At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 217 enrolled
Drug / intervention
Talimogene laherparepvec +1 moredrug
Likely dose
Talimogene laherparepvec: intratumoral injection Day 1 Week 1, Day 1 Week 4, then every 2 weeks; Ipilimumab: IV every 3 weeks for 4 infusionsAI-extracted
Key inclusion· 10
- ✓Histologically confirmed malignant melanoma
- ✓Stage IIIB, IIIC, IVM1a, IVM1b, or IVM1c disease not suitable for surgical resection
- ✓Phase 1: Treatment naïve (no prior chemotherapy, immunotherapy, or targeted therapy)
- ✓Phase 2: Naïve OR 1 prior line if BRAF wild-type, OR up to 2 prior lines if BRAF mutant (including ≥1 BRAF inhibitor)
Key exclusion· 10
- ✕Primary uveal or mucosal melanoma
- ✕Melanoma associated with immunodeficiency states (hereditary immune deficiency, organ transplant, leukemia)
- ✕Phase 1b: CNS metastases present; Phase 2: >3 brain metastases OR clinically active (progressive or untreated) lesions OR progression within 2 months of treatment OR requiring steroids
- ✕Symptomatic autoimmune disease OR autoimmune disease requiring systemic treatment (corticosteroids, immunosuppressants, biologics) in past 2 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 Unresected, Stage IIIB-IV Melanoma
In Brief
A Phase 2 clinical trial evaluating Talimogene laherparepvec and Ipilimumab for Melanoma. Completed, enrolled 217 participants across 40 sites in 3 countries.
Detailed Summary
Phase 1b of the study will evaluate the safety of talimogene laherparepvec in combination with ipilimumab. Phase 2 is a randomized study that will evaluate the safety and efficacy of talimogene laherparepvec in combination with ipilimumab versus ipilumumab alone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesFrance, Germany, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 2012
Enrollment StartFeb 2013
Primary CompletionAug 2016
Study CompletionMar 2021
TodayJul 2026
First PostedDec 4, 2012
Enrollment StartFeb 7, 2013
Primary CompletionAug 23, 2016
Study CompletionMar 9, 2021
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 13.6 years ago
Interventions
Talimogene laherparepvecdrug
Talimogene laherparepvec administered by intratumoral injection on Day 1 of Week 1, Day 1 of Week 4, then every two weeks thereafter.
Ipilimumabdrug
Ipilimumab administered intravenously every 3 weeks for a total of 4 infusions.