Squamous Cell Carcinoma of the Head and NeckPhase 3NCT03349710
Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer
A Phase 3 study testing Nivolumab, Cetuximab and Cisplatin in people with Squamous Cell Carcinoma of the Head and Neck, run by Bristol-Myers Squibb at 55 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- Nivolumab, Cetuximab and Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 55 sitesin 10 countries
- Study dates
- 15 Dec 2017to 14 Oct 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
55 sites in 10 countries.
55 sites in 10 countries
United States21 sites
Pinnacle Research Group, Llc
Anniston, Alabama, 36207
Winship Cancer Insitute, Emory Crawford Long Hospital
Atlanta, Georgia, 30308
HHP Hematology & Oncology Bremerton
Bremerton, Washington, 98310
St. Joseph Regional Cancer Center
Bryan, Texas, 77802-2585
Inova Health System
Falls Church, Virginia, 22042
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, 46845
Cancer Treatment Centers of Phoneix
Goodyear, Arizona, 85338
The University of Texas MD Anderson Cancer Center-merge
Houston, Texas, 77030
Monter Cancer Center - Center for Advanced Medicine Location
Lake Success, New York, 11042
UCLA Health
Los Angeles, California, 90095
CTCA Southeastern Region
Newnan, Georgia, 30265
Nebraska Methodist Hospital
Omaha, Nebraska, 68114-4108
Orlando Health, Inc
Orlando, Florida, 32806
Eastern Regional Medical Center
Philadelphia, Pennsylvania, 19124
Upmc- Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Cancer Center of Central Connecticut
Plainville, Connecticut, 06062
Cancer Care - Torrance Memorial Physician Network
Redondo Beach, California, 90277
Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital
Thomasville, Georgia, 31792
University of Arizona Cancer Center
Tucson, Arizona, 85724-5024
University of Kansas Cancer Center
Westwood, Kansas, 66205
Midwestern Regional medical Center
Zion, Illinois, 60099
Japan12 sites
Local Institution
Akashi-shi, Hyōgo, 6738558
Local Institution
Bunkyo-ku, Tokyo, 113-8519
Local Institution
Fukuoka, Fukuoka, 8128582
Local Institution
Isehara, Kanagawa, 2591193
Local Institution
Kashiwa-shi, Chiba, 2778577
Local Institution
Kobe, Hyōgo, 6500017
Local Institution
Matsuyama, Ehime, 791-0280
Local Institution
Nagoya, Aichi-ken, 4648681
Local Institution
Natori-shi, Miyagi, 981-1293
Local Institution
Osaka, 5418567
Local Institution
Osaka-sayama-shi, Osaka, 5898511
Local Institution
Tsukuba, Ibaraki, 3058576
Spain6 sites
Local Institution
A Coruña, 15706
Local Institution
Barcelona, 08003
Local Institution
Madrid, 28046
Local Institution
Madrid, 28942
Local Institution
Majadahonda, 28222
Local Institution
Valencia, 46015
South Korea4 sites
Local Institution
Cheongju-si, 28644
Local Institution
Jeollanam-do, 58128
Local Institution
Seoul, 06351
Local Institution
Seoul, 06591
France3 sites
Local Institution
Grenoble, 38043
Local Institution
Marseille, 13005
Local Institution
Nice, 6100
Taiwan3 sites
Local Institution
Taichung, 40447
Local Institution
Taichung, 40705
Local Institution
Tainan, 704
Russia2 sites
Local Institution
Moscow, 129515
Local Institution
Yekaterinburg, 620036
About this study
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)
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
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabBiological
Also called BMS-936558, Opdivo
Specified dose on specified day
CetuximabDrug
Also called Erbitux
Specified dose on specified day
CisplatinDrug
Specified dose on specified day
RadiotherapyRadiation
Specified dose on specified day
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Cohort 1 Receives: Biological: Nivolumab; Radiation: Radiotherapy |
| Arm B | Experimental | Cohort 1 Receives: Drug: Cetuximab; Radiation: Radiotherapy |
| Arm C | Experimental | Cohort 2 Receives: Biological: Nivolumab; Drug: Cisplatin; Radiation: Radiotherapy |
| Arm D | Experimental | Cohort 2 Receives: Drug: Cisplatin; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With an Adverse Event (AE)
Number of Participants with an Adverse Event
Measured: 30 Days
Number of Participants With an Serious Adverse Event (SAE)
Number of Participants with an Serious Adverse Event (SAE)
Measured: 30 days
Number of Participants With an Adverse Event Leading to Discontinuation
Number of Participants with an Adverse Event Leading to Discontinuation
Measured: 30 Days
Number of Participants With an Adverse Event Leading to Dose Modification
Number of Participants with an Adverse Event Leading to dose modification
Measured: 30 Days
Number of Participants With Select Adverse Events
Number of Participants with select adverse events.
