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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

Cutaneous subcutaneous soft tissue, or superficial lymphatic metastasis not suitable for surgical resection

Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

Must not have

Woman of childbearing potential that is pregnant or breast-feeding, or planning to become pregnant or breast-feed during protocol treatment and for 3 months after last dose of Talimogene Laherparepvec

History of CTCAE ≥ Grade 2 immune mediated endocrinopathy from prior cancer immunotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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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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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding and do not plan to become pregnant or breastfeed during and for 3 months after treatment.

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I have had a significant immune system reaction from cancer treatment.

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I have an ongoing hepatitis B or C infection.

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I had a severe reaction to previous cancer immunotherapy.

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I am currently taking blood thinners for treatment.

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I have been diagnosed with common variable immunodeficiency.

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I have active herpes skin sores or had serious herpes complications before.

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I have an autoimmune disease like lupus or Crohn's that needed treatment beyond hormone replacement.

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I am HIV positive.

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I am on high doses of immunosuppressants or steroids.

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I have been diagnosed with leukemia or lymphoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

TALIMOGENE LAHERPAREPVEC (TVEC)

2016

Completed Phase 2

~20

Hypofractionated Radiotherapy

2009

Completed Phase 2

~90