Clinical trial NCT03349710: Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Squamous Cell Carcinoma of the Head and Neck
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2017-11-21
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With an Adverse Event (AE)
timeFrame: 30 Days
measure: Number of Participants With an Serious Adverse Event (SAE)
timeFrame: 30 days
measure: Number of Participants With an Adverse Event Leading to Discontinuation
timeFrame: 30 Days
measure: Number of Participants With an Adverse Event Leading to Dose Modification
timeFrame: 30 Days
measure: Number of Participants With Select Adverse Events
timeFrame: 30 Days
measure: Number of Participants With an Immune-mediated Adverse Event (IMAE)
timeFrame: 100 days
measure: Time to Onset and Time to Resolution of Immune-related Adverse Events
timeFrame: 100 days
measure: Number of Participants Who Experienced Death
timeFrame: 100 days
measure: Number of Participants With an Abnormality in Specific Thyroid Tests
timeFrame: 30 Days
measure: Number of Participants With an Abnormality in Specific Liver Tests
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, Llc
state: Alabama
city: Goodyear
country: United States
facility: Cancer Treatment Centers of Phoneix
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Health
state: California
city: Redondo Beach
country: United States
facility: Cancer Care - Torrance Memorial Physician Network
state: California
city: Plainville
country: United States
facility: Cancer Center of Central Connecticut
state: Connecticut
city: Orlando
country: United States
facility: Orlando Health, Inc
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Insitute, Emory Crawford Long Hospital
state: Georgia
city: Newnan
country: United States
facility: CTCA Southeastern Region
state: Georgia
city: Thomasville
country: United States
facility: Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital
state: Georgia
city: Zion
country: United States
facility: Midwestern Regional medical Center
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology, Inc.
state: Indiana
city: Westwood
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Lake Success
country: United States
facility: Monter Cancer Center - Center for Advanced Medicine Location
state: New York
city: Philadelphia
country: United States
facility: Eastern Regional Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Upmc- Hillman Cancer Center
state: Pennsylvania
city: Bryan
country: United States
facility: St. Joseph Regional Cancer Center
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center-merge
state: Texas
city: Falls Church
country: United States
facility: Inova Health System
state: Virginia
city: Bremerton
country: United States
facility: HHP Hematology & Oncology Bremerton
state: Washington
city: Grenoble
country: France
facility: Local Institution
city: Marseille
country: France
facility: Local Institution
city: Nice
country: France
facility: Local Institution
city: Lucca
country: Italy
facility: Local Institution
city: Ravenna
country: Italy
facility: Local Institution
city: Nagoya
country: Japan
facility: Local Institution
state: Aichi
city: Kashiwa-shi
country: Japan
facility: Local Institution
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Local Institution
state: Ehime
city: Fukuoka-shi
country: Japan
facility: Local Institution
state: Fukuoka
city: Akashi-shi
country: Japan
facility: Local Institution
state: Hyogo
city: Kobe-shi
country: Japan
facility: Local Institution
state: Hyogo
city: Tsukuba-shi
country: Japan
facility: Local Institution
state: Ibaraki
city: Isehara
country: Japan
facility: Local Institution
state: Kanagawa
city: Natori-shi
country: Japan
facility: Local Institution
state: Miyagi
city: Osaka-sayama-shi
country: Japan
facility: Local Institution
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Osaka
country: Japan
facility: Local Institution
city: Cheongju-si
country: Korea, Republic of
facility: Local Institution
city: Jeollanam-do
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Gdynia
country: Poland
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Yekaterinburg
country: Russian Federation
facility: Local Institution
city: A Coruna
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Majadahonda
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution
city: Tainan
country: Taiwan
facility: Local Institution
city: Izmir
country: Turkey
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: