A Phase 1, Multi-center, Open-label, Dose De-escalation Study to Evaluate the Safety and Efficacy of Talimogene Laherparepvec in Pediatric Subjects with Advanced Non Central Nervous System Tumors That are Amenable to Direct Injection

Protocol: 
AAAQ6917
Phase: 
I

A Phase 1, Multi-center, Open-label, Dose De-escalation Study to Evaluate the Safety and Efficacy of Talimogene Laherparepvec in Pediatric Subjects with Advanced Non Central Nervous System Tumors That are Amenable to Direct Injection

Are you Eligible? (Inclusion Criteria)

-Male or female subjects aged 2 to ≤ 21 years at the time of informed
consent/assent.
- Should be willing to submit local HSV-1 serostatus within 28 days prior to
enrollment.
-Histologically or cytologically confirmed non-CNS solid tumor that recurred
after standard/frontline therapy, or for which there is no standard/frontline
therapy available.
-Presence of measurable or nonmeasurable disease.
-Subject must be a candidate for intralesional injection, defined as one or more
of the following
* at least 1 injectable lesion ≥ 10 mm in longest diameter
* multiple injectable lesions that in aggregate have a longest diameter of ≥
10 mm
-Other Inclusion Criteria may apply.

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States