Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-24 @ 3:42 PM
NCT ID:
NCT02565992
Eligibility Criteria:
Inclusion Criteria:
* Subjects with metastatic or unresectable stage IIIb/c of IV melanoma for whom treatment with pembrolizumab is indicated and who have at least one cutaneous, subcutaneous tumor or palpable lymph node amenable to intratumoral injection.
* At least one tumor must qualify to be an index lesion for modified WHO criteria.
* Subjects must have adequate hematologic, hepatic and renal function.
* ECOG performance status of 0 or 1.
* Anticipated lifespan greater than 12 weeks
Exclusion Criteria:
* Ocular primary tumors.
* Presence of any central nervous system tumor that has not been stable for at least 4 weeks off corticosteroids.
* Tumors lying in mucosal regions or close to an airway, major blood vessel or spinal cord.
* Subjects with active, known or suspected autoimmune or immunosuppressive disease.
* Subjects previously treated with CVA21.
* Subjects requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days prior to the first treatment.
* Subject has received chemotherapy within the last 4 weeks prior to first treatment.
* Clinically significant cardiovascular disease.
* Females of childbearing potential must have negative serum or urine pregnancy test.
* Subjects requiring or using other investigational agents while on treatment in this trial.
* History of other malignancy within the last 3 years (with exceptions).
* Active infection requiring systemic therapy.
* Known history of HIV disease, active hepatitis B or hepatitis C.
* History or evidence of other clinically significant disorders that would pose a risk to subject safety.
* Inability to give informed consent and comply with the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02565992
Study Brief:
Protocol Section:
NCT02565992