NL-OMON50729
Completed
Phase 3
A Phase 1b/3, Multicenter, Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresectable, Stage IIIB to IVM1c Melanoma (MASTERKEY-265) - 20110265 MASTERKEY
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- 1) Unresectable stage IIIB to IVM1c melanoma
- Sponsor
- Amgen
- Enrollment
- 15
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female age \>\= 18 years with histologically confirmed diagnosis of
- •melanoma and stage IIIB to IVM1c for whom surgery is not recommended. Subjects
- •must have measurable disease and be a candidate for intralesional therapy
- •administration into cutaneous, subcutaneous, or nodal lesions. Subjects must
- •have ECOG performance status of 0 or 1, and adequate hematologic, hepatic,
- •renal, and coagulation function.
- •Subjects with serine/threonine protein kinase B\-Raf V600 (BRAFV600\) wild\-type
- •tumors must not have received any prior systemic anticancer treatment
- •consisting of chemotherapy, immunotherapy, or targeted therapy given in a
- •non\-adjuvant setting for unresectable stage IIIB to IVM1c melanoma. Subjects
Exclusion Criteria
- •Subjects must not have clinically active cerebral metastases and/or
- •carcinomatous meningitis. Subjects with 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.
- •Carcinomatous meningitis is excluded regardless of clinical stability
- •Subjects must not have primary uveal or mucosal melanoma, history or evidence
- •of melanoma associated with immunodeficiency states or history of other
- •malignancy within the past 3 years with the exceptions of the prior
Outcomes
Primary Outcomes
Not specified
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