Head and Neck CancerPhase 3NCT03342352
Nivolumab Plus Epacadostat in Combination With Chemotherapy Versus the EXTREME Regimen in Squamous Cell Carcinoma of the Head and Neck (CheckMate 9NA/ECHO-310)
A Phase 3 study testing Nivolumab, Epacadostat and Carboplatin in people with Head and Neck Cancer, run by Incyte Corporation.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of the combination of nivolumab plus epacadostat in combination with chemotherapy in first-line recurrent or metastatic patients with squamous cell carcinoma of the head and neck (SCCHN) when compared to the standard of care (EXTREME regimen). 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, Epacadostat and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2017to 20 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 SCCHN from any of the following primary sites: oral cavity, oropharynx, hypopharynx, and larynx.
- Must have recurrent or metastatic disease that is not amenable to therapy with curative intent (surgery and/or radiation therapy with or without chemotherapy).
- No prior treatment with systemic anti-cancer therapy for SCCHN unless protocol-defined conditions are met.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to1.
- Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1.
- Documentation of program death ligand-1 (PD-L1) status prior to randomization.
Who cannot join
- Recurrent or metastatic carcinoma of the nasopharynx and paranasal sinuses, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histologies (e.g., mucosal melanoma) and SCCHN of unknown primary origin.
- Untreated central nervous system (CNS) metastases.
- Carcinomatous meningitis.
- Active, known or suspected autoimmune disease.
- Physical and laboratory test findings outside the protocol-defined range.
About this study
Official title: A Randomized, Global, Phase 3 Trial of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Platinum + 5-fluorouracil) Versus the EXTREME Regimen (Cetuximab + Platinum + 5-fluorouracil) in First-line Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) / CheckMate 9NA /ECHO-310
The purpose of this study is to evaluate the safety and efficacy of the combination of nivolumab plus epacadostat in combination with chemotherapy in first-line recurrent or metastatic patients with squamous cell carcinoma of the head and neck (SCCHN) when compared to the standard of care (EXTREME regimen).
- Conditions
- Head and Neck Cancer
- Being tested
- Nivolumab, Epacadostat, Placebo, Carboplatin, Cisplatin
- Keywords
- Squamous cell carcinoma of the head and neck, programmed cell death protein 1 (PD-1) antibody, indoleamine 2,3-dioxygenase (IDO) inhibitor
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Nivolumab administered intravenously at the protocol-defined dose every 3 weeks.
EpacadostatDrug
Also called INCB024360
Epacadostat administered orally at the protocol-defined dose twice daily.
PlaceboDrug
Matching placebo for epacadostat administered orally twice daily.
CarboplatinDrug
Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
CisplatinDrug
Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
CetuximabDrug
Cetuximab administered intravenously at the protocol-defined dose weekly.
5-FluorouracilDrug
5-Fluorouracil administered intravenously at the protocol-defined dose on Days 1-4 for 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Nivolumab plus epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil. Receives: Drug: Nivolumab; Drug: Epacadostat; Drug: Carboplatin; Drug: Cisplatin; Drug: 5-Fluorouracil |
| Arm B | Active comparator | EXTREME regimen. Receives: Drug: Carboplatin; Drug: Cisplatin; Drug: Cetuximab; Drug: 5-Fluorouracil |
| Arm C | Experimental | Nivolumab plus placebo for epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil. Receives: Drug: Nivolumab; Drug: Placebo; Drug: Carboplatin; Drug: Cisplatin; Drug: 5-Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to the EXTREME regimen (Arm B)
Defined as the time between the date of randomization and the date of first documented disease progression (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1]) or death due to any cause, whichever occurs first.
Measured: Up to approximately 35 months
Overall survival (OS) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to the EXTREME regimen (Arm B)
Defined as the time between the date of randomization and the date of death.
Measured: Up to approximately 48 months
Secondary outcomes (6)
Objective response rate (ORR) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) and the EXTREME regimen (Arm B)
Defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group.
Measured: Up to approximately 35 months
Duration of response (DOR) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) and the EXTREME regimen (Arm B)
Defined as the time between the date of first documented response (CR or PR per RECIST v1.1) to the date of the first disease progression (per RECIST v1.1) or death due to any cause, whichever occurs first.
Measured: Up to approximately 35 months
ORR with nivolumab plus placebo in combination with chemotherapy (Arm C)
Defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group.
Measured: Up to approximately 35 months
PFS with nivolumab plus placebo in combination with chemotherapy (Arm C)
Defined as the time between the date of randomization and the date of first documented disease progression (per RECIST v1.1) or death due to any cause, whichever occurs first.
Measured: Up to approximately 35 months
DOR with nivolumab plus placebo in combination with chemotherapy (Arm C)
Defined as the time between the date of first documented response (CR or PR per RECIST v1.1) to the date of the first disease progression (per RECIST v1.1) or death due to any cause, whichever occurs first.
Measured: Up to approximately 35 months
Time to meaningful symptomatic deterioration (TTSD) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to the EXTREME regimen (Arm B)
TTSD assessed by the 10-item Functional Assessment of Cancer Therapy-Head \& Neck (FACT-HN) Symptom Index (FHNSI-10).
