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Melanoma / Skin
General Information
Study Name:
A Study of IMO-2125 in Combination With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma (ILLUMINATE-301)
Age Group:
Adult
Protocol Number:
NCT03445533
Background Information:
Refractory melanoma is a type of cancer mainly found on the skin, which may not be responding to available treatments. Researchers have developed a drug called IMO-2125 (sometimes referred to as "study drug"), which may be used to treat refractory melanoma. This is an investigational study, which means the study drug is experimental and is not approved by the U.S. Food and Drug Administration (FDA). The study is being done to compare the effectiveness of the study drug given in combination with ipilimumab (Yervoy®) compared to ipilimumab given alone.
Offered at:
Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital
Eligibility Information
Participants must be 18 years of age or older
Histologically confirmed metastatic melanoma with measurable (by Response Evaluation Criteria in Solid Tumors [RECIST] v1.1), Stage III (lymph node or in transit lesions) or Stage IVA, IVB, or IVC disease that is accessible for injection
Confirmed progression during or after treatment with any PD-1
Patients with BRAF-positive tumor(s) are eligible for the study if they received prior treatment with a BRAF inhibitor (alone or in combination with a MEK inhibitor) or declined targeted therapy
Additional eligibility in protocol
Ineligibility Information
Ocular melanoma
Prior therapy with a TLR agonist, excluding topical agents
Active systemic infections requiring antibiotics
Known active, hepatitis A, B, or C infection
Known diagnosis of human immunodeficiency virus (HIV) infection
Women who are pregnant or breast-feeding
Impaired cardiac function or clinically significant cardiac disease
Additional ineligibility in protocol
Contact Information
Contact Name:
Wendy Crego, RN, BSN, MSN, OCN, CCRP
For more information go to:
https://clinicaltrials.gov/ct2/show/NCT03445533?term=03445533&rank=1
Contact Phone:
571-472-0632
Contact Email:
wendy.crego@inova.org