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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

Phase 3
18 Years
Open (Enrolling)

Thank you

Trial Information

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

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

Every 12 weeks

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2009

Completion Date:

September 2014

Related Keywords:

  • Melanoma
  • Melanoma
  • GM-CSF
  • Stage IIIb, IIIc and IV Disease
  • oncolytic
  • OncoVex
  • TVec
  • talimogene laherparepvec
  • Melanoma



Roswell Park Cancer Institute Buffalo, New York  14263
Mayo Clinic Rochester, Minnesota  55905
University of Colorado Cancer Center Denver, Colorado  80262
Washington University School of Medicine Saint Louis, Missouri  63110
Medical University of South Carolina Charleston, South Carolina  29425-0721
Mount Sinai School of Medicine New York, New York  10029
Rhode Island Hospital Providence, Rhode Island  02903
MD Anderson Cancer Center Orlando Orlando, Florida  32806
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
Huntsman Cancer Institute Salt Lake City, Utah  84112
James Graham Brown Cancer Center Louisville, Kentucky  40202
Rush University Medical Center Chicago, Illinois  60612-3824
John Wayne Cancer Institute Santa Monica, California  90404
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Oncology and Hematology Associates of Southwest Virginia, Inc. Roanoke, Virginia  24014
Barrett Cancer Center Cincinnati, Ohio  45267-0502
Methodist Estabrook Cancer Center Omaha, Nebraska  68114-4199
Palm Beach Cancer Institute West Palm Beach, Florida  33401
Mary Crowley Medical Research Center Dallas, Texas  75246
Duke University Medical Center Durham, North Carolina  27710
H. Lee Moffitt Cancer Center Tampa, Florida  33612
Emory University Atlanta, Georgia  30322
UCLA Medical Center Los Angeles, California  90095-7059
Lakeland Regional Cancer Center Lakeland, Florida  33805
Thomas Jefferson University Philadelphia, Pennsylvania  19107-6541
Gabrail Cancer Center Canton, Ohio  44718
Vanderbilt Ingram Cancer Center Nashville, Tennessee  37232
University of Miami Miami, Florida  33136
Kansas City Cancer Center Kansas City, Missouri  64111
Indiana University Indianapolis, Indiana  46202
University of Arizona Cancer Center Tucson, Arizona  85724
Wake Forest University School of Medicine Winston-Salem, North Carolina  27157-1023
Mountainside Hospital Montclair, New Jersey  07042
Baptist Cancer Institute Jacksonville, Florida  32207
Cleveland Clinic Foundation, Taussig Cancer Center Cleveland, Ohio  44195
Hubert H Humphrey Cancer Center Robbinsdale, Minnesota  55422
Investigative Clinical Research of Indiana Indianapolis, Indiana  46254
New Mexico Cancer Care Alliance Albuquerque, New Mexico  87106
San Francisco Oncology Associates San Francisco, California  94115
Mount Sinai Medical Center CCOP Miami Beach, Florida  33140
Intermountain Medical Center Murray, Utah  84157
University of Iowa Hospitals & Clinics Iowa City, Iowa  52242
St Luke's Hospital & Health Network Bethlehem, Pennsylvania  18015
St. Louis University Hospital St. Louis, Missouri  63110
University of California San Diego, Moores Cancer Center La Jolla, California  92093
Northern California Melanoma Center, St. Mary's Medical Center San Francisco, California  94117
Redwood Regional Medical Group Inc, North Bay Melanoma Program Sebastopol, California  95472
Cancer Care Center at Lutheran General Hospital Park Ridge, Illinois  60068
Columbia Medical University New York, New York  10032
University of North Carolina At Chapel Hill School of Medicine Chapel Hill, North Carolina  27599
Earle A Chiles Research Institute, Providence Cancer Center Portland, Oregon  97213
Institute for Translational Oncology Research Greenville, South Carolina  29605
Texas Cancer Center, Abilene Abilene, Texas  79701
University of Texas - MD Anderson Houston, Texas  77030
Texas Oncology, Allison Cancer Center Midland, Texas  79701
Aurora/St. Luke's Medical Center Milwaukee, Wisconsin  53215