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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02819843
Recruitment Status : Recruiting
First Posted : June 30, 2016
Last Update Posted : July 2, 2020
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Melanoma Merkel Cell Carcinoma Other Solid Tumors Drug: TALIMOGENE LAHERPAREPVEC (TVEC) Radiation: Hypofractionated Radiotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021


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)



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819843


Contacts
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Contact: Christopher Barker, MD 212-639-8168
Contact: Simon Powell, MD, PhD 212-639-3639

Locations
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United States, New Jersey
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Christopher Barker, MD    212-639-8168      
United States, New York
Memoral Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Christopher Barker, MD    212-639-8168      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Christopher Barker, MD    212-639-8168      
Contact: Simon Powell, MD, PhD    212-639-3639      
Principal Investigator: Christopher Barker, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Amgen
Investigators
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Principal Investigator: Christopher Barker, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02819843    
Other Study ID Numbers: 16-224
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: July 2020
Keywords provided by Memorial Sloan Kettering Cancer Center:
T-VEC (Talimogene Laherparepvec)
Radiotherapy
16-224
Additional relevant MeSH terms:
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Talimogene laherparepvec
Carcinoma, Merkel Cell
Carcinoma
Melanoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Polyomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Carcinoma, Neuroendocrine
Adenocarcinoma
Antineoplastic Agents, Immunological
Antineoplastic Agents