Status:
NO_LONGER_AVAILABLE
Expanded Access Study of Talimogene Laherparepvec for Treatment of Subjects With Unresected Stage IIIB-IVM1c Melanoma
Lead Sponsor:
Amgen
Conditions:
Unresected Stage IIIB to IVM1c Melanoma
Eligibility:
All Genders
18-95 years
Brief Summary
The study is a phase 3b, multicenter, open-label, single-arm study designed to provide expanded access of Talimogene Laherparepvec for the treatment of subjects with unresected stage IIIB to IVM1c mel...
Detailed Description
This is a phase 3b, multicenter, open-label, single-arm, expanded access study of talimogene laherparepvec for the treatment of subjects with unresected stage IIIB to IVM1c melanoma in select European...
Eligibility Criteria
Inclusion
- Provide informed consent prior to initiation of any protocol-specific activities/procedures.
- Male or female age ≥ 18 years at the time of informed consent.
- 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 6.Subject does not qualify for, or cannot access, other comparable or satisfactory alternative therapy for stage IIIB to IVM1c melanoma
- 7\. Candidate for intralesional therapy 8. Adequate organ function. 9. ECOG performance status of 0, 1, or 2.
Exclusion
- Clinically active cerebral metastases.
- Greater than 3 visceral metastases.
- Bone metastases
- Primary ocular or mucosal melanoma.
- History or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease.
- Active herpetic skin lesions or prior complications of HSV-1 infection (eg, herpetic keratitis or encephalitis)
- Known to have acute or chronic active hepatitis B or C infection
- Known to have human immunodeficiency virus infection
- History of other malignancy within the past 3 years
- 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.
- Subject has known sensitivity to any of the products or components to be administered during dosing.
- Subject has entered this protocol previously.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02297529
Last Update
October 31 2019
Active Locations (3)
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1
Research Site
Chur, Switzerland, 7000
2
Research Site
Lausanne, Switzerland, 1011
3
Research Site
Zurich, Switzerland, 8091