Head and Neck CancerPhase 3NCT03386838
An Immuno-therapy Study of Nivolumab in Combination With Experimental Medication BMS-986205 Compared to Standard of Care EXTREME Regimen in First-line Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck
A Phase 3 study testing Nivolumab, BMS-986205 and Cetuximab in people with Head and Neck Cancer, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
This is a study of Nivolumab in combination with experimental medication BMS-986205 compared to the standard of care EXTREME regimen in head and neck cancer that has come back after initial treatment, or is widespread when first diagnosed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Nivolumab, BMS-986205 and Cetuximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2018to 19 Apr 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 confirmed squamous cell carcinoma of the head and neck (SCCHN), from any of the following primary sites only: oral cavity, oropharynx, hypopharynx, and larynx.
- Recurrent or metastatic disease that is not amenable to therapy with curative intent (surgery or radiation therapy with or without chemotherapy)
- No prior treatment with systemic anti-cancer therapy for SCCHN, unless protocol specified criteria are met
- ECOG Performance Status of 0-1
- Measurable disease by CT or MRI per RECIST 1.1 criteria
Who cannot join
- Women who are pregnant or breastfeeding
- Recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell carcinoma that originated from the skin and salivary gland or paranasal sinus, non-squamous histologies (eg, mucosal melanoma)
- Participants with untreated CNS metastases are excluded
- Participants with carcinomatous meningitis
- Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-0000
About this study
Official title: A Randomized, Global, Open-label Study of Nivolumab in Combination With BMS-986205 vs Standard of Care EXTREME Regimen in First-line Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck
This is a study of Nivolumab in combination with experimental medication BMS-986205 compared to the standard of care EXTREME regimen in head and neck cancer that has come back after initial treatment, or is widespread when first diagnosed.
- Conditions
- Head and Neck Cancer
- Being tested
- Nivolumab, BMS-986205, Cetuximab, Cisplatin, Carboplatin
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabBiological
Also called Opdivo, BMS-936558
Specified dose on specified days
BMS-986205Drug
Administered 100mg orally once daily for a maximum of 104 weeks
CetuximabBiological
400 mg/m² intravenous administration once only, then 250 mg/m² weekly maintenance until disease progression, unacceptable toxicity, withdrawal of informed consent, or other reason
CisplatinDrug
Cisplatin (100 mg/m2) every 3 weeks (Up to 6 cycles)
CarboplatinDrug
Carboplatin (AUC of 5 mg per milliliter per minute) every 3 weeks (Up to 6 cycles)
FluorouracilDrug
1000 mg/m² per day for 4 days, every 3 weeks (Up to 6 cycles)
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab and BMS-986205 | Experimental | Nivolumab administered in combination with BMS-986205 Receives: Biological: Nivolumab; Drug: BMS-986205 |
| EXTREME study regimen | Active comparator | Cetuximab + Cisplatin/Carboplatin + Fluorouracil Receives: Biological: Cetuximab; Drug: Cisplatin; Drug: Carboplatin; Drug: Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) as determined by Blinded Independent Central Review (BICR) using RECIST 1.1
Measured: Approximately 2 years
Overall survival (OS)
Measured: Approximately 40 months
Objective response rate (ORR) determined by BICR using RECIST 1.1
Measured: Approximately 2 years
Secondary outcomes (3)
Number of adverse events (AE)
Measured: Approximately 2 years
Number of serious adverse events (SAE)
Measured: Approximately 2 years
Time to meaningful symptomatic deterioration (TTSD)
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start28 Mar 2018
- Primary completion19 Apr 2018
- Study completion19 Apr 2018
Why it stopped: Business objectives have changed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386838
- Sponsor's protocol ID
- CA017-063
- Other IDs
- 2017-003059-46, 2017
- Status last verified
- Apr 2019
- First submitted
- 22 Dec 2017
- Last updated
- 18 Apr 2019
- Results posted
- No
- 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 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Global, Open-label Study of Nivolumab in Combination With BMS-986205 vs Standard of Care EXTREME Regimen in First-line Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck
- ClinicalTrials.gov ID
- NCT03386838
- Acronym / sponsor ID
- CA017-063
- Conditions
- Head and Neck Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business objectives have changed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 19 Apr 2018 (actual)
- Study completion
- 19 Apr 2018 (actual)
- First posted
- 29 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of Nivolumab in combination with experimental medication BMS-986205 compared to the standard of care EXTREME regimen in head and neck cancer that has come back after initial treatment, or is widespread when first diagnosed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nivolumab and BMS-986205 | Experimental | Biological: Nivolumab, Drug: BMS-986205Nivolumab administered in combination with BMS-986205 |
| EXTREME study regimen | Active comparator | Biological: Cetuximab, Drug: Cisplatin, Drug: Carboplatin, Drug: FluorouracilCetuximab + Cisplatin/Carboplatin + Fluorouracil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN), from any of the following primary sites only: oral cavity, oropharynx, hypopharynx, and larynx.
- Recurrent or metastatic disease that is not amenable to therapy with curative intent (surgery or radiation therapy with or without chemotherapy)
- No prior treatment with systemic anti-cancer therapy for SCCHN, unless protocol specified criteria are met
- ECOG Performance Status of 0-1
- Measurable disease by CT or MRI per RECIST 1.1 criteria
Key exclusion criteria (6 listed)
- Women who are pregnant or breastfeeding
- Recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell carcinoma that originated from the skin and salivary gland or paranasal sinus, non-squamous histologies (eg, mucosal melanoma)
- Participants with untreated CNS metastases are excluded
- Participants with carcinomatous meningitis
- Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
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: Opdivo, BMS-936558Specified dose on specified days | Biological | Nivolumab and BMS-986205 |
| BMS-986205Administered 100mg orally once daily for a maximum of 104 weeks | Drug | Nivolumab and BMS-986205 |
| Cetuximab400 mg/m² intravenous administration once only, then 250 mg/m² weekly maintenance until disease progression, unacceptable toxicity, withdrawal of informed consent, or other reason | Biological | EXTREME study regimen |
| CisplatinCisplatin (100 mg/m2) every 3 weeks (Up to 6 cycles) | Drug | EXTREME study regimen |
| CarboplatinCarboplatin (AUC of 5 mg per milliliter per minute) every 3 weeks (Up to 6 cycles) | Drug | EXTREME study regimen |
| Fluorouracil1000 mg/m² per day for 4 days, every 3 weeks (Up to 6 cycles) | Drug | EXTREME study regimen |
Primary outcome
Progression-free survival (PFS) as determined by Blinded Independent Central Review (BICR) using RECIST 1.1
Time frame: Approximately 2 years
Overall survival (OS)
Time frame: Approximately 40 months
Objective response rate (ORR) determined by BICR using RECIST 1.1
Time frame: Approximately 2 years
3 secondary outcomes
Number of adverse events (AE)
Time frame: Approximately 2 years
Number of serious adverse events (SAE)
Time frame: Approximately 2 years
Time to meaningful symptomatic deterioration (TTSD)
Time frame: Approximately 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nivolumab, BMS-986205 and Cetuximab in people with Head and Neck Cancer, run by Bristol-Myers Squibb at 1 site in United States.
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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Progression-free survival (PFS) as determined by Blinded Independent Central Review (BICR) using RECIST 1.1 (time frame: Approximately 2 years). The study lists 3 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 18 Apr 2019.