Select Adverse events include: gastrointestinal, hepatic, hypersensitivity/infusion reaction, pulmonary, renal, or skin.
Measured: 30 Days
Number of Participants With an Immune-mediated Adverse Event (IMAE)
Number of Participants with an immune-mediated adverse event (IMAE)
Measured: 100 days
Time to Onset and Time to Resolution of Immune-related Adverse Events
Time to onset and time to resolution of immune-related adverse events
Measured: 100 days
Number of Participants Who Experienced Death
Number of Participants who experienced death
Measured: 100 days
Number of Participants With an Abnormality in Specific Thyroid Tests
Number of participants with an abnormality in specific thyroid tests
Measured: 30 Days
Number of Participants With an Abnormality in Specific Liver Tests
Number of participants with an abnormality in specific liver tests
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start15 Dec 2017
- Primary completion14 Oct 2019
- Study completion14 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349710
- Sponsor's protocol ID
- CA209-9TM
- Other IDs
- 2017-002676-87, 2017
- Status last verified
- Aug 2021
- First submitted
- 17 Nov 2017
- Last updated
- 9 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03349710
- Acronym / sponsor ID
- CA209-9TM
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 14 Oct 2019 (actual)
- Study completion
- 14 Oct 2019 (actual)
- First posted
- 21 Nov 2017 (actual)
- Results
- Posted 9 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Biological: Nivolumab, Radiation: RadiotherapyCohort 1 |
| Arm B | Experimental | Drug: Cetuximab, Radiation: RadiotherapyCohort 1 |
| Arm C | Experimental | Biological: Nivolumab, Drug: Cisplatin, Radiation: RadiotherapyCohort 2 |
| Arm D | Experimental | Drug: Cisplatin, Radiation: RadiotherapyCohort 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: BMS-936558, OpdivoSpecified dose on specified day | Biological | Arm A, Arm C |
| CetuximabAlso: ErbituxSpecified dose on specified day | Drug | Arm B |
| CisplatinSpecified dose on specified day | Drug | Arm C, Arm D |
| RadiotherapySpecified dose on specified day | Radiation | Arm A, Arm B, Arm C, Arm D |
Primary outcome
Number of Participants With an Adverse Event (AE)
Time frame: 30 Days
Number of Participants with an Adverse Event
Number of Participants With an Serious Adverse Event (SAE)
Time frame: 30 days
Number of Participants with an Serious Adverse Event (SAE)
Number of Participants With an Adverse Event Leading to Discontinuation
Time frame: 30 Days
Number of Participants with an Adverse Event Leading to Discontinuation
Number of Participants With an Adverse Event Leading to Dose Modification
Time frame: 30 Days
Number of Participants with an Adverse Event Leading to dose modification
Number of Participants With Select Adverse Events
Time frame: 30 Days
Number of Participants with select adverse events. Select Adverse events include: gastrointestinal, hepatic, hypersensitivity/infusion reaction, pulmonary, renal, or skin.
Number of Participants With an Immune-mediated Adverse Event (IMAE)
Time frame: 100 days
Number of Participants with an immune-mediated adverse event (IMAE)
Time to Onset and Time to Resolution of Immune-related Adverse Events
Time frame: 100 days
Time to onset and time to resolution of immune-related adverse events
Number of Participants Who Experienced Death
Time frame: 100 days
Number of Participants who experienced death
Number of Participants With an Abnormality in Specific Thyroid Tests
Time frame: 30 Days
Number of participants with an abnormality in specific thyroid tests
Number of Participants With an Abnormality in Specific Liver Tests
Time frame: 30 days
Number of participants with an abnormality in specific liver tests
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
55 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nivolumab, Cetuximab and Cisplatin in people with Squamous Cell Carcinoma of the Head and Neck, run by Bristol-Myers Squibb at 55 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Japan, Spain, South Korea, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With an Adverse Event (AE) (time frame: 30 Days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.