Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors

  • STATUS
    Recruiting
  • End date
    Jun 30, 2024
  • participants needed
    18
  • sponsor
    Amgen
Updated on 20 June 2021

Summary

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

Description

This is a phase 1, multicenter, open-label study of talimogene laherparepvec in pediatric subjects with advanced non-CNS tumors that are amenable to direct injection in the clinical setting. Approximately 18 - 24 pediatric subjects are expected to be enrolled and treated with at least 1 dose of talimogene laherparepvec into 2 cohorts stratified by age. DLT will be evaluated based on at least 9 DLT-evaluable subjects in cohort A1. The DLT evaluation period is 35 days from the initial administration of talimogene laherparepvec.

Details
Condition Advanced Non CNS Tumors
Treatment talimogene laherparepvec
Clinical Study IdentifierNCT02756845
SponsorAmgen
Last Modified on20 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Known or suspected human immunodeficiency virus (HIV) infection
Received live vaccine within 28 days prior to enrollment
No antiplatelet or anticoagulation medications allowed within 7 days prior totalimogene laherparepvec injection except low-dose heparin needed to maintain venous catheter patency
Female subject is pregnant or breast-feeding, or planning to become pregnant during study treatment and through 3 months after the last dose of talimogene laherparepvec
Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 3 months after the last dose of talimogene laherparepvec. Note: Acceptable methods of effective contraception are defined in the informed consent/assent form. Where required by local laws and regulations, additional country-specific contraception requirements may be outlined in a country-specific protocol supplement at the end of the Appendix Section of protocol
Subject has known sensitivity to any of the products or components to be administered during dosing
Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge
History or evidence of any psychiatric disorder, substance abuse or any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
Subject who is unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for HSV-1 induced complications (immunosuppressed individuals, HIV-positive individuals, pregnant women, or children under the age of 1 year) during talimogene laherparepvec treatment and through 28 days after the last dose of talimogene laherparepvec
Evidence of clinically significant immunosuppression such as the following
primary immunodeficiency state such as severe combined immunodeficiency disease
concurrent opportunistic infection
receiving systemic immunosuppressive therapy (> 2 weeks prior to enrollment), including oral steroid doses (with the exception of maintenance physiologic replacement). Subjects who require intermittent use of steroids for inhalation or local steroid injection will not be excluded from the study
less than 6 months from autologous bone marrow transplant or stem cell infusion
history of allogeneic bone marrow transplant
History or evidence of xeroderma pigmentosum
Sexually active subjects and their partners unwilling to use a male or female latex condom to avoid potential viral transmission during sexual contact while on treatment and within 30 days after treatment with talimogene laherparepvec. For those with latex allergies, polyurethane condoms may be used
Prior chemotherapy, treatment dose radiotherapy, or biological cancer therapy within 14 days prior to enrollment or has not recovered to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE) grade 1 or better from adverse event due to cancer therapy administered more than 14 days prior to enrollment
CNS tumor or clinically active brain metastases (patient with a history of treated brain metastases are eligible if there is radiographic evidence of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study)
Currently receiving treatment in another investigational device or drug study, or less than 14 days since ending treatment on another investigational device or drug study(ies) or has not recovered to CTCAE version 4.0 grade 1 or better from adverse event due to other investigational device or drug study administered more than 14 days prior to enrollment. Other investigational procedures while participating in this study are excluded
Major surgery 14 days prior to enrollment or has not recovered to CTCAE version 4.0 grade 1 or better from adverse event due to surgery performed more than 14 days prior to enrollment
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