Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

NCT02823574 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: CA209-7142016-001645-64
• Study Type: interventional
• Target: 425
• Locations: 21 countries
• Sites: 105

Brief Summary

A study in patients with metastatic or recurrent squamous cell cancer of the head and neck to evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate 714)

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (3)

• Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup

  ORR is defined as best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. 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.

  Approximately up to 30 months (from FPFV to Data base lock)

• Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup

  The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.

  Approximately up to 30 months (from FPFV to Data base lock)

• Time to Response (TTR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup

  Time to Response (TTR) for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. 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.

  Approximately up to 30 months (from FPFV to Data base lock)

Secondary Outcomes (31)

• Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup

  From randomization to end of study. Approximately 63 Months

• Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup

  From randomization to disease progression or death. Approximately 63 Months

• Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup

  From randomization to disease progression or death. Approximately 63 Months

• Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup

  From randomization to disease progression or death. Approximately 63 Months

• Overall Survival (OS)

  From randomization to death. Approximately 63 Months

Study Arms (2)

Nivolumab and Ipilimumab

EXPERIMENTAL

Specified dose on specified days

Biological: Nivolumab; Biological: Ipilimumab

Nivolumab and Ipilimumab-placebo

ACTIVE COMPARATOR

Specified dose on specified days

Biological: Nivolumab; Other: Placebo

Interventions

Nivolumab BIOLOGICAL

Also known as: Opdivo

Nivolumab and Ipilimumab; Nivolumab and Ipilimumab-placebo

Ipilimumab BIOLOGICAL

Nivolumab and Ipilimumab

Placebo OTHER

Nivolumab and Ipilimumab-placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed squamous cell head and neck cancer
• Widespread (metastatic) disease, or returned after previous treatment (recurrent)
• Tumor sample must be available for analysis of PDL1 (Programmed death-ligand 1) and HPV \[Human Papilloma Virus (oropharynx only)\]
• Performance status ECOG 0-1 (Eastern Cooperative Oncology Group)

You may not qualify if:

• Previous treatment for metastatic or recurrent disease
• Cancer arising from one of the following primary sites: paranasal sinus, nasopharynx, salivary gland, skin
• Any non-squamous subtype
• Active autoimmune disease
• Positive test for hepatitis B, C or HIV (Human Immunodeficiency Virus) virus
• Previous treatment with checkpoint inhibitor drugs
• Active CNS metastases or carcinomatous meningitis

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (105)

