Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma
Status: | Active, not recruiting |
---|---|
Conditions: | Skin Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/7/2019 |
Start Date: | April 7, 2015 |
End Date: | September 30, 2019 |
A Phase 2, Multicenter, Open-label, Single-arm Trial to Evaluate the Correlation Between Objective Response Rate and Baseline Intratumoral CD8+ Cell Density in Subjects With Unresected Stage IIIB to IVM1c Melanoma Treated With Talimogene Laherparepvec
The study is a phase 2, multi centered, single arm study designed to evaluate the correlation
between cluster of differentiation 8-positive (CD8+) cell density and objective response rate
in adults with unresected stage IIIB to IVM1c melanoma. This study will also evaluate the
safety and tolerability profile of talimogene laherparepvec.
between cluster of differentiation 8-positive (CD8+) cell density and objective response rate
in adults with unresected stage IIIB to IVM1c melanoma. This study will also evaluate the
safety and tolerability profile of talimogene laherparepvec.
Inclusion Criteria:
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
Other Inclusion Criteria May Apply
Exclusion Criteria:
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
Other Exclusion Criteria May Apply
We found this trial at
2
sites
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