Phase 2 Melanoma Trial, Completed NCT02211131 Sponsor: Amgen Condition: Melanoma
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT02211131) enrolled 150 people with melanoma — 74 in the surgery-only group and 76 in the group that received talimogene laherparepvec (an injectable treatment) before surgery. The trial was primarily measuring "recurrence-free survival," which means the length of time after treatment before the cancer came back or a participant died from any cause. A number of secondary measures were also tracked, including the proportion of participants who had no cancer cells detectable at the edges of the removed tissue (called a "clear margin" or R0 resection), the proportion whose surgical sample showed no living tumour cells at all (called a pathological complete response), and how many participants remained recurrence-free at one, two, three, and five years. The reported data shows that for the primary outcome — recurrence-free survival — the median time recorded was 0.0 months in both groups, which the trial's own definition explains: participants who did not achieve a clear surgical margin or who withdrew before surgery were counted as having an event at the very start (day zero), which heavily influences this figure. For the secondary recurrence-free survival checkpoints, the reported data shows the following percentages of participants still recurrence-free at each time point: at one year, approximately 22% in the surgery-only group and 34% in the combination group; at two years, roughly 17% and 30%; at three years, approximately 17% and 28%; and at five years, about 15% and 22%. The reported rate of clear surgical margins (R0) was 37.8% for surgery alone and 42.1% for the combination group. For pathological complete response — no detectable living tumour cells in the removed tissue — the reported figures were 2.7% in the surgery-only group and 17.1% in the combination group. The local recurrence-free survival median was also reported as 0.0 months in both groups, for the same counting reasons noted above. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Melanoma Trial, Completed

NCT02211131
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with advanced melanoma (stage IIIB, IIIC, or IVM1a) that doctors believe can be fully removed by surgery.
  • Any previous cancer treatments (such as chemotherapy, radiation, or other therapies) for your melanoma were finished at least 3 months before joining the trial.
  • You have measurable melanoma that can be injected directly, meaning at least one skin, under-skin, or lymph node tumor that is 10mm (about ½ inch) or larger, or several smaller tumors that together reach that size.
  • You are in generally good physical health (able to carry out normal daily activities with little or no limitation), have normal or near-normal levels of a specific blood marker called LDH, and have blood, liver, kidney, and clotting functions within acceptable ranges (confirm with trial site for exact values).

Who may not be able to join:

  • You have a type of melanoma that started in the eye or in a mucous membrane (such as the mouth or nose).
  • You have a history of melanoma that developed because of a weakened immune system, such as from a genetic immune condition, an organ transplant, or leukemia.
  • You have, or have had, serious autoimmune conditions affecting the lungs, kidneys, or blood vessels, or other significant autoimmune diseases causing symptoms.
  • You have significant immune system suppression, active cold sore-type skin infections (herpes), or a history of serious herpes complications such as eye or brain infections, or you regularly need antiviral medication to treat herpes.
  • You currently have, or have had, active hepatitis B, hepatitis C, or HIV infection.
  • You have previously been treated with the drug talimogene laherparepvec or any type of tumor vaccine.
  • Other criteria may apply (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: MD, Amgen

Australian sites

Research Site, North Sydney, New South Wales
Research Site, Woodville South, South Australia
Research Site, Heidelberg, Victoria

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Completed
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
3 February 2015
Est. completion
30 April 2019

Where this trial is recruiting

🇦🇺 Australia 🇧🇷 Brazil 🇫🇷 France 🇬🇷 Greece 🇵🇱 Poland 🇷🇺 Russia 🇪🇸 Spain 🇨🇭 Switzerland 🇺🇸 United States

3 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Recurrence-Free Survival (RFS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov