Melanoma Vaccine OncoVEX enters Phase III Clinical Trial

Kathleen Blanchard's picture

Researchers have found a melanoma vaccine that has had promising results. A clinical trial is underway and is in Phase III after positive findings from the first two trials. The vaccine, OncoVEX has lead to complete recovery of melanoma in eight patients from an earlier Phase II clinical trial.

Survival in individuals with advanced melanoma is six months to two years, and few treatments exist. Superficial melanoma lesions can be removed from the skin but if the deadly cancer develops in the intestines or other body tissues the prognosis is poor. Early detection of melanoma that often appears as a mole leads to the best outcomes.

"Very few treatment options exist for patients with advanced melanoma, none of them satisfactory, which is why oncologists are so excited about the results we found in our Phase II study," said Dr. Howard Kaufman, associate dean of Rush Medical College and director of the Rush Cancer Program. Kaufman is leading the Phase III study.

OncoVEX was originally developed to treat herpes. Discovery that the vaccine could treat melanoma occurred by accident when scientists put it in a Petri dish with cancer cells. In addition to killing cancer cells, OncoVEX also boosts immunity.


In the Phase II trial, OncoVEX was given to patients with advanced melanoma that had spread to other parts of the body and had not responded to other treatments including Interleukin 2 - an immune boosting therapy that is in Phase IV clinical trials - and who had not responded to chemotherapy.

The overall response rate for melanoma treatment with the vaccine OncoVEX was twenty six percent, compared to 15 percent with other therapies.

The vaccine can be administered at the doctor’s office with or without guided ultrasound and is given directly into melanoma lesions. Patients in the earlier Phase II clinical trial received the vaccine every two weeks for a total of twelve injections, and eight of 50 patients recovered completely.

"What really surprised, and encouraged, us was that the vaccine worked not just on the cells we injected, but on lesions in other parts of the body that we couldn't reach," Kaufman said. "In other words, the vaccine prompted an immune response that was circulated through the bloodstream to distant sites.”

The melanoma vaccine Phase III clinical trial is currently enrolling 430 patients to study OncoVEX in a larger group of patients. The researchers say OncoVEX “showed the best results to date for any vaccine developed for melanoma, but they need to be confirmed in a larger population."

J. Clin. Oncol. 27: 5763-5771



I am one of those who just finished a clinical trial with Onco-Vex and whose CAT scan shows no evidence of disease
I am so happy for you. My husband is receiving the vaccine now on a weekly basis. We are praying that we have a total remission of the disease. Please tell me more about your case.
hi, my friend has malignant melanoma and we heard about vaccine, but as we are from serbia we dont have much informations about it. can you please tell sth more about it. tnx in advance
The link to the trial with details is also in the article. To my knowledge, it is still in clinical trial. I hope your friend has the best possible outcome. It is a difficult cancer.
he started with radio therapy and now is using temadol if you have heard about that drug, in three months we will know result of that treatment, we heard about vaccine and we are interested in because it seems now that this is the onlz treatmnet for this, thank you very much for answer and link i preciate this.
You are so welcome. Again, wishing the best. mom has malignant melanoma and the cancer metastasis was found in her bone.bone marrow.brain and liver.she is using temodale but not interleukin2.because it can not be found in iran. can u tell me how can I find this vaccine??can I find it in europe? mom has malignant melanoma and the cancer metastasis was found in her bone.bone marrow.brain and liver.she is using temodale but not interleukin2.because it can not be found in iran. can u tell me how can I find this vaccine??can I find it in europe?
Are these trials randomized or will the patient be getting the Onconvex vaccine. Thank-you
My mother, a known diabetic on medication since 4 months was recently diagnosed with a non-healing ulcer on the lateral aspect of her right heel. An excision was made and the sample was sent for biopsy. The biopsy report showed that it was a case of malignant melanoma ( nodular type ) Clarkes stage IV and a Breslow thickness of 3mm. We were advised to consult a surgical oncologist who then recommended a PET-CT scan of whole body. The scan report indicated that no metabolically active disease state was noted and there was no inguinal node infiltration. The doctor then performed a surgery on 09/07/2010 by wide local excision on the heel and applying sural artery flap and a skin graft. My mother was advised complete bed rest until the wound heals.
going to see Dr. Kaufman this week...hope to hear some other positive stories.
To the person whose CAT scan showed no disease after the OncoVex trial, I would love to talk to you about your experience. I am an Australian journalist writing about gene therapies. Please contact me @ [email protected]