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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03386838
Recruitment Status : Withdrawn (Business objectives have changed.)
First Posted : December 29, 2017
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Biological: Nivolumab Drug: BMS-986205 Biological: Cetuximab Drug: Cisplatin Drug: Carboplatin Drug: Fluorouracil Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 28, 2018
Actual Primary Completion Date : April 19, 2018
Actual Study Completion Date : April 19, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Nivolumab and BMS-986205
Nivolumab administered in combination with BMS-986205
 Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Drug: BMS-986205
Administered 100mg orally once daily for a maximum of 104 weeks
Active Comparator: EXTREME study regimen
Cetuximab + Cisplatin/Carboplatin + Fluorouracil
 Biological: Cetuximab
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

Drug: Cisplatin
Cisplatin (100 mg/m2) every 3 weeks (Up to 6 cycles)

Drug: Carboplatin
Carboplatin (AUC of 5 mg per milliliter per minute) every 3 weeks (Up to 6 cycles)

Drug: Fluorouracil
1000 mg/m² per day for 4 days, every 3 weeks (Up to 6 cycles)


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival (PFS) as determined by Blinded Independent Central Review (BICR) using RECIST 1.1 [ Time Frame: Approximately 2 years ]
  2. Overall survival (OS) [ Time Frame: Approximately 40 months ]
  3. Objective response rate (ORR) determined by BICR using RECIST 1.1 [ Time Frame: Approximately 2 years ]

Secondary Outcome Measures :
  1. Number of adverse events (AE) [ Time Frame: Approximately 2 years ]
  2. Number of serious adverse events (SAE) [ Time Frame: Approximately 2 years ]
  3. Time to meaningful symptomatic deterioration (TTSD) [ Time Frame: Approximately 2 years ]

Eligibility Criteria
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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

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

Contacts and Locations
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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): NCT03386838


Locations
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United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212-0000
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03386838    
Other Study ID Numbers: CA017-063
2017-003059-46 ( EudraCT Number )
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Carboplatin
Fluorouracil
Nivolumab
 Cetuximab
Linrodostat
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Enzyme Inhibitors