University of Arizona Cancer Center

Tucson, Arizona, 85724-5024, United States

Location

Local Institution - 0034

Duarte, California, 91010, United States

Location

Los Angeles Cancer Network

Los Angeles, California, 90017, United States

Location

Ucla Department Of Medicine

Los Angeles, California, 90095, United States

Location

Local Institution - 0098

Redondo Beach, California, 90277, United States

Location

Local Institution - 0004

Sacramento, California, 95816, United States

Location

Local Institution - 0072

San Francisco, California, 94158, United States

Location

Local Institution - 0097

San Luis Obispo, California, 93401, United States

Location

Central Coast Med Oncology

Santa Maria, California, 93454, United States

Location

Local Institution - 0101

New Haven, Connecticut, 06520, United States

Location

Local Institution - 0007

Tampa, Florida, 33612, United States

Location

Local Institution - 0010

Atlanta, Georgia, 30322, United States

Location

Local Institution - 0015

Decatur, Georgia, 30033, United States

Location

Local Institution - 0087

Chicago, Illinois, 60637, United States

Location

Ft. Wayne Med Onco-Hema Inc

Fort Wayne, Indiana, 46845, United States

Location

Local Institution - 0005

Louisville, Kentucky, 40202, United States

Location

Oncology Associated Of Western Kentucky

Paducah, Kentucky, 42003, United States

Location

Local Institution - 0001

Boston, Massachusetts, 02215, United States

Location

Local Institution - 0071

Boston, Massachusetts, 02215, United States

Location

Local Institution - 0042

Rochester, Minnesota, 55905, United States

Location

Mission Hospital, Inc

Asheville, North Carolina, 28801, United States

Location

Local Institution - 0103

Cincinnati, Ohio, 45219, United States

Location

Local Institution - 0070

Cleveland, Ohio, 44106, United States

Location

Local Institution - 0008

Portland, Oregon, 97239, United States

Location

Local Institution - 0006

Pittsburgh, Pennsylvania, 15232, United States

Location

Donald Guthrie Foundation

Sayre, Pennsylvania, 18840, United States

Location

Local Institution - 0102

Dallas, Texas, 75390, United States

Location

Local Institution - 0038

Seattle, Washington, 98109, United States

Location

Local Institution - 0121

Pergamino, Buenos Aires, 0, Argentina

Location

Local Institution - 0111

Buenos Aires, C1181ACH, Argentina

Location

Local Institution - 0023

Ghent, 9000, Belgium

Location

Local Institution - 0074

Sint-Niklaas, 9100, Belgium

Location

Local Institution - 0053

Yvoir, 5530, Belgium

Location

Local Institution - 0046

Belo Horizonte, Minas Gerais, 30130-090, Brazil

Location

Local Institution - 0124

Ipatinga, Minas Gerais, 35160-158, Brazil

Location

Local Institution - 0047

Curitiba, Paraná, 81480-580, Brazil

Location

Local Institution - 0125

Caxias do Sul, Rio Grande do Sul, 95070-560, Brazil

Location

Local Institution - 0051

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Local Institution - 0052

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Local Institution - 0045

Barretos, São Paulo, 14784-400, Brazil

Location

Local Institution - 0123

Santo André, São Paulo, 09060-870, Brazil

Location

Local Institution - 0048

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Local Institution

Rio de Janeiro, 20231-050, Brazil

Location

Local Institution - 0049

São Paulo, 04039-004, Brazil

Location

Local Institution - 0050

São Paulo, 05403-010, Brazil

Location

Local Institution - 0013

Edmonton, Alberta, T6G 1Z2, Canada

Location

Local Institution - 0056

Ottawa, Ontario, K1H 8L6, Canada

Location

Local Institution - 0012

Toronto, Ontario, M5G 1Z5, Canada

Location

Local Institution - 0016

Montreal, Quebec, H2X 3E4, Canada

Location

Local Institution - 0014

Québec, Quebec, G1J 1Z4, Canada

Location

Local Institution - 0115

Santiago, Santiago Metropolitan, Chile

Location

Local Institution - 0022

Brno, 656 53, Czechia

Location

Local Institution - 0020

Hradec Králové, 500 05, Czechia

Location

Local Institution - 0021

Olomouc, 779 00, Czechia

Location

Local Institution - 0069

Helsinki, 00290, Finland

Location

Local Institution - 0032

Amiens, 80054, France

Location

Local Institution - 0120

Bordeaux, 33075, France

