Status:
COMPLETED
Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Ono Pharmaceutical Co. Ltd
Conditions:
Squamous Cell Carcinoma of the Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 radiotherap...
Eligibility Criteria
Inclusion
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- 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
- 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
Key Trial Info
Start Date :
December 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2019
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT03349710
Start Date
December 15 2017
End Date
October 14 2019
Last Update
August 9 2021
Active Locations (55)
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1
Pinnacle Research Group, Llc
Anniston, Alabama, United States, 36207
2
Cancer Treatment Centers of Phoneix
Goodyear, Arizona, United States, 85338
3
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724-5024
4
UCLA Health
Los Angeles, California, United States, 90095