-Napoca, 400015
    Romania

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    Craiova, 200347
    Romania

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    Oradea, 410469
    Romania

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  • Local Institution

    Krasnodar, 350040
    Russian Federation

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    Moscow, 125284
    Russian Federation

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  • Local Institution

    Chur, 7000
    Switzerland

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    St.Gallen, 9007
    Switzerland

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    Zuerich, 8091
    Switzerland

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    Taichung, 40705
    Taiwan

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    Taipei,
    Taiwan

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  • Local Institution

    ?stanbul, 34890
    Turkey

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    Adana, 01170
    Turkey

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    Diyarbak?r, 21280
    Turkey

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    Diyarbakır, 21280
    Turkey

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    Izmir, 35000
    Turkey

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  • Local Institution

    İstanbul, 34890
    Turkey

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  • Local Institution

    London, Greater London SW3 6JJ
    United Kingdom

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  • Local Institution

    Sutton, Surrey SM2 5PT
    United Kingdom

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    Leeds, WEST Yorkshire LS9 7TF
    United Kingdom

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    Bebington, CH63 4JY
    United Kingdom

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    Northwood, HA6 2RN
    United Kingdom

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    Whitchurch, CF14 2TL
    United Kingdom

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    Atlanta, Georgia 30322
    United States

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    Decatur, Georgia 30033
    United States

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  • Local Institution

    New Orleans, Louisiana 70121
    United States

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    Boston, Massachusetts 02215
    United States

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    Rochester, New York 14642
    United States

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    Columbus, Ohio 43210
    United States

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    Portland, Oregon 97227
    United States

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    Philadelphia, Pennsylvania 19107
    United States

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  • Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212-0000
    United States

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  • Local Institution

    Charleston, South Carolina 29425
    United States

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  • Local Institution

    Fort Sam Houston, Texas 78234
    United States

    Site Not Available

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