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

Description

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)

Study Start Date

September, 22 2016

Estimated Completion Date

October 2020

Interventions

  • Biological: Ipilimumab
  • Other: Placebo
  • Biological: Nivolumab

Study ID

Bristol-Myers Squibb -- CA209-714

Status

Recruiting

Trial ID

NCT02823574

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

400

Sponsor

Bristol-Myers Squibb

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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 Other protocol defined inclusion/exclusion criteria could apply

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (142)

Study Location Distance Name Phone Email
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Robert Haddad Site 0001 617-632-6817 None
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Robert Haddad Site 0001 617-632-6817 None
Mass General Hospital - Boston, Massachusetts 2.4 miles Robert Haddad Site 0071 None None
Mass General Hospital - Boston, Massachusetts 2.4 miles Robert Haddad Site 0071 None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Robert Haddad Site 0001 617-632-6817 None
Mass General Hospital - Boston, Massachusetts 2.4 miles Robert Haddad Site 0071 None None
Mass General Hospital - Boston, Massachusetts 2.4 miles Robert Haddad Site 0071 None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Robert Haddad Site 0001 617-632-6817 None
Mass General Hospital - Boston, Massachusetts 2.4 miles Robert Haddad Site 0071 None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Robert Haddad Site 0001 617-632-6817 None
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Robert Haddad Site 0001 617-632-6817 None
Mass General Hospital - Boston, Massachusetts 2.4 miles Robert Haddad Site 0071 None None
Yale University School Of Medicine - New Haven, Connecticut 119.2 miles Barbara Burtness Site 0101 None None
Yale University School Of Medicine - New Haven, Connecticut 119.2 miles Barbara Burtness Site 0101 None None
Yale University School Of Medicine - New Haven, Connecticut 119.2 miles Barbara Burtness Site 0101 None None
Yale University School Of Medicine - New Haven, Connecticut 119.2 miles Barbara Burtness Site 0101 None None
Yale University School Of Medicine - New Haven, Connecticut 119.2 miles Barbara Burtness Site 0101 None None
Yale University School Of Medicine - New Haven, Connecticut 119.2 miles Barbara Burtness Site 0101 None None
Donald Guthrie Foundation - Sayre, Pennsylvania 279.7 miles Philip Lowry Site 0009 None None
Donald Guthrie Foundation - Sayre, Pennsylvania 279.7 miles Philip Lowry Site 0009 None None
Donald Guthrie Foundation - Sayre, Pennsylvania 279.7 miles Philip Lowry Site 0009 None None
Donald Guthrie Foundation - Sayre, Pennsylvania 279.7 miles Philip Lowry Site 0009 None None
Donald Guthrie Foundation - Sayre, Pennsylvania 279.7 miles Philip Lowry Site 0009 None None
Donald Guthrie Foundation - Sayre, Pennsylvania 279.7 miles Philip Lowry Site 0009 None None
UPMC - Pittsburgh, Pennsylvania 477.2 miles Robert Ferris Site 0006 None None
UPMC - Pittsburgh, Pennsylvania 477.2 miles Robert Ferris Site 0006 None None
UPMC - Pittsburgh, Pennsylvania 477.2 miles Robert Ferris Site 0006 None None
UPMC - Pittsburgh, Pennsylvania 477.2 miles Robert Ferris Site 0006 None None
UPMC - Pittsburgh, Pennsylvania 477.2 miles Robert Ferris Site 0006 None None
UPMC - Pittsburgh, Pennsylvania 477.2 miles Robert Ferris Site 0006 None None
University Hospitals Cleveland Medical Center - Cleveland, Ohio 544.0 miles Michael Gibson Site 0070 216-844-1545 None
