Nivolumab Plus Epacadostat in Combination With Chemotherapy Versus the EXTREME Regimen in Squamous Cell Carcinoma of the Head and Neck (CheckMate 9NA/ECHO-310)
19 december 2019 uppdaterad av: 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).
Studieöversikt
Status
Indragen
Betingelser
Studietyp
Interventionell
Fas
- Fas 3
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Arm A
Nivolumab plus epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil.
|
Nivolumab administreras intravenöst i den protokolldefinierade dosen var tredje vecka.
Epacadostat administreras oralt i den protokolldefinierade dosen två gånger dagligen.
Andra namn:
Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
5-Fluorouracil administered intravenously at the protocol-defined dose on Days 1-4 for 6 cycles.
|
|
Aktiv komparator: Arm B
EXTREME regimen.
|
Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
5-Fluorouracil administered intravenously at the protocol-defined dose on Days 1-4 for 6 cycles.
Cetuximab administered intravenously at the protocol-defined dose weekly.
|
|
Experimentell: Arm C
Nivolumab plus placebo for epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil.
|
Nivolumab administreras intravenöst i den protokolldefinierade dosen var tredje vecka.
Matchande placebo för epacadostat administrerat oralt två gånger dagligen.
Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
5-Fluorouracil administered intravenously at the protocol-defined dose on Days 1-4 for 6 cycles.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Progression-free survival (PFS) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to the EXTREME regimen (Arm B)
Tidsram: 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)
Tidsram: Up to approximately 48 months
|
Defined as the time between the date of randomization and the date of death.
|
Up to approximately 48 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Objective response rate (ORR) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) and the EXTREME regimen (Arm B)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studierektor: Vinny Hayreh, MD, Bristol-Myers Squibb Research and Development
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 december 2017
Primärt slutförande (Faktisk)
20 april 2018
Avslutad studie (Faktisk)
20 april 2018
Studieregistreringsdatum
Först inskickad
9 november 2017
Först inskickad som uppfyllde QC-kriterierna
9 november 2017
Första postat (Faktisk)
14 november 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 december 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 december 2019
Senast verifierad
1 december 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter histologisk typ
- Neoplasmer
- Neoplasmer efter plats
- Neoplasmer, körtel och epitel
- Neoplasmer i huvud och hals
- Neoplasmer, skivepitelceller
- Carcinom
- Karcinom, skivepitel
- Skivepitelcancer i huvud och hals
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Antineoplastiska medel, immunologiska
- Immune Checkpoint-hämmare
- Karboplatin
- Fluorouracil
- Nivolumab
- Cetuximab
Andra studie-ID-nummer
- CA2099NA/ECHO-310
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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