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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Melanoma

Thank you

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 SiteAnaheim, California  
Research SiteArlington Heights, Illinois  
Research SiteAmes, Iowa  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteChattanooga, Tennessee  
Research SiteIvins, Utah