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

Primary Purpose

Unresected Stage IIIB to IVM1c Melanoma

Status

No longer available

Phase

Locations

Switzerland

Study Type

Expanded Access

Intervention

Talimogene Laherparepvec

About this trial

This is an expanded access trial for Unresected Stage IIIB to IVM1c Melanoma focused on measuring unresected, Melanoma, expanded access, EU

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Research Site
Research Site
Research Site

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT02297529

First Posted

October 17, 2014

Last Updated

October 29, 2019

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT02297529

Brief Title

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

Official Title

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

Study Type

Expanded Access

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

No longer available

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

5. Study Description

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.

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 countries. Subjects with unresected stage lllB-IVM1c melanoma who are not eligible for or cannot access ongoing talimogene laherparepvec clinical trials and who meet the eligibility criteria outlined will be considered for participation in this protocol. Eligible subjects will be treated with talimogene laherparepvec until the subject has achieved a complete response, all injectable tumors have disappeared, clinically relevant (resulting in clinical deterioration or requiring change of therapy) disease progression beyond 6 months of therapy, intolerance of protocol treatment, or until talimogene laherparepvec receives marketing authorization approval in Europe for the treatment of melanoma, whichever occurs first. Subjects will be followed for safety approximately 30 (+7) days after the end of treatment. Thereafter, subjects who provide consent will be followed under an ongoing separate registry protocol for the long-term survival follow-up of subjects treated with talimogene laherparepvec in clinical trials. The registry protocol will also monitor for late and long-term adverse events thought to be potentially related to talimogene laherparepvec.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Unresected Stage IIIB to IVM1c Melanoma

Keywords

unresected, Melanoma, expanded access, EU

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Talimogene Laherparepvec

Intervention Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Chur

ZIP/Postal Code

7000

Country

Switzerland

Facility Name

Research Site

City

Lausanne

ZIP/Postal Code

1011

Country

Switzerland

Facility Name

Research Site

City

Zürich

ZIP/Postal Code

8091

Country

Switzerland

12. IPD Sharing Statement

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

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

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