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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 (CheckMate 651)

Primary Purpose

Head and Neck Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Nivolumab

Ipilimumab

Cetuximab/Erbitux

Cisplatin/Platinol

Carboplatin/Paraplatin

Fluorouracil/Adrucil

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically confirmed metastatic or recurrent squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx & larynx) that is not amenable to curative therapy.
No prior systemic cancer therapy for recurrent or metastatic disease (except if chemotherapy was part of multimodal treatment completed 6 months prior to enrolment).
Measurable disease detected by imaging exam (CT or MRI).
Have tumor tissue for PD L1 expression testing, and for oropharyngeal cancer have results from testing of HPV p16 status.

Exclusion Criteria:

Metastatic or recurrent carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell carcinoma originating from skin and salivary glands or non squamous histologies (eg. mucosal melanoma).
No prior treatment with anti PD1, anti PD L1, anti CTLA 4 antibody or any other antibody or drugs targeting T cell costimulation or checkpoint pathways, or cetuximab or EGFR inhibitors in any treatment setting.
Participants with certain diseases such as active autoimmune disease, type I diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorder.
Inadequate hematologic, renal or hepatic function.

Other protocol defined inclusion/exclusion criteria could apply

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nivolumab and Ipilimumab

Extreme Regimen

Arm Description

Specified dose on specified days

Outcomes

Primary Outcome Measures

Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20

Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates)

Overall Survival (OS) in All Randomized Participants

Secondary Outcome Measures

Overall Survival (OS) in Randomized Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥ 1

Progression Free Survival (PFS)

PFS is defined as the time between the date of randomization and the date of first documented tumor progression, based on Blinded Independent Central Review (BICR) assessments (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria), or death due to any cause, whichever occurs first. Participants who neither progress nor die will be censored on the date of their last tumor assessment. Participants who receive subsequent anti-cancer therapy prior to documented progression, will be censored on the date of their last tumor assessment prior to subsequent therapy. (Based on Kaplan-Meier Estimates) Progression is defined as at least a 20% increase in the sum of diameters of target lesions, in addition the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Objective Response Rate (ORR)

Objective Response Rate (ORR) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria by blinded independent central review (BICR) assessment. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Duration of Objective Response (DOR)

The time between the first documented response (Complete response (CR) or partial response (PR)) and progression or death, per RECIST 1.1 by blinded independent central review (BICR) assessment. (Based on Kaplan-Meier Estimates) Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Full Information

NCT ID

NCT02741570

First Posted

April 13, 2016

Last Updated

August 31, 2023

Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02741570

Brief Title

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

Acronym

CheckMate 651

Official Title

An Open Label, Randomized, Two Arm Phase III Study of Nivolumab in Combination With Ipilimumab Versus Extreme Study Regimen (Cetuximab + Cisplatin/Carboplatin + Fluorouracil) as First Line Therapy in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

October 5, 2016 (Actual)

Primary Completion Date

May 10, 2021 (Actual)

Study Completion Date

September 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The main purpose of this study is to compare nivolumab and ipilimumab with the extreme regimen as first line treatment in patients with recurrent or metastatic squamous cell of the head and neck cancer

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

947 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nivolumab and Ipilimumab

Arm Type

Experimental

Arm Description

Specified dose on specified days

Arm Title

Extreme Regimen

Arm Type

Active Comparator

Arm Description

Specified dose on specified days

Intervention Type

Biological

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

BMS-936558, Opdivo

Intervention Type

Biological

Intervention Name(s)

Ipilimumab

Other Intervention Name(s)

BMS-734016, Yervoy

Intervention Type

Drug

Intervention Name(s)

Cetuximab/Erbitux

Intervention Type

Drug

Intervention Name(s)

Cisplatin/Platinol

Intervention Type

Drug

Intervention Name(s)

Carboplatin/Paraplatin

Intervention Type

Drug

Intervention Name(s)

Fluorouracil/Adrucil

Primary Outcome Measure Information:

Title

Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20

Description

Time Frame

From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months)

Title

Overall Survival (OS) in All Randomized Participants

Description

Time Frame

From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months)

Secondary Outcome Measure Information:

Title

Overall Survival (OS) in Randomized Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥ 1

Description

Time Frame

From randomization to date of death or date the participant was last known to be alive (Up to approximately 65 months)

Title

Progression Free Survival (PFS)

Description

Time Frame

From randomization to disease progression or death (Up to approximately 65 months)

Title

Objective Response Rate (ORR)

