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T-VEC + Radiotherapy for Melanoma
Study Summary
This trial will test the effectiveness of a new cancer treatment, T-VEC, either alone or in combination with radiotherapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am 18 years old or older.I am not pregnant or breastfeeding and do not plan to become pregnant or breastfeed during and for 3 months after treatment.I have not received a live vaccine in the last 28 days.I had a severe reaction to previous cancer immunotherapy.I am currently taking blood thinners for treatment.I am currently responding to a cancer treatment.I have been diagnosed with common variable immunodeficiency.I have active herpes skin sores or had serious herpes complications before.My condition has been stable or worsening, but I can continue my current treatment while in this study.I have an autoimmune disease like lupus or Crohn's that needed treatment beyond hormone replacement.I had hepatitis before but now have immunity and no active infection.My side effects from previous treatments have either gone away or are not getting worse.My cancer spread to the skin or just under it and cannot be removed by surgery.I can take care of myself and am up and about more than half of my waking hours.I have a skin or shallow lymph cancer spot larger than 10 mm that can be treated with injection and radiation.My skin cancer that was previously treated with radiation can be treated again, as it's been over 6 months and the previous dose was not too high.My cancer has spread, and the largest spot is bigger than 10 mm or shows up on a PET/CT scan.I have had a significant immune system reaction from cancer treatment.I have an ongoing hepatitis B or C infection.You are expected to live for more than 4 months.I am HIV positive.My cancer is confirmed to be melanoma, Merkel cell carcinoma, or another solid tumor.I am on high doses of immunosuppressants or steroids.I am a woman who can have children and agree to use birth control during and for 3 months after treatment.I am taking medication for herpes.I have been diagnosed with leukemia or lymphoma.My blood clots normally.You have a serious condition that weakens your immune system.
- Group 1: Intralesional TALIMOGENE LAHERPAREPVEC with radiotherapy
- Group 2: Intralesional TALIMOGENE LAHERPAREPVEC without radiotherapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many participants has this experiment attracted?
"This clinical trial has ceased accepting candidates, with the initial posting being on June 21st 2016 and last update occurring July 13th 2022. As an alternative, 3130 studies related to melanoma are welcoming participants and 22 trials involving TALIMOGENE LAHERPAREPVEC (TVEC) have open slots for enrolment."
Could you provide details on any past investigations with TALIMOGENE LAHERPAREPVEC (TVEC)?
"Currently, 22 medical trials are researching TALIMOGENE LAHERPAREPVEC (TVEC), none of which is in the final phase. Both Santa Monica and 242 other sites have these clinical studies underway."
Is this a groundbreaking research endeavor?
"Since the premiere trial in 2015, sponsored by Amgen and involving 30 participants, TALIMOGENE LAHERPAREPVEC (TVEC) has been subject to extensive research. By 2020 it had achieved Phase 1 & 2 drug approval, leading to 22 current studies occurring across 93 cities and 16 countries."
Are there vacancies for participants in this clinical investigation?
"Regrettably, recruitment for this trial has concluded. Initially posted on 21st June 2016 and edited most recently on 13th July 2022, it is no longer accepting participants. For those seeking alternate trials, 3130 clinical studies are actively recruiting patients with melanoma and 22 alternative sites offer TALIMOGENE LAHERPAREPVEC (TVEC)."
Has the United States Food and Drug Administration (FDA) authorized TALIMOGENE LAHERPAREPVEC (TVEC)?
"The safety of TALIMOGENE LAHERPAREPVEC (TVEC) was assessed as a 2 due to the fact that Phase 2 data exists demonstrating its relative safety, but no efficacy-related information is available."
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