Phase 3
Completed N=437
Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma
Source: ClinicalTrials.gov NCT00769704 ↗Enrolled (actual)
437
Serious AEs
22.0%
Results posted
Dec 2015
Primary outcomePrimary: Durable Response Rate — 2.1; 16.3 percentage of participants — p=<0.0001
Summary
The objective of this study is to evaluate the efficacy and safety of treatment with talimogene laherparepvec compared to subcutaneously administered GM-CSF in patients with unresectable Stage IIIb, IIIc and Stage IV melanoma. The efficacy endpoints of the study aim to demonstrate overall clinical benefit for patients treated with talimogene laherparepvec as compared to GM-CSF.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Durable Response Rate |
2.1; 16.3 | <0.0001 sig |
| SECONDARY Overall Survival |
18.9; 23.3 | 0.0511 |
| SECONDARY Objective Response Rate |
5.7; 26.4 | <0.0001 sig |
| SECONDARY Duration of Response |
2.8; NA | 0.0868 |
| SECONDARY Response Onset |
3.7; 4.1 | 0.2020 |
| SECONDARY Time to Treatment Failure |
2.9; 8.2 | <0.0001 sig |
| SECONDARY Response Interval |
7.5; NA | 0.0050 sig |
Eligibility Criteria
Inclusion Criteria
- Males or females age ≥ 18 years
- Stage IIIb, IIIc or stage IV disease that is not surgically resectable
- Injectable disease (i.e. suitable for direct injection or through the use of ultrasound guidance)
- At least 1 injectable cutaneous, subcutaneous or nodal melanoma lesion >= 10 mm in longest diameter or, multiple injectable melanoma lesions which in aggregate have a longest diameter of >= 10 mm
- Serum lactate dehydrogenase (LDH) levels less than 1.5 x upper limit of normal (ULN)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Prolongation in International Normalized Ratio (INR), Prothrombin Time (PT), and Partial Thromboplastin Time (PTT) when the result is from therapeutic anticoagulation treatment are permitted for patients whose injectable lesions are cutaneous and/or subcutaneous such that direct pressure could be applied in the event of excessive bleeding
Exclusion Criteria
- Clinically active cerebral or any bone metastases. Patients with up to 3 (neurological performance status of 0) cerebral metastases may be enrolled, provided that all lesions have been adequately treated with stereotactic radiation therapy, craniotomy, gammaknife therapy, with no evidence of progression, and have not required steroids, for at least two (2) months prior to randomization
- Greater than 3 visceral metastases (this does not include lung metastases or nodal metastases associated with visceral organs). For patients with 3 cm, and liver lesions must meet Response Evaluation Criteria In Solid Tumors (RECIST) criteria for stable disease for at least 1 month prior to randomization
Data sourced from ClinicalTrials.gov (NCT00769704). 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.