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

Nivolumab Plus Epacadostat in Combination With Chemotherapy Versus the EXTREME Regimen in Squamous Cell Carcinoma of the Head and Neck (CheckMate 9NA/ECHO-310)



Sponsors

Lead Sponsor


Collaborators



Source

Incyte Corporation

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

Yes

Is Fda Regulated Device

No


Brief 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).

Overall Status

Not yet recruiting

Start Date

2017-12-01

Completion Date

2023-01-01

Primary Completion Date

2021-11-01

Phase

Phase 3

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Progression-free survival (PFS) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to the EXTREME regimen (Arm B)
Up to approximately 35 months
Overall survival (OS) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) to the EXTREME regimen (Arm B)
Up to approximately 48 months

Secondary Outcome

Measure

Time Frame

Objective response rate (ORR) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) and the EXTREME regimen (Arm B)
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)
Up to approximately 35 months
ORR with nivolumab plus placebo in combination with chemotherapy (Arm C)
Up to approximately 35 months
PFS with nivolumab plus placebo in combination with chemotherapy (Arm C)
Up to approximately 35 months
DOR with nivolumab plus placebo in combination with chemotherapy (Arm C)
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)
Up to approximately 60 months

Enrollment

550

Condition


Intervention

Intervention Type

Drug

Intervention Name


Description

Nivolumab administered intravenously at the protocol-defined dose every 3 weeks.

Arm Group Label

Arm A

Arm C



Intervention Type

Drug

Intervention Name


Description

Epacadostat administered orally at the protocol-defined dose twice daily.

Arm Group Label

Arm A

Other Name

INCB024360


Intervention Type

Drug

Intervention Name


Description

Matching placebo for epacadostat administered orally twice daily.

Arm Group Label

Arm C


Intervention Type

Drug

Intervention Name


Description

Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.

Arm Group Label

Arm A

Arm B

Arm C



Intervention Type

Drug

Intervention Name


Description

Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.

Arm Group Label

Arm A

Arm B

Arm C



Intervention Type

Drug

Intervention Name


Description

Cetuximab administered intravenously at the protocol-defined dose weekly.

Arm Group Label

Arm B


Intervention Type

Drug

Intervention Name


Description

5-Fluorouracil administered intravenously at the protocol-defined dose on Days 1-4 for 6 cycles.

Arm Group Label

Arm A

Arm B

Arm C




Eligibility

Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Vijayvel Jayaprakash, MBBS, PhD
Study Director
Bristol-Myers Squibb Research and Development

Overall Contact

Last Name

Incyte Corporation Call Center (US)

Phone

1.855.463.3463

Email



Location

Facility

Status

University of California at San Diego Moores Cancer Center
La Jolla California 92037 United States
Not yet recruiting

Location Countries

Country

United States


Verification Date

2017-11-01

Lastchanged Date

2017-11-09

Firstreceived Date

2017-11-09

Responsible Party

Responsible Party Type

Sponsor


Keywords


Has Expanded Access

No

Condition Browse


Number Of Arms

3

Intervention Browse

Mesh Term

Nivolumab

Cisplatin

Carboplatin

Cetuximab

Fluorouracil

Antibodies, Monoclonal



Arm Group

Arm Group Label

Arm A

Arm Group Type

Experimental

Description

Nivolumab plus epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil.


Arm Group Label

Arm B

Arm Group Type

Active Comparator

Description

EXTREME regimen.


Arm Group Label

Arm C

Arm Group Type

Experimental

Description

Nivolumab plus placebo for epacadostat in combination with platinum (carboplatin/cisplatin) plus 5 fluorouracil.



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Incyte Corporation Call Center (ex-US)

Phone

+800 00027423

Email



Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)


Study First Submitted

November 9, 2017

Study First Submitted Qc

November 9, 2017

Study First Posted

November 14, 2017

Last Update Submitted

November 9, 2017

Last Update Submitted Qc

November 9, 2017

Last Update Posted

November 14, 2017


ClinicalTrials.gov processed this data on November 14, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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