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

April 9, 2024 updated by: Memorial Sloan Kettering Cancer Center

A Phase II Randomized Trial of Intralesional Talimogene Laherparepvec (TALIMOGENE LAHERPAREPVEC) With or Without Radiotherapy for Cutaneous Melanoma, Merkel Cell Carcinoma, or Other Solid Tumors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intralesional TALIMOGENE LAHERPAREPVEC with radiotherapy
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
Experimental: Intralesional TALIMOGENE LAHERPAREPVEC without radiotherapy
Patients will receive Talimogene Laherparepvec alone, as described above, without radiotherapy.
Drug: TALIMOGENE LAHERPAREPVEC (TVEC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
response
Time Frame: 16 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Amgen

Investigators

  • Principal Investigator: Christopher Barker, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2016

Primary Completion (Actual)

February 22, 2024

Study Completion (Actual)

February 22, 2024

Study Registration Dates

First Submitted

June 28, 2016

First Submitted That Met QC Criteria

June 28, 2016

First Posted (Estimated)

June 30, 2016

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-224

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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