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An Immuno-therapy Study of Nivolumab in Combination With Experimental Medication BMS-986205 Compared to Standard of Care EXTREME Regimen in First-line Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck

Primary Purpose

Head and Neck Cancer

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Nivolumab
BMS-986205
Cetuximab
Cisplatin
Carboplatin
Fluorouracil
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN), from any of the following primary sites only: oral cavity, oropharynx, hypopharynx, and larynx.
  • Recurrent or metastatic disease that is not amenable to therapy with curative intent (surgery or radiation therapy with or without chemotherapy)
  • No prior treatment with systemic anti-cancer therapy for SCCHN, unless protocol specified criteria are met
  • ECOG Performance Status of 0-1
  • Measurable disease by CT or MRI per RECIST 1.1 criteria

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell carcinoma that originated from the skin and salivary gland or paranasal sinus, non-squamous histologies (eg, mucosal melanoma)
  • Participants with untreated CNS metastases are excluded
  • Participants with carcinomatous meningitis
  • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast

Other protocol defined inclusion/exclusion criteria could apply

Sites / Locations

  • Allegheny General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nivolumab and BMS-986205

EXTREME study regimen

Arm Description

Nivolumab administered in combination with BMS-986205

Cetuximab + Cisplatin/Carboplatin + Fluorouracil

Outcomes

Primary Outcome Measures

Progression-free survival (PFS) as determined by Blinded Independent Central Review (BICR) using RECIST 1.1
Overall survival (OS)
Objective response rate (ORR) determined by BICR using RECIST 1.1

Secondary Outcome Measures

Number of adverse events (AE)
Number of serious adverse events (SAE)
Time to meaningful symptomatic deterioration (TTSD)

Full Information

First Posted
December 22, 2017
Last Updated
April 16, 2019
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03386838
Brief Title
An Immuno-therapy Study of Nivolumab in Combination With Experimental Medication BMS-986205 Compared to Standard of Care EXTREME Regimen in First-line Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck
Official Title
A Randomized, Global, Open-label Study of Nivolumab in Combination With BMS-986205 vs Standard of Care EXTREME Regimen in First-line Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Business objectives have changed.
Study Start Date
March 28, 2018 (Actual)
Primary Completion Date
April 19, 2018 (Actual)
Study Completion Date
April 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a study of Nivolumab in combination with experimental medication BMS-986205 compared to the standard of care EXTREME regimen in head and neck cancer that has come back after initial treatment, or is widespread when first diagnosed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nivolumab and BMS-986205
Arm Type
Experimental
Arm Description
Nivolumab administered in combination with BMS-986205
Arm Title
EXTREME study regimen
Arm Type
Active Comparator
Arm Description
Cetuximab + Cisplatin/Carboplatin + Fluorouracil
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo, BMS-936558
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
BMS-986205
Intervention Description
Administered 100mg orally once daily for a maximum of 104 weeks
Intervention Type
Biological
Intervention Name(s)
Cetuximab
Intervention Description
400 mg/m² intravenous administration once only, then 250 mg/m² weekly maintenance until disease progression, unacceptable toxicity, withdrawal of informed consent, or other reason
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin (100 mg/m2) every 3 weeks (Up to 6 cycles)
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin (AUC of 5 mg per milliliter per minute) every 3 weeks (Up to 6 cycles)
Intervention Type
Drug
Intervention Name(s)
Fluorouracil
Intervention Description
1000 mg/m² per day for 4 days, every 3 weeks (Up to 6 cycles)
Primary Outcome Measure Information:
Title
Progression-free survival (PFS) as determined by Blinded Independent Central Review (BICR) using RECIST 1.1
Time Frame
Approximately 2 years
Title
Overall survival (OS)
Time Frame
Approximately 40 months
Title
Objective response rate (ORR) determined by BICR using RECIST 1.1
Time Frame
Approximately 2 years
Secondary Outcome Measure Information:
Title
Number of adverse events (AE)
Time Frame
Approximately 2 years
Title
Number of serious adverse events (SAE)
Time Frame
Approximately 2 years
Title
Time to meaningful symptomatic deterioration (TTSD)
Time Frame
Approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN), from any of the following primary sites only: oral cavity, oropharynx, hypopharynx, and larynx. Recurrent or metastatic disease that is not amenable to therapy with curative intent (surgery or radiation therapy with or without chemotherapy) No prior treatment with systemic anti-cancer therapy for SCCHN, unless protocol specified criteria are met ECOG Performance Status of 0-1 Measurable disease by CT or MRI per RECIST 1.1 criteria Exclusion Criteria: Women who are pregnant or breastfeeding Recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell carcinoma that originated from the skin and salivary gland or paranasal sinus, non-squamous histologies (eg, mucosal melanoma) Participants with untreated CNS metastases are excluded Participants with carcinomatous meningitis Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast Other protocol defined inclusion/exclusion criteria could apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212-0000
Country
United States

12. IPD Sharing Statement

Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

An Immuno-therapy Study of Nivolumab in Combination With Experimental Medication BMS-986205 Compared to Standard of Care EXTREME Regimen in First-line Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck

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