Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors

Completed · Phase 1

Conditions studied: Advanced Non CNS Tumors

In brief

This is a phase 1 study to evaluate the safety of intralesional talimogene laherparepvec administration in pediatric subjects with advanced non-CNS tumors that are amenable to direct injection

Key facts

Study ID

NCT02756845

Run by

Amgen

People needed

15

Starts

2017-08-16

Expected to finish

2022-11-29

Last updated by the study team

2024-02-20

Who can join

Age: 2 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject's legally acceptable representative has provided informed consent/assent when the subject is legally too young to provide informed consent/assent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
• Should be willing to submit local HSV-1 serostatus within 28 days prior to enrollment.
• 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
• Life expectancy > 4 months from the date of enrollment.
• Male or female subjects 2 to ≤ 21 years of age at the time of informed consent/assent.
• 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 non-measurable lesions as defined by irRC-RECIST
• Performance status as per protocol
• Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to dosing.
• Adequate organ function as defined in protocol
• Exclusion Criteria
• Diagnosis of leukemia, non-Hodgkin's lymphoma, Hodgkin's disease, or other hematologic malignancy.
• Radiotherapy to the bone marrow within 6 weeks prior to enrollment OR within 3 months prior to enrollment if prior radiotherapy to the craniospinal axis or to at least 60% of the pelvis was received; within 2 weeks prior to enrollment if local palliative radiotherapy was received.
• Primary ocular or mucosal melanoma.
• History of other malignancy within the past 5 years with the following exception:
• malignancy treated with curative intent and with no known active disease present and has not received chemotherapy for > 5 years before enrolment and felt to be at low risk for recurrence by the treating physician.
• History or evidence of active autoimmune disease that requires systemic treatment (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• Active herpetic skin lesions or prior complications of herpetic infection (eg, herpetic keratitis or encephalitis).
• Prior treatment with talimogene laherparepvec or any other oncolytic virus.
• Prior treatment with a tumor vaccine.
• Requires intermittent or chronic treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use.
• Expected to require other cancer therapy while on study with the exception of local palliative radiation treatment.
• Has acute or chronic active hepatitis B virus or hepatitis C virus infection or received treatment with nucleotide analogs such as those used in the treatment of hepatitis B virus (eg, lamivudine, adefovir, tenofovir, telbivudine, and entecavir), ribavirin, or interferon alpha within 12 weeks of initiation of study treatment.

Where it is running

• AI Dupont Hospital for Children — Wilmington, Delaware, United States
• Nemours du Pont Hospital in Florida — Jacksonville, Florida, United States
• Ann and Robert H Lurie Childrens Hospital of Chicago — Chicago, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Childrens Hospital of Michigan — Detroit, Michigan, United States
• Columbia University Medical Center — New York, New York, United States
• Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio, United States
• Nationwide Childrens Hospital — Columbus, Ohio, United States
• Childrens Hospital of Philidelphia — Philadelphia, Pennsylvania, United States
• Universitair Ziekenhuis Gent — Ghent, Belgium
• Centre Hospitalier Universitaire Sainte Justine — Montreal, Quebec, Canada
• Institut Hematologie et Oncologie Pediatrique — Lyon, France
• Centre Hospitalier Universitaire de Marseille - Hopital de la Timone — Marseille, France
• Institut Curie — Paris, France
• IRCCS Ospedale Pediatrico Bambino — Roma, Italy
• Hospital Universitario Virgen del Rocio — Seville, Andalusia, Spain
• Hospital Universitari Vall d Hebron — Barcelona, Catalonia, Spain
• Hospital Sant Joan de Deu — Esplugues de Llobregat, Catalonia, Spain
• Hospital Universitari i Politecnic La Fe — Valencia, Valencia, Spain
• Hospital Universitario Infantil Niño Jesus — Madrid, Spain
• Universitaets-Kinderspital beider Basel — Basel, Switzerland
• Universitaets-Kinderspital — Zurich, Switzerland

Full record on ClinicalTrials.gov

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