Phase 1b/2, Multicenter, Open-label Trial to Evaluate the Safety and Efficacy of Talimogene Laherparepvec and Ipilimumab Compared to Ipilimumab Alone in Subjects With Previously Untreated, Unresectable, Stage IIIb-IV Melanoma
18 Years
N/A
Both
Melanoma
Trial Information
Phase 1b/2, Multicenter, Open-label Trial to Evaluate the Safety and Efficacy of Talimogene Laherparepvec and Ipilimumab Compared to Ipilimumab Alone in Subjects With Previously Untreated, Unresectable, Stage IIIb-IV Melanoma
Inclusion Criteria:
- Histologically confirmed diagnosis of malignant melanoma.
- Stage IIIb, IIIc, IVM1a, IVM1b, or IVM1c disease that is not suitable for surgical
resection
- Treatment naïve: Must not have received any prior systemic anticancer treatment
consisting of chemotherapy, immunotherapy, or targeted therapy for unresectable stage
IIIb to IV melanoma.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate hematologic, hepatic, renal, and coagulation functions
Exclusion Criteria:
- Primary uveal or mucosal melanoma
- History or evidence of melanoma associated with immunodeficiency states (eg,
hereditary immune deficiency, organ transplant, or leukemia)
- History or evidence of central nervous system (CNS) metastases
- History or evidence of gastrointestinal inflammatory bowel disease (ulcerative
colitis or Crohn disease) or other symptomatic autoimmune disease
- History of or plan for splenectomy or splenic irradiation
- Active herpetic skin lesions
- Requires intermittent or chronic systemic (intravenous or oral) treatment with an
antiherpetic drug (eg, acyclovir), other than intermittent topical use
- Known human immunodeficiency virus (HIV) disease
- Known acute or chronic hepatitis B or hepatitis C infection
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and Tolerability
Outcome Description:
Phase 1b: Determine the safety and tolerability of talimogene laherparepvec in combination with ipilimumab as assessed by incidence of dose-limiting toxicities (DLT)
Outcome Time Frame:
24 months following last subject enrolled
Safety Issue:
Yes
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
United States: Food and Drug Administration
Study ID:
20110264
NCT ID:
NCT01740297
Start Date:
February 2013
Completion Date:
July 2017
Related Keywords:
- Melanoma
- melanoma, talimogene laherparepvec, ipilimumab, metastatic melanoma, melanoma, immunotherapy, unresectable melanoma, oncolytic immunotherapy,
- Melanoma
Name | Location |
|---|---|
| Research Site | Anaheim, California |
| Research Site | Arlington Heights, Illinois |
| Research Site | Ames, Iowa |
| Research Site | Albany, New York |
| Research Site | Asheville, North Carolina |
| Research Site | Chattanooga, Tennessee |
| Research Site | Ivins, Utah |
