Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

PHASE3CompletedINTERVENTIONAL
Enrollment

947

Participants

Timeline

Start Date

October 5, 2016

Primary Completion Date

May 10, 2021

Study Completion Date

September 22, 2022

Conditions
Head and Neck Cancer
Interventions
BIOLOGICAL

Nivolumab

BIOLOGICAL

Ipilimumab

DRUG

Cetuximab/Erbitux

DRUG

Cisplatin/Platinol

DRUG

Carboplatin/Paraplatin

DRUG

Fluorouracil/Adrucil

Trial Locations (133)

1090

Local Institution - 0071, Vienna

2010

Local Institution - 0127, Darlinghurst

2065

Local Institution - 0019, St Leonards

2148

Local Institution - 0142, Blacktown

2250

Local Institution - 0128, Gosford

3000

Local Institution - 0131, Melbourne

3168

Local Institution - 0022, Clayton

4010

Local Institution - 0075, Linz

4031

Local Institution - 0072, Basel

4102

Local Institution - 0077, Brisbane

4814

Local Institution - 0036, Douglas

5112

Local Institution - 0021, Elizabeth Vale

6009

Local Institution - 0020, Nedlands

8091

Local Institution - 0073, Zurich

10002

Local Institution - 0098, Taipei

10126

Local Institution - 0043, Torino

12100

Local Institution - 0044, Cuneo

13005

Local Institution - 0126, Marseille

14000

Local Institution - 0030, Mexico City

14564

Local Institution - 0017, Nea Kifissia

15123

Local Institution - 0018, Athens

15232

Local Institution - 0013, Pittsburgh

19047

Local Institution - 0010, Langhorne

19107

Local Institution - 0015, Philadelphia

20133

Local Institution - 0042, Milan

20246

Local Institution - 0067, Hamburg

22301

Local Institution - 0011, Fairfax

22908

Local Institution - 0003, Charlottesville

28034

Local Institution - 0085, Madrid

28041

Local Institution - 0082, Madrid

28204

Local Institution - 0012, Charlotte

30322

Local Institution - 0111, Atlanta

30625

Local Institution - 0092, Hanover

31096

Local Institution - 0062, Haifa

32204

Local Institution - 0028, Jacksonville

33075

Local Institution - 0094, Bordeaux

33612

Local Institution - 0008, Tampa

37000

Local Institution - 0032, León

38700

Local Institution - 0140, La Tronche

40705

Local Institution - 0097, Taichung

41013

Local Institution - 0084, Seville

41124

Azienda Ospedaliera Universitaria Di Modena, Modena

43210

Local Institution - 0007, Columbus

46026

Local Institution - 0081, Valencia

47014

IRST Meldola, Meldola (FC)

48109

Local Institution - 0004, Ann Arbor

49100

Local Institution - 0063, Petah Tikva

52621

Local Institution - 0061, Ramat Gan

53127

Local Institution - 0068, Bonn

54007

Local Institution - 0051, Thessaloniki

55131

Local Institution - 0070, Mainz

58000

Local Institution - 0031, Morelia

59000

Local Institution - 0090, Lille

60637

Local Institution - 0006, Chicago

64239

Local Institution - 0064, Tel Aviv

64320

Local Institution - 0033, Monterrey

67200

Local Institution - 0089, Strasbourg

68000

Local Institution - 0035, Oaxaca City

69004

Local Institution - 0138, Lyon

69120

Local Institution - 0079, Heidelberg

69373

Local Institution - 0054, Lyon

75005

Local Institution - 0039, Paris

75020

Local Institution - 0088, Paris

75390

Local Institution - 0139, Dallas

75908

Local Institution, Paris

77030

Local Institution - 0009, Houston

Local Institution - 0014, Houston

79106

Local Institution - 0078, Freiburg im Breisgau

80054

Local Institution - 0133, Amiens

80131

Aorn Dei Colli, Napoli

Istituto Nazionale Tumori Fondazione Pascale, Napoli

81675

Local Institution - 0065, München

89081

Local Institution - 0069, Ulm

91010

Local Institution - 0135, Duarte

91120

Local Institution - 0060, Jerusalem

94305

Local Institution - 0005, Stanford

94805

Local Institution - 0040, Villejuif

97070

Local Institution - 0066, Würzburg

1040045

Local Institution - 0101, Chuo-ku

1138519

Local Institution - 0153, Bunkyo-ku

2360004

Local Institution - 0150, Yokohama

2591193

Local Institution - 0152, Isehara

3290498

Local Institution, Shimotsuke-shi

3620806

Local Institution - 0149, Kitaadachi-gun

4118777

Local Institution - 0114, Sunto-gun

4648681

Local Institution - 0106, Nagoya

5698686

Local Institution - 0099, Takatsuki-shi

5898511

Local Institution - 0146, Osakasayaha

6738558

Local Institution - 0107, Akashi-shi

7610793

Local Institution - 0109, Kita-gun

8108563

Local Institution - 0113, Fukuoka

9808574

Local Institution - 0108, Sendai

9811293

Local Institution - 0151, Natori-shi

90610000

Local Institution - 0120, Porto Alegre

85724-5024

Local Institution - 0134, Tucson

02215

Local Institution - 0001, Boston

Local Institution - 0080, Boston

Local Institution - 0093, Boston

26506-9162

Local Institution - 0125, Morgantown

30130-090

Local Institution - 0148, Belo Horizonte

98700-000

Local Institution - 0121, Ijuí

90035-903

Local Institution - 0122, Porto Alegre

14784-400

Local Institution - 0117, Barretos

15091-000

Local Institution - 0123, Sao Jose de Rio Preto

01246-000

Local Institution - 0118, São Paulo

04039-004

Local Institution - 0124, São Paulo

06189

Local Institution - 0055, Nice

04103

Local Institution - 0074, Leipzig

Unknown

Local Institution - 0147, Dublin

06132

Azienda Ospedaliera Di Perugia, Perugia

00168

Fondazione Policlinico Universitario A. Gemelli, Roma

277-8577

Local Institution - 0100, Kashiwa

0608648

Local Institution - 0105, Sapporo

650-0017

Local Institution - 0102, Kobe

135-8550

Local Institution - 0104, Koto-ku

03100

Local Institution - 0034, Mexico City

85-796

Local Institution - 0037, Bydgoszcz

80-952

Local Institution - 0023, Gdansk

44-101

Local Institution - 0129, Gliwice

31-826

Local Institution - 0026, Krakow

02-781

Local Institution - 0025, Warsaw

06351

Local Institution - 0096, Gangnam-gu

05505

Local Institution - 0110, Seoul

06591

Local Institution - 0095, Seoul

08035

Local Institution - 0083, Barcelona

08908

Local Institution - 0130, L'Hospitalet Del Llobregat

NE4 6BE

Local Institution - 0049, Newcastle upon Tyne

SW3 6JJ

Local Institution - 0045, London

M20 4BX

Local Institution - 0046, Manchester

SO16 6YD

Local Institution - 0047, Southampton

SM2 5PT

Local Institution - 0091, Sutton

B15 2TH

Local Institution - 0050, Birmingham

S10 2SJ

Local Institution - 0132, Sheffield

Sponsors
All Listed Sponsors
collaborator

Ono Pharmaceutical Co. Ltd

INDUSTRY

lead

Bristol-Myers Squibb

INDUSTRY