University Hospitals Cleveland Medical Center - Cleveland, Ohio 544.0 miles Michael Gibson Site 0070 216-844-1545 None
University Hospitals Cleveland Medical Center - Cleveland, Ohio 544.0 miles Michael Gibson Site 0070 216-844-1545 None
University Hospitals Cleveland Medical Center - Cleveland, Ohio 544.0 miles Michael Gibson Site 0070 216-844-1545 None
University Hospitals Cleveland Medical Center - Cleveland, Ohio 544.0 miles Michael Gibson Site 0070 216-844-1545 None
University Hospitals Cleveland Medical Center - Cleveland, Ohio 544.0 miles Michael Gibson Site 0070 216-844-1545 None
Ft Wayne Med OncoHema Inc - Fort Wayne, Indiana 727.2 miles Sunil Babu Site 0095 None None
Ft Wayne Med OncoHema Inc - Fort Wayne, Indiana 727.2 miles Sunil Babu Site 0095 None None
Ft Wayne Med OncoHema Inc - Fort Wayne, Indiana 727.2 miles Sunil Babu Site 0095 None None
Ft Wayne Med OncoHema Inc - Fort Wayne, Indiana 727.2 miles Sunil Babu Site 0095 None None
Ft Wayne Med OncoHema Inc - Fort Wayne, Indiana 727.2 miles Sunil Babu Site 0095 None None
Ft Wayne Med OncoHema Inc - Fort Wayne, Indiana 727.2 miles Sunil Babu Site 0095 None None
University Of Cincinnati Medical School - Cincinnati, Ohio 737.6 miles Trisha WiseDraper Site 0103 None None
University Of Cincinnati Medical School - Cincinnati, Ohio 737.6 miles Trisha WiseDraper Site 0103 None None
University Of Cincinnati Medical School - Cincinnati, Ohio 737.6 miles Trisha WiseDraper Site 0103 None None
University Of Cincinnati Medical School - Cincinnati, Ohio 737.6 miles Trisha WiseDraper Site 0103 None None
University Of Cincinnati Medical School - Cincinnati, Ohio 737.6 miles Trisha WiseDraper Site 0103 None None
University Of Cincinnati Medical School - Cincinnati, Ohio 737.6 miles Trisha WiseDraper Site 0103 None None
Mission Hospital Inc - Asheville, North Carolina 773.5 miles Christopher Chay Site 0011 828-213-2539 None
Mission Hospital Inc - Asheville, North Carolina 773.5 miles Christopher Chay Site 0011 828-213-2539 None
Mission Hospital Inc - Asheville, North Carolina 773.5 miles Christopher Chay Site 0011 828-213-2539 None
Mission Hospital Inc - Asheville, North Carolina 773.5 miles Christopher Chay Site 0011 828-213-2539 None
Mission Hospital Inc - Asheville, North Carolina 773.5 miles Christopher Chay Site 0011 828-213-2539 None
Mission Hospital Inc - Asheville, North Carolina 773.5 miles Christopher Chay Site 0011 828-213-2539 None
University Of Louisville - Louisville, Kentucky 823.2 miles None None None
University Of Louisville - Louisville, Kentucky 823.2 miles None None None
University Of Louisville - Louisville, Kentucky 823.2 miles None None None
University Of Louisville - Louisville, Kentucky 823.2 miles None None None
University Of Chicago - Chicago, Illinois 848.0 miles Everett Vokes Site 0087 None None
University Of Chicago - Chicago, Illinois 848.0 miles Everett Vokes Site 0087 None None
University Of Chicago - Chicago, Illinois 848.0 miles Everett Vokes Site 0087 None None
University Of Chicago - Chicago, Illinois 848.0 miles Everett Vokes Site 0087 None None
University Of Chicago - Chicago, Illinois 848.0 miles Everett Vokes Site 0087 None None
University Of Chicago - Chicago, Illinois 848.0 miles Everett Vokes Site 0087 None None
Winship Cancer Institute - Atlanta, Georgia 932.0 miles Dong Shin Site 0010 404-686-2553 None
Winship Cancer Institute - Atlanta, Georgia 932.0 miles Dong Shin Site 0010 404-686-2553 None
Winship Cancer Institute - Atlanta, Georgia 932.0 miles Dong Shin Site 0010 404-686-2553 None
Winship Cancer Institute - Atlanta, Georgia 932.0 miles Dong Shin Site 0010 404-686-2553 None
Winship Cancer Institute - Atlanta, Georgia 932.0 miles Dong Shin Site 0010 404-686-2553 None
