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

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
BioVex Limited
ClinicalTrials.gov Identifier:
NCT00769704
First received: October 7, 2008
Last updated: September 30, 2014
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Melanoma
Biological: OncoVEXGM-CSF (talimogene laherparepvec)
Biological: GM-CSF
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by BioVex Limited:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 439
Study Start Date: April 2009
Study Completion Date: September 2014
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
OncoVEXGM-CSF (talimogene laherparepvec)
Biological: OncoVEXGM-CSF (talimogene laherparepvec)
Up to 4 mL of 10^8 pfu/mL/per injection
Other Name: talimogene laherparepvec
Active Comparator: 2
GM-CSF
Biological: GM-CSF
125 µg/m2 daily subcutaneously for 14 consecutive days followed by 14 days of rest
Other Names:
  • GM-CSF
  • Leukine
  • Sargramostim

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769704

  Show 83 Study Locations
Sponsors and Collaborators
BioVex Limited
Amgen
Investigators
Study Director: MD Amgen
  More Information

No publications provided

Responsible Party: BioVex Limited
ClinicalTrials.gov Identifier: NCT00769704     History of Changes
Other Study ID Numbers: 005/05
Study First Received: October 7, 2008
Last Updated: September 30, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada
South Africa: Medicines Control Council

Keywords provided by BioVex Limited:
Melanoma
OncoVEXGM-CSF
GM-CSF
Stage IIIb, IIIc and IV Disease
oncolytic
OncoVex
TVec
talimogene laherparepvec

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 23, 2014