Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02756845|
Recruitment Status : Recruiting
First Posted : April 29, 2016
Last Update Posted : June 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced Non CNS Tumors||Drug: Talimogene Laherparepvec||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
Approximately 18 to 24 treated pediatric subjects are expected to be enrolled into 2 cohorts stratified by age (permissible based on the incidence of DLTs, a minimum of 6 subjects/cohort and a minimum of 18 subjects total).
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||August 16, 2017|
|Estimated Primary Completion Date :||August 4, 2022|
|Estimated Study Completion Date :||June 30, 2024|
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 ≤ 21 years). Cohort B1 (age 2 to < 12 years). The DLRT will review the safety data of the first 3 subjects in the older age cohort A1 to decide if the younger age cohort B1 can be opened for enrollment. If dose de-escalation is needed and if permissible based on the incidence of DLTs, additional DLT-evaluable subjects will be enrolled and treated at a lower dose level of talimogene laherparepvec. Dose de-escalation cohorts will be assigned as follows and the same DLT rules will be applied: Cohort A2 (age 12 to ≤ 21 years), Cohort B2 (age 2 to < 12 years).
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
- Subject incidence of DLT [ Time Frame: At least 35 days from administration of talimogene laherpaprevec. ]To evaluate the safety of talimogene laherparepvec, as assessed by incidence of dose-limiting toxicities (DLT).
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02756845
|Contact: Amgen Call Centerfirstname.lastname@example.org|