Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374602
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-03-27
Brief Title:
Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer
Sponsor:
Saint Petersburg State University Russia
Organization:
Saint Petersburg State University Russia
Study Overview
Official Title:
Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot phase 2 study evaluate the effectiveness and safety of pembrolizumab and lenvatinib in patients with anaplastic thyroid cancer Patients with anaplastic thyroid cancer who are treatment-naive BRAF-negative and who were previously treated with chemptherapy or targeted therapy are scheduled to undergo pembrolizumab and lenvatinib and evaluate the outcomes according to the primary and secondary endpoints
Detailed Description:
The aim of the study was to demonstrate the efficacy and safety of pembrolizumab and lenvatinib in patients with anaplastic thyroid cancer
Scientific hypothesis the combination of pembrolizumab and lenvatinib is effective and safe in patients with anaplastic thyroid cancer
Trial design materials and methods this study is a pilot Phase 2 study This study is prospective and open-label Patients who meet the criteria will be treated with a combination of pembrolizumab and lenvatinib and outcomes will be assessed according to primary and secondary endpoints
All patients will receive one regimen of antitumor treatment exploratory therapy The control will be carried out by monitoring the initial state in dynamics
Before starting research therapy data will be recorded for each patient in an individual registration card
Before starting research therapy clinical and laboratory parameters will be evaluated and computed tomography of the brain neck thoracic and abdominal cavities with intravenous contrast will be performed initial assessment of the prevalence of the tumor process
Mutations in the BRAF V600 gene microsatellite instability MSI and PD-L1 expression will be determined in the tumor material first of all and the following molecular genetic variants will be determined in the second place planned RET NTRK ALK ROS1
Research therapy includes pembrolizumab 200 mg intravenously for 30 minutes cycle 21 days in combination with targeted therapy with lenvatinib 20 mg 2 capsules of 10 mg 1 time per day daily Dose modification in case of toxicity for pembrolizumab is not provided For lenvatinib a sequential dose reduction is provided depending on the previous level 14 mg 10 mg 8 mg When the dose is reduced a return to the previous level is not carried out
Duration of treatment pembrolizumab - up to 35 cycles until progression or intolerable toxicity depending on what comes first Lenvatinib - before progression or intolerable toxicity
Follow-up period of patients
follow-up during active treatment within the framework of the study - before progression or intolerable toxicity patient survival monitoring - documenting subsequent lines of antitumor treatment before the patients death or loss of contact with him patient safety monitoring - 30 and 90 days from the date of the final dose
Assessment of the response to treatment assessment of clinical and laboratory parameters computed tomography of the brain neck thoracic and abdominal cavities with intravenous contrast will be carried out monthly or according to clinical indications in the first 6 months then - according to the decision of the research team Based on the results of the control study the response to treatment will be evaluated according to the iRECIST criteria Patients who meet the criteria for progression will be excluded from the study
When converting a tumor to resectability and planning surgical treatment it is recommended to suspend taking lenvatinib at least a week before surgery and resume taking it at least 2 weeks after There is no relationship between pembrolizumab and complications associated with surgical treatment and no interruptions in treatment are required
Scientific hypothesis the combination of pembrolizumab and lenvatinib is effective and safe in patients with anaplastic thyroid cancer
Trial design materials and methods this study is a pilot Phase 2 study This study is prospective and open-label Patients who meet the criteria will be treated with a combination of pembrolizumab and lenvatinib and outcomes will be assessed according to primary and secondary endpoints
All patients will receive one regimen of antitumor treatment exploratory therapy The control will be carried out by monitoring the initial state in dynamics
Before starting research therapy data will be recorded for each patient in an individual registration card
Before starting research therapy clinical and laboratory parameters will be evaluated and computed tomography of the brain neck thoracic and abdominal cavities with intravenous contrast will be performed initial assessment of the prevalence of the tumor process
Mutations in the BRAF V600 gene microsatellite instability MSI and PD-L1 expression will be determined in the tumor material first of all and the following molecular genetic variants will be determined in the second place planned RET NTRK ALK ROS1
Research therapy includes pembrolizumab 200 mg intravenously for 30 minutes cycle 21 days in combination with targeted therapy with lenvatinib 20 mg 2 capsules of 10 mg 1 time per day daily Dose modification in case of toxicity for pembrolizumab is not provided For lenvatinib a sequential dose reduction is provided depending on the previous level 14 mg 10 mg 8 mg When the dose is reduced a return to the previous level is not carried out
Duration of treatment pembrolizumab - up to 35 cycles until progression or intolerable toxicity depending on what comes first Lenvatinib - before progression or intolerable toxicity
Follow-up period of patients
follow-up during active treatment within the framework of the study - before progression or intolerable toxicity patient survival monitoring - documenting subsequent lines of antitumor treatment before the patients death or loss of contact with him patient safety monitoring - 30 and 90 days from the date of the final dose
Assessment of the response to treatment assessment of clinical and laboratory parameters computed tomography of the brain neck thoracic and abdominal cavities with intravenous contrast will be carried out monthly or according to clinical indications in the first 6 months then - according to the decision of the research team Based on the results of the control study the response to treatment will be evaluated according to the iRECIST criteria Patients who meet the criteria for progression will be excluded from the study
When converting a tumor to resectability and planning surgical treatment it is recommended to suspend taking lenvatinib at least a week before surgery and resume taking it at least 2 weeks after There is no relationship between pembrolizumab and complications associated with surgical treatment and no interruptions in treatment are required
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None