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Study to Evaluate the Safety/ Efficacy of T-VEC in Japanese Subjects With Unresectable Stage IIIB-IV Malignant Melanoma

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03064763
Recruitment Status : Active, not recruiting
First Posted : February 27, 2017
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
No formal statistical hypothesis will be tested for safety endpoints in this trial. Based on the well tolerated safety profile from a global phase 3 study, it is hypothesized that talimogene laherparepvec will be safe and well tolerated in Japanese subjects with unresectable Stage IIIB-IVM1c melanoma. A DRR is hypothesized to be consistent with results from the global phase 3 study

Condition or disease Intervention/treatment Phase
Unresectable Stage IIIB-IV Malignant Melanoma Drug: Talimogene laherparepvec Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 1, Multi-center, Open-Label, Dose De-escalation Study to Evaluate the Safety and Efficacy of Talimogene Laherparepvec in Japanese Subjects With Unresectable Stage IIIB-IV Malignant Melanoma
Actual Study Start Date : March 7, 2017
Estimated Primary Completion Date : June 28, 2019
Estimated Study Completion Date : April 16, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: talimogene laherparepvec
All subjects will receive open-label talimogene laherparepvec
Drug: Talimogene laherparepvec
T-VEC will be administered by intralesional injection only into injectable cutaneous, subcutaneous, and nodal tumors, with or without image ultrasound guidance. On day 1 (week 0) the first dose of talimogene laherparepvec will be up to 4.0 mL of 106 PFU/mL. The second injection up to 4.0 mL of 108 or 107 PFU/mL, should be administered 3 weeks (+ 5) days after the initial injection (no sooner than day 22 but should not be delayed more than 5 days after the 21-day time point). The dose of 108 PFU/mL will be diluted 1:10 to obtain a concentration of 107 PFU/mL immediately prior to injection. Subsequent injections up to 4.0 mL of 108 or 107 PFU/mL should be given every 2 wks (± 3) days. The maximum volume of talimogene laherparepvec to be administered at each treatment visit is 4.0 mL




Primary Outcome Measures :
  1. Incidence of dose limiting toxicities (DLTs)of talimogene laherparepvec [ Time Frame: 35 days ]
    To evaluate the safety of talimogene laherparepvec, subjects will be assessed by incidence of dose limiting toxicities (DLTs).

  2. The anti-tumor activity of T-VEC as assessed by DRR using modified WHO response criteria. [ Time Frame: 4 years ]
    To evaluate for the anti-tumor activity of T-VEC as assessed by DRR using modified WHO response criteria.

  3. Incidence of dose limiting toxicities (DLTs) of talimogene laherparepvec [ Time Frame: 35 days ]
    To evaluate the tolerability of talimogene laherparepvec, subjects will be assessed by incidence of dose limiting toxicities (DLTs).


Secondary Outcome Measures :
  1. Evaluate the anti-tumor activity of talimogene laherparepvec [ Time Frame: 4 years ]
    To evaluate the anti-tumor activity of talimogene laherparepvec

  2. Evaluate overall survival (OS) [ Time Frame: 4 years ]
    To Evaluate Overall Survival (OS)


Other Outcome Measures:
  1. The safety of talimogene laherparepvec as determined by subject incidence of adverse events [ Time Frame: 4 years ]
    To evaluate the safety of talimogene laherparepvec as determined by subject incidence of adverse events

  2. The safety of talimogene laherparepvec as determined by subject incidence of clinically relevant laboratory abnormalities where not defined as DLTs. [ Time Frame: 4 years ]
    To evaluate the safety of talimogene laherparepvec as determined by subject incidence of clinically relevant laboratory abnormalities where not defined as DLTs.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed diagnosis of melanoma
  • Subject with stage IIIB to IVM1c melanoma that is not surgically resectable
  • Subject who is treatment naive and is determined by the physician to be not suitable or eligible for the approved systemic anticancer drug therapy in Japan. Subject may also have received prior systemic anticancer treatment consisting of chemotherapy, immunotherapy, or targeted therapy. Treatment for melanoma must have been completed at least 28 days prior to enrollment.
  • Candidate for intralesional therapy (ie, disease is appropriate for direct injection or through the use of ultrasound guidance, where appropriate) defined as one or more of the following:

    • at least 1 injectable cutaneous, subcutaneous, or nodal melanoma lesion greater or equal to 10 mm in longest diameter, OR
    • multiple injectable melanoma lesions that in aggregate have a longest diameter of greater or equal to 10 mm
  • Measurable disease defined as one or more of the following:

    • at least 1 melanoma lesion that can be accurately and serially measured in at least 2 dimensions and for which the greatest diameter is greater or equal to 10 mm as measured by contrast-enhanced or spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or ultrasound for nodal/soft tissue disease (including lymph nodes)
    • at least 1 greater or equal to10 mm longest diameter superficial cutaneous or subcutaneous melanoma lesion as measured by calipers
    • multiple superficial melanoma lesions which in aggregate have a total diameter of greater or equal to 10 mm
  • Serum lactate dehydrogenase (LDH) levels less than or equal to 1.5 X upper limit of normal (ULN) within 28 days prior to enrollment
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Other Inclusion Criteria May Apply.

Exclusion Criteria:

  • Clinically active cerebral metastases. Subjects with up to 3 cerebral metastases may be enrolled, provided that all lesions have been adequately treated with stereotactic radiation therapy (including Gamma Knife) or craniotomy, with no evidence of progression and have not required steroids for at least 2 months prior to enrollment.
  • Greater than 3 visceral metastases (this does not include lung metastases or nodal metastases associated with visceral organs). For subjects with less than or equal to 3 visceral metastases, no lesion greater than 3 cm in longest dimension and liver lesions must be stable for at least 1 month prior to enrollment.
  • Bone metastases
  • Primary ocular or mucosal melanoma
  • History or evidence of symptomatic autoimmune disease (eg, pneumonitis, glomerulonephritis, vasculitis, or other), or history of autoimmune disease that required systemic treatment (ie, use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) in past 2 months prior to enrollment.
  • Active herpetic skin lesions or prior complications of herpetic infection (eg, herpetic keratitis or encephalitis).
  • Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use.
  • Previous treatment with talimogene laherparepvec
  • Other investigational procedures while participating in this study are excluded.
  • Known to have acute or chronic active hepatitis B infection, acute or chronic active hepatitis C infection or human immunodeficiency virus (HIV) infection
  • Subject has known sensitivity to bovine- or porcine derived components or to any of the products or components to be administered during dosing.
  • History of other malignancy within the past 3 years
  • Other Exclusion Criteria May Apply

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): NCT03064763


Locations
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Japan
Research Site
Nagoya-shi, Aichi, Japan, 466-8560
Research Site
Kashiwa-shi, Chiba, Japan, 277-8577
Research Site
Sapporo-shi, Hokkaido, Japan, 060-8543
Research Site
Kumamoto-shi, Kumamoto, Japan, 860-8556
Research Site
Matsumoto-shi, Nagano, Japan, 390-8621
Research Site
Niigata-shi, Niigata, Japan, 951-8566
Research Site
Osaka-shi, Osaka, Japan, 541-8567
Research Site
Sunto-gun, Shizuoka, Japan, 411-8777
Research Site
Chuo-ku, Tokyo, Japan, 104-0045
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03064763     History of Changes
Other Study ID Numbers: 20140270
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
URL: https://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Amgen:
Unresectable Stage IIIB-IV Malignant Melanoma

Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Talimogene laherparepvec
Antineoplastic Agents, Immunological
Antineoplastic Agents