Squamous Cell Carcinoma of the Head and Neck (SCCHN) MedDRA version: 20.0 Level: PT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Incyte Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Histologically confirmed SCCHN from any of the following primary sites: oral cavity, oropharynx, hypopharynx, and larynx. b) Must have recurrent or metastatic disease that is not amenable to therapy with curative intent (surgery and/or radiation therapy with or without chemotherapy). Participants that refuse potentially curative salvage surgery for recurrent disease are ineligible. c) No prior treatment with systemic anti-cancer therapy for recurrent or metastatic SCCHN unless both of the following conditions are met: i) Prior chemotherapy was given as adjuvant or neoadjuvant or as part of multimodal (chemotherapy, radiation) treatment for locally advanced disease. These treatments must have been completed > 6 months prior to enrollment. ii) There was no evidence of disease progression for at least 6 months after completion of previous systemic therapy regimen as described in c.i. d) ECOG Performance Status of 0-1 e) Measureable disease by CT or MRI, per RECIST 1.1 criteria f) Documentation of HPV p16 (positive or negative) status is required for only SCCHN tumor of the oropharynx. HPV p-16 status is not required for other eligible SCCHN indications. g) Documentation of PD-L1 status (expressing or non-expressing) by 28-8 pharmDX IHC performed by the analyzing laboratory prior to randomization. Participants with non-evaluable results of PD-L1 testing can be randomized only after confirmation from the Study Director/Medical Monitor. NOTE: Only 10% of randomized participants may be included into the study as PD-L1 non-evaluable. Once this cutoff is reached, participants with non-evaluable results will not be permitted to be randomized. No restriction will be placed on PD-L1 levels in this study; however, PD-L1 status will be used for randomization. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 275 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 511
Exclusion criteria
Exclusion criteria: a) Recurrent or metastatic carcimona of the nasopharynx and paranasal sinuses, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histologies (eg, mucosal melanoma) and SCCHN of unknown primary origin b) Participants with untreated CNS metastases. Participants are eligible if CNS metastases have been adequately treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization. c) Participants with carcinomatous meningitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare progression-free survival (PFS), as determined by blinded independent central review (BICR), and overall survival (OS) of nivolumab plus epacadostat in combination with chemotherapy (Arm A) to the EXTREME regimen (Arm B) as first-line treatment in participants with recurrent or metastatic SCCHN;Secondary Objective: - To compare the objective response rate (ORR) and to estimate duration of response (DOR) of nivolumab plus epacadostat in combination with chemotherapy (Arm A) and the EXTREME regimen (Arm B) in participants with recurrent or metastatic SCCHN - To estimate the contribution of nivolumab based on ORR, PFS, and DOR of nivolumab plus placebo for epacadostat in combination with chemotherapy (Arm C) as first-line treatment in participants with recurrent or metastatic SCCHN - To evaluate time to symptomatic deterioration in participants treated with nivolumab plus epacadostat in combination with chemotherapy (Arm A) or the EXTREME regimen (Arm B);Primary end point(s): - PFS as determined by BICR - OS;Timepoint(s) of evaluation of this end point: This will be evaluated throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - ORR as determined by BICR - Duration of objective response as determined by BICR - PFS - Time to meaningful symptomatic deterioration (TTSD) as measured by the 10- item Functional Assessment of Cancer - Therapy-Head & Neck (FACT-HN) Symptom Index (FHNSI-10);Timepoint(s) of evaluation of this end point: Secondary endpoints will be evaluated at various timepoints as detailed in the protocol Schedule of Activities | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Denmark, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Poland, Portugal, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States
Contacts
Public ContactClinical Trials Information
Incyte Corporation
Outcome results
None listed