Description

Time Frame

From randomization up to approximately 65 months

Title

Duration of Objective Response (DOR)

Description

Time Frame

From randomization to the first documented response (CR or PR) and progression (up to approximately 65 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed metastatic or recurrent squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx & larynx) that is not amenable to curative therapy. No prior systemic cancer therapy for recurrent or metastatic disease (except if chemotherapy was part of multimodal treatment completed 6 months prior to enrolment). Measurable disease detected by imaging exam (CT or MRI). Have tumor tissue for PD L1 expression testing, and for oropharyngeal cancer have results from testing of HPV p16 status. Exclusion Criteria: Metastatic or recurrent carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell carcinoma originating from skin and salivary glands or non squamous histologies (eg. mucosal melanoma). No prior treatment with anti PD1, anti PD L1, anti CTLA 4 antibody or any other antibody or drugs targeting T cell costimulation or checkpoint pathways, or cetuximab or EGFR inhibitors in any treatment setting. Participants with certain diseases such as active autoimmune disease, type I diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorder. Inadequate hematologic, renal or hepatic function. Other protocol defined inclusion/exclusion criteria could apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Local Institution - 0134

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724-5024

Country

United States

Facility Name

Local Institution - 0135

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Facility Name

Local Institution - 0005

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Local Institution - 0028

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32204

Country

United States

Facility Name

Local Institution - 0008

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Local Institution - 0111

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Local Institution - 0006

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Local Institution - 0001

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Local Institution - 0080

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Local Institution - 0093

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Local Institution - 0004

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Local Institution - 0012

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Local Institution - 0007

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Local Institution - 0010

City

Langhorne

State/Province

Pennsylvania

ZIP/Postal Code

19047

Country

United States

Facility Name

Local Institution - 0015

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Local Institution - 0013

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Facility Name

Local Institution - 0139

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

Local Institution - 0009

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Local Institution - 0014

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Local Institution - 0003

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Facility Name

Local Institution - 0011

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22301

Country

United States

Facility Name

Local Institution - 0125

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506-9162

Country

United States

Facility Name

Local Institution - 0142

City

Blacktown

State/Province

New South Wales

ZIP/Postal Code

2148

Country

Australia

Facility Name

Local Institution - 0127

City

Darlinghurst

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

Local Institution - 0128

City

Gosford

State/Province

New South Wales

ZIP/Postal Code

2250

Country

Australia

Facility Name

Local Institution - 0019

City

St. Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

Local Institution - 0077

City

Brisbane

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Local Institution - 0036

City

Douglas

State/Province

Queensland

ZIP/Postal Code

4814

Country

Australia

Facility Name

Local Institution - 0021

City

Elizabeth Vale

State/Province

South Australia

ZIP/Postal Code

5112

Country

Australia

Facility Name

Local Institution - 0022

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

Local Institution - 0131

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3000

Country

Australia

Facility Name

Local Institution - 0020

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

Local Institution - 0075

City

Linz

ZIP/Postal Code

4010

Country

Austria

Facility Name

Local Institution - 0071