Measured: Up to approximately 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start15 Dec 2017
- Primary completion20 Apr 2018
- Study completion20 Apr 2018
Why it stopped: Study was cancelled prior to enrolling any patients.
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 Incyte CorporationThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Vinny Hayreh, MD, Study director, Bristol-Myers Squibb Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342352
- Sponsor's protocol ID
- CA2099NA/ECHO-310
- Status last verified
- Dec 2019
- First submitted
- 9 Nov 2017
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Global, Phase 3 Trial of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Platinum + 5-fluorouracil) Versus the EXTREME Regimen (Cetuximab + Platinum + 5-fluorouracil) in First-line Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) / CheckMate 9NA /ECHO-310
- ClinicalTrials.gov ID
- NCT03342352
- Acronym / sponsor ID
- CA2099NA/ECHO-310
- Conditions
- Head and Neck Cancer
- Keywords
- Squamous cell carcinoma of the head and neck, programmed cell death protein 1 (PD-1) antibody, indoleamine 2,3-dioxygenase (IDO) inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was cancelled prior to enrolling any patients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 20 Apr 2018 (actual)
- Study completion
- 20 Apr 2018 (actual)
- First posted
- 14 Nov 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.
The purpose of this study is to evaluate the safety and efficacy of the combination of nivolumab plus epacadostat in combination with chemotherapy in first-line recurrent or metastatic patients with squamous cell carcinoma of the head and neck (SCCHN) when compared to the standard of care (EXTREME regimen).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Nivolumab, Drug: Epacadostat, Drug: Carboplatin, Drug: Cisplatin, Drug: 5-FluorouracilNivolumab plus epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil. |
| Arm B | Active comparator | Drug: Carboplatin, Drug: Cisplatin, Drug: Cetuximab, Drug: 5-FluorouracilEXTREME regimen. |
| Arm C | Experimental | Drug: Nivolumab, Drug: Placebo, Drug: Carboplatin, Drug: Cisplatin, Drug: 5-FluorouracilNivolumab plus placebo for epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed SCCHN from any of the following primary sites: oral cavity, oropharynx, hypopharynx, and larynx.
- Must have recurrent or metastatic disease that is not amenable to therapy with curative intent (surgery and/or radiation therapy with or without chemotherapy).
- No prior treatment with systemic anti-cancer therapy for SCCHN unless protocol-defined conditions are met.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to1.
- Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1.
Key exclusion criteria (5 listed)
- Recurrent or metastatic carcinoma of the nasopharynx and paranasal sinuses, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histologies (e.g., mucosal melanoma) and SCCHN of unknown primary origin.
- Untreated central nervous system (CNS) metastases.
- Carcinomatous meningitis.
- Active, known or suspected autoimmune disease.
- Physical and laboratory test findings outside the protocol-defined range.
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 |
|---|---|---|
| NivolumabNivolumab administered intravenously at the protocol-defined dose every 3 weeks. | Drug | Arm A, Arm C |
| EpacadostatAlso: INCB024360Epacadostat administered orally at the protocol-defined dose twice daily. | Drug | Arm A |
| PlaceboMatching placebo for epacadostat administered orally twice daily. | Drug | Arm C |
| CarboplatinCarboplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles. | Drug | Arm A, Arm B, Arm C |
| CisplatinCisplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles. | Drug | Arm A, Arm B, Arm C |
| CetuximabCetuximab administered intravenously at the protocol-defined dose weekly. | Drug | Arm B |
| 5-Fluorouracil5-Fluorouracil administered intravenously at the protocol-defined dose on Days 1-4 for 6 cycles. | Drug | Arm A, Arm B, Arm C |
Primary outcome
Progression-free survival (PFS) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to the EXTREME regimen (Arm B)
Time frame: Up to approximately 35 months
Defined as the time between the date of randomization and the date of first documented disease progression (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1]) or death due to any cause, whichever occurs first.
Overall survival (OS) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to the EXTREME regimen (Arm B)
Time frame: Up to approximately 48 months
Defined as the time between the date of randomization and the date of death.
6 secondary outcomes
Objective response rate (ORR) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) and the EXTREME regimen (Arm B)
Time frame: Up to approximately 35 months
Duration of response (DOR) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) and the EXTREME regimen (Arm B)
Time frame: Up to approximately 35 months
ORR with nivolumab plus placebo in combination with chemotherapy (Arm C)
Time frame: Up to approximately 35 months
PFS with nivolumab plus placebo in combination with chemotherapy (Arm C)
Time frame: Up to approximately 35 months
DOR with nivolumab plus placebo in combination with chemotherapy (Arm C)
Time frame: Up to approximately 35 months
Time to meaningful symptomatic deterioration (TTSD) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to the EXTREME regimen (Arm B)
Time frame: Up to approximately 60 months
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 20 Dec 2019.
- Individual participant dataSharing planned: No
Related trials for Head and Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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.
Vinny Hayreh, MD study director
Bristol-Myers Squibb Research and Development
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nivolumab, Epacadostat and Carboplatin in people with Head and Neck Cancer, run by Incyte Corporation.
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 6 inclusion and 5 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 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to the EXTREME regimen (Arm B) (time frame: Up to approximately 35 months). The study lists 2 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 20 Dec 2019.