Trial to Evaluate the efficacy of Talimogene Laherparepvec when it is used in combination with Pembrolizumab for subjects with Melanoma

Phase 1

• Conditions: nresectable/Metastatic Stage IIIB-IVM1d Melanoma; MedDRA version: 20.0 Level: LLT Classification code 10027481 Term: Metastatic melanoma System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-001906-61-ES
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-11
• Last Update Posted: 11 March 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

This study will enroll subjects
-who are male or female age > 18 years at the time of informed consent
-with histologically confirmed diagnosis of melanoma (unresectable or
metastatic stage IIIB, IIIC, IIID, IVM1a, IVM1b, IVM1c, or IVM1d melanoma).
- Subjects with stage IVM1d and up to 3 cerebral metastases may be enrolled, provided that all lesions have been adequately treated with stereotactic radiation therapy, craniotomy, or gamma knife therapy, with no evidence of progression and not requiring steroids for at least 2 months prior to enrollment.
-Subjects must have measurable disease and be a candidate for intralesional therapy.
-Subjects must have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
-Adequate hematologic, hepatic, renal, and coagulation function.
- Subject must also have received prior anti-PD-1 therapy for at least 2 to 3 consecutive cycles within an 8 week period and have disease progression as defined by RECIST v1.1 criteria.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

-Subjects must not have clinically active cerebral melanoma metastases and/or carcinomatous meningitis.
-Subjects must not have primary uveal or mucosal melanoma, history or evidence of melanoma associated with immunodeficiency states (eg, hereditary immune deficiency, organ transplant, or leukemia), or history of other malignancy within the past 3 years with the exceptions noted in Section 6.2 of the protocol.
-Subjects must not have been previously treated with talimogene laherparepvec, any other oncolytic viruses, or tumor vaccine (unless administered in the adjuvant setting).
-Subjects must not have a history or evidence of symptomatic autoimmune glomerulonephritis, vasculitis, or other symptomatic autoimmune disease, or active autoimmune disease or syndrome that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy.
-Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
-Subjects must not have active herpetic skin lesions or prior complications of herpetic infection (eg, herpetic keratitis or encephalitis) and must not require intermittent or chronic treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified