Clinical Trials /

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

NCT02819843

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
  • Melanoma
  • Merkel Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: 16-224
  • NCT ID: NCT02819843

Conditions

  • Melanoma
  • Merkel Cell Carcinoma
  • Other Solid Tumors

Interventions

DrugSynonymsArms
TALIMOGENE LAHERPAREPVEC (TVEC)Intralesional TALIMOGENE LAHERPAREPVEC with radiotherapy

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Intralesional TALIMOGENE LAHERPAREPVEC with radiotherapyExperimentalPatients 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.
  • TALIMOGENE LAHERPAREPVEC (TVEC)
Intralesional TALIMOGENE LAHERPAREPVEC without radiotherapyExperimentalPatients will receive Talimogene Laherparepvec alone, as described above, without radiotherapy.
  • TALIMOGENE LAHERPAREPVEC (TVEC)

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:response
Time Frame:16 weeks
Safety Issue:
Description: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.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

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

Last Updated

September 10, 2019