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

NCT02819843 | Completed Phase 2 Results

• 1 other identifier: 16-224
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Melanoma; Merkel Cell Carcinoma; Other Solid Tumors

Keywords

T-VEC (Talimogene Laherparepvec); Radiotherapy; 16-224

Outcome Measures

Primary Outcomes (1)

• Best Response

  Overall subject level response is defined as partial or complete (\>50% or greater decrease in largest lesion) by the modified World Health Organization (mWHO) criteria, and will include measurements of tumor size by CT component of PET/CT, and clinically by digital photography.

  16 weeks

Study Arms (2)

Intralesional TALIMOGENE LAHERPAREPVEC with radiotherapy

EXPERIMENTAL

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.

Drug: TALIMOGENE LAHERPAREPVEC (TVEC); Radiation: Hypofractionated Radiotherapy

Intralesional TALIMOGENE LAHERPAREPVEC without radiotherapy

EXPERIMENTAL

Patients will receive Talimogene Laherparepvec alone, as described above, without radiotherapy.

Drug: TALIMOGENE LAHERPAREPVEC (TVEC)

Interventions

TALIMOGENE LAHERPAREPVEC (TVEC) DRUG

Intralesional TALIMOGENE LAHERPAREPVEC with radiotherapy; Intralesional TALIMOGENE LAHERPAREPVEC without radiotherapy

Hypofractionated Radiotherapy RADIATION

Intralesional TALIMOGENE LAHERPAREPVEC with radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Amgen: collaborator

Study Sites (3)

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Melanoma; Carcinoma, Merkel Cell

Interventions

talimogene laherparepvec; Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Dr. Christopher Barker, MD
• Organization: Memorial Sloan Kettering Cancer Center

barkerc@mskcc.org

212-639-8168

Study Officials

• Christopher Barker, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: June 30, 2016
• Study Start: June 21, 2016
• Primary Completion: February 22, 2024
• Study Completion: February 22, 2024
• Last Updated: January 29, 2025
• Results First Posted: January 29, 2025

Record last verified: 2024-04

Locations

US (3)