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. desember 2019 oppdatert 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).
Studieoversikt
Status
Tilbaketrukket
Forhold
Studietype
Intervensjonell
Fase
- Fase 3
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Arm A
Nivolumab plus epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil.
|
Nivolumab administrert intravenøst med protokolldefinert dose hver 3. uke.
Epacadostat administrert oralt i protokolldefinert dose to ganger daglig.
Andre navn:
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.
|
|
Eksperimentell: Arm C
Nivolumab plus placebo for epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil.
|
Nivolumab administrert intravenøst med protokolldefinert dose hver 3. uke.
Matchende placebo for epacadostat administrert oralt to ganger daglig.
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-free survival (PFS) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to the EXTREME regimen (Arm B)
Tidsramme: 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)
Tidsramme: Up to approximately 48 months
|
Defined as the time between the date of randomization and the date of death.
|
Up to approximately 48 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Objective response rate (ORR) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) and the EXTREME regimen (Arm B)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Vinny Hayreh, MD, Bristol-Myers Squibb Research and Development
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. desember 2017
Primær fullføring (Faktiske)
20. april 2018
Studiet fullført (Faktiske)
20. april 2018
Datoer for studieregistrering
Først innsendt
9. november 2017
Først innsendt som oppfylte QC-kriteriene
9. november 2017
Først lagt ut (Faktiske)
14. november 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. desember 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. desember 2019
Sist bekreftet
1. desember 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter histologisk type
- Neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer, kjertel og epitel
- Neoplasmer i hode og nakke
- Neoplasmer, plateepitelceller
- Karsinom
- Karsinom, plateepitel
- Plateepitelkarsinom i hode og nakke
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Antimetabolitter, antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antineoplastiske midler, immunologiske
- Immune Checkpoint-hemmere
- Karboplatin
- Fluorouracil
- Nivolumab
- Cetuximab
Andre studie-ID-numre
- CA2099NA/ECHO-310
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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