Winship Cancer Institute - Atlanta, Georgia 932.0 miles Dong Shin Site 0010 404-686-2553 None
Oncology Associated Of Western Kentucky - Paducah, Kentucky 1,000.2 miles Winston Chua Site 0100 None None
Oncology Associated Of Western Kentucky - Paducah, Kentucky 1,000.2 miles Winston Chua Site 0100 None None
Oncology Associated Of Western Kentucky - Paducah, Kentucky 1,000.2 miles Winston Chua Site 0100 None None
Oncology Associated Of Western Kentucky - Paducah, Kentucky 1,000.2 miles Winston Chua Site 0100 None None
Oncology Associated Of Western Kentucky - Paducah, Kentucky 1,000.2 miles Winston Chua Site 0100 None None
Oncology Associated Of Western Kentucky - Paducah, Kentucky 1,000.2 miles Winston Chua Site 0100 None None
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Katharine Price Site 0042 None None
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Katharine Price Site 0042 None None
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Katharine Price Site 0042 None None
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Katharine Price Site 0042 None None
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Katharine Price Site 0042 None None
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Katharine Price Site 0042 None None
UT Southwestern Medical Center - Dallas, Texas 1,543.9 miles Saad Khan Site 0102 None None
UT Southwestern Medical Center - Dallas, Texas 1,543.9 miles Saad Khan Site 0102 None None
UT Southwestern Medical Center - Dallas, Texas 1,543.9 miles Saad Khan Site 0102 None None
UT Southwestern Medical Center - Dallas, Texas 1,543.9 miles Saad Khan Site 0102 None None
UT Southwestern Medical Center - Dallas, Texas 1,543.9 miles Saad Khan Site 0102 None None
UT Southwestern Medical Center - Dallas, Texas 1,543.9 miles Saad Khan Site 0102 None None
Oregon Health Science University - Portland, Oregon 2,538.3 miles Khaled Tolba Site 0008 503-418-9652 None
Oregon Health Science University - Portland, Oregon 2,538.3 miles Khaled Tolba Site 0008 503-418-9652 None
Oregon Health Science University - Portland, Oregon 2,538.3 miles Khaled Tolba Site 0008 503-418-9652 None
Oregon Health Science University - Portland, Oregon 2,538.3 miles Khaled Tolba Site 0008 503-418-9652 None
Oregon Health Science University - Portland, Oregon 2,538.3 miles Khaled Tolba Site 0008 503-418-9652 None
Oregon Health Science University - Portland, Oregon 2,538.3 miles Khaled Tolba Site 0008 503-418-9652 None
City Of Hope - Duarte, California 2,578.2 miles Erminia Massarelli Site 0034 None None
City Of Hope - Duarte, California 2,578.2 miles Erminia Massarelli Site 0034 None None
City Of Hope - Duarte, California 2,578.2 miles Erminia Massarelli Site 0034 None None
City Of Hope - Duarte, California 2,578.2 miles Erminia Massarelli Site 0034 None None
City Of Hope - Duarte, California 2,578.2 miles Erminia Massarelli Site 0034 None None
City Of Hope - Duarte, California 2,578.2 miles Erminia Massarelli Site 0034 None None
Los Angeles Cancer Network - Los Angeles, California 2,596.3 miles Lasika Seneviratne Site 0099 None None
Los Angeles Cancer Network - Los Angeles, California 2,596.3 miles Lasika Seneviratne Site 0099 None None
Los Angeles Cancer Network - Los Angeles, California 2,596.3 miles Lasika Seneviratne Site 0099 None None
Los Angeles Cancer Network - Los Angeles, California 2,596.3 miles Lasika Seneviratne Site 0099 None None
Los Angeles Cancer Network - Los Angeles, California 2,596.3 miles Lasika Seneviratne Site 0099 None None
Los Angeles Cancer Network - Los Angeles, California 2,596.3 miles Lasika Seneviratne Site 0099 None None
