Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04731740
Status:
WITHDRAWN
Last Update Posted:
2024-03-25
First Post:
2021-01-26
Brief Title:
Pembrolizumab and LenvatinibChemotherapy for Poorly DifferentiatedAnaplastic Thyroid Cancer
Sponsor:
Saint Petersburg State University Russia
Organization:
Saint Petersburg State University Russia
Study Overview
Official Title:
Pembrolizumab in Combination With Standard 1st Line Therapy Lenvatinib Chemotherapy for Locally Advanced or Metastatic Poorly Differentiated or Anaplastic Thyroid Cancer
Status:
WITHDRAWN
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to evaluate the efficacy of the combination of lenvatinib with pembrolizumab and to establish a safe and effective systemic treatment regimen for patients with metastatic anaplastic thyroid cancer ATC poorly differentiated thyroid cancer PDTC
Lenvatinib is an anti-angiogenic and antiproliferative drug used in differentiated thyroid cancer It blocks proliferative genes such as RET and PDGFR and further inhibits major proliferation pathways such as VEGF receptor signaling and FGFR1-4
Pembrolizumab is an immune checkpoint inhibitor that targets PD-1 located on lymphocytes The response to pembrolizumab treatment is associated among other things with increased expression of PD-L1 as well as with the frequency of somatic mutations in the respective tumors Patients with ATC PDTC show high expression of PD-L1
Lenvatinib is an anti-angiogenic and antiproliferative drug used in differentiated thyroid cancer It blocks proliferative genes such as RET and PDGFR and further inhibits major proliferation pathways such as VEGF receptor signaling and FGFR1-4
Pembrolizumab is an immune checkpoint inhibitor that targets PD-1 located on lymphocytes The response to pembrolizumab treatment is associated among other things with increased expression of PD-L1 as well as with the frequency of somatic mutations in the respective tumors Patients with ATC PDTC show high expression of PD-L1
Detailed Description:
Primary endpoint
1 Objective Response Ratio ORR Time frame prior to study completion average 3 years
Evaluate the effectiveness of a combination of a PD-1 inhibitor pembrolizumab with a multikinase inhibitor lenvatinib using an objective response rate ORR in poorly differentiated or anaplastic thyroid cancer at 12 weeks and 24 weeks after starting treatment
Evaluate the efficacy of the investigators choice of chemotherapy plus PD-1 inhibitor pembrolizumab using an objective response rate ORR in poorly differentiated or anaplastic thyroid cancer at 12 weeks and 24 weeks after initiation of treatment Includes patients with a confirmed partial PR and complete response CR as the best response according to RECIST v 11
2 Overall survival at 6 months in the pembrolizumab and lenvatinib cohort Time frame 6 months
Secondary endpoints
1 Safety Profile Number Severity of Serious Adverse Events SAEs Timeline SAEs will be reported in the clinical trial within 6 months of the end of the study
2 Duration of Response DoR Time frame from date of first documented clinical response PR CR to date of first documented progression date of death from any cause or patient failure whichever comes first is estimated to be 36 months
3 Progression-Free Survival PFS Time frame from date of enrollment to date of first documented progression date of death from any cause or patient failure whichever is earlier up to 36 months
4 Overall Survival OS Time frame from the date of enrollment to the date of death from any cause or patient failure whichever comes first estimated up to 36 months
Study design Prospective interventional two-cohort non-comparative single-center study
1 Objective Response Ratio ORR Time frame prior to study completion average 3 years
Evaluate the effectiveness of a combination of a PD-1 inhibitor pembrolizumab with a multikinase inhibitor lenvatinib using an objective response rate ORR in poorly differentiated or anaplastic thyroid cancer at 12 weeks and 24 weeks after starting treatment
Evaluate the efficacy of the investigators choice of chemotherapy plus PD-1 inhibitor pembrolizumab using an objective response rate ORR in poorly differentiated or anaplastic thyroid cancer at 12 weeks and 24 weeks after initiation of treatment Includes patients with a confirmed partial PR and complete response CR as the best response according to RECIST v 11
2 Overall survival at 6 months in the pembrolizumab and lenvatinib cohort Time frame 6 months
Secondary endpoints
1 Safety Profile Number Severity of Serious Adverse Events SAEs Timeline SAEs will be reported in the clinical trial within 6 months of the end of the study
2 Duration of Response DoR Time frame from date of first documented clinical response PR CR to date of first documented progression date of death from any cause or patient failure whichever comes first is estimated to be 36 months
3 Progression-Free Survival PFS Time frame from date of enrollment to date of first documented progression date of death from any cause or patient failure whichever is earlier up to 36 months
4 Overall Survival OS Time frame from the date of enrollment to the date of death from any cause or patient failure whichever comes first estimated up to 36 months
Study design Prospective interventional two-cohort non-comparative single-center study
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?:
False
Is an FDA AA801 Violation?:
None