Clinical trial NCT03386838: 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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Head and Neck Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-12-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Progression-free survival (PFS) as determined by Blinded Independent Central Review (BICR) using RECIST 1.1
timeFrame: Approximately 2 years
measure: Overall survival (OS)
timeFrame: Approximately 40 months
measure: Objective response rate (ORR) determined by BICR using RECIST 1.1
timeFrame: Approximately 2 years
Secondary outcomes:
measure: Number of adverse events (AE)
timeFrame: Approximately 2 years
measure: Number of serious adverse events (SAE)
timeFrame: Approximately 2 years
measure: Time to meaningful symptomatic deterioration (TTSD)
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: