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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03342352
• Other study ID #: CA2099NA/ECHO-310
• Status: Withdrawn
• Phase: Phase 3
• Start date: December 15, 2017
• Est. completion date: April 20, 2018

Study information

• Verified date: December 2019
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 20, 2018
• Est. primary completion date: April 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• Nivolumab
Nivolumab administered intravenously at the protocol-defined dose every 3 weeks.
• Epacadostat
Epacadostat administered orally at the protocol-defined dose twice daily.
• Placebo
Matching placebo for epacadostat administered orally twice daily.
• Carboplatin
Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
• Cisplatin
Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
• Cetuximab
Cetuximab administered intravenously at the protocol-defined dose weekly.
• 5-Fluorouracil
5-Fluorouracil administered intravenously at the protocol-defined dose on Days 1-4 for 6 cycles.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Incyte Corporation	Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to approximately 35 months
Primary	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.	Up to approximately 48 months
Secondary	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.	Up to approximately 35 months
Secondary	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.	Up to approximately 35 months
Secondary	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.	Up to approximately 35 months
Secondary	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.	Up to approximately 35 months
Secondary	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.	Up to approximately 35 months
Secondary	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).	Up to approximately 60 months