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Trial record 1 of 1 for:    9NA | SCCHN | Bristol-Myers Squibb
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Nivolumab Plus Epacadostat in Combination With Chemotherapy Versus the EXTREME Regimen in Squamous Cell Carcinoma of the Head and Neck (CheckMate 9NA/ECHO-310)

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ClinicalTrials.gov Identifier: NCT03342352
Recruitment Status : Withdrawn (Study was cancelled prior to enrolling any patients.)
First Posted : November 14, 2017
Last Update Posted : May 23, 2018
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Incyte Corporation

Brief 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).

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: Nivolumab Drug: Epacadostat Drug: Placebo Drug: Carboplatin Drug: Cisplatin Drug: Cetuximab Drug: 5-Fluorouracil Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 15, 2017
Actual Primary Completion Date : April 20, 2018
Actual Study Completion Date : April 20, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

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 Name: 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: Cetuximab
Cetuximab administered intravenously at the protocol-defined dose weekly.

Drug: 5-Fluorouracil
5-Fluorouracil administered intravenously at the protocol-defined dose on Days 1-4 for 6 cycles.

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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342352


Sponsors and Collaborators
Incyte Corporation
Bristol-Myers Squibb
Investigators
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Study Director: Vinny Hayreh, MD Bristol-Myers Squibb Research and Development

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03342352     History of Changes
Other Study ID Numbers: CA2099NA/ECHO-310
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Incyte Corporation:
Squamous cell carcinoma of the head and neck
programmed cell death protein 1 (PD-1) antibody
indoleamine 2,3-dioxygenase (IDO) inhibitor

Additional relevant MeSH terms:
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Squamous Cell Carcinoma of Head and Neck
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cisplatin
Carboplatin
Nivolumab
Fluorouracil
Cetuximab
Antineoplastic Agents
Antineoplastic Agents, Immunological
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs