Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
The study will explore the hypothesis that intratumoral CD8+ cell density at baseline correlates with objective response rate in adults with unresected stage IIIB to IVMIc melanoma treated with talimogene laherparepvec.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Provided informed consent prior to initiation of any study-specific activities/procedures
2. Subject with stage IIIB to IVM1c melanoma for whom surgery is not recommended
3. Candidate for intralesional therapy
4. Measurable disease with greatest diameter ≥ 10 mm
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Adequate organ function
You may not be if
1. Clinically active cerebral metastases.
2. Bone metastases
3. Primary ocular or mucosal melanoma
4. Active herpetic skin lesions or prior complications of herpes simplex virus type 1 (HSV-1) infection (eg, herpetic keratitis or encephalitis)
5. Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use
6. Female subject is pregnant or breast-feeding, or planning to become pregnant during study treatment and through 3 months after the last dose of talimogene laherparepvec
7. Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception
Clareo Health | Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma
