Melanoma Clinical Trial

A Study of T-VEC (Talimogene Laherparepvec) With or Without Radiotherapy for Melanoma, Merkel Cell Carcinoma, or Other Solid Tumors

Summary

The purpose of this phase II clinical study is to test the good and bad effects of T-VEC (talimogene laherparepvec) with or without hypofractionated radiotherapy on people with melanoma, Merkel cell carcinoma, or other solid tumors with skin metastasis.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Man or woman ≥ 18 years old
Life expectancy > 4 months
Histopathologically confirmed melanoma, Merkel cell carcinoma or other solid tumor malignancy
Cutaneous subcutaneous soft tissue, or superficial lymphatic metastasis not suitable for surgical resection
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

Cutaneous subcutaneous soft tissue, or superficial lymphatic metastasis that is amenable to injection and irradiation and > 10 mm in longest dimension

° Cutaneous metastasis in a region of previous radiation therapy is amenable to radiation therapy as part of this protocol if at least 6 months has elapsed since prior radiotherapy and the dose of radiotherapy previously administered did not exceed an equivalent dose of 60 Gy in 2 Gy equivalent fractions at the skin surface (using linear-quadratic modeling with alpha/beta=11.5)

Metastasis that is > 10 mm in longest dimensionor exhibits radiotracer uptake consistent with metastasis on PET/CT
Adequate coagulation function (platelet count >50 k/mcL, international normalized ratio of < 1.5)
Resolution or stabilization of clinically significant adverse events from prior therapy
Able to provide valid written informed consent

Exclusion Criteria:

Active herpetic skin lesions or prior complications of HSV-1 infection (such as herpetic keratitis, herpetic encephalitis)
Receipt of a therapeutic anticoagulant
Receipt of live vaccine within 28 days of planned first dose of TVEC

Receipt of another cancer therapy (targeted therapy, chemotherapy, investigational therapy, immunotherapy, radiotherapy or surgery) which is yielding an overall response (by response criteria in this study)

° Patients with stable or progressing disease (as determined by at least 2 consecutive assessments at 6-week interval) can continue to receive the same therapy during treatment as part of this protocol

History of symptomatic autoimmune disease (such as lupus, scleroderma, Crohn's disease, ulcerative colitis) requiring systemic treatment (for example corticosteroids or immunosuppressants); replacement therapy (for example, thyroxine, insulin) is not considered a systemic treatment
History of high grade (CTCAE ≥ Grade 3) immune mediated adverse event from prior cancer immunotherapy
History of CTCAE ≥ Grade 2 immune mediated endocrinopathy from prior cancer immunotherapy
Intermittent or chronic use of oral or intravenous antiherpetic drug (such as acyclovir)

Active or chronic hepatitis B or C infection

° Previously infected, with evidence of immunity and no evidence of active hepatitis is not an exclusion criterion

Known human immunodeficiency virus (HIV) infection
Known leukemia or lymphoma
Common variable immunodeficiency
Patients requiring chronic high dose immunosuppressants including steroids (prednisone daily equivalent of ≥ 10 mg)
Known severe congenital or acquired cellular or humoral immunodeficient or immunocompromised patients
High likelihood of protocol non-compliance (in opinion of investigator)
Woman of childbearing potential unwilling to use effective contraception during protocol treatment and for 3 months after last dose of Talimogene Laherparepvec
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

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

19

Study ID:

NCT02819843

Recruitment Status:

Active, not recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 3 Locations for this study

See Locations Near You

Memorial Sloan Kettering Monmouth
Middletown New Jersey, 07748, United States
Memoral Sloan Kettering Westchester
Harrison New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

19

Study ID:

NCT02819843

Recruitment Status:

Active, not recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.