Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/6/2019
Start Date:December 15, 2017
End Date:October 6, 2019

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A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Participants With Cisplatin Ineligible and Cisplatin Eligible Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

This study has two, independent, cohorts, both in locally advanced squamous cell head and
neck cancer. The purpose of the first cohort is to determine whether nivolumab in combination
with radiotherapy is more effective than cetuximab in combination with radiotherapy, in
subjects who are ineligible for cisplatin. The purpose of the second cohort is to determine
whether nivolumab, cisplatin, and radiotherapy is more effective than cisplatin and
radiotherapy in subjects who are eligible to receive cisplatin


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

Inclusion Criteria:

- Histologically proven squamous cell carcinoma of the head and neck (SCCHN) from one of
the following primary sites: oral cavity, oropharynx, hypopharynx, and larynx

- Locally advanced disease which is unresectable, or resectable but suitable for an
organ sparing approach

- No previous radiotherapy or systemic treatment for SCCHN

Exclusion Criteria:

- Carcinoma originating in the nasopharynx or paranasal sinus, squamous cell carcinoma
that originated from the skin and salivary gland or non-squamous histology (e.g.,
mucosal melanoma), squamous cell carcinoma of unknown primary

- Clinical or radiological evidence of metastatic disease

- Prior radiotherapy that overlaps with radiation fields

Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
34
sites
Hattiesburg, Mississippi 39401
Phone: 601-261-1700
692
mi
from 43215
Hattiesburg, MS
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11143 Parkview Plaza Dr # 100
Fort Wayne, Indiana 46845
(260) 484-8830
Phone: 26043608007912
Fort Wayne Medical Oncology and Hematology Fort Wayne Medical Oncology and Hematology provides state-of-the-art cancer...
137
mi
from 43215
Fort Wayne, IN
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24 Sturtevant St
Orlando, Florida 32806
Phone: 321-841-1077
795
mi
from 43215
Orlando, FL
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Anniston, Alabama 36207
Phone: 256-236-0055
461
mi
from 43215
Anniston, AL
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Atlanta, Georgia 30308
Phone: 404-778-4576
?
mi
from 43215
Atlanta, GA
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Bakersfield, California 93309
Phone: 661-862-8548
1982
mi
from 43215
Bakersfield, CA
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Boston, Massachusetts 02115
643
mi
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Boston, MA
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Bremerton, Washington 98310
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Bremerton, WA
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986
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Bryan, TX
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126
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Cleveland, OH
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Darlinghurst, New South Wales
9456
mi
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Darlinghurst,
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Des Moines, Iowa 50314
Phone: 515-643-2175
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Des Moines, IA
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Detroit, Michigan 48201
Phone: 313-576-9382
164
mi
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Detroit, MI
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282
mi
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Evanston, IL
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Falls Church, Virginia 22042
Phone: 703-970-6447
320
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Falls Church, VA
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Goodyear, Arizona 85338
Phone: 623-207-3899
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Goodyear, AZ
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Phone: 713-563-5550
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
995
mi
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Houston, TX
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La Jolla, California 92093
Phone: 858-822-1561
1953
mi
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La Jolla, CA
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757 Westwood Plaza
Los Angeles, California 90095
Phone: 310-825-7412
1982
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Los Angeles, CA
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Newark, Delaware 19713
388
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Newark, DE
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Newnan, Georgia 30265
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Newnan, GA
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Omaha, NE
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Philadelphia, Pennsylvania 19124
Phone: 215-537-3160
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Philadelphia, PA
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Pittsburgh, Pennsylvania 15232
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Pittsburgh, PA
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Plainville, Connecticut
Phone: 860-621-9316
544
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Plainville, CT
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Redondo Beach, California 90277
Phone: 310-750-3376
1984
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Redondo Beach, CA
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-747-8092
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
397
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Saint Louis, MO
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San Antonio, Texas 78229
1138
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San Antonio, TX
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1555 Higuera Street
San Luis Obispo, California 93401
Phone: 805-543-5577
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San Luis Obispo, CA
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750 East Adams Street
Syracuse, New York 13210
Phone: 315-464-3603
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Syracuse, NY
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633
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Thomasville, GA
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Tucson, Arizona 85724
Phone: 520-694-9047
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Tucson, AZ
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Westwood, Kansas 66205
Phone: 913-588-4254
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Westwood, KS
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Zion, Illinois 60099
303
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Zion, IL
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