Ucla Department Of Medicine - Los Angeles, California 2,605.2 miles Deborah Wong Site 0003 310-825-7412 None
Ucla Department Of Medicine - Los Angeles, California 2,605.2 miles Deborah Wong Site 0003 310-825-7412 None
Ucla Department Of Medicine - Los Angeles, California 2,605.2 miles Deborah Wong Site 0003 310-825-7412 None
Ucla Department Of Medicine - Los Angeles, California 2,605.2 miles Deborah Wong Site 0003 310-825-7412 None
Ucla Department Of Medicine - Los Angeles, California 2,605.2 miles Deborah Wong Site 0003 310-825-7412 None
Ucla Department Of Medicine - Los Angeles, California 2,605.2 miles Deborah Wong Site 0003 310-825-7412 None
Torrance Health Association - Redondo Beach, California 2,609.2 miles Hugo Hool Site 0098 None None
Torrance Health Association - Redondo Beach, California 2,609.2 miles Hugo Hool Site 0098 None None
Torrance Health Association - Redondo Beach, California 2,609.2 miles Hugo Hool Site 0098 None None
Torrance Health Association - Redondo Beach, California 2,609.2 miles Hugo Hool Site 0098 None None
Torrance Health Association - Redondo Beach, California 2,609.2 miles Hugo Hool Site 0098 None None
Torrance Health Association - Redondo Beach, California 2,609.2 miles Hugo Hool Site 0098 None None
Sutter Cancer Center - Sacramento, California 2,628.2 miles Deepti Behl Site 0004 None None
Sutter Cancer Center - Sacramento, California 2,628.2 miles Deepti Behl Site 0004 None None
Sutter Cancer Center - Sacramento, California 2,628.2 miles Deepti Behl Site 0004 None None
Sutter Cancer Center - Sacramento, California 2,628.2 miles Deepti Behl Site 0004 None None
Sutter Cancer Center - Sacramento, California 2,628.2 miles Deepti Behl Site 0004 None None
Sutter Cancer Center - Sacramento, California 2,628.2 miles Deepti Behl Site 0004 None None
Central Coast Med Oncology - Santa Maria, California 2,676.2 miles Robert Dichmann Site 0096 None None
Central Coast Med Oncology - Santa Maria, California 2,676.2 miles Robert Dichmann Site 0096 None None
Central Coast Med Oncology - Santa Maria, California 2,676.2 miles Robert Dichmann Site 0096 None None
Central Coast Med Oncology - Santa Maria, California 2,676.2 miles Robert Dichmann Site 0096 None None
Central Coast Med Oncology - Santa Maria, California 2,676.2 miles Robert Dichmann Site 0096 None None
Central Coast Med Oncology - Santa Maria, California 2,676.2 miles Robert Dichmann Site 0096 None None
Coastal Integrative Cancer Care - San Luis Obispo, California 2,680.9 miles Brian Dicarlo Site 0097 None None
Coastal Integrative Cancer Care - San Luis Obispo, California 2,680.9 miles Brian Dicarlo Site 0097 None None
Coastal Integrative Cancer Care - San Luis Obispo, California 2,680.9 miles Brian Dicarlo Site 0097 None None
Coastal Integrative Cancer Care - San Luis Obispo, California 2,680.9 miles Brian Dicarlo Site 0097 None None
Coastal Integrative Cancer Care - San Luis Obispo, California 2,680.9 miles Brian Dicarlo Site 0097 None None
Coastal Integrative Cancer Care - San Luis Obispo, California 2,680.9 miles Brian Dicarlo Site 0097 None None
Ucsf - San Francisco, California 2,698.0 miles Alain Algazi Site 0072 415-502-3569 None
Ucsf - San Francisco, California 2,698.0 miles Alain Algazi Site 0072 415-502-3569 None
Ucsf - San Francisco, California 2,698.0 miles Alain Algazi Site 0072 415-502-3569 None
Ucsf - San Francisco, California 2,698.0 miles Alain Algazi Site 0072 415-502-3569 None
Ucsf - San Francisco, California 2,698.0 miles Alain Algazi Site 0072 415-502-3569 None
Ucsf - San Francisco, California 2,698.0 miles Alain Algazi Site 0072 415-502-3569 None

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