A Study of T-VEC (Talimogene Laherparepvec) With or Without Radiotherapy for Melanoma, Merkel Cell Carcinoma, or Other Solid Tumors
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Response |
1; 1; 0; 0; 2; 5 | — |
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
Data sourced from ClinicalTrials.gov (NCT02819843). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.