Anaplastic (ATC) or Poorly Differentiated Thyroid Carcinoma (PDTC) MedDRA version: 20.0 Level: PT Classification code 10076603 Term: Poorly differentiated thyroid carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10002240 Term: Anaplastic thyroid cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: LENVIMA
Product Name: LENVIMA
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Lenvatinib
CAS Number: 857890-39-2
Current Sponsor code: Lenvatinib
Other descriptive name: LENVATINIB
Sponsors
Medical Center - University of Freiburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged >18 years without upper age limit 2. Patient with histologically confirmed anaplastic or poorly differentiated thyroid carcinoma 3. At least one measurable target lesion according to irRECIST meeting the following criteria: • Lymph node (LN) lesion that measures at least 1 dimension as =1.5 cm in the short axis • Non-nodal lesion that measures =1.0 cm in the longest diameter • The lesion is suitable for repeat measurement using computerized tomography/magnetic resonance imaging (CT/MRI). Lesions that have had external beam radiotherapy (EBRT) or locoregional therapy must show radiographic evidence of disease progression based on irRECIST to be deemed a target lesion 4. ECOG performance status of 0-1 5. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP =160/90 mmHg at screening and no change in antihypertensive medications within 1 week before registration. 6. Adequate renal function defined as creatinine =1.5xULN or calculated creatinine clearance =30 mL/min per the Cockcroft and Gault formula if creatinine level is >1.5xULN 7. Adequate bone marrow function defined by: • Absolute neutrophil count (ANC) =1,000/µL • Platelets =70,000/µL • Hemoglobin =8 g/dL 8. Adequate blood coagulation function defined by International Normalized ratio (INR) =1.5 9. Adequate liver function defined by: • Total bilirubin =1.5xULN except for unconjugated hyperbilirubinemia of Gilbert’s syndrome • Alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) =3 xULN (in the case of liver metastases =5xULN), unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase. In case alkaline phosphatase is >3 xULN (in absence of liver metastases) or >5 xULN (in presence of liver metastases) AND subject also is known to have bone metastases, the liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase 10. Written informed consent obtained according to international guidelines and local laws Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received lenvatinib for more than four weeks or pembrolizumab or any other immune checkpoint inhibitor therapy (other kinase inhibitor therapies like sorafenib are permitted) 2. Patients with central nervous system (CNS) metastases, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 1 week before starting treatment in this study; any signs (e.g., radiologic) or symptoms of brain metastases must be stable for at least 2 week before registration. 3. Active other malignancy within the last two years , which is not controlled by local or hormonal treatment (except for aromatase inhibitors). 4. Known intolerance to study drug (or any of the excipients) 5. Radiation therapy within 7 days prior to start of study treatment with the exception of palliative radiotherapy to bone lesions, which is allowed if completed one day prior to the first intake of lenvatinib.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to obtain first information on the efficacy of combination therapy of lenvatinib and pembrolizumab in patients with ATC or PDTC, measured as Objective Response Rate (ORR) obtained 12 weeks after start of the study treatment. ;Secondary Objective: Secondary objective is to assess Overall Survival (OS), Progression Free Survival (PFS), Clinical Benefit Rate (CBR), response duration and safety of combination therapy. ;Primary end point(s): Objective Response Rate (ORR) 12 weeks after start of the study treatment (Day 1).;Timepoint(s) of evaluation of this end point: 12 weeks after start of the study treatment (Day 1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival (OS), Progression free survival (PFS), Clinical Benefit Rate (CBR), duration of response (DOR), Quality of Life (QOL);Timepoint(s) of evaluation of this end point: 36 months after registration of the last patient | — |
Countries
Germany
Contacts
Public ContactMedical Clinic 1 - ECTU
Medical Center - University of Freiburg
Outcome results
None listed