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Local Institution - 0148

City

Belo Horizonte

State/Province

Minas Gerais

ZIP/Postal Code

30130-090

Country

Brazil

Facility Name

Local Institution - 0121

City

Ijui

State/Province

RIO Grande DO SUL

ZIP/Postal Code

98700-000

Country

Brazil

Facility Name

Local Institution - 0122

City

Porto Alegre

State/Province

RIO Grande DO SUL

ZIP/Postal Code

90035-903

Country

Brazil

Facility Name

Local Institution - 0120

City

Porto Alegre

State/Province

RIO Grande DO SUL

ZIP/Postal Code

90610000

Country

Brazil

Facility Name

Local Institution - 0117

City

Barretos

State/Province

Sao Paulo

ZIP/Postal Code

14784-400

Country

Brazil

Facility Name

Local Institution - 0123

City

Sao Jose De Rio Preto

State/Province

Sao Paulo

ZIP/Postal Code

15091-000

Country

Brazil

Facility Name

Local Institution - 0118

City

Sao Paulo

ZIP/Postal Code

01246-000

Country

Brazil

Facility Name

Local Institution - 0124

City

Sao Paulo

ZIP/Postal Code

04039-004

Country

Brazil

Facility Name

Local Institution - 0133

City

Amiens

State/Province

Somme

ZIP/Postal Code

80054

Country

France

Facility Name

Local Institution - 0094

City

Bordeaux

ZIP/Postal Code

33075

Country

France

Facility Name

Local Institution - 0140

City

La Tronche

ZIP/Postal Code

38700

Country

France

Facility Name

Local Institution - 0090

City

Lille

ZIP/Postal Code

59000

Country

France

Facility Name

Local Institution - 0138

City

Lyon

ZIP/Postal Code

69004

Country

France

Facility Name

Local Institution - 0054

City

Lyon

ZIP/Postal Code

69373

Country

France

Facility Name

Local Institution - 0126

City

Marseille

ZIP/Postal Code

13005

Country

France

Facility Name

Local Institution - 0055

City

Nice Cedex 2

ZIP/Postal Code

06189

Country

France

Facility Name

Local Institution - 0039

City

Paris

ZIP/Postal Code

75005

Country

France

Facility Name

Local Institution - 0088

City

Paris

ZIP/Postal Code

75020

Country

France

Facility Name

Local Institution

City

Paris

ZIP/Postal Code

75908

Country

France

Facility Name

Local Institution - 0089

City

Strasbourg

ZIP/Postal Code

67200

Country

France

Facility Name

Local Institution - 0040

City

Villejuif Cedex

ZIP/Postal Code

94805

Country

France

Facility Name

Local Institution - 0068

City

Bonn

ZIP/Postal Code

53127

Country

Germany

Facility Name

Local Institution - 0078

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Local Institution - 0067

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Local Institution - 0092

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Local Institution - 0079

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Local Institution - 0074

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Local Institution - 0070

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Local Institution - 0065

City

Muenchen

ZIP/Postal Code

81675

Country

Germany

Facility Name

Local Institution - 0069

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Local Institution - 0066

City

Wuerzburg

ZIP/Postal Code

97070

Country

Germany

Facility Name

Local Institution - 0018

City

Athens

ZIP/Postal Code

15123

Country

Greece

Facility Name

Local Institution - 0017

City

Nea Kifissia

ZIP/Postal Code

14564

Country

Greece

Facility Name

Local Institution - 0051

City

Thessaloniki

ZIP/Postal Code

54007

Country

Greece

Facility Name

Local Institution - 0147

City

Dublin 8

State/Province

Dublin

Country

Ireland

Facility Name

Local Institution - 0062

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Local Institution - 0060

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Local Institution - 0063

City

Petah-tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Local Institution - 0061

City

Ramat-gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Local Institution - 0064

City

Tel-Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Local Institution - 0042

City

Milano

State/Province

ZIP/Postal Code

20133

Country

Italy

Facility Name

Local Institution - 0043

City

Torino

State/Province

ZIP/Postal Code

10126

Country

Italy

Facility Name

Local Institution - 0044

City

Cuneo

ZIP/Postal Code

12100

Country

Italy

Facility Name

IRST Meldola

City

Meldola (fc)

ZIP/Postal Code

47014

Country

Italy

Facility Name

Azienda Ospedaliera Universitaria Di Modena

City

Modena

ZIP/Postal Code

41124

Country

Italy

Facility Name

Aorn Dei Colli

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Istituto Nazionale Tumori Fondazione Pascale

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Azienda Ospedaliera Di Perugia

