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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

Tracking Information
First Submitted Date  ICMJE June 28, 2016
First Posted Date  ICMJE June 30, 2016
Last Update Posted Date July 2, 2020
Actual Study Start Date  ICMJE June 2016
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of T-VEC (Talimogene Laherparepvec) With or Without Radiotherapy for Melanoma, Merkel Cell Carcinoma, or Other Solid Tumors
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Melanoma
  • Merkel Cell Carcinoma
  • Other Solid Tumors
Intervention  ICMJE
  • Drug: TALIMOGENE LAHERPAREPVEC (TVEC)
  • Radiation: Hypofractionated Radiotherapy
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: TALIMOGENE LAHERPAREPVEC (TVEC)
    • Radiation: Hypofractionated Radiotherapy
  • Experimental: Intralesional TALIMOGENE LAHERPAREPVEC without radiotherapy
    Patients will receive Talimogene Laherparepvec alone, as described above, without radiotherapy.
    Intervention: Drug: TALIMOGENE LAHERPAREPVEC (TVEC)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 28, 2016)
34
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christopher Barker, MD 212-639-8168
Contact: Simon Powell, MD, PhD 212-639-3639
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02819843
Other Study ID Numbers  ICMJE 16-224
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Amgen
Investigators  ICMJE
Principal Investigator: Christopher Barker, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP