Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer

NCT06374602 | Recruiting Phase 2 DMC

• 1 other identifier: 33
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Anaplastic Thyroid Cancer

Keywords

Anaplastic thyroid cancer; Immunotherapy; Targeted therapy; Lenvatinib; Pembrolizumab

Outcome Measures

Primary Outcomes (3)

• Objective response rate

  The proportion of participants with a partial or complete response to the therapy. It is determined according to the iRECIST criteria.

  Each month from date of treatment initiation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

• Progression-Free Survival

  The time from the date of treatment initiation to the radiological progression or death of the patient for any reason.

  6-month, 1-year, 2-year

• Safety and Tolerability assessment (Incidence of Treatment-Emergent Adverse Events)

  Safety assessment will be assessed on the basis of adverse events (according to CTCAE 5.0)

  Each visit (every 21 days) assessed up to 48 months

Secondary Outcomes (2)

• Overall survival

  6-month, 1-year, 2-year

• The assessment of conversion to resectability

  Each month from date of treatment initiation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Study Arms (1)

Intervention group

EXPERIMENTAL

Treatment-naive patients with BRAF-negative anaplastic thyroid cancer and previously treated patients, including patients with BRAF-positive anaplastic thyroid cancer (resistant to anti-BRAF therapy).

Drug: Pembrolizumab + Lenvatinib

Interventions

Pembrolizumab + Lenvatinib DRUG

Pembrolizumab is a programmed death receptor-1 (PD-1)-blocking antibody. Lenvatinib is Lenvatinib is a kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4).

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• immunohistochemically verified anaplastic thyroid cancer that is not eligible to R0-R1 surgery;
• age ≥ 18 years;
• functional status of ECOG 0-2;
• adequate function of internal organs and bone marrow;
• the ability to give written informed consent.

You may not qualify if:

• patients with a mutation in the BRAF V600 gene without previous targeted therapy with BRAF/MEK inhibitors;
• patients with clinically significant hemoptysis and bleeding (for example, from the gastrointestinal tract or tumor-associated bleeding);
• tumor invasion into large vessels;
• patients with open wounds and fistulas;
• contraindications to taking any of the studied drugs;
• patients with poor functional status (ECOG 3-4);
• continuous use of immunosuppressive therapy;
• prior therapy with investigational drugs;
• pregnancy, breast-feeding

Sponsors & Collaborators

• Saint Petersburg State University, Russia: lead

Study Sites (1)

Saint Petersburg State University Hospital

Saint Petersburg, 190020, Russia

RECRUITING

MeSH Terms

Conditions

Thyroid Carcinoma, Anaplastic

Interventions

pembrolizumab; lenvatinib

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Ilya Sleptsov, MD

CONTACT

+7(921)951-70-88; newsurgery@yandex.ru

Ernest Dzhelialov

CONTACT

+7(911)134-50-44; ernest.dzhelialov@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 18, 2024
• Study Start: March 25, 2024
• Primary Completion: March 25, 2026
• Study Completion (Estimated): June 25, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

RU (1)