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 |
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
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
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11143 Parkview Plaza Dr # 100
Fort Wayne, Indiana 46845
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...
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Bakersfield, California 93309
Phone: 661-862-8548
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Cleveland, Ohio 44106
Phone: 216-231-3241
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1515 Holcombe Blvd
Houston, Texas 77030
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...
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Omaha, Nebraska 68114
Phone: 402-354-5831
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660 S Euclid Ave
Saint Louis, Missouri 63110
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...
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1555 Higuera Street
San Luis Obispo, California 93401
San Luis Obispo, California 93401
Phone: 805-543-5577
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Thomasville, Georgia 31792
Phone: 229-584-5468
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