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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03349710




Registration number
NCT03349710
Ethics application status
Date submitted
17/11/2017
Date registered
21/11/2017
Date last updated
9/08/2021

Titles & IDs
Public title
Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer
Scientific 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)
Secondary ID [1] 0 0
2017-002676-87
Secondary ID [2] 0 0
CA209-9TM
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Carcinoma of the Head and Neck 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Nivolumab
Treatment: Drugs - Cetuximab
Treatment: Drugs - Cisplatin
Treatment: Other - Radiotherapy

Experimental: Arm A - Cohort 1

Experimental: Arm B - Cohort 1

Experimental: Arm C - Cohort 2

Experimental: Arm D - Cohort 2


Other interventions: Nivolumab
Specified dose on specified day

Treatment: Drugs: Cetuximab
Specified dose on specified day

Treatment: Drugs: Cisplatin
Specified dose on specified day

Treatment: Other: Radiotherapy
Specified dose on specified day
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With an Adverse Event (AE)
Timepoint [1] 0 0
30 Days
Primary outcome [2] 0 0
Number of Participants With an Serious Adverse Event (SAE)
Timepoint [2] 0 0
30 days
Primary outcome [3] 0 0
Number of Participants With an Adverse Event Leading to Discontinuation
Timepoint [3] 0 0
30 Days
Primary outcome [4] 0 0
Number of Participants With an Adverse Event Leading to Dose Modification
Timepoint [4] 0 0
30 Days
Primary outcome [5] 0 0
Number of Participants With Select Adverse Events
Timepoint [5] 0 0
30 Days
Primary outcome [6] 0 0
Number of Participants With an Immune-mediated Adverse Event (IMAE)
Timepoint [6] 0 0
100 days
Primary outcome [7] 0 0
Time to Onset and Time to Resolution of Immune-related Adverse Events
Timepoint [7] 0 0
100 days
Primary outcome [8] 0 0
Number of Participants Who Experienced Death
Timepoint [8] 0 0
100 days
Primary outcome [9] 0 0
Number of Participants With an Abnormality in Specific Thyroid Tests
Timepoint [9] 0 0
30 Days
Primary outcome [10] 0 0
Number of Participants With an Abnormality in Specific Liver Tests
Timepoint [10] 0 0
30 days

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/10/2019
Sample size
Target
Accrual to date
Final
74
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
France
State/province [16] 0 0
Grenoble
Country [17] 0 0
France
State/province [17] 0 0
Marseille
Country [18] 0 0
France
State/province [18] 0 0
Nice
Country [19] 0 0
Italy
State/province [19] 0 0
Lucca
Country [20] 0 0
Italy
State/province [20] 0 0
Ravenna
Country [21] 0 0
Japan
State/province [21] 0 0
Aichi
Country [22] 0 0
Japan
State/province [22] 0 0
Chiba
Country [23] 0 0
Japan
State/province [23] 0 0
Ehime
Country [24] 0 0
Japan
State/province [24] 0 0
Fukuoka
Country [25] 0 0
Japan
State/province [25] 0 0
Hyogo
Country [26] 0 0
Japan
State/province [26] 0 0
Ibaraki
Country [27] 0 0
Japan
State/province [27] 0 0
Kanagawa
Country [28] 0 0
Japan
State/province [28] 0 0
Miyagi
Country [29] 0 0
Japan
State/province [29] 0 0
Osaka
Country [30] 0 0
Japan
State/province [30] 0 0
Tokyo
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Cheongju-si
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Jeollanam-do
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Seoul
Country [34] 0 0
Poland
State/province [34] 0 0
Gdynia
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Moscow
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Yekaterinburg
Country [37] 0 0
Spain
State/province [37] 0 0
A Coruna
Country [38] 0 0
Spain
State/province [38] 0 0
Barcelona
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid
Country [40] 0 0
Spain
State/province [40] 0 0
Majadahonda
Country [41] 0 0
Spain
State/province [41] 0 0
Valencia
Country [42] 0 0
Taiwan
State/province [42] 0 0
Taichung
Country [43] 0 0
Taiwan
State/province [43] 0 0
Tainan
Country [44] 0 0
Turkey
State/province [44] 0 0
Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Ono Pharmaceutical Co. Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT03349710
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03349710