Phase 2
Completed N=112
Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma
Unresected Stage IIIb to IVM1c Melanoma
Source: ClinicalTrials.gov NCT02366195 ↗
Enrolled (actual)
112
Serious AEs
29.7%
Results posted
Jul 2018
Primary outcomePrimary: Odds Ratio of Baseline Intratumoral CD8+ Cell Density and Objective Response Rate — 1.11 ratio — p=0.387
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Odds Ratio of Baseline Intratumoral CD8+ Cell Density and Objective Response Rate |
1.11 | 0.387 |
| SECONDARY Odds Ratio of Baseline Intratumoral CD8+ Cell Density and Durable Response Rate |
1.40; 1.18 | 0.056 |
| SECONDARY Hazards Ratio of Baseline Intratumoral CD8+ Cell Density and Duration of Response |
0.74; 0.91 | 0.335 |
| SECONDARY Correlation Between Baseline Intratumoral CD8+ Cell Density and Changes in Tumor Burden |
0.03; 0.01 | 0.82 |
| SECONDARY Odds Ratio of Change From Baseline Intratumoral CD8+ Cell Density and Objective Response Rate |
0.94; 0.98 | 0.660 |
| SECONDARY Odds Ratio of Change From Baseline in Intratumoral CD8+ Cell Density and Durable Response Rate |
0.99; 0.93 | 0.974 |
| SECONDARY Hazard Ratio of Change From Baseline in Intratumoral CD8+ Cell Density and Duration of Response |
1.28; 1.12 | 0.626 |
| SECONDARY Correlation Between Change From Baseline in Intratumoral CD8+ Cell Density and Changes in Tumor Burden |
-0.18; -0.19 | 0.18 |
| SECONDARY Objective Response Rate |
27.0; 28.8 | — |
| SECONDARY Duration of Response |
NA; NA | — |
| SECONDARY Time to Treatment Failure |
8.1; 8.1 | — |
| SECONDARY Durable Response Rate |
13.5; 21.6 | — |
| SECONDARY Overall Survival |
NA; NA | — |
| SECONDARY Change From Baseline in Tumor Burden |
16.420; -5.883; -10.085; -13.074; -21.407; -30.404 | — |
| SECONDARY Number of Participants With Adverse Events |
108; 38; 11; 33; 4; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Provided informed consent prior to initiation of any study-specific activities/procedures
- Subject with stage IIIB to IVM1c melanoma for whom surgery is not recommended
- Candidate for intralesional therapy
- Measurable disease with greatest diameter ≥ 10 mm
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
Other Inclusion Criteria May Apply
Exclusion Criteria
- Clinically active cerebral metastases.
- Bone metastases
- Primary ocular or mucosal melanoma
- Active herpetic skin lesions or prior complications of herpes simplex virus type 1 (HSV-1) infection (eg, herpetic keratitis or encephalitis)
- Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use
- 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
- Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception
Other Exclusion Criteria May Apply
Data sourced from ClinicalTrials.gov (NCT02366195). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.