Expanded Access Study of Talimogene Laherparepvec for Treatment of Subjects With Unresected Stage IIIB-IVM1c Melanoma

NCT02297529 | Unknown

• 2 other identifiers: 201203282014-002834-30
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 3

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 melanoma. The study will also evaluate the safety and tolerability of Talimogene Laherparepvec.

Conditions

Unresected Stage IIIB to IVM1c Melanoma

Keywords

unresected, Melanoma, expanded access, EU

Interventions

Talimogene Laherparepvec DRUG

Open label single arm study. The initial dose of talimogene laherparepvec is up to 4.0 mL of 106 PFU/mL. Subsequent doses of talimogene laherparepvec are up to 4.0 mL of 108 PFU/mL.

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \. Candidate for intralesional therapy 8. Adequate organ function. 9. ECOG performance status of 0, 1, or 2.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (3)

Research Site

Chur, 7000, Switzerland

Location

Research Site

Lausanne, 1011, Switzerland

Location

Research Site

Zurich, 8091, Switzerland

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Melanoma

Interventions

talimogene laherparepvec

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: November 21, 2014
• Last Updated: October 31, 2019

Record last verified: 2019-10

Locations

CH (3)