Status:
WITHDRAWN
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
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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,...
Eligibility Criteria
Inclusion
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- 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
- 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
Key Trial Info
Start Date :
March 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03386838
Start Date
March 28 2018
End Date
April 19 2018
Last Update
April 18 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212-0000