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Trial record 5 of 30 for:    Talimogene laherparepvec

Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2017 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT02756845
First received: December 15, 2015
Last updated: February 22, 2017
Last verified: February 2017
  Purpose
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

Condition Intervention Phase
Advanced Non CNS Tumors
Drug: Talimogene Laherparepvec
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Subject incidence of DLT [ Time Frame: At least 35 days from administration of talimogene laherpaprevec. ]
    To evaluatethe safety of talimogene laherparepvec, as assessed by incidence of dose-limiting toxicities (DLT)


Secondary Outcome Measures:
  • Subject incidence of adverse events. [ Time Frame: Start of treatment through 30 (+7) days after end of treatment. ]
  • Subject incidence of laboratory abnormalities [ Time Frame: Start of treatment through 30 (+7) days after end of treatment. ]
  • Overall Response Rate (ORR) [ Time Frame: Up to 24 months of treatment. ]
    Response evaluation by Investigator using irRC-RECIST.

  • Duration of Response (DOR) [ Time Frame: Up to 24 months of treatment ]
    Response evaluation by Investigator using irRC-RECIST.

  • Time to Response (TTR) [ Time Frame: Up to 24 months of treatment ]
    Response evaluation by Investigator using irRC-RECIST.

  • Time to Progression (TTP) [ Time Frame: Up to 24 months of treatment ]
    Response evaluation by Investigator using irRC-RECIST.

  • Progression-free Survival (PFS) [ Time Frame: Up to 24 months of treatment ]
    Response evaluation by Investigator using irRC-RECIST.

  • Overall Survival (OS) [ Time Frame: Up to 24 months of treatment ]
    Response evaluation by Investigator using irRC-RECIST.


Estimated Enrollment: 18
Study Start Date: May 2017
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Talimogene Laherparepvec (TVEC)

The first dose of talimogene laherparepvec will be administered at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (+3 days) later. Subsequent doses of up to 4.0 mL of 10ᶺ8 PFU/mL will be administered every 14 days (± 3 days) thereafter. Cohorts will be assigned as follows:

  • Cohort A1 (age 12 to < 18 years; HSV-1 seropositive)
  • Cohort A2 (age 12 to < 18 years; HSV-1 seronegative)
  • Cohort B1 (age 2 to < 12 years; HSV-1 seropositive)
  • Cohort B2 (age 2 to < 12 years; HSV-1 seronegative)
  • Cohort C1 (age 0 to < 2 years; HSV-1 seropositive)
  • Cohort C2 (age 0 to < 2 years; HSV-1 seronegative Once Cohort A1 is determined safe based on DLT rules, cohorts A2, B1, C1 can be opened simultaneously for enrollment. Cohorts B2 and C2 may be opened once cohort A2 is determined safe.
Drug: Talimogene Laherparepvec
Talimogene laherparepvec will be administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance. The first dose of talimogene laherparepvec will be up to 4.0 mL of 10^6 PFU/mL administered on day 1. The second injection, up to 4.0 mL of 10^8 PFU/mL (or up to 4.0 mL of 10^6 PFU/mL for a dose de-escalated cohort), will be administered 21 (+3) days after the initial injection. All subsequent injections, up to 4.0 mL of 10^8 PFU/mL (or up to 4.0 mL of 10^6 PFU/mL for a dose de-escalated cohort), will be administered every 14 (± 3) days. The treatment cycle interval may be increased due to toxicity.
Other Name: TVEC

Detailed 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. Talimogene laherparepvec will be administered by intralesional injection to approximately 18 to 36 pediatric subjects with advanced non-CNS tumors. Pediatric subjects will be enrolled into cohorts stratified by age and baseline herpes simplex virus type-1 (HSV-1) serostatus (3 to 6 subjects/cohort). DLT will be evaluated based on 3 to 6 DLT-evaluable subjects in each cohort The DLT evaluation period is 35 days from the initial administration of talimogene laherparepvec.
  Eligibility

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Male or female subjects aged 0 to < 18 years at the time of informed consent/assent
  • 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 therapy or for which there is no standard 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
  • Performance status as outlined in protocol
  • Life expectancy > 4 months from the date of enrollment
  • Other Inclusion Criteria May Apply.

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
  • CNS tumor or clinically active brain metastases
  • Primary ocular or mucosal melanoma
  • History or evidence of giant congenital melanocytic nevi, dysplastic nevis syndrome or xeroderma pigmentosum
  • History of other malignancy within the past 5 years with exception(s) outlined in protocol, History or evidence of active autoimmune disease that requires systemic treatment, replacement therapy is not considered a form of systemic treatment
  • Evidence of clinically significant immunosuppression as outlined in protocol
  • Active herpetic skin lesions or prior complications of herpetic infection
  • Additional Exclusion Criteria May Apply.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02756845

Contacts
Contact: Amgen Call Center 866-572-6436

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02756845     History of Changes
Other Study ID Numbers: 20110261
2015-003645-25 ( EudraCT Number )
Study First Received: December 15, 2015
Last Updated: February 22, 2017

Keywords provided by Amgen:
Non CNS Tumor

ClinicalTrials.gov processed this record on March 24, 2017