Expanded Access Protocol of Talimogene Laherparepvec for Subjects With Unresected, Stage lllB to IVM1c Melanoma

February 26, 2016 updated by: Amgen

A Phase 3b, Multicenter, Open-label, Single-arm, Expanded Access Protocol of Talimogene Laherparepvec for the Treatment of Subjects With Unresected, Stage lllB to IVM1c Melanoma

Expanded access of Talimogene Laherparepvec for subjects with unresected, stage IIIb to IVM1c Melanoma.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

Expanded access of Talimogene Laherparepvec for subjects with unresected, stage IIIb to IVM1c Melanoma that may not meet the eligibility criteria to enroll in another ongoing Talimogene Laherparepvec study or do not have access to enroll in an ongoing Talimogene Laherparepvec study.

Study Type

Expanded Access

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
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Research Site
      • Mobile, Alabama, United States, 36604
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Research Site
    • California
      • Duarte, California, United States, 91010
        • Research Site
      • La Jolla, California, United States, 92093-0698
        • Research Site
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Research Site
      • Jacksonville, Florida, United States, 32207
        • Research Site
      • Miami Beach, Florida, United States, 33140
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States, 63110-1093
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Research Site
      • Omaha, Nebraska, United States, 68198
        • Research Site
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • Research Site
    • New York
      • New York, New York, United States, 10016
        • Research Site
    • North Carolina
      • Winston Salem, North Carolina, United States, 27157
        • Research Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97213
        • Research Site
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75390
        • Research Site
      • Dallas, Texas, United States, 75230
        • Research Site
    • Wisconsin
      • Franklin, Wisconsin, United States, 53132
        • Research Site
      • Wauwatosa, Wisconsin, United States, 53226
        • Research Site

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 to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed diagnosis of melanoma
  • Subject has unresected stage lllB to IVM1c melanoma regardless of prior therapy
  • Subject who is not eligible for or cannot access ongoing talimogene laherparepvec clinical trials
  • Candidate for intralesional therapy (ie, disease is appropriate for direct injection or through the use of ultrasound guidance) defined as one of the following:
  • for a subject not previously treated with talimogene laherparepvec:
  • at least 1 injectable cutaneous, subcutaneous, or nodal melanoma lesion ≥ 10 mm in longest diameter, or
  • multiple injectable melanoma lesions that in aggregate have a longest diameter of ≥ 10 mm
  • for a subject previously treated with talimogene laherparepvec:
  • at least 1 injectable cutaneous, subcutaneous, or nodal melanoma lesion must be present (no minimal size criteria)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Adequate organ function determined within 35 days prior to enrollment
  • Serum LDH levels less than or equal to 1.5 ULN within 35 days prior to enrollment
  • For a subject who previously received talimogene laherparepvec in another clinical trial, subject must have ended treatment for reason(s) other than disease progression or intolerability to talimogene laherparepvec

Exclusion Criteria:

  • Clinically active cerebral metastases. Subjects with up to 3 (neurological performance status of 0) cerebral metastases may be enrolled, provided that all lesions have been adequately treated with stereotactic radiation therapy, craniotomy, gammaknife therapy, with no evidence of progression, and have not required steroids, for at least two (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 > 3 cm, and liver lesions must meet RECIST criteria for stable disease for at least 1 month prior to enrollment.
  • Bone metastases
  • Primary ocular or mucosal melanoma
  • History or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease
  • Evidence of clinically significant immunosuppression
  • Active herpetic skin lesions or prior complications of HSV-1 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
  • Currently receiving treatment with another investigational device or drug study besides talimogene laherparepvec, or less than 28 days since ending treatment with another investigational device or drug study(s)
  • Other investigational procedures while participating in this protocol are excluded
  • Known to have acute or chronic active hepatitis B or hepatitis C infection
  • Known to have human immunodeficiency virus infection
  • History of other malignancy within the past 3 years with the following exceptions:
  • malignancy treated with curative intent and with no known active disease present for ≥ 3 years before enrollment and felt to be at low risk for recurrence by the treating physician
  • adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  • adequately treated cervical carcinoma in situ without evidence of disease
  • adequately treated breast ductal carcinoma in situ without evidence of disease
  • prostatic intraepithelial neoplasia without evidence of prostate cancer
  • adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ
  • Subject has known sensitivity to any of the products or components to be administered during dosing
  • History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen medical monitor, if consulted, would pose a risk to subject safety or interfere with the protocol evaluation, procedures or completion
  • Female subject is pregnant or breast-feeding, or planning to become pregnant during protocol treatment and through 3 months after the last dose of talimogene laherparepvec
  • Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during protocol treatment and through 3 months after the 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?

Collaborators and Investigators

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

Sponsor

Amgen

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.

General Publications

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 Registration Dates

First Submitted

May 1, 2014

First Submitted That Met QC Criteria

May 23, 2014

First Posted (ESTIMATE)

May 28, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 1, 2016

Last Update Submitted That Met QC Criteria

February 26, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120166

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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