Location

Local Institution - 0073

Clermont-Ferrand, 63011, France

Location

Local Institution - 0089

Clichy, 92110, France

Location

Local Institution - 0029

Lyon, 69373, France

Location

Local Institution - 0075

Marseille, 13385, France

Location

Local Institution - 0079

Nice, 06189, France

Location

Local Institution - 0030

Rennes, 35042, France

Location

Local Institution - 0088

Villejuif, 94805, France

Location

Local Institution - 0026

Dublin, Dublin, Ireland

Location

Local Institution

Milan, 20133, Italy

Location

Local Institution - 0119

Napoli, 80131, Italy

Location

Local Institution - 0090

Mérida, Yucatán, 97070, Mexico

Location

Local Institution - 0107

Mérida, Yucatán, 97138, Mexico

Location

Local Institution - 0108

Oaxaca City, 68040, Mexico

Location

Local Institution - 0068

Amsterdam, 1066 CX, Netherlands

Location

Local Institution - 0028

Amsterdam, 1081 HV, Netherlands

Location

Local Institution - 0027

Groningen, 9713 GZ, Netherlands

Location

Local Institution - 0065

Bergen, 5021, Norway

Location

Local Institution - 0064

Oslo, 0379, Norway

Location

Local Institution - 0055

Bucharest, 010991, Romania

Location

Local Institution - 0054

Cluj-Napoca, 400015, Romania

Location

Local Institution - 0033

Craiova, 200347, Romania

Location

Local Institution - 0060

Iași, 700483, Romania

Location

Local Institution - 0059

Suceava, 720237, Romania

Location

Local Institution - 0031

Moscow, 121309, Russia

Location

Local Institution - 0092

Ryazan, 390011, Russia

Location

Local Institution

Port Elizabeth, Eastern Cape, 6045, South Africa

Location

Local Institution

Pretoria, Gauteng, 0084, South Africa

Location

Local Institution - 0017

Sandton, Gauteng, 2199, South Africa

Location

Local Institution

Cape Town, Western Cape, 7700, South Africa

Location

Local Institution - 0040

A Coruña, 15009, Spain

Location

Local Institution - 0116

Barcelona, 08035, Spain

Location

Local Institution - 0039

Barcelona, 08036, Spain

Location

Local Institution - 0077

Madrid, 28041, Spain

Location

Local Institution - 0076

Marbella, 29603, Spain

Location

Local Institution - 0041

San Sabastian Gipuzkoa, 20014, Spain

Location

Local Institution - 0067

Gothenburg, 413 45, Sweden

Location

Local Institution - 0037

Lund, 221 85, Sweden

Location

Local Institution - 0035

Stockholm, 171 76, Sweden

Location

Local Institution - 0063

Adana, 01250, Turkey (Türkiye)

Location

Local Institution - 0066

Antalya, 07070, Turkey (Türkiye)

Location

Local Institution - 0062

Izmir, 35340, Turkey (Türkiye)

Location

Local Institution - 0110

Aberdeen, Aberdeenshire, AB25 2ZN, United Kingdom

Location

Local Institution - 0086

London, Greater London, SW3 6JJ, United Kingdom

Location

Local Institution - 0083

Metropolitan Borough of Wirral, Merseyside, L63 4JY, United Kingdom

Location

Local Institution - 0081

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Local Institution - 0114

Cardiff, CF14 2TL, United Kingdom

Location

Local Institution - 0084

Glasgow, G12 0YN, United Kingdom

Location

Local Institution - 0082

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related Publications (1)

• Harrington KJ, Ferris RL, Gillison M, Tahara M, Argiris A, Fayette J, Schenker M, Bratland A, Walker JWT, Grell P, Even C, Chung CH, Redman R, Coutte A, Salas S, Grant C, de Azevedo S, Soulieres D, Hansen AR, Wei L, Khan TA, Miller-Moslin K, Roberts M, Haddad R. Efficacy and Safety of Nivolumab Plus Ipilimumab vs Nivolumab Alone for Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: The Phase 2 CheckMate 714 Randomized Clinical Trial. JAMA Oncol. 2023 Jun 1;9(6):779-789. doi: 10.1001/jamaoncol.2023.0147.

  PMID: 37022706 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.gov

Please Email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: July 1, 2016
• First Posted: July 6, 2016
• Study Start: November 8, 2016
• Primary Completion: January 23, 2019
• Study Completion: April 21, 2022
• Last Updated: May 3, 2023
• Results First Posted: April 21, 2022

Record last verified: 2023-04

Locations

IE (1); AR (2); CA (5); ES (6); US (28); TU (3); SE (3); CL (1); CZ (3); IT (2); FR (9); FI (1); RO (5); ME (3); GB (7); BE (3); NL (3); NO (2); ZA (4); BR (12); RU (2)