Efficacy and Safety Study of OncoVEXGM-CSF Compared to GM-CSF in Melanoma

This study has been completed.
Information provided by (Responsible Party):
BioVex Limited
ClinicalTrials.gov Identifier:
First received: October 7, 2008
Last updated: January 26, 2015
Last verified: January 2015

October 7, 2008
January 26, 2015
April 2009
February 2013   (final data collection date for primary outcome measure)
Achieving a statistically significant improvement in durable response rate, defined as the rate of CR or PR lasting continuously for 6 or more months, as compared to control therapy. [ Time Frame: Every 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00769704 on ClinicalTrials.gov Archive Site
To evaluate overall survival in patients treated with OncoVEXGM-CSF as compared to control therapy. [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
Efficacy and Safety Study of OncoVEXGM-CSF Compared to GM-CSF in Melanoma
A Randomized Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Treatment With OncoVEXGM-CSF Compared to Subcutaneously Administered GM-CSF in Melanoma Patients With Unresectable Stage IIIb, IIIc and IV Disease
The objective of this study is to evaluate the efficacy and safety of treatment with OncoVEXGM-CSF compared to subcutaneously administered GM-CSF melanoma patients with unresectable Stage IIIb, IIIc and Stage IV disease. The efficacy endpoints of the study aim to demonstrate overall clinical benefit for patients treated with OncoVEXGM-CSF as compared to GM-CSF.
This study is being conducted to learn about the safety and risks of using OncoVEXGM-CSF to treat patients with melanoma and to see if OncoVEXGM CSF can destroy these tumours compared to GM-CSF. This study may provide information on the usefulness of OncoVEXGM-CSF as a future treatment for melanoma. This study may also provide information on the safety and usefulness of GM-CSF as compared to OncoVEXGM-CSF as a treatment for melanoma.
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Biological: OncoVEXGM-CSF (talimogene laherparepvec)
    Up to 4 mL of 10^8 pfu/mL/per injection
    Other Name: talimogene laherparepvec
  • Biological: GM-CSF
    125 µg/m2 daily subcutaneously for 14 consecutive days followed by 14 days of rest
    Other Names:
    • Leukine
    • Sargramostim
  • Experimental: 1
    OncoVEXGM-CSF (talimogene laherparepvec)
    Intervention: Biological: OncoVEXGM-CSF (talimogene laherparepvec)
  • Active Comparator: 2
    Intervention: Biological: GM-CSF
Andtbacka RH, Kaufman HL, Collichio F, Amatruda T, Senzer N, Chesney J, Delman KA, Spitler LE, Puzanov I, Agarwala SS, Milhem M, Cranmer L, Curti B, Lewis K, Ross M, Guthrie T, Linette GP, Daniels GA, Harrington K, Middleton MR, Miller WH Jr, Zager JS, Ye Y, Yao B, Li A, Doleman S, VanderWalde A, Gansert J, Coffin RS. Talimogene Laherparepvec Improves Durable Response Rate in Patients With Advanced Melanoma. J Clin Oncol. 2015 Sep 1;33(25):2780-8. doi: 10.1200/JCO.2014.58.3377. Epub 2015 May 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
September 2014
February 2013   (final data collection date for primary outcome measure)

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 LDH levels less than 1.5 x ULN
  • ECOG Performance Status of 0 or 1
  • Prolongation in INR, PT, and 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 visceral metastases, no lesion >3 cm, and liver lesions must meet RECIST criteria for SD for at least 1 month prior to randomization
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   South Africa,   United Kingdom
BioVex Limited
BioVex Limited
Study Director: MD Amgen
BioVex Limited
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP