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

December 19, 2019 updated by: Incyte Corporation

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Nivolumab plus epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil.
Drug: Nivolumab
Nivolumab administered intravenously at the protocol-defined dose every 3 weeks.
Drug: Epacadostat
Epacadostat administered orally at the protocol-defined dose twice daily.
Other Names:
  • INCB024360
Drug: Carboplatin
Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
Drug: Cisplatin
Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
Drug: 5-Fluorouracil
5-Fluorouracil administered intravenously at the protocol-defined dose on Days 1-4 for 6 cycles.
Active Comparator: Arm B
EXTREME regimen.
Drug: Carboplatin
Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
Drug: Cisplatin
Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
Drug: 5-Fluorouracil
5-Fluorouracil administered intravenously at the protocol-defined dose on Days 1-4 for 6 cycles.
Drug: Cetuximab
Cetuximab administered intravenously at the protocol-defined dose weekly.
Experimental: Arm C
Nivolumab plus placebo for epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil.
Drug: Nivolumab
Nivolumab administered intravenously at the protocol-defined dose every 3 weeks.
Drug: Placebo
Matching placebo for epacadostat administered orally twice daily.
Drug: Carboplatin
Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
Drug: Cisplatin
Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
Drug: 5-Fluorouracil
5-Fluorouracil administered intravenously at the protocol-defined dose on Days 1-4 for 6 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
Time Frame: Up to approximately 48 months
Defined as the time between the date of randomization and the date of death.
Up to approximately 48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
Up to approximately 35 months
ORR with nivolumab plus placebo in combination with chemotherapy (Arm C)
Time Frame: Up to approximately 35 months
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.
Up to approximately 35 months
PFS with nivolumab plus placebo in combination with chemotherapy (Arm C)
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 RECIST v1.1) or death due to any cause, whichever occurs first.
Up to approximately 35 months
DOR with nivolumab plus placebo in combination with chemotherapy (Arm C)
Time Frame: Up to approximately 35 months
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.
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
TTSD assessed by the 10-item Functional Assessment of Cancer Therapy-Head & Neck (FACT-HN) Symptom Index (FHNSI-10).
Up to approximately 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Collaborators

Bristol-Myers Squibb

Investigators

  • Study Director: Vinny Hayreh, MD, Bristol-Myers Squibb Research and Development

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2017

Primary Completion (Actual)

April 20, 2018

Study Completion (Actual)

April 20, 2018

Study Registration Dates

First Submitted

November 9, 2017

First Submitted That Met QC Criteria

November 9, 2017

First Posted (Actual)

November 14, 2017

Study Record Updates

Last Update Posted (Actual)

December 20, 2019

Last Update Submitted That Met QC Criteria

December 19, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA2099NA/ECHO-310

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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