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:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT02574260
Eligibility Criteria:
Inclusion Criteria:
1. Previously participated in Study 002/03 and met 1 of the following:
1. Received the maximum 24 treatment injections in Study 002/03 and had not yet achieved a complete response (CR) and whose response to OncoVEX\^GM-CSF indicated that treatment beyond 12 months was warranted, or
2. Did achieve a CR in Study 002/03 and developed disease progression within 12 months of achieving a CR, or
3. Terminated treatment in Study 002/03 to allow for treatment of brain metastases. Treatment for brain metastases was no longer ongoing and the patient was able to return to OncoVEX\^GM-CSF injections within 3 months of completing treatment for brain metastases.
2. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
Exclusion Criteria:
1. Prior Common Toxicity Criteria for Adverse Events (CTCAE) Grade 3 or 4 toxicity related to OncoVEX\^GM-CSF of any organ system (with the exception of injection site reactions, fever and vomiting);
2. History of Grade 3 fatigue lasting \> 1 week while on OncoVEX\^GM-CSF treatment;
3. History of Grade 3 arthralgia/myalgias while on OncoVEX\^GM-CSF treatment;
4. History of ≥ Grade 2 autoimmune reactions, allergic reactions or urticaria or other OncoVEX\^GM-CSF-related non-hematological toxicities while on OncoVEX\^GM-CSF treatment that required a dose delay or discontinuation of OncoVEX\^GM-CSF therapy;
5. Symptomatic malignant disease progression that required alternative melanoma treatment;
6. Primary malignancy disease progression despite treatment with OncoVEX\^GM-CSF;
7. Patient requested to be withdrawn from or was unable to comply with the demands of Study 002/03.
8. Patient was withdrawn from Study 002/03 at the discretion of the Investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02574260
Study Brief:
Protocol Section:
NCT02574260