City

Perugia

ZIP/Postal Code

06132

Country

Italy

Facility Name

Fondazione Policlinico Universitario A. Gemelli

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

Local Institution - 0106

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

4648681

Country

Japan

Facility Name

Local Institution - 0100

City

Kashiwa

State/Province

Chiba

ZIP/Postal Code

277-8577

Country

Japan

Facility Name

Local Institution - 0113

City

Fukuoka-shi

State/Province

Fukuoka

ZIP/Postal Code

8108563

Country

Japan

Facility Name

Local Institution - 0105

City

Sapporo-shi

State/Province

Hokkaido

ZIP/Postal Code

0608648

Country

Japan

Facility Name

Local Institution - 0107

City

Akashi-shi

State/Province

Hyogo

ZIP/Postal Code

6738558

Country

Japan

Facility Name

Local Institution - 0102

City

Kobe-shi

State/Province

Hyogo

ZIP/Postal Code

650-0017

Country

Japan

Facility Name

Local Institution - 0152

City

Isehara

State/Province

Kanagawa

ZIP/Postal Code

2591193

Country

Japan

Facility Name

Local Institution - 0150

City

Yokohama-shi

State/Province

Kanagawa

ZIP/Postal Code

2360004

Country

Japan

Facility Name

Local Institution - 0151

City

Natori-shi

State/Province

Miyagi

ZIP/Postal Code

9811293

Country

Japan

Facility Name

Local Institution - 0108

City

Sendai-shi

State/Province

Miyagi

ZIP/Postal Code

9808574

Country

Japan

Facility Name

Local Institution - 0146

City

Osakasayaha

State/Province

Osaka

ZIP/Postal Code

5898511

Country

Japan

Facility Name

Local Institution - 0099

City

Takatsuki-shi

State/Province

Osaka

ZIP/Postal Code

5698686

Country

Japan

Facility Name

Local Institution - 0149

City

Kitaadachi-gun

State/Province

Saitama

ZIP/Postal Code

3620806

Country

Japan

Facility Name

Local Institution - 0114

City

Sunto-gun

State/Province

Shizuoka

ZIP/Postal Code

4118777

Country

Japan

Facility Name

Local Institution

City

Shimotsuke-shi

State/Province

Tochigi

ZIP/Postal Code

3290498

Country

Japan

Facility Name

Local Institution - 0153

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

1138519

Country

Japan

Facility Name

Local Institution - 0101

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

1040045

Country

Japan

Facility Name

Local Institution - 0104

City

Koto-ku

State/Province

Tokyo

ZIP/Postal Code

135-8550

Country

Japan

Facility Name

Local Institution - 0109

City

Kita-gun

ZIP/Postal Code

7610793

Country

Japan

Facility Name

Local Institution - 0096

City

Gangnam-gu

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Local Institution - 0110

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Local Institution - 0095

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Local Institution - 0034

City

Mexico City

State/Province

Distrito Federal

ZIP/Postal Code

03100

Country

Mexico

Facility Name

Local Institution - 0030

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

14000

Country

Mexico

Facility Name

Local Institution - 0032

City

Leon de los Aldama

State/Province

Guanajuato

ZIP/Postal Code

37000

Country

Mexico

Facility Name

Local Institution - 0031

City

Morelia

State/Province

Michoacan

ZIP/Postal Code

58000

Country

Mexico

Facility Name

Local Institution - 0033

City

Monterrey

State/Province

Nuevo LEON

ZIP/Postal Code

64320

Country

Mexico

Facility Name

Local Institution - 0035

City

Oaxaca

ZIP/Postal Code

68000

Country

Mexico

Facility Name

Local Institution - 0037

City

Bydgoszcz

ZIP/Postal Code

85-796

Country

Poland

Facility Name

Local Institution - 0023

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Local Institution - 0129

City

Gliwice

ZIP/Postal Code

44-101

Country

Poland

Facility Name

Local Institution - 0026

City

Krakow

ZIP/Postal Code

31-826

Country

Poland

Facility Name

Local Institution - 0025

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Local Institution - 0083

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Local Institution - 0130

City

L'Hospitalet Del Llobregat

ZIP/Postal Code

08908

Country

Spain

Facility Name

Local Institution - 0085

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Local Institution - 0082

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Local Institution - 0084

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Local Institution - 0081

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Local Institution - 0072

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Local Institution - 0073

City

Zuerich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Local Institution - 0097

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

Local Institution - 0098

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Local Institution - 0049

City

Newcastle Upon Tyne

State/Province

Durham

ZIP/Postal Code

NE4 6BE

Country

United Kingdom

Facility Name

Local Institution - 0045

City

London

State/Province

Greater London

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Facility Name

Local Institution - 0046

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Local Institution - 0047

City

Southampton

State/Province

Hampshire

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

Local Institution - 0091

City

Sutton

State/Province

Surrey

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Facility Name

Local Institution - 0050

City

Birmingham

State/Province

West Midlands

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

Local Institution - 0132

City

Sheffield

ZIP/Postal Code

S10 2SJ

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

33684371

Citation

Hwang M, Seiwert TY. Are taxanes the future for head and neck cancer? Pragmatism in the immunotherapy era. Lancet Oncol. 2021 Apr;22(4):413-415. doi: 10.1016/S1470-2045(21)00121-2. Epub 2021 Mar 5. No abstract available. Erratum In: Lancet Oncol. 2021 Apr;22(4):e134.

Results Reference

derived

Links:

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

BMS Clinical Trial Information

URL

https://www.bmsstudyconnect.com/s/US/English/USenHome

Description

BMS Clinical Trial Patient Recruiting

URL

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

Description

FDA Safety Alerts and Recalls

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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 (CheckMate 651)

Head and Neck Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial