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Virus Therapy

T-VEC + Radiotherapy for Melanoma

Phase 2
Waitlist Available
Led By Christopher Barker, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Man or woman ≥ 18 years old
Resolution or stabilization of clinically significant adverse events from prior therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

Study Summary

This trial will test the effectiveness of a new cancer treatment, T-VEC, either alone or in combination with radiotherapy.

Who is the study for?
Adults with melanoma, Merkel cell carcinoma, or other solid tumors unsuitable for surgery can join this trial. They must have a life expectancy over 4 months, be in fairly good health (ECOG status 0-2), and have skin metastasis that's big enough to inject and irradiate. Pregnant women, those with certain infections like HIV or hepatitis B/C, people on high-dose immunosuppressants or anticoagulants, and anyone likely not to follow the study rules cannot participate.Check my eligibility
What is being tested?
This phase II trial is testing T-VEC (a type of cancer treatment) alone or combined with hypofractionated radiotherapy—this means radiation given in larger doses over fewer sessions. The goal is to see how well these treatments work on skin metastases from various cancers and what side effects they might cause.See study design
What are the potential side effects?
T-VEC may lead to flu-like symptoms, pain at the injection site, fatigue, chills, fever, nausea. Radiotherapy could cause skin irritation where it's applied. Both treatments together might increase the chances of these side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My side effects from previous treatments have either gone away or are not getting worse.
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My cancer spread to the skin or just under it and cannot be removed by surgery.
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I can take care of myself and am up and about more than half of my waking hours.
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I have a skin or shallow lymph cancer spot larger than 10 mm that can be treated with injection and radiation.
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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.
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My cancer has spread, and the largest spot is bigger than 10 mm or shows up on a PET/CT scan.
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My cancer is confirmed to be melanoma, Merkel cell carcinoma, or another solid tumor.
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My blood clots normally.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
response

Trial Design

2Treatment groups
Experimental Treatment
Group I: Intralesional TALIMOGENE LAHERPAREPVEC without radiotherapyExperimental Treatment1 Intervention
Patients will receive Talimogene Laherparepvec alone, as described above, without radiotherapy.
Group II: Intralesional TALIMOGENE LAHERPAREPVEC with radiotherapyExperimental Treatment2 Interventions
Patients will receive 3 radiotherapy treatments (one treatment every 3-5 days) during weeks 3 and 4. The first treatment will occur 6 (+/- 2) hours after the Talimogene Laherparepvec administration at week 3.Talimogene Laherparepvec will be administered at weeks 0, 3, 5, 7, 9, 11, 13 and 15. The first dose of Talimogene Laherparepvec will be 10^6 plaque forming units (PFU)/mL, followed three weeks later by a dose of 10^8 pfu/mL.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiotherapy
2009
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,927 Previous Clinical Trials
591,388 Total Patients Enrolled
76 Trials studying Melanoma
15,959 Patients Enrolled for Melanoma
AmgenIndustry Sponsor
1,354 Previous Clinical Trials
1,383,125 Total Patients Enrolled
23 Trials studying Melanoma
19,487 Patients Enrolled for Melanoma
Christopher Barker, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
327 Total Patients Enrolled

Media Library

Talimogene Laherparepvec (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02819843 — Phase 2
Melanoma Research Study Groups: Intralesional TALIMOGENE LAHERPAREPVEC with radiotherapy, Intralesional TALIMOGENE LAHERPAREPVEC without radiotherapy
Melanoma Clinical Trial 2023: Talimogene Laherparepvec Highlights & Side Effects. Trial Name: NCT02819843 — Phase 2
Talimogene Laherparepvec (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02819843 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI

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."

Answered by AI
~0 spots leftby Jun 2024