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8110 Gatehouse Road, Falls Church, VA 22042

Lymph node and tumor immunomonitoring to predict immunotherapy response in melanoma

General Information

Age Group

Adult

Status

Recruiting

Protocol Number

Inova U19-06-3623

Background Information

The purpose of this study is to predict who will and who will not respond to nivolumab treatment by analyzing pre-treatment and post-treatment changes in patients. This study will take 24 months, where patients will be enrolled for 12 months with the entire study complete within 12 months of the last patient’s enrollment. This study will include blood draws, tissue biopsies, and surgery exactly like that of routine care.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Dr.
Fairfax, VA 22031

A department of Inova Fairfax Hospital

Eligibility Information

  • Meets diagnostic criteria for de novo/recurrent stage III melanoma or unresectable stage III/IV melanomas with multiple (sub)cutaneous metastases
  • Participants agree to provide archived tumor tissues for research purpose (retrospective cohort)
  • Participants must be willing to undergo biopsy or surgery according to the study timeline (prospective cohort)
  • Participants are recommended and planned to start nivolumab for melanoma (prospective cohort)

Ineligibility Information

  • Females who are pregnant or breast-feeding
  • Known history of immunodeficient or immunocompromised patients (e.g., comorbidity with chronic viral infection such as HIV/HBV/HCV)