Adjuvant Nivolumab and Lirilumab in Patients With Relapsed, Resectable Squamous Cell Carcinoma of the Head and Neck
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|ClinicalTrials.gov Identifier: NCT03341936|
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : March 29, 2018
This research study is studying a combination of two immunotherapy drugs, as a possible treatment for locoregionally recurrent squamous cell carcinoma of the head and neck.
The immunotherapy drugs involved in this study are:
- Nivolumab (Opdivo™)
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma of the Head and Neck||Drug: Nivolumab Drug: Lirilumab||Phase 2|
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug or combination of drugs to learn whether it works in treating a specific disease. "Investigational" means that the drug/s is being studied.
The purpose of this study is to evaluate effectiveness (how well the drug/s work) of nivolumab in combination with lirilumab in participants with SCCHN.
Nivolumab and lirilumab are types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells. Both nivolumab and lirilumab have been demonstrated to activate the immune system to attack cancer cells in participants with different types of cancers.
In November, 2016, the Food and Drug Administration (FDA) approved nivolumab for the treatment of participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). Lirilumab is not FDA approved as of now.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adjuvant Nivolumab and Lirilumab in Patients With Relapsed, Resectable Squamous Cell Carcinoma of the Head and Neck|
|Actual Study Start Date :||March 15, 2018|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2025|
Nivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells
Lirilumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells
- Disease-free survival [ Time Frame: 1 year ]
- Best overall Response Rate [ Time Frame: at the time of salvage surgery ]
- Disease-free survival [ Time Frame: 2 years ]
- Overall Survival Rate [ Time Frame: 3 years ]
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): NCT03341936
|Contact: Alec Kacew||617-632-5475||Alec_Kacew@dfci.harvard.edu|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Alec Kacew 617-632-5475 Alec_Kacew@dfci.harvard.edu|
|Principal Investigator: Glenn J. Hanna, MD|
|Principal Investigator:||Genn J. Hanna, MD||Dana-Farber Cancer Institute|