Screening Trial of Nivolumab With Image Guided, Stereotactic Body Radiotherapy (SBRT) Versus Nivolumab Alone in Patients With Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT02684253
Phase
PHASE2
Status
Completed

Conditions

  • Head and Neck Squamous Cell Carcinoma (HNSCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
  • Stereotactic Body Radiation Therapy (SBRT) — RADIATION

Study Details

Nivolumab is an antibody (a type of human protein) that is designed to boost your body's immune system. It does this by allowing immune cells to grow and fight the cancer. Nivolumab has been approved by the FDA for the treatment of melanoma (a form of skin cancer) and lung cancer. It is currently under study for the treatment of head and neck squamous cell cancer.

Key Dates

Start date
Feb 11, 2016
Status verified
Jan 2021
Primary completion
Jan 22, 2021
Completion
Jan 22, 2021

Study Design

Enrollment
65 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab 3mg/kg IV every 2 weeks
    Nivolumab 3mg/kg IV every 2 weeks
  • Experimental: Stereotactic Body Radiotherapy & Nivolumab
    Image Guided, Stereotactic Body Radiotherapy (27 Gy over 3 fractions given every other day) to a single lesion to start by study day 14 (study day 1 is day of first dose of Nivolumab). Nivolumab 3mg/kg IV starting day 1 and then every 2 weeks thereafter. Treatment with Nivolumab will continue until progression or unacceptable toxicity.

Primary Outcome Measure

Percentage of Participants With Overall Response Rate [ Time Frame: 96 weeks ]

Locations (6)

FacilityCityStateZIPSite coordinators
Memoral Sloan Kettering Cancer CenterBasking RidgeNew Jersey--
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering Cancer Center @ SuffolkCommackNew York11725-
Memorial Sloan Kettering WestchesterHarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan Kettering at Mercy Medical CenterRockville CentreNew York--

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Memoral Sloan Kettering Cancer Center· Basking Ridge, NJMemorial Sloan Kettering Monmouth· Middletown, NJMemorial Sloan Kettering Cancer Center @ Suffolk· Commack, NYMemorial Sloan Kettering Westchester· Harrison, NYMemorial Sloan Kettering Cancer Center· New York, NYMemorial Sloan Kettering at Mercy Medical Center· Rockville Centre, NY

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